Study: NCT00996346

Adverse event: Rhinitis (Runny nose)
Serious: no
Organ System: General disorders
Frequency: 3 affected / 6 at risk

Adverse event: Hemoglobin levels decreased
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 6 at risk

Adverse event: Leukocytes decreased
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 6 at risk

Adverse event: Neutrophils decreased
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 6 at risk

Adverse event: Platelet count decreased
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 6 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 4 affected / 6 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 2 affected / 6 at risk

Adverse event: Dermatology/Skin - Other
Serious: no
Organ System: General disorders
Frequency: 1 affected / 6 at risk

Adverse event: Anorexia (Loss of appetite)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 6 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 6 at risk

Adverse event: Stomatitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 6 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 6 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Investigations
Frequency: 2 affected / 6 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Investigations
Frequency: 1 affected / 6 at risk

Adverse event: INR (Prothrombin time)
Serious: no
Organ System: Investigations
Frequency: 1 affected / 6 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 1 affected / 6 at risk

Adverse event: Vision blurred
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 6 at risk

Adverse event: Ear, nose and throat examination abnormal
Serious: no
Organ System: General disorders
Frequency: 1 affected / 6 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 6 at risk

Adverse event: Back pain
Serious: no
Organ System: General disorders
Frequency: 2 affected / 6 at risk

Adverse event: Arthralgia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 6 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: General disorders
Frequency: 1 affected / 6 at risk

Adverse event: Hypoxia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 6 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 6 at risk

Adverse event: Thrombosis
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 6 at risk

Adverse event: Hypersensitivity
Serious: no
Organ System: General disorders
Frequency: 1 affected / 8 at risk

Adverse event: Rhinitis (Runny nose)
Serious: no
Organ System: General disorders
Frequency: 1 affected / 8 at risk

Adverse event: Hemoglobin levels decreased
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 8 at risk

Adverse event: Hemolysis (red blood cell destruction)
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 4 affected / 8 at risk

Adverse event: Leukocytes decreased
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 6 affected / 8 at risk

Adverse event: Lymphocyte count decreased
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 8 affected / 8 at risk

Adverse event: Neutrophils decreased
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 8 at risk

Adverse event: Platelet count decreased
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 8 at risk

Adverse event: Hypotension
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 8 at risk

Adverse event: Sinus tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 8 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 3 affected / 8 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 8 at risk

Adverse event: Rigors/chills
Serious: no
Organ System: General disorders
Frequency: 1 affected / 8 at risk

Adverse event: Acne
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 8 at risk

Adverse event: Alopecia (Hair loss)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 8 at risk

Adverse event: Dry skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 8 at risk

Adverse event: Pruritus (Itching)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 8 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 8 at risk

Adverse event: Anorexia (Loss of appetite)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 8 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 8 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 8 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 8 at risk

Adverse event: Epistaxis
Serious: no
Organ System: General disorders
Frequency: 1 affected / 8 at risk

Adverse event: Myositis (Muscle inflammation)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 8 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 8 at risk

Adverse event: Edema: limbs
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 8 at risk

Adverse event: Edema: head and neck
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 8 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 8 at risk

Adverse event: Blood alkaline phosphatase increased
Serious: no
Organ System: Investigations
Frequency: 3 affected / 8 at risk

Adverse event: Aspartate aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 8 at risk

Adverse event: Blood creatinine increased
Serious: no
Organ System: Investigations
Frequency: 3 affected / 8 at risk

Adverse event: Hypercalcaemia
Serious: no
Organ System: Investigations
Frequency: 1 affected / 8 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Investigations
Frequency: 6 affected / 8 at risk

Adverse event: Hypoalbuminaemia
Serious: no
Organ System: Investigations
Frequency: 4 affected / 8 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Investigations
Frequency: 1 affected / 8 at risk

Adverse event: Hypomagnesaemia
Serious: no
Organ System: Investigations
Frequency: 3 affected / 8 at risk

Adverse event: Hyponatraemia
Serious: no
Organ System: Investigations
Frequency: 4 affected / 8 at risk

Adverse event: Hypophosphataemia
Serious: no
Organ System: Investigations
Frequency: 1 affected / 8 at risk

Adverse event: INR (Prothrombin time)
Serious: no
Organ System: Investigations
Frequency: 1 affected / 8 at risk

Adverse event: Laboratory test abnormal
Serious: no
Organ System: Investigations
Frequency: 3 affected / 8 at risk

Adverse event: Prothromboplastin time
Serious: no
Organ System: Investigations
Frequency: 1 affected / 8 at risk

Adverse event: Extraocular muscle disorder
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 8 at risk

Adverse event: Fracture
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 8 at risk

Adverse event: Gait disturbance
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 8 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 8 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 8 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 3 affected / 8 at risk

Adverse event: Peripheral sensory neuropathy
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 8 at risk

Adverse event: Vision blurred
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 8 at risk

Adverse event: Ear, nose and throat examination abnormal
Serious: no
Organ System: General disorders
Frequency: 1 affected / 8 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: General disorders
Frequency: 3 affected / 8 at risk

Adverse event: Bone pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 8 at risk

Adverse event: Chest pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 8 at risk

Adverse event: Laryngeal pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 8 at risk

Adverse event: Hypoxia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 8 at risk

Adverse event: Leukocytes decreased
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 3 at risk

Adverse event: Lymphocyte count decreased
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 3 at risk

Adverse event: Neutrophils decreased
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 3 at risk

Adverse event: Platelet count decreased
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 3 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 2 affected / 3 at risk

Adverse event: Weight decreased
Serious: no
Organ System: General disorders
Frequency: 1 affected / 3 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 3 at risk

Adverse event: Abdominal distention
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 3 at risk

Adverse event: Anorexia (Loss of appetite)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 3 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 3 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 3 at risk

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

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 3 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 3 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Investigations
Frequency: 2 affected / 3 at risk

Adverse event: Hypoalbuminaemia
Serious: no
Organ System: Investigations
Frequency: 1 affected / 3 at risk

Adverse event: Hypocalcaemia
Serious: no
Organ System: Investigations
Frequency: 1 affected / 3 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Investigations
Frequency: 1 affected / 3 at risk

Adverse event: Prothromboplastin time
Serious: no
Organ System: Investigations
Frequency: 1 affected / 3 at risk

Adverse event: Muscular weakness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 3 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 3 at risk

Adverse event: Cognitive disorder
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 3 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 3 at risk

Adverse event: Dizziness
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 3 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 1 affected / 3 at risk

Adverse event: Vision blurred
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 3 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 3 at risk

Adverse event: Musculoskeletal chest pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 3 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 3 at risk