Study: NCT00494299

Adverse event: Neutrophil count
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 229 at risk

Adverse event: Haemoglobin
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 229 at risk

Adverse event: PLATELETS
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 229 at risk

Adverse event: International normalised ratio
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 229 at risk

Adverse event: EDEMA: LIMB
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 229 at risk

Adverse event: CARDIAC ISCHEMIA/INFARCTION
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 229 at risk

Adverse event: Diabetes mellitus
Serious: yes
Organ System: Endocrine disorders
Frequency: 1 affected / 229 at risk

Adverse event: Ascites
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 229 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 229 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 229 at risk

Adverse event: Dysphagia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 229 at risk

Adverse event: Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 229 at risk

Adverse event: GI - OTHER (SPECIFY)
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 229 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 229 at risk

Adverse event: PAIN, ABDOMEN NOS
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 229 at risk

Adverse event: Cholecystitis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 229 at risk

Adverse event: LIVER DYSFUNCTION
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 229 at risk

Adverse event: HEPATOBILIARY - OTHER (SPECIFY)
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 3 affected / 229 at risk

Adverse event: INFECTION (DOCUMENTED CLINICALLY), LUNG (PNEUMONIA)
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 229 at risk

Adverse event: INFECTION WITH NORMAL ANC, BLOOD
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 229 at risk

Adverse event: INFECTION WITH NORMAL ANC, BILIARY TREE
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 229 at risk

Adverse event: INFECTION WITH NORMAL ANC, LIVER
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 229 at risk

Adverse event: INFECTION WITH NORMAL ANC, LUNG (PNEUMONIA)
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 229 at risk

Adverse event: Alanine aminotransferase
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 229 at risk

Adverse event: Amylase
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 229 at risk

Adverse event: Aspartate aminotransferase
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 229 at risk

Adverse event: BILIRUBIN (HYPERBILIRUBINEMIA)
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 229 at risk

Adverse event: Hypoglycaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 229 at risk

Adverse event: Lipase
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 229 at risk

Adverse event: METABOLIC/LAB - OTHER (SPECIFY)
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 229 at risk

Adverse event: Fracture
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 229 at risk

Adverse event: MUSCULOSKELETAL - OTHER (SPECIFY)
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 229 at risk

Adverse event: CNS ISCHEMIA
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 229 at risk

Adverse event: Encephalopathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 6 affected / 229 at risk

Adverse event: MOOD ALTERATION, DEPRESSION
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 229 at risk

Adverse event: HAND-FOOT SKIN REACTION
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 229 at risk

Adverse event: RASH/DESQUAMATION
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 229 at risk

Adverse event: CNS HEMORRHAGE
Serious: yes
Organ System: Vascular disorders
Frequency: 3 affected / 229 at risk

Adverse event: HEMORRHAGE, GI, ESOPHAGUS
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 229 at risk

Adverse event: HEMORRHAGE, GI, VARICES (ESOPHAGEAL)
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 229 at risk

Adverse event: HEMORRHAGE, GI, STOMACH
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 229 at risk

Adverse event: HEMORRHAGE, GI, LOWER GI NOS
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 229 at risk

Adverse event: ARTERY INJURY, AORTA
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 229 at risk

Adverse event: VASCULAR - OTHER (SPECIFY)
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 229 at risk

Adverse event: THROMBOSIS/THROMBUS/EMBOLISM
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 229 at risk

Adverse event: Neutrophil count
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 35 affected / 229 at risk

Adverse event: Lymphopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 17 affected / 229 at risk

Adverse event: PLATELETS
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 64 affected / 229 at risk

Adverse event: LEUKOCYTES
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 23 affected / 229 at risk

Adverse event: EDEMA: LIMB
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 30 affected / 229 at risk

Adverse event: Hypertension
Serious: no
Organ System: Cardiac disorders
Frequency: 76 affected / 229 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 45 affected / 229 at risk

Adverse event: Ascites
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 27 affected / 229 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 30 affected / 229 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 81 affected / 229 at risk

Adverse event: DISTENSION
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 13 affected / 229 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 15 affected / 229 at risk

Adverse event: MUCOSITIS (FUNCTIONAL/SYMPTOMATIC), ORAL CAVITY
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 26 affected / 229 at risk

