Study: NCT00117637

Adverse event: Hypersensitivity
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 97 at risk

Adverse event: Haemoglobin
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 97 at risk

Adverse event: Cardio-respiratory arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 97 at risk

Adverse event: cardiac ischemia / infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 97 at risk

Adverse event: cardiac general - other
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 97 at risk

Adverse event: death not associated with CTCAE term, death NOS
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 97 at risk

Adverse event: death not associated with CTCAE term, disease progress
Serious: yes
Organ System: General disorders
Frequency: 10 affected / 97 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 97 at risk

Adverse event: Fatigue
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 97 at risk

Adverse event: constitutional symptoms - other
Serious: yes
Organ System: General disorders
Frequency: 6 affected / 97 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 97 at risk

Adverse event: obstruction, GI, stomach
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 97 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 97 at risk

Adverse event: hemorrhage - other
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 97 at risk

Adverse event: hemorrhage pulmonary, bronchopulmonary NOS
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 97 at risk

Adverse event: infection with normal ANC, abdomen NOS
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 97 at risk

Adverse event: infection with normal ANC, lung (pneumonia)
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 97 at risk

Adverse event: infection with unknown ANC, bronchus
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 97 at risk

Adverse event: infection with unknown ANC, upper airway NOS
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 97 at risk

Adverse event: bilirubin (hyperbilirubinemia)
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 97 at risk

Adverse event: Hyperkalaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 97 at risk

Adverse event: Hypocalcaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 97 at risk

Adverse event: Hypoglycaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 97 at risk

Adverse event: metabolic / lab - other
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 97 at risk

Adverse event: CNS ischemia
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 97 at risk

Adverse event: neurology - other
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 97 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 97 at risk

Adverse event: Somnolence
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 97 at risk

Adverse event: pain, back
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 97 at risk

Adverse event: pain, chest / thorax NOS
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 97 at risk

Adverse event: pain, tumor pain
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 97 at risk

Adverse event: pain, abdomen NOS
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 97 at risk

Adverse event: pain, head / headache
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 97 at risk

Adverse event: pain, bone
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 97 at risk

Adverse event: pain, other
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 97 at risk

Adverse event: Pleural effusion
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 97 at risk

Adverse event: dyspnea (shortness of breath)
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 97 at risk

Adverse event: Renal failure
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 3 affected / 97 at risk

Adverse event: Urinary retention
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 97 at risk

Adverse event: hand-foot skin reaction
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 97 at risk

Adverse event: Ulcer
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 97 at risk

Adverse event: secondary malignancy (possibly related to cancer treat)
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 97 at risk

Adverse event: thrombosis / thrombus / embolism
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 97 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Immune system disorders
Frequency: 6 affected / 97 at risk

Adverse event: Neutrophil count
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 97 at risk

Adverse event: Haemoglobin
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 14 affected / 97 at risk

Adverse event: platelets
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 97 at risk

Adverse event: leukocytes
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 97 at risk

Adverse event: Hypertension
Serious: no
Organ System: Cardiac disorders
Frequency: 24 affected / 97 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 10 affected / 97 at risk

Adverse event: Insomnia
Serious: no
Organ System: General disorders
Frequency: 2 affected / 97 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 48 affected / 97 at risk

Adverse event: Weight decreased
Serious: no
Organ System: General disorders
Frequency: 26 affected / 97 at risk

Adverse event: constitutional symptoms - other
Serious: no
Organ System: General disorders
Frequency: 7 affected / 97 at risk

Adverse event: rigors / chills
Serious: no
Organ System: General disorders
Frequency: 1 affected / 97 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 34 affected / 97 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 12 affected / 97 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 54 affected / 97 at risk

Adverse event: Dry mouth
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 97 at risk

Adverse event: mucositis (functional / symptomatic), oral cavity
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 12 affected / 97 at risk

Adverse event: mucositis (clinical exam), oral cavity
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 97 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 24 affected / 97 at risk

Adverse event: Taste disorder
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 97 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 18 affected / 97 at risk

Adverse event: hemorrhage pulmonary, nose
Serious: no
Organ System: Vascular disorders
Frequency: 5 affected / 97 at risk

Adverse event: infection with normal ANC, urinary tract NOS
Serious: no
Organ System: Infections and infestations
Frequency: 7 affected / 97 at risk

Adverse event: infection - other
Serious: no
Organ System: Infections and infestations
Frequency: 12 affected / 97 at risk

Adverse event: infection with unknown ANC, urinary tract NOS
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 97 at risk

Adverse event: edema: limb
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 4 affected / 97 at risk

