Study: NCT00791778

Adverse event: Haemoglobin
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 123 at risk

Adverse event: Lymphatics - Other
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 123 at risk

Adverse event: SupraVentricular arrhythmia, Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 123 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 123 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 123 at risk

Adverse event: Enteritis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 123 at risk

Adverse event: Fistula, GI, Colon/Cecum/Appendix
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 123 at risk

Adverse event: Mucositis (functional/symptomatic), Esophagus
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 123 at risk

Adverse event: Ileus
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 123 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 123 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 123 at risk

Adverse event: Pain, Chest/thorax NOS
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 123 at risk

Adverse event: Pain, Abdomen NOS
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 123 at risk

Adverse event: Pain, Head/headache
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 123 at risk

Adverse event: Liver dysfunction
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 123 at risk

Adverse event: Hypersensitivity
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 123 at risk

Adverse event: Allergy - Other
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 123 at risk

Adverse event: Infection (Documented clinically), Urinary tract NOS
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 123 at risk

Adverse event: Infection with normal ANC, Urinary tract NOS
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 123 at risk

Adverse event: Intraop injury - Other
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 123 at risk

Adverse event: Fracture
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 123 at risk

Adverse event: Mood Alteration, Anxiety
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 123 at risk

Adverse event: Neurology - Other
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 123 at risk

Adverse event: Syncope (fainting)
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 123 at risk

Adverse event: Fistula, GU, Vagina
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 123 at risk

Adverse event: Hand-foot skin reaction
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 123 at risk

Adverse event: Dermatology - Other
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 123 at risk

Adverse event: Rash/desquamation
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 123 at risk

Adverse event: Urticaria
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 123 at risk

Adverse event: Thrombosis/embolism (vascular access)
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 123 at risk

Adverse event: Neutrophil count
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 12 affected / 123 at risk

Adverse event: Platelets
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 9 affected / 123 at risk

Adverse event: Leukocytes
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 10 affected / 123 at risk

Adverse event: Edema: Limb
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 4 affected / 123 at risk

Adverse event: Hypertension
Serious: no
Organ System: Cardiac disorders
Frequency: 45 affected / 123 at risk

Adverse event: Tinnitus
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 7 affected / 123 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 20 affected / 123 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 24 affected / 123 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 48 affected / 123 at risk

Adverse event: Gastritis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 123 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 123 at risk

Adverse event: Mucositis (functional/symptomatic), Oral cavity
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 25 affected / 123 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 33 affected / 123 at risk

Adverse event: GI - Other
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 123 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 22 affected / 123 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 11 affected / 123 at risk

Adverse event: Insomnia
Serious: no
Organ System: General disorders
Frequency: 8 affected / 123 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 38 affected / 123 at risk

Adverse event: Pain, Back
Serious: no
Organ System: General disorders
Frequency: 10 affected / 123 at risk

Adverse event: Pain, Extremity - limb
Serious: no
Organ System: General disorders
Frequency: 11 affected / 123 at risk

Adverse event: Pain, Abdomen NOS
Serious: no
Organ System: General disorders
Frequency: 21 affected / 123 at risk

Adverse event: Pain, Head/headache
Serious: no
Organ System: General disorders
Frequency: 29 affected / 123 at risk

Adverse event: Pain, Joint
Serious: no
Organ System: General disorders
Frequency: 13 affected / 123 at risk

Adverse event: Pain, Muscle
Serious: no
Organ System: General disorders
Frequency: 7 affected / 123 at risk

Adverse event: Pain, Other (Specify)
Serious: no
Organ System: General disorders
Frequency: 7 affected / 123 at risk

Adverse event: Pain, Pain NOS
Serious: no
Organ System: General disorders
Frequency: 10 affected / 123 at risk

Adverse event: Pain, Stomach
Serious: no
Organ System: General disorders
Frequency: 7 affected / 123 at risk

Adverse event: Pain, Throat/pharynx/larynx
Serious: no
Organ System: General disorders
Frequency: 7 affected / 123 at risk

Adverse event: Flu-like syndrome
Serious: no
Organ System: General disorders
Frequency: 11 affected / 123 at risk

Adverse event: Hypersensitivity
Serious: no
Organ System: Immune system disorders
Frequency: 7 affected / 123 at risk

Adverse event: Infection (Documented clinically), Upper airway NOS
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 123 at risk

Adverse event: Infection - Other
Serious: no
Organ System: Infections and infestations
Frequency: 7 affected / 123 at risk

Adverse event: Infection with unknown ANC, Upper airway NOS
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 123 at risk

Adverse event: Alanine aminotransferase
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 13 affected / 123 at risk

Adverse event: Aspartate aminotransferase
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 12 affected / 123 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 7 affected / 123 at risk

Adverse event: Hypophosphataemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 8 affected / 123 at risk

Adverse event: Metabolic/Lab - Other
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 9 affected / 123 at risk

Adverse event: Musculoskeletal - Other
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 10 affected / 123 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 9 affected / 123 at risk

Adverse event: Neuropathy: sensory
Serious: no
Organ System: Nervous system disorders
Frequency: 16 affected / 123 at risk

Adverse event: Cystitis
Serious: no
Organ System: Renal and urinary disorders
Frequency: 3 affected / 123 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 11 affected / 123 at risk

Adverse event: Pulmonary - Other
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 9 affected / 123 at risk

Adverse event: Dyspnea (shortness of breath)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 6 affected / 123 at risk

Adverse event: Voice changes
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 13 affected / 123 at risk

Adverse event: Alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 14 affected / 123 at risk

Adverse event: Dry skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 13 affected / 123 at risk

