Study: NCT01077128

Adverse event: Dysarthria
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 500 at risk

Adverse event: Extradural haematoma
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 500 at risk

Adverse event: Hypoaesthesia
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 500 at risk

Adverse event: Paraplegia
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 500 at risk

Adverse event: Paresis
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 500 at risk

Adverse event: Spinal cord ischaemia
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 500 at risk

Adverse event: Spinal cord haematoma
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 500 at risk

Adverse event: Eosinophilia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 500 at risk

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 500 at risk

Adverse event: Leukocytosis
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 500 at risk

Adverse event: Lymphadenopathy
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 500 at risk

Adverse event: Thrombocytosis
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 500 at risk

Adverse event: Asthenia
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 500 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 500 at risk

Adverse event: Chills
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 500 at risk

Adverse event: Fatigue
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 500 at risk

Adverse event: Oedema, peripheral
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 500 at risk

Adverse event: Muscle contractions involuntary
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 500 at risk

Adverse event: Pain in extremity
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 500 at risk

Adverse event: Rhabdomyolysis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 500 at risk

Adverse event: Pruritus
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 500 at risk

Adverse event: Pustular psoriasis
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 500 at risk

Adverse event: Skin exfoliation
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 500 at risk

Adverse event: Ischaemic stroke
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 500 at risk

Adverse event: Transient ischaemic attack
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 500 at risk

Adverse event: Thyroiditis acute
Serious: yes
Organ System: Endocrine disorders
Frequency: 1 affected / 500 at risk

Adverse event: Hepatosplenomegaly
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 500 at risk

Adverse event: Lower respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 500 at risk

Adverse event: Road traffic accident
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 500 at risk

Adverse event: Electromyogram abnormal
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 500 at risk

Adverse event: Cutaneous T-cell lymphoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 500 at risk

Adverse event: Ectopic pregnancy
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 500 at risk

Adverse event: Vaginal haemorrhage
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 500 at risk

Adverse event: Pleural effusion
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 500 at risk

Adverse event: Abortion induced
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 500 at risk