Study: NCT00091260

Adverse event: Neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 15 affected / 82 at risk

Adverse event: Leukopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 5 affected / 82 at risk

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 82 at risk

Adverse event: Thrombocytopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 82 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 82 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 82 at risk

Adverse event: organ rejection
Serious: yes
Organ System: Cardiac disorders
Notes: rejection of previously transplanted heart
Frequency: 1 affected / 1 at risk

Adverse event: cardiac, other
Serious: yes
Organ System: Cardiac disorders
Frequency: 5 affected / 82 at risk

Adverse event: Fatigue
Serious: yes
Organ System: General disorders
Frequency: 18 affected / 82 at risk

Adverse event: Decreased Performance Status
Serious: yes
Organ System: General disorders
Frequency: 15 affected / 82 at risk

Adverse event: fever/infection
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 82 at risk

Adverse event: Rash
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 9 affected / 82 at risk

Adverse event: Nail disorder
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 82 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 82 at risk

Adverse event: Dysphagia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 82 at risk

Adverse event: Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 82 at risk

Adverse event: Infection
Serious: yes
Organ System: Infections and infestations
Notes: upper respiratory infection
Frequency: 19 affected / 82 at risk

Adverse event: increased creatinine
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 6 affected / 82 at risk

Adverse event: decreased phosphate
Serious: yes
Organ System: Investigations
Frequency: 13 affected / 82 at risk

Adverse event: increased INR
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 82 at risk

Adverse event: Muscle spasms
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 82 at risk

Adverse event: Dizziness
Serious: yes
Organ System: General disorders
Frequency: 6 affected / 82 at risk

Adverse event: Pancreatitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 82 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 82 at risk

Adverse event: Thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 6 affected / 82 at risk

Adverse event: Gout
Serious: yes
Organ System: General disorders
Frequency: 4 affected / 82 at risk

Adverse event: Neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 26 affected / 82 at risk

Adverse event: Leukopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 21 affected / 82 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 52 affected / 82 at risk

Adverse event: Thrombocytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 27 affected / 82 at risk

Adverse event: Hypotension
Serious: no
Organ System: Cardiac disorders
Frequency: 7 affected / 82 at risk

Adverse event: Chest pain
Serious: no
Organ System: Cardiac disorders
Frequency: 7 affected / 82 at risk

Adverse event: cardiac, other
Serious: no
Organ System: Cardiac disorders
Frequency: 5 affected / 82 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 54 affected / 82 at risk

Adverse event: Somnolence
Serious: no
Organ System: General disorders
Frequency: 11 affected / 82 at risk

Adverse event: Decreased performance status
Serious: no
Organ System: General disorders
Frequency: 30 affected / 82 at risk

Adverse event: fever/infection
Serious: no
Organ System: Infections and infestations
Frequency: 21 affected / 82 at risk

Adverse event: Insomnia
Serious: no
Organ System: General disorders
Frequency: 39 affected / 82 at risk

Adverse event: Weight change
Serious: no
Organ System: General disorders
Frequency: 16 affected / 82 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 29 affected / 82 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 22 affected / 82 at risk

Adverse event: Hot flush
Serious: no
Organ System: General disorders
Frequency: 4 affected / 82 at risk

Adverse event: Derm/skin other
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 7 affected / 82 at risk

Adverse event: Cushingoid
Serious: no
Organ System: Endocrine disorders
Frequency: 4 affected / 82 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 14 affected / 82 at risk

Adverse event: Early satiety
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 18 affected / 82 at risk

Adverse event: Change in appetite
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 12 affected / 82 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 31 affected / 82 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 30 affected / 82 at risk

Adverse event: Dysphagia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 82 at risk

Adverse event: dry membranes
Serious: no
Organ System: General disorders
Frequency: 13 affected / 82 at risk

Adverse event: Haemorrhoids
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 13 affected / 82 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 17 affected / 82 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 24 affected / 82 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 13 affected / 82 at risk

Adverse event: GI other
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 82 at risk

Adverse event: hemorrhage - nose
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 82 at risk

Adverse event: Easy bruising
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 17 affected / 82 at risk

Adverse event: pulmonary infection
Serious: no
Organ System: Infections and infestations
Frequency: 26 affected / 82 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 10 affected / 82 at risk

Adverse event: Oedema
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 41 affected / 82 at risk

Adverse event: Hyponatraemia
Serious: no
Organ System: Investigations
Frequency: 14 affected / 82 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Investigations
Frequency: 15 affected / 82 at risk

Adverse event: increased creatinine
Serious: no
Organ System: Investigations
Frequency: 40 affected / 82 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Investigations
Frequency: 43 affected / 82 at risk

Adverse event: Hyperbilirubinaemia
Serious: no
Organ System: Investigations
Frequency: 7 affected / 82 at risk

Adverse event: increased alkylase phosphate
Serious: no
Organ System: Investigations
Frequency: 24 affected / 82 at risk

Adverse event: increased alanine aminotransferase test
Serious: no
Organ System: Investigations
Frequency: 17 affected / 82 at risk

Adverse event: Hypoalbuminaemia
Serious: no
Organ System: Investigations
Frequency: 33 affected / 82 at risk

Adverse event: Hypocalcaemia
Serious: no
Organ System: Investigations
Frequency: 31 affected / 82 at risk

Adverse event: Muscle spasms
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 53 affected / 82 at risk

Adverse event: numbness - extremities
Serious: no
Organ System: Nervous system disorders
Frequency: 11 affected / 82 at risk

Adverse event: Muscular weakness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 16 affected / 82 at risk

Adverse event: pain - muscle
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 9 affected / 82 at risk

Adverse event: pain - extremities
Serious: no
Organ System: Nervous system disorders
Frequency: 10 affected / 82 at risk

Adverse event: mood alteration
Serious: no
Organ System: Psychiatric disorders
Frequency: 10 affected / 82 at risk

Adverse event: Dizziness
Serious: no
Organ System: General disorders
Frequency: 42 affected / 82 at risk

Adverse event: tremors
Serious: no
Organ System: General disorders
Frequency: 6 affected / 82 at risk

Adverse event: Muscle spasms
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 8 affected / 82 at risk

Adverse event: tingling - extremities
Serious: no
Organ System: Nervous system disorders
Frequency: 17 affected / 82 at risk

Adverse event: Visual impairment
Serious: no
Organ System: Eye disorders
Frequency: 11 affected / 82 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 12 affected / 82 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 13 affected / 82 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 25 affected / 82 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 28 affected / 82 at risk

Adverse event: Dysuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 5 affected / 82 at risk

Adverse event: flu-like syndrome
Serious: no
Organ System: General disorders
Frequency: 11 affected / 82 at risk

Adverse event: post nasal drip
Serious: no
Organ System: Immune system disorders
Frequency: 19 affected / 82 at risk

Adverse event: elevated blood urea nitrogen blood test
Serious: no
Organ System: Investigations
Frequency: 11 affected / 82 at risk