Adverse event: Hand-foot skin reaction
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 81 affected / 123 at risk

Adverse event: Dermatology - Other
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 22 affected / 123 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 24 affected / 123 at risk

Adverse event: Rash/desquamation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 62 affected / 123 at risk

Adverse event: Flushing
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 10 affected / 123 at risk

Adverse event: Urticaria
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 7 affected / 123 at risk

Adverse event: Neutrophil count
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 123 at risk

Adverse event: Constipation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 123 at risk

Adverse event: Ileus
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 123 at risk

Adverse event: Obstruction, GI, Ileum
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 123 at risk

Adverse event: Obstruction, GI, Small bowel NOS
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 123 at risk

Adverse event: Pain, Back
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 123 at risk

Adverse event: Pain, Abdomen NOS
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 123 at risk

Adverse event: Pain, Other (Specify)
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 123 at risk

Adverse event: Pain, Kidney
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 123 at risk

Adverse event: Syndromes - Other
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 123 at risk

Adverse event: No Code In CTCAE
Serious: yes
Organ System: General disorders
Frequency: 6 affected / 123 at risk

Adverse event: Cholecystitis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 123 at risk

Adverse event: Fracture
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 123 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 / 123 at risk

Adverse event: Syncope (fainting)
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 123 at risk

Adverse event: Pulmonary - Other
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 123 at risk

Adverse event: Wound complication, non-infectious
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 123 at risk

Adverse event: Rash/desquamation
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 123 at risk

Adverse event: Ulcer
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 123 at risk

Adverse event: Neutrophil count
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 8 affected / 123 at risk

Adverse event: Leukocytes
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 123 at risk

Adverse event: Edema: Limb
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 14 affected / 123 at risk

Adverse event: Hypertension
Serious: no
Organ System: Cardiac disorders
Frequency: 8 affected / 123 at risk

Adverse event: Tinnitus
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 123 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 123 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 18 affected / 123 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 22 affected / 123 at risk

Adverse event: Gastritis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 123 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 123 at risk

Adverse event: Mucositis (functional/symptomatic), Oral cavity
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 123 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 26 affected / 123 at risk

Adverse event: GI - Other
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 10 affected / 123 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 17 affected / 123 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 10 affected / 123 at risk

Adverse event: Insomnia
Serious: no
Organ System: General disorders
Frequency: 8 affected / 123 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 28 affected / 123 at risk

Adverse event: Pain, Back
Serious: no
Organ System: General disorders
Frequency: 16 affected / 123 at risk

Adverse event: Pain, Extremity - limb
Serious: no
Organ System: General disorders
Frequency: 15 affected / 123 at risk

Adverse event: Pain, Abdomen NOS
Serious: no
Organ System: General disorders
Frequency: 20 affected / 123 at risk

Adverse event: Pain, Head/headache
Serious: no
Organ System: General disorders
Frequency: 19 affected / 123 at risk

Adverse event: Pain, Joint
Serious: no
Organ System: General disorders
Frequency: 17 affected / 123 at risk

Adverse event: Pain, Muscle
Serious: no
Organ System: General disorders
Frequency: 9 affected / 123 at risk

Adverse event: Pain, Other (Specify)
Serious: no
Organ System: General disorders
Frequency: 11 affected / 123 at risk

Adverse event: Pain, Pain NOS
Serious: no
Organ System: General disorders
Frequency: 5 affected / 123 at risk

Adverse event: Pain, Stomach
Serious: no
Organ System: General disorders
Frequency: 8 affected / 123 at risk

Adverse event: Pain, Throat/pharynx/larynx
Serious: no
Organ System: General disorders
Frequency: 2 affected / 123 at risk

Adverse event: Flu-like syndrome
Serious: no
Organ System: General disorders
Frequency: 16 affected / 123 at risk

Adverse event: Hypersensitivity
Serious: no
Organ System: Immune system disorders
Frequency: 3 affected / 123 at risk

Adverse event: Infection (Documented clinically), Upper airway NOS
Serious: no
Organ System: Infections and infestations
Frequency: 7 affected / 123 at risk

Adverse event: Infection - Other
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 123 at risk

Adverse event: Infection with unknown ANC, Upper airway NOS
Serious: no
Organ System: Infections and infestations
Frequency: 7 affected / 123 at risk

Adverse event: Alanine aminotransferase
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 6 affected / 123 at risk

Adverse event: Aspartate aminotransferase
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 7 affected / 123 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 123 at risk

Adverse event: Hypophosphataemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 123 at risk

Adverse event: Metabolic/Lab - Other
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 123 at risk

Adverse event: Musculoskeletal - Other
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 9 affected / 123 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 6 affected / 123 at risk

Adverse event: Neuropathy: sensory
Serious: no
Organ System: Nervous system disorders
Frequency: 15 affected / 123 at risk

Adverse event: Cystitis
Serious: no
Organ System: Renal and urinary disorders
Frequency: 8 affected / 123 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 13 affected / 123 at risk

Adverse event: Pulmonary - Other
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 11 affected / 123 at risk

Adverse event: Dyspnea (shortness of breath)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 8 affected / 123 at risk

Adverse event: Voice changes
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 123 at risk

Adverse event: Alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 6 affected / 123 at risk

Adverse event: Dry skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 15 affected / 123 at risk

Adverse event: Hand-foot skin reaction
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 17 affected / 123 at risk

Adverse event: Dermatology - Other
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 11 affected / 123 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 11 affected / 123 at risk

Adverse event: Rash/desquamation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 18 affected / 123 at risk

Adverse event: Flushing
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 123 at risk