Study: NCT02212015

Adverse event: Lumbar spinal stenosis
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 26 at risk

Adverse event: Pleural effusion
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 26 at risk

Adverse event: Palpitations
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 26 at risk

Adverse event: Erysipelas
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 26 at risk

Adverse event: Tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 26 at risk

Adverse event: Gastrointestinal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 26 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 26 at risk

Adverse event: Alanine aminotransferase increased
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 26 at risk

Adverse event: General physical health deterioration
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 26 at risk

Adverse event: Pneumothorax
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 26 at risk

Adverse event: Dehydration
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 26 at risk

Adverse event: Neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 26 at risk

Adverse event: Spinal pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 26 at risk

Adverse event: Blood bilirubin increased
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 26 at risk

Adverse event: Aspartate aminotransferase increased
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 26 at risk

Adverse event: Alanine aminotransferase increased
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 26 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 4 affected / 26 at risk

Adverse event: Aspartate aminotransferase increased
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 4 affected / 26 at risk

Adverse event: Allergic reation to a drug
Serious: no
Organ System: Product Issues
Frequency: 2 affected / 26 at risk

Adverse event: General physical health deterioration
Serious: no
Organ System: General disorders
Frequency: 2 affected / 26 at risk

Adverse event: Alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 8 affected / 26 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 26 at risk

Adverse event: Inappetance
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 26 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 12 affected / 26 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 26 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 26 at risk

Adverse event: Blood bilirubin increased
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 2 affected / 26 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 16 affected / 26 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 26 at risk

Adverse event: Epistaxis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 26 at risk

Adverse event: Dysgeusia
Serious: no
Organ System: Nervous system disorders
Frequency: 11 affected / 26 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 26 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 26 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 26 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 26 at risk

Adverse event: Erysipels
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 26 at risk

Adverse event: Erythema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 26 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 4 affected / 26 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: General disorders
Frequency: 4 affected / 26 at risk

Adverse event: Weight decreased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 26 at risk

Adverse event: Hand-foot syndrome
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 5 affected / 26 at risk

Adverse event: Tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 26 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 26 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 26 at risk

Adverse event: Leukopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 6 affected / 26 at risk

Adverse event: Flatulence
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 26 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 12 affected / 26 at risk

Adverse event: Mucosal inflammation
Serious: no
Organ System: General disorders
Frequency: 4 affected / 26 at risk

Adverse event: Nail dystrophia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 26 at risk

Adverse event: Neuropathia
Serious: no
Organ System: Nervous system disorders
Frequency: 8 affected / 26 at risk

Adverse event: Neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 5 affected / 26 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 26 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 26 at risk

Adverse event: Vertigo
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 26 at risk

Adverse event: Stomatitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 26 at risk

Adverse event: Thoracical pain
Serious: no
Organ System: General disorders
Frequency: 2 affected / 26 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 26 at risk

Adverse event: Oedema leg
Serious: no
Organ System: General disorders
Frequency: 7 affected / 26 at risk

Adverse event: Exsikkosis
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 26 at risk