Study: NCT00586495

Adverse event: Haemoglobin
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 95 at risk

Adverse event: Leukocytes
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 95 at risk

Adverse event: Platelets
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 95 at risk

Adverse event: Prolonged QTC
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 95 at risk

Adverse event: Cardiac ischemia/infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 95 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 95 at risk

Adverse event: Left ventricular dysfunction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 95 at risk

Adverse event: Pericardial effusion
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 95 at risk

Adverse event: Constitutional symptoms - other
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 95 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 95 at risk

Adverse event: Death not associated with CTCAE term, death NOS
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 95 at risk

Adverse event: Death not associated with CTCAE term, disease progression NOS
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 95 at risk

Adverse event: Decreased appetite
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 95 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 95 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 95 at risk

Adverse event: Distension
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 95 at risk

Adverse event: GI - other
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 95 at risk

Adverse event: Ileus
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 95 at risk

Adverse event: Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 95 at risk

Adverse event: Ulcer, GI, duodeum
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 95 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 95 at risk

Adverse event: Hemorrhage pulmonary, bronchus
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 95 at risk

Adverse event: Hemorrhage, GI, colon
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 95 at risk

Adverse event: Hemorrhage, GI, duodenum
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 95 at risk

Adverse event: Cholecystitis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 3 affected / 95 at risk

Adverse event: Liver dysfunction
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 2 affected / 95 at risk

Adverse event: Infection - other
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 95 at risk

Adverse event: Infection with normal ANC, bronchus
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 95 at risk

Adverse event: Infection with normal ANC, lung (pneumonia)
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 95 at risk

Adverse event: Infection with normal ANC, upper airway NOS
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 95 at risk

Adverse event: Edema: limb
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 95 at risk

Adverse event: Lymphatics - other
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 95 at risk

Adverse event: Alanine aminotransferase
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 95 at risk

Adverse event: Amylase
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 95 at risk

Adverse event: Aspartate aminotransferase
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 95 at risk

Adverse event: Bilirubin (hyperbilirubinemia)
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 95 at risk

Adverse event: Blood creatine phosphokinase
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 95 at risk

Adverse event: Gamma-glutamyltransferase
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 95 at risk

Adverse event: Hypercalcaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 95 at risk

Adverse event: Hyperkalaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 95 at risk

Adverse event: Hypoalbuminaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 95 at risk

Adverse event: Hypokalaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 95 at risk

Adverse event: Hyponatraemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 95 at risk

Adverse event: Lipase
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 95 at risk

Adverse event: Metabolic/lab - other
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 95 at risk

Adverse event: Proteinuria
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 95 at risk

Adverse event: Fracture
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 95 at risk

Adverse event: Dizziness
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 95 at risk

Adverse event: Somnolence
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 95 at risk

Adverse event: Cataract
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 95 at risk

Adverse event: No code in CTCAE
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 95 at risk

Adverse event: Pain, abdomen NOS
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 95 at risk

Adverse event: Pain, tumor pain
Serious: yes
Organ System: General disorders
Frequency: 4 affected / 95 at risk

Adverse event: Cough
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 95 at risk

Adverse event: Dyspnea (shortness of breath)
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 95 at risk

Adverse event: Hypoxia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 95 at risk

Adverse event: Pleural effusion
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 95 at risk

Adverse event: Pulmonary - other
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 95 at risk

Adverse event: Syndromes - other
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 95 at risk

Adverse event: Hypersensitivity
Serious: no
Organ System: Immune system disorders
Frequency: 6 affected / 95 at risk

Adverse event: Auditory/ear - other
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 5 affected / 95 at risk

Adverse event: Blood - other
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 5 affected / 95 at risk

Adverse event: Haemoglobin
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 14 affected / 95 at risk

Adverse event: Leukocytes
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 7 affected / 95 at risk

Adverse event: Lymphopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 8 affected / 95 at risk

Adverse event: Hypertension
Serious: no
Organ System: Cardiac disorders
Frequency: 41 affected / 95 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 31 affected / 95 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 19 affected / 95 at risk

Adverse event: Hypothermia
Serious: no
Organ System: General disorders
Frequency: 7 affected / 95 at risk

Adverse event: Insomnia
Serious: no
Organ System: General disorders
Frequency: 8 affected / 95 at risk

Adverse event: Rigors/chills
Serious: no
Organ System: General disorders
Frequency: 6 affected / 95 at risk

Adverse event: Weight decreased
Serious: no
Organ System: General disorders
Frequency: 28 affected / 95 at risk

Adverse event: Alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 48 affected / 95 at risk

Adverse event: Dermatology - other
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 15 affected / 95 at risk

Adverse event: Dry skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 6 affected / 95 at risk

