Study: NCT00370552

Adverse event: Blood creatinine increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 45 at risk

Adverse event: Thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 45 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 45 at risk

Adverse event: Cholecystitis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 45 at risk

Adverse event: Hypersensitivity
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 45 at risk

Adverse event: Headache
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 45 at risk

Adverse event: Sciatica
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 45 at risk

Adverse event: Migraine
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 45 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 45 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 45 at risk

Adverse event: Abdominal pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 45 at risk

Adverse event: Large intestine perforation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 45 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 45 at risk

Adverse event: Neutropenic sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 45 at risk

Adverse event: Bacterial infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 45 at risk

Adverse event: Gastroenteritis viral
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 45 at risk

Adverse event: Bladder obstruction
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 45 at risk

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 45 at risk

Adverse event: Thrombocytopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 45 at risk

Adverse event: Malaise
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 45 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 45 at risk

Adverse event: Asthenia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 45 at risk

Adverse event: Malignant neoplasm progression
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 45 at risk

Adverse event: Vision blurred
Serious: no
Organ System: Eye disorders
Frequency: 3 affected / 45 at risk

Adverse event: Weight decreased
Serious: no
Organ System: Investigations
Frequency: 7 affected / 45 at risk

Adverse event: Weight increased
Serious: no
Organ System: Investigations
Frequency: 3 affected / 45 at risk

Adverse event: Flushing
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 45 at risk

Adverse event: Hot flush
Serious: no
Organ System: Vascular disorders
Frequency: 3 affected / 45 at risk

Adverse event: Hypotension
Serious: no
Organ System: Vascular disorders
Frequency: 4 affected / 45 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 14 affected / 45 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 5 affected / 45 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 5 affected / 45 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 3 affected / 45 at risk

Adverse event: Depressed mood
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 45 at risk

Adverse event: Hypersensitivity
Serious: no
Organ System: Immune system disorders
Frequency: 3 affected / 45 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 17 affected / 45 at risk

Adverse event: Lethargy
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 45 at risk

Adverse event: Migraine
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 45 at risk

Adverse event: Sciatica
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 45 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 45 at risk

Adverse event: Dysgeusia
Serious: no
Organ System: Nervous system disorders
Frequency: 9 affected / 45 at risk

Adverse event: Dysaesthesia
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 45 at risk

Adverse event: Paraesthesia
Serious: no
Organ System: Nervous system disorders
Frequency: 11 affected / 45 at risk

Adverse event: Hypoaesthesia
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 45 at risk

Adverse event: Neuropathy peripheral
Serious: no
Organ System: Nervous system disorders
Frequency: 12 affected / 45 at risk

Adverse event: Peripheral motor neuropathy
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 45 at risk

Adverse event: Peripheral sensory neuropathy
Serious: no
Organ System: Nervous system disorders
Frequency: 12 affected / 45 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 18 affected / 45 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 16 affected / 45 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 27 affected / 45 at risk

Adverse event: Dry mouth
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 45 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 45 at risk

Adverse event: Gastritis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 45 at risk

Adverse event: Toothache
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 45 at risk

Adverse event: Stomatitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 45 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 20 affected / 45 at risk

Adverse event: Haemorrhoids
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 45 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 11 affected / 45 at risk

Adverse event: Gingival bleeding
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 45 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 45 at risk

Adverse event: Vertigo
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 6 affected / 45 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 45 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 45 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 45 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 45 at risk

Adverse event: Folliculitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 45 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 45 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 45 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 45 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 45 at risk

Adverse event: Dysuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 5 affected / 45 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 10 affected / 45 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 45 at risk

Adverse event: Neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 7 affected / 45 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 8 affected / 45 at risk

Adverse event: Alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 17 affected / 45 at risk

Adverse event: Dry skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 45 at risk

Adverse event: Erythema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 45 at risk

Adverse event: Nail disorder
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 10 affected / 45 at risk

Adverse event: Palmar-plantar erythrodysaesthesia syndrome
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 45 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 12 affected / 45 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 7 affected / 45 at risk

