Study: NCT01115491

Adverse event: Lung (pneumonia)
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 32 at risk

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

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 32 at risk

Adverse event: Nervous system disorder
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 32 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 32 at risk

Adverse event: Thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 32 at risk

Adverse event: Urinary bladder haemorrhage
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 32 at risk

Adverse event: Haemorrhage intracranial
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 32 at risk

Adverse event: Back pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 32 at risk

Adverse event: Olfactory nerve disorder
Serious: no
Organ System: Nervous system disorders
Frequency: 9 affected / 32 at risk

Adverse event: Nervous system disorder
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 32 at risk

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

Adverse event: Depressed level of consciousness
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 32 at risk

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

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

Adverse event: Ataxia
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 32 at risk

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

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

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

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

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

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

Adverse event: Lymphocyte count decreased
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 16 affected / 32 at risk

Adverse event: Platelet count decreased
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 15 affected / 32 at risk

Adverse event: Neutrophil count decreased
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 6 affected / 32 at risk

Adverse event: White blood cell count decreased
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 32 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 18 affected / 32 at risk

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

Adverse event: General symptom
Serious: no
Organ System: General disorders
Frequency: 3 affected / 32 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 11 affected / 32 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 8 affected / 32 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 32 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 32 at risk

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

Adverse event: Taste alteration (dysgeusia)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 32 at risk

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

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 8 affected / 32 at risk

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

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

Adverse event: Lung (pneumonia)
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 32 at risk

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

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 9 affected / 32 at risk

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

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

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

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

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 7 affected / 32 at risk

Adverse event: Glucose, serum-high (hyperglycaemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 32 at risk

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

Adverse event: Oedema peripheral
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 5 affected / 32 at risk

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

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