Study: NCT00492297

Adverse event: Blood - other
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 83 at risk

Adverse event: Haemoglobin
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 83 at risk

Adverse event: Leukocytes
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 83 at risk

Adverse event: Neutrophile
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 83 at risk

Adverse event: Platelets
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 5 affected / 83 at risk

Adverse event: Cardiac arrhythmia - other
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 83 at risk

Adverse event: Palpitations
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 83 at risk

Adverse event: Prolonged QTC
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 83 at risk

Adverse event: Supraventricular arrhythmia, atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 83 at risk

Adverse event: Cardiac ischemia/infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 83 at risk

Adverse event: Fatigue
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 83 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 4 affected / 83 at risk

Adverse event: Death not associated with CTAE term, disease progression nos
Serious: yes
Organ System: General disorders
Frequency: 7 affected / 83 at risk

Adverse event: Dermatology - other
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 83 at risk

Adverse event: Ascites
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 83 at risk

Adverse event: Constipation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 83 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 83 at risk

Adverse event: Hemorrhage - other
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 83 at risk

Adverse event: Hemorrhage, GI, lower GI
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 83 at risk

Adverse event: Hemorrhage, GI, upper GI nos
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 83 at risk

Adverse event: Hepathobiliary - other
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 83 at risk

Adverse event: Liver dysfunction
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 83 at risk

Adverse event: Febrile neutropenia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 83 at risk

Adverse event: Infection (doc. clinic), foreign body (e.g. graft, implant, pros, stent)
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 83 at risk

Adverse event: Infection (documented clinically), lung (pneumonia)
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 83 at risk

Adverse event: Infection (documented clinically), upper airway nos
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 83 at risk

Adverse event: Infection - other
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 83 at risk

Adverse event: Device/prosthesis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 83 at risk

Adverse event: Musculoskeletal - other
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 83 at risk

Adverse event: Confusional state
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 83 at risk

Adverse event: Neurology - other
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 83 at risk

Adverse event: Ocular - other
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 83 at risk

Adverse event: Pain, abdomen nos
Serious: yes
Organ System: General disorders
Frequency: 5 affected / 83 at risk

Adverse event: Pain, chest/thorax nos
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 83 at risk

Adverse event: Pain, head/headache
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 83 at risk

Adverse event: Pain, other
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 83 at risk

Adverse event: Pleural effusion
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 83 at risk

Adverse event: Renal - other
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 83 at risk

Adverse event: Secondary malignancy (possibly related to cancer treatment)
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 83 at risk

Adverse event: Thrombosis/thrombus/embolism
Serious: yes
Organ System: Vascular disorders
Frequency: 4 affected / 83 at risk

Adverse event: Neutrophil count
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 42 affected / 83 at risk

Adverse event: Haemoglobin
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 15 affected / 83 at risk

Adverse event: Platelets
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 24 affected / 83 at risk

Adverse event: Leukocytes
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 15 affected / 83 at risk

Adverse event: Cardiac arrhythmia - other
Serious: no
Organ System: Cardiac disorders
Frequency: 5 affected / 83 at risk

Adverse event: Hypertension
Serious: no
Organ System: Cardiac disorders
Frequency: 16 affected / 83 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 10 affected / 83 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 51 affected / 83 at risk

Adverse event: Constitutional symptoms - other
Serious: no
Organ System: General disorders
Frequency: 7 affected / 83 at risk

Adverse event: Hyperhidrosis
Serious: no
Organ System: General disorders
Frequency: 10 affected / 83 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 18 affected / 83 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 44 affected / 83 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 43 affected / 83 at risk

Adverse event: Gastritis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 83 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 83 at risk

Adverse event: Mucositis (functional/symptomatic), oral cavity
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 83 at risk

Adverse event: Mucositis (clinical exam), oral cavity
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 14 affected / 83 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 38 affected / 83 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 24 affected / 83 at risk

Adverse event: Infection - other
Serious: no
Organ System: Infections and infestations
Frequency: 13 affected / 83 at risk

Adverse event: Alanine aminotransferase
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 83 at risk

Adverse event: Amylase
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 83 at risk

Adverse event: Metabolic/lab - other
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 6 affected / 83 at risk

Adverse event: Mood alteration, depression
Serious: no
Organ System: Nervous system disorders
Frequency: 6 affected / 83 at risk

Adverse event: Neurology - other
Serious: no
Organ System: Nervous system disorders
Frequency: 7 affected / 83 at risk

Adverse event: Neuropathy: Sensory
Serious: no
Organ System: Nervous system disorders
Frequency: 19 affected / 83 at risk

Adverse event: Pain, back
Serious: no
Organ System: General disorders
Frequency: 10 affected / 83 at risk

Adverse event: Pain, chest/thorax nos
Serious: no
Organ System: General disorders
Frequency: 5 affected / 83 at risk

Adverse event: Pain, extremity-limb
Serious: no
Organ System: General disorders
Frequency: 14 affected / 83 at risk

Adverse event: Pain, abdomen nos
Serious: no
Organ System: General disorders
Frequency: 24 affected / 83 at risk

Adverse event: Pain, head/headache
Serious: no
Organ System: General disorders
Frequency: 16 affected / 83 at risk

Adverse event: Pain, joint
Serious: no
Organ System: General disorders
Frequency: 16 affected / 83 at risk

Adverse event: Pain, other
Serious: no
Organ System: General disorders
Frequency: 7 affected / 83 at risk

Adverse event: Pain, pelvis
Serious: no
Organ System: General disorders
Frequency: 6 affected / 83 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 12 affected / 83 at risk

Adverse event: Dyspnea (shortness of breath)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 10 affected / 83 at risk

Adverse event: Voice changes
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 83 at risk

Adverse event: Alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 20 affected / 83 at risk

Adverse event: Hand-foot skin reaction
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 37 affected / 83 at risk

Adverse event: Dermatology - other
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 22 affected / 83 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 7 affected / 83 at risk

Adverse event: Rash/desquamation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 33 affected / 83 at risk

Adverse event: Flushing
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 16 affected / 83 at risk