Adverse event: Bone pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 9 affected / 45 at risk

Adverse event: Neck pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 5 affected / 45 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 10 affected / 45 at risk

Adverse event: Muscle spasms
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 45 at risk

Adverse event: Muscular weakness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 45 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 10 affected / 45 at risk

Adverse event: Musculoskeletal pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 6 affected / 45 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 12 affected / 45 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 8 affected / 45 at risk

Adverse event: Dysphonia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 45 at risk

Adverse event: Epistaxis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 23 affected / 45 at risk

Adverse event: Rhinorrhoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 45 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 45 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 2 affected / 45 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 13 affected / 45 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 7 affected / 45 at risk

Adverse event: Asthenia
Serious: no
Organ System: General disorders
Frequency: 20 affected / 45 at risk

Adverse event: Chest pain
Serious: no
Organ System: General disorders
Frequency: 4 affected / 45 at risk

Adverse event: Chest discomfort
Serious: no
Organ System: General disorders
Frequency: 1 affected / 45 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: General disorders
Frequency: 5 affected / 45 at risk

Adverse event: Mucosal inflammation
Serious: no
Organ System: General disorders
Frequency: 7 affected / 45 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 45 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 45 at risk

Adverse event: Hypertensive crisis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 45 at risk

Adverse event: Hypersensitivity
Serious: yes
Organ System: Immune system disorders
Frequency: 2 affected / 45 at risk

Adverse event: Ataxia
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 45 at risk

Adverse event: Peripheral motor neuropathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 45 at risk

Adverse event: Diverticular perforation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 45 at risk

Adverse event: Anal abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 45 at risk

Adverse event: Tooth abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 45 at risk

Adverse event: Diverticulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 45 at risk

Adverse event: Abdominal abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 45 at risk

Adverse event: Subcutaneous abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 45 at risk

Adverse event: Leukopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 45 at risk

Adverse event: Neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 45 at risk

Adverse event: Febrile neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 45 at risk

Adverse event: Urticaria
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 45 at risk

Adverse event: Arthralgia
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 45 at risk

Adverse event: Pain in extremity
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 45 at risk

Adverse event: Musculoskeletal pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 45 at risk

Adverse event: Dysphonia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 45 at risk

Adverse event: Hernia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 45 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 45 at risk

Adverse event: Mucosal inflammation
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 45 at risk

Adverse event: Malignant neoplasm progression
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 45 at risk

Adverse event: Dry eye
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 45 at risk

Adverse event: Weight decreased
Serious: no
Organ System: Investigations
Frequency: 9 affected / 45 at risk

Adverse event: Weight increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 45 at risk

Adverse event: Neutrophil count decreased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 45 at risk

Adverse event: Tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 45 at risk

Adverse event: Hot flush
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 45 at risk

Adverse event: Hypotension
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 45 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 22 affected / 45 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 8 affected / 45 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 9 affected / 45 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 3 affected / 45 at risk

Adverse event: Depressed mood
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 45 at risk

Adverse event: Hypersensitivity
Serious: no
Organ System: Immune system disorders
Frequency: 2 affected / 45 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 15 affected / 45 at risk

Adverse event: Lethargy
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 45 at risk

Adverse event: Sciatica
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 45 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 45 at risk

Adverse event: Dysgeusia
Serious: no
Organ System: Nervous system disorders
Frequency: 9 affected / 45 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 45 at risk

Adverse event: Dysaesthesia
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 45 at risk

Adverse event: Paraesthesia
Serious: no
Organ System: Nervous system disorders
Frequency: 11 affected / 45 at risk

Adverse event: Hypoaesthesia
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 45 at risk

Adverse event: Neuropathy peripheral
Serious: no
Organ System: Nervous system disorders
Frequency: 14 affected / 45 at risk

Adverse event: Peripheral motor neuropathy
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 45 at risk

Adverse event: Peripheral sensory neuropathy
Serious: no
Organ System: Nervous system disorders
Frequency: 19 affected / 45 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 14 affected / 45 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 45 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 14 affected / 45 at risk

