Study: NCT01316224

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 52 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 52 at risk

Adverse event: Vertigo
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 52 at risk

Adverse event: Abdominal pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 52 at risk

Adverse event: Ascites
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 52 at risk

Adverse event: Gastrointestinal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 52 at risk

Adverse event: Chest pain
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 52 at risk

Adverse event: General physical health deterioration
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 52 at risk

Adverse event: Localised oedema
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 52 at risk

Adverse event: Therapy non-responder
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 52 at risk

Adverse event: Pain
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 52 at risk

Adverse event: Hepatic steatosis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 52 at risk

Adverse event: Tonsillitis bacterial
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 52 at risk

Adverse event: Alpha 1 foetoprotein increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 52 at risk

Adverse event: Cardiac murmur
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 52 at risk

Adverse event: Liver function test abnormal
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 52 at risk

Adverse event: Transaminases increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 52 at risk

Adverse event: Arthritis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 52 at risk

Adverse event: Dactylitis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 52 at risk

Adverse event: Muscle spasms
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 52 at risk

Adverse event: Neck pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 52 at risk

Adverse event: Pain in extremity
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 52 at risk

Adverse event: Psoriatic arthropathy
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 52 at risk

Adverse event: Hepatic cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 52 at risk

Adverse event: Melanocytic naevus
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 52 at risk

Adverse event: Uterine leiomyoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 52 at risk

Adverse event: Headache
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 52 at risk

Adverse event: Syncope
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 52 at risk

Adverse event: Bipolar I disorder
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 52 at risk

Adverse event: Breast calcifications
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 52 at risk

Adverse event: Mammary duct ectasia
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 52 at risk

Adverse event: Uterine haemorrhage
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 52 at risk

Adverse event: Cough
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 52 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 52 at risk

Adverse event: Pleural effusion
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 52 at risk

Adverse event: Blister
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 52 at risk

Adverse event: Dermatosis
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 52 at risk

Adverse event: Erythema
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 52 at risk

Adverse event: Psoriasis
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 52 at risk

Adverse event: Rash generalized
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 52 at risk

Adverse event: Toxic skin eruption
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 52 at risk

Adverse event: Mastectomy
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 52 at risk

Adverse event: Hypertensive crisis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 52 at risk

Adverse event: Influenza like illness
Serious: no
Organ System: General disorders
Frequency: 5 affected / 52 at risk