Adverse event: Alanine aminotransferase
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 97 at risk

Adverse event: Aspartate aminotransferase
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 6 affected / 97 at risk

Adverse event: Blood creatinine
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 97 at risk

Adverse event: Hyperuricaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 8 affected / 97 at risk

Adverse event: Lipase
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 16 affected / 97 at risk

Adverse event: Confusional state
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 97 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 97 at risk

Adverse event: mood alteration, depression
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 97 at risk

Adverse event: neuropathy: sensory
Serious: no
Organ System: Nervous system disorders
Frequency: 6 affected / 97 at risk

Adverse event: pain, back
Serious: no
Organ System: General disorders
Frequency: 12 affected / 97 at risk

Adverse event: pain, extremity - limb
Serious: no
Organ System: General disorders
Frequency: 7 affected / 97 at risk

Adverse event: pain, tumor pain
Serious: no
Organ System: General disorders
Frequency: 4 affected / 97 at risk

Adverse event: pain, abdomen NOS
Serious: no
Organ System: General disorders
Frequency: 14 affected / 97 at risk

Adverse event: pain, head / headache
Serious: no
Organ System: General disorders
Frequency: 5 affected / 97 at risk

Adverse event: pain, joint
Serious: no
Organ System: General disorders
Frequency: 4 affected / 97 at risk

Adverse event: pain, muscle
Serious: no
Organ System: General disorders
Frequency: 9 affected / 97 at risk

Adverse event: pain, bone
Serious: no
Organ System: General disorders
Frequency: 9 affected / 97 at risk

Adverse event: pain, other
Serious: no
Organ System: General disorders
Frequency: 18 affected / 97 at risk

Adverse event: pain, neuralgia / peripheral nerve
Serious: no
Organ System: General disorders
Frequency: 5 affected / 97 at risk

Adverse event: pain, stomach
Serious: no
Organ System: General disorders
Frequency: 5 affected / 97 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 12 affected / 97 at risk

Adverse event: dyspnea (shortness of breath)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 13 affected / 97 at risk

Adverse event: voice changes
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 8 affected / 97 at risk

Adverse event: renal - other
Serious: no
Organ System: Renal and urinary disorders
Frequency: 6 affected / 97 at risk

Adverse event: Alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 40 affected / 97 at risk

Adverse event: Dry skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 10 affected / 97 at risk

Adverse event: hand-foot skin reaction
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 57 affected / 97 at risk

Adverse event: dermatology - other
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 7 affected / 97 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 14 affected / 97 at risk

Adverse event: rash / desquamation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 40 affected / 97 at risk

Adverse event: flu-like syndrome
Serious: no
Organ System: General disorders
Frequency: 5 affected / 97 at risk

Adverse event: Hypersensitivity
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 90 at risk

Adverse event: auditory / ear - other
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 90 at risk

Adverse event: Haemoglobin
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 6 affected / 90 at risk

Adverse event: conduction abnormality, asystole
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 90 at risk

Adverse event: supraventricular arrhythmia, supraventricular arrhythmi
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 90 at risk

Adverse event: cardiac ischemia / infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 90 at risk

Adverse event: cardiac general - other
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 90 at risk

Adverse event: death not associated with CTCAE term, disease progress
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 90 at risk

Adverse event: Fatigue
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 90 at risk

Adverse event: constitutional symptoms - other
Serious: yes
Organ System: General disorders
Frequency: 4 affected / 90 at risk

Adverse event: Ascites
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 90 at risk

Adverse event: Constipation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 90 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 90 at risk

Adverse event: Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 90 at risk

Adverse event: perforation, GI, colon
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 90 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 90 at risk

Adverse event: Haematoma
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 90 at risk

Adverse event: hemorrhage, GI, colon
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 90 at risk

Adverse event: hemorrhage, GI, stomach
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 90 at risk

Adverse event: hemorrhage, GI, lower GI NOS
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 90 at risk

Adverse event: hemorrhage, GI, upper GI NOS
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 90 at risk

Adverse event: hepatobiliary - other
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 90 at risk

Adverse event: infection (documented clinically), appendix
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 90 at risk

Adverse event: infection with normal ANC, lung (pneumonia)
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 90 at risk

Adverse event: Fracture
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 90 at risk

Adverse event: Alanine aminotransferase
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 90 at risk

Adverse event: Aspartate aminotransferase
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 90 at risk

Adverse event: bilirubin (hyperbilirubinemia)
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 90 at risk

Adverse event: metabolic / lab - other
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 90 at risk