Adverse event: Dry mouth
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 45 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 45 at risk

Adverse event: Gastritis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 45 at risk

Adverse event: Toothache
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 45 at risk

Adverse event: Flatulence
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 45 at risk

Adverse event: Stomatitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 10 affected / 45 at risk

Adverse event: Odynophagia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 45 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 12 affected / 45 at risk

Adverse event: Oesophagitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 45 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 11 affected / 45 at risk

Adverse event: Gingival bleeding
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 45 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 45 at risk

Adverse event: Vertigo
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 45 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 45 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 45 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 45 at risk

Adverse event: Laryngitis
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 45 at risk

Adverse event: Oral herpes
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 45 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 45 at risk

Adverse event: Folliculitis
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 45 at risk

Adverse event: Tooth abscess
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 45 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 45 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 45 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 45 at risk

Adverse event: Dysuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 45 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 9 affected / 45 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 45 at risk

Adverse event: Neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 10 affected / 45 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 45 at risk

Adverse event: Alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 22 affected / 45 at risk

Adverse event: Dry skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 45 at risk

Adverse event: Erythema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 6 affected / 45 at risk

Adverse event: Onychalgia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 45 at risk

Adverse event: Nail disorder
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 8 affected / 45 at risk

Adverse event: Nail dystrophy
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 45 at risk

Adverse event: Skin hyperpigmentation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 45 at risk

Adverse event: Palmar-plantar erythrodysaesthesia syndrome
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 45 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 12 affected / 45 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 9 affected / 45 at risk

Adverse event: Bone pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 6 affected / 45 at risk

Adverse event: Neck pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 45 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 10 affected / 45 at risk

Adverse event: Muscle spasms
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 45 at risk

Adverse event: Muscular weakness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 45 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 8 affected / 45 at risk

Adverse event: Musculoskeletal pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 6 affected / 45 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 8 affected / 45 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 6 affected / 45 at risk

Adverse event: Dysphonia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 45 at risk

Adverse event: Epistaxis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 17 affected / 45 at risk

Adverse event: Rhinorrhoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 45 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 45 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 3 affected / 45 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 9 affected / 45 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 10 affected / 45 at risk

Adverse event: Asthenia
Serious: no
Organ System: General disorders
Frequency: 23 affected / 45 at risk

Adverse event: Chest pain
Serious: no
Organ System: General disorders
Frequency: 3 affected / 45 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: General disorders
Frequency: 8 affected / 45 at risk

Adverse event: Mucosal inflammation
Serious: no
Organ System: General disorders
Frequency: 10 affected / 45 at risk

Adverse event: Angina pectoris
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 32 at risk

Adverse event: Infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 32 at risk

Adverse event: Bacteroides infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 32 at risk

Adverse event: Rash
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 32 at risk

Adverse event: Cough
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 32 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 32 at risk

Adverse event: Dysphonia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 32 at risk

Adverse event: Pneumonitis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 32 at risk

Adverse event: Oropharyngeal pain
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 32 at risk

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 32 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 32 at risk

Adverse event: Dry eye
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 32 at risk

Adverse event: Vision blurred
Serious: no
Organ System: Eye disorders
Frequency: 3 affected / 32 at risk

Adverse event: Weight decreased
Serious: no
Organ System: Investigations
Frequency: 3 affected / 32 at risk

Adverse event: Weight increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 32 at risk

Adverse event: Neutrophil count decreased
Serious: no
Organ System: Investigations
Frequency: 3 affected / 32 at risk

Adverse event: Tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 32 at risk

Adverse event: Flushing
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 32 at risk

Adverse event: Hot flush
Serious: no
Organ System: Vascular disorders
Frequency: 5 affected / 32 at risk

Adverse event: Haemorrhage
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 32 at risk

Adverse event: Hypotension
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 32 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 10 affected / 32 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 4 affected / 32 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 6 affected / 32 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 3 affected / 32 at risk

Adverse event: Depressed mood
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 32 at risk

Adverse event: Hypersensitivity
Serious: no
Organ System: Immune system disorders
Frequency: 2 affected / 32 at risk

