Study: NCT00101400

Adverse event: Haemoglobin
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 54 at risk

Adverse event: Coagulation - Other
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 54 at risk

Adverse event: Supraventricular Arrhythmia, Supraventricular Tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 54 at risk

Adverse event: Cardiac General - Other
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 54 at risk

Adverse event: Decreased appetite
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 54 at risk

Adverse event: Ascites
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 54 at risk

Adverse event: Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 54 at risk

Adverse event: Perforation, GI, Colon
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 54 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 54 at risk

Adverse event: Death Not Associated With CTCAE Term, Disease Progression NOS
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 54 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 54 at risk

Adverse event: Fatigue
Serious: yes
Organ System: General disorders
Frequency: 7 affected / 54 at risk

Adverse event: Pain, Back
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 54 at risk

Adverse event: Pain, Chest/Thorax NOS
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 54 at risk

Adverse event: Pain, Abdomen NOS
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 54 at risk

Adverse event: Pain, Head/Headache
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 54 at risk

Adverse event: Liver Dysfunction
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 3 affected / 54 at risk

Adverse event: Hepatobiliary - Other
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 2 affected / 54 at risk

Adverse event: Bilirubin (Hyperbilirubinemia)
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 54 at risk

Adverse event: Hypercalcaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 54 at risk

Adverse event: Hyperkalaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 54 at risk

Adverse event: Dizziness
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 54 at risk

Adverse event: Neuropathy: Motor
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 54 at risk

Adverse event: CNS Necrosis
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 54 at risk

Adverse event: Neurology - Other
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 54 at risk

Adverse event: Renal failure
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 54 at risk

Adverse event: Pleural effusion
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 54 at risk

Adverse event: Hypoxia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 54 at risk

Adverse event: Pulmonary - Other
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 54 at risk

Adverse event: Dyspnea (Shortness Of Breath)
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 7 affected / 54 at risk

Adverse event: Erythema multiforme
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 54 at risk

Adverse event: Neutrophil count
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 54 at risk

Adverse event: Haemoglobin
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 5 affected / 54 at risk

Adverse event: Platelets
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 5 affected / 54 at risk

Adverse event: Leukocytes
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 54 at risk

Adverse event: Dermal Change
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 54 at risk

Adverse event: Edema: Limb
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 7 affected / 54 at risk

Adverse event: Hypertension
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 54 at risk

Adverse event: Cardiac General - Other
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 54 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 29 affected / 54 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 13 affected / 54 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 14 affected / 54 at risk

Adverse event: Dysphagia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 54 at risk

Adverse event: Gastritis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 54 at risk

Adverse event: Mucositis (Clinical Exam), Oral Cavity
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 54 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 19 affected / 54 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 11 affected / 54 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 7 affected / 54 at risk

Adverse event: Insomnia
Serious: no
Organ System: General disorders
Frequency: 6 affected / 54 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 27 affected / 54 at risk

Adverse event: Weight decreased
Serious: no
Organ System: General disorders
Frequency: 3 affected / 54 at risk

Adverse event: Constitutional Symptoms - Other
Serious: no
Organ System: General disorders
Frequency: 5 affected / 54 at risk

Adverse event: Pain, Back
Serious: no
Organ System: General disorders
Frequency: 4 affected / 54 at risk

Adverse event: Pain, Extremity - Limb
Serious: no
Organ System: General disorders
Frequency: 4 affected / 54 at risk

Adverse event: Pain, Abdomen NOS
Serious: no
Organ System: General disorders
Frequency: 9 affected / 54 at risk

Adverse event: Pain, Head/Headache
Serious: no
Organ System: General disorders
Frequency: 6 affected / 54 at risk

Adverse event: Pain, Joint
Serious: no
Organ System: General disorders
Frequency: 4 affected / 54 at risk

Adverse event: Pain, Bone
Serious: no
Organ System: General disorders
Frequency: 9 affected / 54 at risk

Adverse event: Pain, Other
Serious: no
Organ System: General disorders
Frequency: 16 affected / 54 at risk

Adverse event: Pain, Liver
Serious: no
Organ System: General disorders
Frequency: 3 affected / 54 at risk

Adverse event: Pain, Stomach
Serious: no
Organ System: General disorders
Frequency: 6 affected / 54 at risk

Adverse event: Hepatobiliary - Other
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 3 affected / 54 at risk

Adverse event: Infection - Other
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 54 at risk

Adverse event: Blood alkaline phosphatase
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 7 affected / 54 at risk

Adverse event: Alanine aminotransferase
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 10 affected / 54 at risk

Adverse event: Aspartate aminotransferase
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 8 affected / 54 at risk

Adverse event: Gamma-glutamyltransferase
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 7 affected / 54 at risk

Adverse event: Bilirubin (Hyperbilirubinemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 54 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 54 at risk

Adverse event: Hyponatraemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 54 at risk

Adverse event: Metabolic/Lab - Other
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 54 at risk

Adverse event: Mood Alteration, Anxiety
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 54 at risk

Adverse event: Confusional state
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 54 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 6 affected / 54 at risk

Adverse event: Neurology - Other
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 54 at risk

Adverse event: Neuropathy: Sensory
Serious: no
Organ System: Nervous system disorders
Frequency: 7 affected / 54 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 54 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 11 affected / 54 at risk

Adverse event: Pleural effusion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 54 at risk

Adverse event: Pulmonary - Other
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 54 at risk

Adverse event: Dyspnea (Shortness Of Breath)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 14 affected / 54 at risk

Adverse event: Alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 9 affected / 54 at risk

Adverse event: Dry skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 54 at risk

Adverse event: Hand-Foot Skin Reaction
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 13 affected / 54 at risk

Adverse event: Nail disorder
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 54 at risk

Adverse event: Dermatology - Other
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 7 affected / 54 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 15 affected / 54 at risk

Adverse event: Rash/Desquamation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 21 affected / 54 at risk

Adverse event: Flushing
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 54 at risk

Adverse event: Hemorrhage Pulmonary, Nose
Serious: no
Organ System: Vascular disorders
Frequency: 3 affected / 54 at risk