Study: NCT00392392

Adverse event: Pain - Abdomen
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 29 at risk

Adverse event: Infection - Skin
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 29 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 29 at risk

Adverse event: Left ventricular dysfunction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 29 at risk

Adverse event: Pain - Chest
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 29 at risk

Adverse event: Hemorrhage - Nose
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 29 at risk

Adverse event: Wound Complication, Non-Infectious
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 29 at risk

Adverse event: Oesophagitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 29 at risk

Adverse event: Infection - Sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 29 at risk

Adverse event: Blood creatinine
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 29 at risk

Adverse event: Alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 19 affected / 29 at risk

Adverse event: Alanine aminotransferase
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 7 affected / 29 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 29 at risk

Adverse event: Aspartate aminotransferase
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 4 affected / 29 at risk

Adverse event: Left ventricular dysfunction
Serious: no
Organ System: Cardiac disorders
Notes: Decreased LVEF
Frequency: 5 affected / 29 at risk

Adverse event: Rigors/Chills
Serious: no
Organ System: General disorders
Frequency: 2 affected / 29 at risk

Adverse event: Carbon dioxide
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 29 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 11 affected / 29 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 6 affected / 29 at risk

Adverse event: Blood creatinine
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 29 at risk

Adverse event: Mood Alteration - Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 3 affected / 29 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 16 affected / 29 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 7 affected / 29 at risk

Adverse event: Oedema
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 29 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 25 affected / 29 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 2 affected / 29 at risk

Adverse event: Haemoglobin
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 29 affected / 29 at risk

Adverse event: Hemorrhage Pulmonary - Nose
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 19 affected / 29 at risk

Adverse event: Hemorrhage, GI - Rectal
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 29 at risk

Adverse event: Hemorrhage, GU
Serious: no
Organ System: Renal and urinary disorders
Frequency: 3 affected / 29 at risk

Adverse event: Haemorrhoids
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 29 at risk

Adverse event: Hot flush
Serious: no
Organ System: Endocrine disorders
Frequency: 4 affected / 29 at risk

Adverse event: Hypersensitivity
Serious: no
Organ System: Immune system disorders
Frequency: 2 affected / 29 at risk

Adverse event: Hypertension
Serious: no
Organ System: Cardiac disorders
Frequency: 15 affected / 29 at risk

Adverse event: Infection - Breast
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 29 at risk

Adverse event: Infection - Sepsis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 29 at risk

Adverse event: Infection - Sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 8 affected / 29 at risk

Adverse event: Infection - URI
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 29 at risk

Adverse event: Infection - UTI
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 29 at risk

Adverse event: Insomnia
Serious: no
Organ System: General disorders
Frequency: 8 affected / 29 at risk

Adverse event: Leukocytes
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 26 affected / 29 at risk

Adverse event: Lymphopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 29 at risk

Adverse event: Blood alkaline phosphatase
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 29 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 12 affected / 29 at risk

Adverse event: Hypoalbuminaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 29 at risk

Adverse event: Hypoglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 29 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 29 at risk

Adverse event: Hypomagnesaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 29 at risk

Adverse event: Mood Alteration - Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 11 affected / 29 at risk

Adverse event: Mucosal inflammation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 29 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 25 affected / 29 at risk

Adverse event: Neuropathy - NOS
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 29 at risk

Adverse event: Neuropathy - Sensory
Serious: no
Organ System: Nervous system disorders
Frequency: 11 affected / 29 at risk

Adverse event: Neutrophil count
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 27 affected / 29 at risk

Adverse event: Pain - Abdomen
Serious: no
Organ System: General disorders
Frequency: 3 affected / 29 at risk

Adverse event: Pain - Back
Serious: no
Organ System: General disorders
Frequency: 6 affected / 29 at risk

Adverse event: Pain - Bone
Serious: no
Organ System: General disorders
Frequency: 3 affected / 29 at risk

Adverse event: Pain - Breast
Serious: no
Organ System: General disorders
Frequency: 3 affected / 29 at risk

Adverse event: Pain - Chest
Serious: no
Organ System: General disorders
Frequency: 8 affected / 29 at risk

Adverse event: Pain - Headache
Serious: no
Organ System: General disorders
Frequency: 18 affected / 29 at risk

Adverse event: Pain - Joint
Serious: no
Organ System: General disorders
Frequency: 8 affected / 29 at risk

Adverse event: Pain - Limb
Serious: no
Organ System: General disorders
Frequency: 8 affected / 29 at risk

Adverse event: Pain - Muscle
Serious: no
Organ System: General disorders
Frequency: 8 affected / 29 at risk

Adverse event: Pain - Neck
Serious: no
Organ System: General disorders
Frequency: 3 affected / 29 at risk

Adverse event: Pain - NOS
Serious: no
Organ System: General disorders
Frequency: 3 affected / 29 at risk

Adverse event: Pain - Oral
Serious: no
Organ System: General disorders
Frequency: 4 affected / 29 at risk

Adverse event: Pain - Throat
Serious: no
Organ System: General disorders
Frequency: 3 affected / 29 at risk

Adverse event: Pain - Urinary
Serious: no
Organ System: General disorders
Frequency: 4 affected / 29 at risk

Adverse event: Palpitations
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 29 at risk

Adverse event: Phlebitis
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 29 at risk

Adverse event: Platelets
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 21 affected / 29 at risk

Adverse event: Proteinuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 7 affected / 29 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 29 at risk

Adverse event: Dermatitis - Radiation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 29 at risk

Adverse event: Acne
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 29 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 10 affected / 29 at risk

Adverse event: Oesophagitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 29 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 29 at risk

Adverse event: Sinus congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 29 at risk

Adverse event: Hyperhidrosis
Serious: no
Organ System: General disorders
Frequency: 4 affected / 29 at risk

Adverse event: Tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 29 at risk

Adverse event: Taste disorder
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 29 at risk

Adverse event: Pollakiuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 29 at risk

Adverse event: Ocular - Visual Changes
Serious: no
Organ System: Eye disorders
Frequency: 3 affected / 29 at risk

Adverse event: Voice Changes
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 29 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 29 at risk

Adverse event: Asthenia
Serious: no
Organ System: General disorders
Frequency: 2 affected / 29 at risk

Adverse event: Weight increased
Serious: no
Organ System: General disorders
Frequency: 2 affected / 29 at risk

Adverse event: Wound complication
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 29 at risk

Adverse event: Wound dehiscence
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 29 at risk

Adverse event: Hyponatraemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 29 at risk