Adverse event: MUCOSITIS (CLINICAL EXAM), ORAL CAVITY
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 13 affected / 229 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 26 affected / 229 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 16 affected / 229 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 37 affected / 229 at risk

Adverse event: Weight increased
Serious: no
Organ System: General disorders
Frequency: 4 affected / 229 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 46 affected / 229 at risk

Adverse event: Weight decreased
Serious: no
Organ System: General disorders
Frequency: 28 affected / 229 at risk

Adverse event: PAIN, BACK
Serious: no
Organ System: General disorders
Frequency: 13 affected / 229 at risk

Adverse event: PAIN, EXTREMITY-LIMB
Serious: no
Organ System: General disorders
Frequency: 12 affected / 229 at risk

Adverse event: PAIN, ABDOMEN NOS
Serious: no
Organ System: General disorders
Frequency: 29 affected / 229 at risk

Adverse event: PAIN, HEAD/HEADACHE
Serious: no
Organ System: General disorders
Frequency: 25 affected / 229 at risk

Adverse event: PAIN, JOINT
Serious: no
Organ System: General disorders
Frequency: 10 affected / 229 at risk

Adverse event: FLU-LIKE SYNDROME
Serious: no
Organ System: General disorders
Frequency: 44 affected / 229 at risk

Adverse event: INFECTION - OTHER (SPECIFY)
Serious: no
Organ System: Infections and infestations
Frequency: 12 affected / 229 at risk

Adverse event: Blood alkaline phosphatase
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 16 affected / 229 at risk

Adverse event: Alanine aminotransferase
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 59 affected / 229 at risk

Adverse event: Amylase
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 51 affected / 229 at risk

Adverse event: Aspartate aminotransferase
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 70 affected / 229 at risk

Adverse event: BILIRUBIN (HYPERBILIRUBINEMIA)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 36 affected / 229 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 12 affected / 229 at risk

Adverse event: Hypoalbuminaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 19 affected / 229 at risk

Adverse event: Lipase
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 105 affected / 229 at risk

Adverse event: Hypophosphataemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 79 affected / 229 at risk

Adverse event: METABOLIC/LAB - OTHER (SPECIFY)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 86 affected / 229 at risk

Adverse event: Proteinuria
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 31 affected / 229 at risk

Adverse event: MUSCULOSKELETAL - OTHER (SPECIFY)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 19 affected / 229 at risk

Adverse event: NEUROPATHY: SENSORY
Serious: no
Organ System: Nervous system disorders
Frequency: 13 affected / 229 at risk

Adverse event: VOICE CHANGES
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 35 affected / 229 at risk

Adverse event: Alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 95 affected / 229 at risk

Adverse event: HAND-FOOT SKIN REACTION
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 188 affected / 229 at risk

Adverse event: DERMATOLOGY - OTHER (SPECIFY)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 13 affected / 229 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 26 affected / 229 at risk

Adverse event: RASH/DESQUAMATION
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 99 affected / 229 at risk

Adverse event: CONDUCTION ABNORMALITY, AV BLOCK-3RD DEGREE (COMPLETE AV BLOCK)
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 227 at risk

Adverse event: Hyperthyroidism
Serious: yes
Organ System: Endocrine disorders
Frequency: 1 affected / 227 at risk

Adverse event: Decreased appetite
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 227 at risk

Adverse event: Ascites
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 227 at risk

Adverse event: Constipation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 227 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 227 at risk

Adverse event: Fatigue
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 227 at risk

Adverse event: PAIN, BACK
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 227 at risk

Adverse event: PAIN, ABDOMEN NOS
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 227 at risk

Adverse event: Cholecystitis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 227 at risk

Adverse event: INFECTION WITH NORMAL ANC, SKIN (CELLULITIS)
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 227 at risk

Adverse event: METABOLIC/LAB - OTHER (SPECIFY)
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 227 at risk

Adverse event: Fracture
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 227 at risk

Adverse event: MUSCULOSKELETAL - OTHER (SPECIFY)
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 227 at risk

Adverse event: Encephalopathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 227 at risk

Adverse event: SYNCOPE (FAINTING)
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 227 at risk