Adverse event: CNS ischemia
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 90 at risk

Adverse event: Confusional state
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 90 at risk

Adverse event: Dizziness
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 90 at risk

Adverse event: Hydrocephalus
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 90 at risk

Adverse event: mood alteration, depression
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 90 at risk

Adverse event: neurology - other
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 90 at risk

Adverse event: pain, extremity - limb
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 90 at risk

Adverse event: pain, abdomen NOS
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 90 at risk

Adverse event: Cough
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 90 at risk

Adverse event: Pneumonitis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 90 at risk

Adverse event: Pneumothorax
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 90 at risk

Adverse event: dyspnea (shortness of breath)
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 90 at risk

Adverse event: Urinary retention
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 90 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 90 at risk

Adverse event: Neutrophil count
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 13 affected / 90 at risk

Adverse event: Haemoglobin
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 23 affected / 90 at risk

Adverse event: platelets
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 11 affected / 90 at risk

Adverse event: leukocytes
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 11 affected / 90 at risk

Adverse event: Hypertension
Serious: no
Organ System: Cardiac disorders
Frequency: 7 affected / 90 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 30 affected / 90 at risk

Adverse event: Insomnia
Serious: no
Organ System: General disorders
Frequency: 8 affected / 90 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 41 affected / 90 at risk

Adverse event: Weight decreased
Serious: no
Organ System: General disorders
Frequency: 24 affected / 90 at risk

Adverse event: constitutional symptoms - other
Serious: no
Organ System: General disorders
Frequency: 11 affected / 90 at risk

Adverse event: rigors / chills
Serious: no
Organ System: General disorders
Frequency: 10 affected / 90 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 28 affected / 90 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 90 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 14 affected / 90 at risk

Adverse event: Dry mouth
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 90 at risk

Adverse event: mucositis (functional / symptomatic), oral cavity
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 90 at risk

Adverse event: mucositis (clinical exam), oral cavity
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 90 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 26 affected / 90 at risk

Adverse event: Taste disorder
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 90 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 15 affected / 90 at risk

Adverse event: hemorrhage pulmonary, nose
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 90 at risk

Adverse event: infection with normal ANC, urinary tract NOS
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 90 at risk

Adverse event: infection - other
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 90 at risk

Adverse event: infection with unknown ANC, urinary tract NOS
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 90 at risk

Adverse event: edema: limb
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 5 affected / 90 at risk

Adverse event: Alanine aminotransferase
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 8 affected / 90 at risk

Adverse event: Aspartate aminotransferase
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 9 affected / 90 at risk

Adverse event: Blood creatinine
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 6 affected / 90 at risk

Adverse event: Hyperuricaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 90 at risk

Adverse event: Lipase
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 90 at risk

Adverse event: Confusional state
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 90 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 9 affected / 90 at risk

Adverse event: mood alteration, depression
Serious: no
Organ System: Nervous system disorders
Frequency: 15 affected / 90 at risk

Adverse event: neuropathy: sensory
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 90 at risk

Adverse event: pain, back
Serious: no
Organ System: General disorders
Frequency: 5 affected / 90 at risk

Adverse event: pain, extremity - limb
Serious: no
Organ System: General disorders
Frequency: 7 affected / 90 at risk

Adverse event: pain, tumor pain
Serious: no
Organ System: General disorders
Frequency: 5 affected / 90 at risk

Adverse event: pain, abdomen NOS
Serious: no
Organ System: General disorders
Frequency: 10 affected / 90 at risk

Adverse event: pain, head / headache
Serious: no
Organ System: General disorders
Frequency: 13 affected / 90 at risk

Adverse event: pain, joint
Serious: no
Organ System: General disorders
Frequency: 5 affected / 90 at risk

Adverse event: pain, muscle
Serious: no
Organ System: General disorders
Frequency: 6 affected / 90 at risk

Adverse event: pain, bone
Serious: no
Organ System: General disorders
Frequency: 8 affected / 90 at risk

Adverse event: pain, other
Serious: no
Organ System: General disorders
Frequency: 10 affected / 90 at risk

Adverse event: pain, neuralgia / peripheral nerve
Serious: no
Organ System: General disorders
Frequency: 1 affected / 90 at risk

Adverse event: pain, stomach
Serious: no
Organ System: General disorders
Frequency: 4 affected / 90 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 15 affected / 90 at risk

Adverse event: dyspnea (shortness of breath)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 10 affected / 90 at risk

Adverse event: Alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 6 affected / 90 at risk

Adverse event: Dry skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 9 affected / 90 at risk

