Study: NCT01200342

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 7 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 7 at risk

Adverse event: Blood alkaline phosphatase increased
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 4 affected / 7 at risk

Adverse event: Alopecia
Serious: no
Organ System: General disorders
Frequency: 2 affected / 7 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 5 affected / 7 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Psychiatric disorders
Frequency: 4 affected / 7 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 7 at risk

Adverse event: Aspartate aminotransferase increased
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 7 at risk

Adverse event: Blood bilirubin increased
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 7 at risk

Adverse event: Vision blurred
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 7 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Frequency: 4 affected / 7 at risk

Adverse event: Confusional state
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 7 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Notes: 1 event = Grade 3
Frequency: 5 affected / 7 at risk

Adverse event: Cough
Serious: no
Organ System: General disorders
Frequency: 2 affected / 7 at risk

Adverse event: Blood creatinine increased
Serious: no
Organ System: Renal and urinary disorders
Frequency: 3 affected / 7 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 7 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 7 at risk

Adverse event: Dizziness
Serious: no
Organ System: Ear and labyrinth disorders
Notes: 1 event = Grade 3
Frequency: 4 affected / 7 at risk

Adverse event: Dry mouth
Serious: no
Organ System: General disorders
Frequency: 1 affected / 7 at risk

Adverse event: Dry skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 7 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 7 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 7 at risk

Adverse event: Eye disorders
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 7 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: 1 event = Grade 3
Frequency: 6 affected / 7 at risk

Adverse event: Febrile neutropenia
Serious: no
Organ System: Infections and infestations
Notes: Grade 3
Frequency: 1 affected / 7 at risk

Adverse event: Pyrexia
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 7 at risk

Adverse event: Gait disturbance
Serious: no
Organ System: Nervous system disorders
Notes: Loss of balance
Frequency: 1 affected / 7 at risk

Adverse event: Gastrointestinal disorders
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 7 at risk

Adverse event: Muscular weakness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 7 at risk

Adverse event: Hallucination
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 7 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 7 at risk

Adverse event: Hot flush
Serious: no
Organ System: General disorders
Frequency: 1 affected / 7 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Endocrine disorders
Notes: 2 events = Grade 3; 1 event = Grade 4
Frequency: 4 affected / 7 at risk

Adverse event: Hyperkalaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 7 at risk

Adverse event: Hyperuricaemia
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 7 at risk

Adverse event: Hypoalbuminaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 7 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 7 at risk

Adverse event: Hypomagnesaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 7 at risk

Adverse event: Hyponatraemia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: 1 event = Grade 3
Frequency: 3 affected / 7 at risk

Adverse event: Hypotension
Serious: no
Organ System: Cardiac disorders
Notes: Grade 3
Frequency: 1 affected / 7 at risk

Adverse event: Infections and infestations
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 7 at risk

Adverse event: Lymphocyte count decreased
Serious: no
Organ System: Immune system disorders
Frequency: 5 affected / 7 at risk

Adverse event: Stomatitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 7 at risk

Adverse event: Musculoskeletal and connective tissue disorder
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 7 at risk

Adverse event: Nausea
Serious: no
Organ System: General disorders
Frequency: 6 affected / 7 at risk

Adverse event: Neutrophil count decreased
Serious: no
Organ System: Immune system disorders
Notes: 2 events = Grade 3; 2 events = Grade 4
Frequency: 4 affected / 7 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Notes: l.thorax
Frequency: 1 affected / 7 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Notes: lower back
Frequency: 1 affected / 7 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Notes: Abdominal
Frequency: 1 affected / 7 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Notes: gr. 1 BL pain
Frequency: 1 affected / 7 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Notes: joint pains
Frequency: 1 affected / 7 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Notes: 1 event = Grade 3
Frequency: 2 affected / 7 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Notes: sharp joint pains
Frequency: 1 affected / 7 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Notes: Lt nares through eye
Frequency: 1 affected / 7 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 7 at risk

Adverse event: Pain of skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 7 at risk

Adverse event: Peripheral sensory neuropathy
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 7 affected / 7 at risk

Adverse event: Platelet count decreased
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: 1 event = Grade 3
Frequency: 6 affected / 7 at risk

Adverse event: Pruritus
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 7 at risk

Adverse event: Rash maculo-papular
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 7 at risk

Adverse event: Skin and subcutaneous tissue disorders
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 7 at risk

Adverse event: Skin infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 7 at risk

Adverse event: Syncope
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 7 at risk

Adverse event: Embolism
Serious: no
Organ System: Vascular disorders
Notes: 1 event = Grade 3
Frequency: 1 affected / 7 at risk

Adverse event: Urinary incontinence
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 7 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 7 at risk

Adverse event: Vascular disorders
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 7 at risk

Adverse event: Vomiting
Serious: no
Organ System: General disorders
Notes: 1 event = Grade 3
Frequency: 6 affected / 7 at risk

Adverse event: Weight decreased
Serious: no
Organ System: General disorders
Frequency: 2 affected / 7 at risk

Adverse event: White blood cell count decreased
Serious: no
Organ System: Immune system disorders
Notes: 3 events = Grade 3
Frequency: 4 affected / 7 at risk