Adverse event: RENAL - OTHER (SPECIFY)
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 2 affected / 227 at risk

Adverse event: DERMATOLOGY - OTHER (SPECIFY)
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 227 at risk

Adverse event: HEMORRHAGE, GI, ABDOMEN NOS
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 227 at risk

Adverse event: HEMORRHAGE, GI, COLON
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 227 at risk

Adverse event: HEMORRHAGE, GI, VARICES (ESOPHAGEAL)
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 227 at risk

Adverse event: HEMORRHAGE, GI, LIVER
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 227 at risk

Adverse event: Neutrophil count
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 16 affected / 227 at risk

Adverse event: Lymphopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 8 affected / 227 at risk

Adverse event: PLATELETS
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 10 affected / 227 at risk

Adverse event: LEUKOCYTES
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 15 affected / 227 at risk

Adverse event: EDEMA: LIMB
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 20 affected / 227 at risk

Adverse event: Hypertension
Serious: no
Organ System: Cardiac disorders
Frequency: 21 affected / 227 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 18 affected / 227 at risk

Adverse event: Ascites
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 10 affected / 227 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 21 affected / 227 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 27 affected / 227 at risk

Adverse event: DISTENSION
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 227 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 16 affected / 227 at risk

Adverse event: MUCOSITIS (FUNCTIONAL/SYMPTOMATIC), ORAL CAVITY
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 227 at risk

Adverse event: MUCOSITIS (CLINICAL EXAM), ORAL CAVITY
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 227 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 18 affected / 227 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 11 affected / 227 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 25 affected / 227 at risk

Adverse event: Weight increased
Serious: no
Organ System: General disorders
Frequency: 12 affected / 227 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 34 affected / 227 at risk

Adverse event: Weight decreased
Serious: no
Organ System: General disorders
Frequency: 3 affected / 227 at risk

Adverse event: PAIN, BACK
Serious: no
Organ System: General disorders
Frequency: 19 affected / 227 at risk

Adverse event: PAIN, EXTREMITY-LIMB
Serious: no
Organ System: General disorders
Frequency: 11 affected / 227 at risk

Adverse event: PAIN, ABDOMEN NOS
Serious: no
Organ System: General disorders
Frequency: 21 affected / 227 at risk

Adverse event: PAIN, HEAD/HEADACHE
Serious: no
Organ System: General disorders
Frequency: 21 affected / 227 at risk

Adverse event: PAIN, JOINT
Serious: no
Organ System: General disorders
Frequency: 15 affected / 227 at risk

Adverse event: FLU-LIKE SYNDROME
Serious: no
Organ System: General disorders
Frequency: 56 affected / 227 at risk

Adverse event: INFECTION - OTHER (SPECIFY)
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 227 at risk

Adverse event: Blood alkaline phosphatase
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 227 at risk

Adverse event: Alanine aminotransferase
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 29 affected / 227 at risk

Adverse event: Amylase
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 18 affected / 227 at risk

Adverse event: Aspartate aminotransferase
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 29 affected / 227 at risk

Adverse event: BILIRUBIN (HYPERBILIRUBINEMIA)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 12 affected / 227 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 11 affected / 227 at risk

Adverse event: Hypoalbuminaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 227 at risk

Adverse event: Lipase
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 19 affected / 227 at risk

Adverse event: Hypophosphataemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 22 affected / 227 at risk

Adverse event: METABOLIC/LAB - OTHER (SPECIFY)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 27 affected / 227 at risk

Adverse event: Proteinuria
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 227 at risk

Adverse event: MUSCULOSKELETAL - OTHER (SPECIFY)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 12 affected / 227 at risk

Adverse event: NEUROPATHY: SENSORY
Serious: no
Organ System: Nervous system disorders
Frequency: 9 affected / 227 at risk

Adverse event: VOICE CHANGES
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 227 at risk

Adverse event: Alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 8 affected / 227 at risk

Adverse event: HAND-FOOT SKIN REACTION
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 17 affected / 227 at risk

Adverse event: DERMATOLOGY - OTHER (SPECIFY)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 8 affected / 227 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 31 affected / 227 at risk

Adverse event: RASH/DESQUAMATION
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 37 affected / 227 at risk