Adverse event: hand-foot skin reaction
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 90 at risk

Adverse event: dermatology - other
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 90 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 12 affected / 90 at risk

Adverse event: rash / desquamation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 8 affected / 90 at risk

Adverse event: flu-like syndrome
Serious: no
Organ System: General disorders
Frequency: 20 affected / 90 at risk

Adverse event: Haemoglobin
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 49 at risk

Adverse event: platelets
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 49 at risk

Adverse event: cardiac general - other
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 49 at risk

Adverse event: death not associated with CTCAE term, disease progress
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 49 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 49 at risk

Adverse event: hemorrhage pulmonary, bronchopulmonary NOS
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 49 at risk

Adverse event: hemorrhage, GI, anus
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 49 at risk

Adverse event: hemorrhage, GI, varices (rectal)
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 49 at risk

Adverse event: infection (documented clinically), lung (pneumonia)
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 49 at risk

Adverse event: edema: limb
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 49 at risk

Adverse event: Hypoglycaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 49 at risk

Adverse event: pain, extremity - limb
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 49 at risk

Adverse event: pain, tumor pain
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 49 at risk

Adverse event: pain, bone
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 49 at risk

Adverse event: pain, other
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 49 at risk

Adverse event: dyspnea (shortness of breath)
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 49 at risk

Adverse event: airway obstruction, bronchus
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 49 at risk

Adverse event: pulmonary - other
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 49 at risk

Adverse event: Haemoglobin
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 10 affected / 49 at risk

Adverse event: platelets
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 49 at risk

Adverse event: Lymphopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 4 affected / 49 at risk

Adverse event: Hypertension
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 49 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 2 affected / 49 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 16 affected / 49 at risk

Adverse event: Weight decreased
Serious: no
Organ System: General disorders
Frequency: 12 affected / 49 at risk

Adverse event: constitutional symptoms - other
Serious: no
Organ System: General disorders
Frequency: 3 affected / 49 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 11 affected / 49 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 49 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 12 affected / 49 at risk

Adverse event: mucositis (functional / symptomatic), oral cavity
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 49 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 49 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 49 at risk

Adverse event: infection with normal ANC, urinary tract NOS
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 49 at risk

Adverse event: infection - other
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 49 at risk

Adverse event: infection with normal ANC, upper airway NOS
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 49 at risk

Adverse event: edema: limb
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 5 affected / 49 at risk

Adverse event: Blood creatinine
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 49 at risk

Adverse event: Hyperuricaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 49 at risk

Adverse event: Lipase
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 49 at risk

Adverse event: Amylase
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 49 at risk

Adverse event: Hypoalbuminaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 49 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 49 at risk

Adverse event: Hyponatraemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 49 at risk

Adverse event: metabolic / lab - other
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 49 at risk

Adverse event: mood alteration, depression
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 49 at risk

Adverse event: neuropathy: sensory
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 49 at risk

Adverse event: pain, back
Serious: no
Organ System: General disorders
Frequency: 2 affected / 49 at risk

Adverse event: pain, extremity - limb
Serious: no
Organ System: General disorders
Frequency: 1 affected / 49 at risk

Adverse event: pain, abdomen NOS
Serious: no
Organ System: General disorders
Frequency: 3 affected / 49 at risk

Adverse event: pain, joint
Serious: no
Organ System: General disorders
Frequency: 3 affected / 49 at risk

Adverse event: pain, bone
Serious: no
Organ System: General disorders
Frequency: 4 affected / 49 at risk

Adverse event: pain, other
Serious: no
Organ System: General disorders
Frequency: 5 affected / 49 at risk

Adverse event: pain, chest / thorax NOS
Serious: no
Organ System: General disorders
Frequency: 1 affected / 49 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 49 at risk

Adverse event: dyspnea (shortness of breath)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 49 at risk

Adverse event: Alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 49 at risk

Adverse event: Dry skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 49 at risk

Adverse event: hand-foot skin reaction
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 8 affected / 49 at risk

Adverse event: dermatology - other
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 49 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 49 at risk

Adverse event: rash / desquamation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 49 at risk

Adverse event: Haemoglobin
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 4 affected / 61 at risk

Adverse event: supraventricular arrhythmia, atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 61 at risk

Adverse event: cardiac ischemia / infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 61 at risk

Adverse event: cardiac general - other
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 61 at risk

Adverse event: death not associated with CTCAE term, disease progress
Serious: yes
Organ System: General disorders
Frequency: 7 affected / 61 at risk

Adverse event: Fatigue
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 61 at risk