Adverse event: Drug hypersensitivity
Serious: no
Organ System: Immune system disorders
Frequency: 2 affected / 32 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 14 affected / 32 at risk

Adverse event: Lethargy
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 32 at risk

Adverse event: Migraine
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 32 at risk

Adverse event: Sciatica
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 32 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 32 at risk

Adverse event: Dysgeusia
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 32 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 32 at risk

Adverse event: Dysaesthesia
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 32 at risk

Adverse event: Paraesthesia
Serious: no
Organ System: Nervous system disorders
Frequency: 8 affected / 32 at risk

Adverse event: Hypoaesthesia
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 32 at risk

Adverse event: Neuropathy peripheral
Serious: no
Organ System: Nervous system disorders
Frequency: 14 affected / 32 at risk

Adverse event: Peripheral motor neuropathy
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 32 at risk

Adverse event: Peripheral sensory neuropathy
Serious: no
Organ System: Nervous system disorders
Frequency: 12 affected / 32 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 12 affected / 32 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 13 affected / 32 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 18 affected / 32 at risk

Adverse event: Dry mouth
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 32 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 32 at risk

Adverse event: Gastritis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 32 at risk

Adverse event: Flatulence
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 32 at risk

Adverse event: Gingivitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 32 at risk

Adverse event: Stomatitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 32 at risk

Adverse event: Odynophagia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 32 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 10 affected / 32 at risk

Adverse event: Haemorrhoids
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 32 at risk

Adverse event: Oesophagitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 32 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 32 at risk

Adverse event: Gingival bleeding
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 32 at risk

Adverse event: Abdominal pain lower
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 32 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 32 at risk

Adverse event: Vertigo
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 32 at risk

Adverse event: Ear pain
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 2 affected / 32 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Infections and infestations
Frequency: 7 affected / 32 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 32 at risk

Adverse event: Cellulitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 32 at risk

Adverse event: Oral herpes
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 32 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 32 at risk

Adverse event: Tooth abscess
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 32 at risk

Adverse event: Skin infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 32 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 32 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 32 at risk

Adverse event: Vaginal infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 32 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 32 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 32 at risk

Adverse event: Dysuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 32 at risk

Adverse event: Pollakiuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 32 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 32 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 4 affected / 32 at risk

Adverse event: Neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 8 affected / 32 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 7 affected / 32 at risk

Adverse event: Alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 17 affected / 32 at risk

Adverse event: Dry skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 6 affected / 32 at risk

Adverse event: Erythema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 7 affected / 32 at risk

Adverse event: Nail disorder
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 15 affected / 32 at risk

Adverse event: Nail dystrophy
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 32 at risk

Adverse event: Skin hyperpigmentation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 32 at risk

Adverse event: Palmar-plantar erythrodysaesthesia syndrome
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 32 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 5 affected / 32 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 12 affected / 32 at risk

Adverse event: Bone pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 32 at risk

Adverse event: Neck pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 32 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 9 affected / 32 at risk

Adverse event: Groin pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 32 at risk

Adverse event: Muscular weakness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 32 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 32 at risk

Adverse event: Musculoskeletal pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 7 affected / 32 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 8 affected / 32 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 8 affected / 32 at risk

Adverse event: Dysphonia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 32 at risk

Adverse event: Epistaxis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 21 affected / 32 at risk

Adverse event: Rhinorrhoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 32 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 32 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 2 affected / 32 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 10 affected / 32 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 9 affected / 32 at risk

Adverse event: Asthenia
Serious: no
Organ System: General disorders
Frequency: 13 affected / 32 at risk

Adverse event: Chest pain
Serious: no
Organ System: General disorders
Frequency: 2 affected / 32 at risk

Adverse event: Chest discomfort
Serious: no
Organ System: General disorders
Frequency: 2 affected / 32 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: General disorders
Frequency: 4 affected / 32 at risk

Adverse event: Mucosal inflammation
Serious: no
Organ System: General disorders
Frequency: 8 affected / 32 at risk