Study: NCT00551421

Adverse event: Myocardial ischaemia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 16 at risk

Adverse event: troponin elevation
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 16 at risk

Adverse event: Insomnia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 16 at risk

Adverse event: acneiform rash
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 16 at risk

Adverse event: Dry skin
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 16 at risk

Adverse event: rash/desquamation
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 8 affected / 16 at risk

Adverse event: Pain of skin
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 16 at risk

Adverse event: Small intestinal obstruction
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 16 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 16 at risk

Adverse event: mucositis or stomatitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 16 at risk

Adverse event: AST elevation
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 16 at risk

Adverse event: Hyperbilirubinaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 16 at risk

Adverse event: Hyperglycaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 16 at risk

Adverse event: Hypoalbuminaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 16 at risk

Adverse event: Hypokalaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 16 at risk

Adverse event: Hypophosphataemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 16 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 16 at risk

Adverse event: hand-foot reaction
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 16 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 16 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 13 affected / 16 at risk

Adverse event: fever without neutropenia
Serious: no
Organ System: General disorders
Frequency: 2 affected / 16 at risk

Adverse event: Insomnia
Serious: no
Organ System: General disorders
Frequency: 2 affected / 16 at risk

Adverse event: rigors/chills
Serious: no
Organ System: General disorders
Frequency: 3 affected / 16 at risk

Adverse event: Weight decreased
Serious: no
Organ System: General disorders
Frequency: 2 affected / 16 at risk

Adverse event: weakness (non-neuropathic)
Serious: no
Organ System: General disorders
Frequency: 1 affected / 16 at risk

Adverse event: acneiform rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 16 at risk

Adverse event: Dry skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 16 at risk

Adverse event: edema of head and neck
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 16 at risk

Adverse event: edema of limb
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 16 at risk

Adverse event: edema trunk/genital
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 16 at risk

Adverse event: Erythema multiforme
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 16 at risk

Adverse event: Lymphoedema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 16 at risk

Adverse event: Nail disorder
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 16 at risk

Adverse event: other
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 16 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 7 affected / 16 at risk

Adverse event: rash/desquamation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 5 affected / 16 at risk

Adverse event: skin (other)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 16 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 16 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 16 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 16 at risk

Adverse event: Dehydration
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 16 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 16 at risk

Adverse event: distension/bloating
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 16 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 16 at risk

Adverse event: Oesophagitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 16 at risk

Adverse event: mucositis or stomatitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 16 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 16 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 16 at risk

Adverse event: incontinence - urinary
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 16 at risk

Adverse event: Proteinuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 16 at risk

Adverse event: Vaginal discharge
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 16 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 9 affected / 16 at risk

Adverse event: Leukopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 16 at risk

Adverse event: Lymphopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 16 at risk

Adverse event: Thrombocytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 16 at risk

Adverse event: urinary tract
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 16 at risk

Adverse event: colitis - infectious
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 16 at risk

Adverse event: ALT elevation
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 16 at risk

Adverse event: AST elevation
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 16 at risk

Adverse event: alkaline phosphatase elevation
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 6 affected / 16 at risk

Adverse event: hepatic (other)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 16 at risk

Adverse event: Hyperbilirubinaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 16 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 6 affected / 16 at risk

Adverse event: Hyperkalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 16 at risk

Adverse event: Hypoalbuminaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 7 affected / 16 at risk

Adverse event: Hypocalcaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 16 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 16 at risk

Adverse event: Hypomagnesaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 7 affected / 16 at risk

Adverse event: Hyponatraemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 16 at risk

Adverse event: Hypophosphataemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 16 at risk

Adverse event: INR elevation
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 16 at risk

Adverse event: PTT prolongation
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 16 at risk

Adverse event: metabolic/lab (other)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 16 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 16 at risk

Adverse event: neuropathy (sensory)
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 16 at risk

Adverse event: eyelid dysfunction
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 16 at risk

Adverse event: Vision blurred
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 16 at risk

Adverse event: ocular (other)
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 16 at risk

Adverse event: Epistaxis
Serious: no
Organ System: General disorders
Frequency: 3 affected / 16 at risk

Adverse event: voice changes/dysarthria
Serious: no
Organ System: General disorders
Frequency: 1 affected / 16 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 16 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 16 at risk

Adverse event: Haemoglobin
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 16 at risk

Adverse event: Neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 16 at risk

Adverse event: neurologic (other)
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 16 at risk

Adverse event: gastrointestinal (other)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 16 at risk

Adverse event: infection (other)
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 16 at risk