Adverse event: constitutional symptoms - other
Serious: yes
Organ System: General disorders
Frequency: 5 affected / 61 at risk

Adverse event: Ascites
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 61 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 61 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 61 at risk

Adverse event: Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 61 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 61 at risk

Adverse event: Ileus
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 61 at risk

Adverse event: GI - other
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 61 at risk

Adverse event: hemorrhage, GI, lower GI NOS
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 61 at risk

Adverse event: liver dysfunction
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 61 at risk

Adverse event: infection - other
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 61 at risk

Adverse event: edema: limb
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 61 at risk

Adverse event: Osteoporosis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 61 at risk

Adverse event: neurology - other
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 61 at risk

Adverse event: speech impairment
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 61 at risk

Adverse event: pain, chest / thorax NOS
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 61 at risk

Adverse event: pain, extremity - limb
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 61 at risk

Adverse event: pain, abdomen NOS
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 61 at risk

Adverse event: pain, other
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 61 at risk

Adverse event: pain, joint
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 61 at risk

Adverse event: dyspnea (shortness of breath)
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 61 at risk

Adverse event: Acute respiratory distress syndrome
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 61 at risk

Adverse event: pulmonary - other
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 61 at risk

Adverse event: hand-foot skin reaction
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 61 at risk

Adverse event: thrombosis / thrombus / embolism
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 61 at risk

Adverse event: Haemoglobin
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 8 affected / 61 at risk

Adverse event: platelets
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 4 affected / 61 at risk

Adverse event: Lymphopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 61 at risk

Adverse event: Hypertension
Serious: no
Organ System: Cardiac disorders
Frequency: 13 affected / 61 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 4 affected / 61 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 22 affected / 61 at risk

Adverse event: Weight decreased
Serious: no
Organ System: General disorders
Frequency: 10 affected / 61 at risk

Adverse event: constitutional symptoms - other
Serious: no
Organ System: General disorders
Frequency: 4 affected / 61 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 61 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 61 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 31 affected / 61 at risk

Adverse event: mucositis (functional / symptomatic), oral cavity
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 61 at risk

Adverse event: mucositis (clinical exam), oral cavity
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 61 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 14 affected / 61 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 61 at risk

Adverse event: infection - other
Serious: no
Organ System: Infections and infestations
Frequency: 7 affected / 61 at risk

Adverse event: infection (documented clinically), urinary tract NOS
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 61 at risk

Adverse event: infection with normal ANC, upper airway NOS
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 61 at risk

Adverse event: edema: limb
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 61 at risk

Adverse event: Hyperuricaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 61 at risk

Adverse event: Lipase
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 7 affected / 61 at risk

Adverse event: Amylase
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 61 at risk

Adverse event: Hypercalcaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 61 at risk

Adverse event: Hypoalbuminaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 61 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 61 at risk

Adverse event: Hyponatraemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 61 at risk

Adverse event: metabolic / lab - other
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 61 at risk

Adverse event: mood alteration, depression
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 61 at risk

Adverse event: neuropathy: sensory
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 61 at risk

Adverse event: pain, back
Serious: no
Organ System: General disorders
Frequency: 4 affected / 61 at risk

Adverse event: pain, extremity - limb
Serious: no
Organ System: General disorders
Frequency: 7 affected / 61 at risk

Adverse event: pain, abdomen NOS
Serious: no
Organ System: General disorders
Frequency: 7 affected / 61 at risk

Adverse event: pain, head / headache
Serious: no
Organ System: General disorders
Frequency: 5 affected / 61 at risk

Adverse event: pain, joint
Serious: no
Organ System: General disorders
Frequency: 3 affected / 61 at risk

Adverse event: pain, muscle
Serious: no
Organ System: General disorders
Frequency: 4 affected / 61 at risk

Adverse event: pain, bone
Serious: no
Organ System: General disorders
Frequency: 1 affected / 61 at risk

Adverse event: pain, other
Serious: no
Organ System: General disorders
Frequency: 9 affected / 61 at risk

Adverse event: pain, chest / thorax NOS
Serious: no
Organ System: General disorders
Frequency: 5 affected / 61 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 6 affected / 61 at risk

Adverse event: dyspnea (shortness of breath)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 61 at risk

Adverse event: Alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 17 affected / 61 at risk

Adverse event: Dry skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 6 affected / 61 at risk

Adverse event: hand-foot skin reaction
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 28 affected / 61 at risk

Adverse event: dermatology - other
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 5 affected / 61 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 6 affected / 61 at risk

Adverse event: rash / desquamation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 17 affected / 61 at risk