Study: NCT00243503

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 60 at risk

Adverse event: Febrile neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 60 at risk

Adverse event: Immune thrombocytopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 60 at risk

Adverse event: Thrombocytopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 60 at risk

Adverse event: Cardiac failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 60 at risk

Adverse event: Cardiac failure acute
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 60 at risk

Adverse event: Cardiogenic shock
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 60 at risk

Adverse event: Left ventricular dysfunction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 60 at risk

Adverse event: Anal fistula
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 60 at risk

Adverse event: Oesophageal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 60 at risk

Adverse event: Oesophagitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 60 at risk

Adverse event: Pancreatitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 60 at risk

Adverse event: Periodontal disease
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 60 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 60 at risk

Adverse event: Asthenia
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 60 at risk

Adverse event: Multiple organ dysfunction syndrome
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 60 at risk

Adverse event: Cholecystitis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 60 at risk

Adverse event: Cellulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 60 at risk

Adverse event: Pilonidal disease
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 60 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 60 at risk

Adverse event: Skin infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 60 at risk

Adverse event: Ejection fraction decreased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 60 at risk

Adverse event: Hypercalcaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 60 at risk

Adverse event: Hyponatraemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 60 at risk

Adverse event: Bone pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 60 at risk

Adverse event: Headache
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 60 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 60 at risk

Adverse event: Epistaxis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 60 at risk

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 60 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 60 at risk

Adverse event: Drug interaction
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 60 at risk

Adverse event: Device related infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 60 at risk

Adverse event: Decreased appetite
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 60 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 8 affected / 60 at risk

Adverse event: Leukopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 6 affected / 60 at risk

Adverse event: Neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 17 affected / 60 at risk

Adverse event: Thrombocytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 16 affected / 60 at risk

Adverse event: Left ventricular dysfunction
Serious: no
Organ System: Cardiac disorders
Frequency: 10 affected / 60 at risk

Adverse event: Hypothyroidism
Serious: no
Organ System: Endocrine disorders
Frequency: 5 affected / 60 at risk

Adverse event: Eyelid oedema
Serious: no
Organ System: Eye disorders
Frequency: 6 affected / 60 at risk

Adverse event: Lacrimation increased
Serious: no
Organ System: Eye disorders
Frequency: 6 affected / 60 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 11 affected / 60 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 60 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 10 affected / 60 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 36 affected / 60 at risk

Adverse event: Dry mouth
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 60 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 20 affected / 60 at risk

Adverse event: Gingival bleeding
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 60 at risk

Adverse event: Gingival pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 60 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 20 affected / 60 at risk

Adverse event: Rectal haemorrhage
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 60 at risk

Adverse event: Stomatitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 60 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 21 affected / 60 at risk

Adverse event: Asthenia
Serious: no
Organ System: General disorders
Frequency: 29 affected / 60 at risk

Adverse event: Chest pain
Serious: no
Organ System: General disorders
Frequency: 3 affected / 60 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Frequency: 5 affected / 60 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 19 affected / 60 at risk

Adverse event: Mucosal inflammation
Serious: no
Organ System: General disorders
Frequency: 21 affected / 60 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: General disorders
Frequency: 4 affected / 60 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 4 affected / 60 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 11 affected / 60 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 60 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 60 at risk

Adverse event: Ejection fraction decreased
Serious: no
Organ System: Investigations
Frequency: 13 affected / 60 at risk

Adverse event: Electrocardiogram QT prolonged
Serious: no
Organ System: Investigations
Frequency: 3 affected / 60 at risk

Adverse event: Weight decreased
Serious: no
Organ System: Investigations
Frequency: 11 affected / 60 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 7 affected / 60 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 6 affected / 60 at risk

Adverse event: Bone pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 7 affected / 60 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 5 affected / 60 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 6 affected / 60 at risk

Adverse event: Dysgeusia
Serious: no
Organ System: Nervous system disorders
Frequency: 27 affected / 60 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 18 affected / 60 at risk

Adverse event: Paraesthesia
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 60 at risk

Adverse event: Peripheral sensory neuropathy
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 60 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 7 affected / 60 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 5 affected / 60 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 9 affected / 60 at risk

Adverse event: Chromaturia
Serious: no
Organ System: Renal and urinary disorders
Frequency: 4 affected / 60 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 60 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 9 affected / 60 at risk

Adverse event: Epistaxis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 18 affected / 60 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 60 at risk

Adverse event: Acne
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 7 affected / 60 at risk

Adverse event: Dry skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 15 affected / 60 at risk

Adverse event: Erythema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 6 affected / 60 at risk

Adverse event: Hair colour changes
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 7 affected / 60 at risk

Adverse event: Palmar-plantar erythrodysaesthesia syndrome
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 10 affected / 60 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 9 affected / 60 at risk

Adverse event: Skin discolouration
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 60 at risk

Adverse event: Yellow skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 13 affected / 60 at risk

Adverse event: Haematoma
Serious: no
Organ System: Vascular disorders
Frequency: 3 affected / 60 at risk

Adverse event: Hot flush
Serious: no
Organ System: Vascular disorders
Frequency: 4 affected / 60 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 25 affected / 60 at risk

Adverse event: Vertigo
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 3 affected / 60 at risk

Adverse event: Abdominal distension
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 60 at risk

Adverse event: Cheilitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 60 at risk

Adverse event: Haemorrhoids
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 60 at risk

Adverse event: Blood alkaline phosphatase increased
Serious: no
Organ System: Investigations
Frequency: 3 affected / 60 at risk

Adverse event: Platelet count decreased
Serious: no
Organ System: Investigations
Frequency: 3 affected / 60 at risk

Adverse event: Dysphonia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 60 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 5 affected / 60 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 18 affected / 60 at risk