Adverse event: Flushing
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 5 affected / 95 at risk

Adverse event: Hand-foot skin reaction
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 61 affected / 95 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 19 affected / 95 at risk

Adverse event: Rash/desquamation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 54 affected / 95 at risk

Adverse event: Hot flush
Serious: no
Organ System: Endocrine disorders
Frequency: 5 affected / 95 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 27 affected / 95 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 18 affected / 95 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 58 affected / 95 at risk

Adverse event: Distension
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 95 at risk

Adverse event: GI - other
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 95 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 95 at risk

Adverse event: Mucositis (clinical exam), oral cavity
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 95 at risk

Adverse event: Mucositis (functional/symptomatic), oral cavity
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 95 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 15 affected / 95 at risk

Adverse event: Periodontal
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 95 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 16 affected / 95 at risk

Adverse event: Hemorrhage pulmonary, bronchopulmonary NOS
Serious: no
Organ System: Vascular disorders
Frequency: 6 affected / 95 at risk

Adverse event: Hemorrhage pulmonary, nose
Serious: no
Organ System: Vascular disorders
Frequency: 7 affected / 95 at risk

Adverse event: Infection - other
Serious: no
Organ System: Infections and infestations
Frequency: 12 affected / 95 at risk

Adverse event: Infection with normal ANC, Bronchus
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 95 at risk

Adverse event: Infection with normal ANC, Lung (Pneumonia)
Serious: no
Organ System: Infections and infestations
Frequency: 12 affected / 95 at risk

Adverse event: Edema: head and neck
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 7 affected / 95 at risk

Adverse event: Edema: limb
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 16 affected / 95 at risk

Adverse event: Blood alkaline phosphatase
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 15 affected / 95 at risk

Adverse event: Alanine aminotransferase
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 23 affected / 95 at risk

Adverse event: Amylase
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 43 affected / 95 at risk

Adverse event: Aspartate aminotransferase
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 24 affected / 95 at risk

Adverse event: Bilirubin (hyperbilirubinemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 95 at risk

Adverse event: Blood creatinine
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 8 affected / 95 at risk

Adverse event: Gamma-glutamyltransferase
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 7 affected / 95 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 95 at risk

Adverse event: Hyperuricaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 15 affected / 95 at risk

Adverse event: Hypoalbuminaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 11 affected / 95 at risk

Adverse event: Lipase
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 62 affected / 95 at risk

Adverse event: Metabolic/lab - other
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 38 affected / 95 at risk

Adverse event: Proteinuria
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 12 affected / 95 at risk

Adverse event: Musculoskeletal - other
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 12 affected / 95 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 6 affected / 95 at risk

Adverse event: Neuropathy - sensory
Serious: no
Organ System: Nervous system disorders
Frequency: 6 affected / 95 at risk

Adverse event: Ocular surface disease
Serious: no
Organ System: Eye disorders
Frequency: 5 affected / 95 at risk

Adverse event: Pain, abdomen NOS
Serious: no
Organ System: General disorders
Frequency: 11 affected / 95 at risk

Adverse event: Pain, back
Serious: no
Organ System: General disorders
Frequency: 23 affected / 95 at risk

Adverse event: Pain, chest/thorax NOS
Serious: no
Organ System: General disorders
Frequency: 10 affected / 95 at risk

Adverse event: Pain, dental/teeth/peridontal
Serious: no
Organ System: General disorders
Frequency: 5 affected / 95 at risk

Adverse event: Pain, extremity/limb
Serious: no
Organ System: General disorders
Frequency: 13 affected / 95 at risk

Adverse event: Pain, head/headache
Serious: no
Organ System: General disorders
Frequency: 18 affected / 95 at risk

Adverse event: Pain, joint
Serious: no
Organ System: General disorders
Frequency: 16 affected / 95 at risk

Adverse event: Pain, other
Serious: no
Organ System: General disorders
Frequency: 8 affected / 95 at risk

Adverse event: Pain, stomach
Serious: no
Organ System: General disorders
Frequency: 6 affected / 95 at risk

Adverse event: Pain, throat/pharynx/larynx
Serious: no
Organ System: General disorders
Frequency: 10 affected / 95 at risk

Adverse event: Pain, tumor pain
Serious: no
Organ System: General disorders
Frequency: 15 affected / 95 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 21 affected / 95 at risk

Adverse event: Dyspnea (shortness of breath)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 8 affected / 95 at risk

Adverse event: Pleural effusion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 95 at risk

Adverse event: Pulmonary - other
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 95 at risk

Adverse event: Voice changes
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 18 affected / 95 at risk

Adverse event: Flu-like syndrome
Serious: no
Organ System: General disorders
Frequency: 34 affected / 95 at risk