Study: NCT00832637

Adverse event: Hypersensitivity
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 33 at risk

Adverse event: Hemolysis (Red blood cell destruction)
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 33 at risk

Adverse event: Fatigue
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 33 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 33 at risk

Adverse event: Anorexia (Loss of appetite)
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 33 at risk

Adverse event: Ascites
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 33 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 33 at risk

Adverse event: Gastritis (Stomach lining inflammation)
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 33 at risk

Adverse event: Upper gastrointestinal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 33 at risk

Adverse event: Device related infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 33 at risk

Adverse event: Febrile neutropenia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 33 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 33 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 33 at risk

Adverse event: Hypokalemia (Low potassium level in blood)
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 33 at risk

Adverse event: Extrapyramidal disorder
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 33 at risk

Adverse event: Abdominal pain
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 33 at risk

Adverse event: Chest pain
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 33 at risk

Adverse event: Renal failure
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 33 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 4 affected / 33 at risk

Adverse event: Rhinitis (Runny nose)
Serious: no
Organ System: General disorders
Frequency: 5 affected / 33 at risk

Adverse event: Haemoglobin decreased
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 5 affected / 33 at risk

Adverse event: Hemolysis (Red blood cell destruction)
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 7 affected / 33 at risk

Adverse event: Leukocytes decreased
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 7 affected / 33 at risk

Adverse event: Neutrophils decreased
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 7 affected / 33 at risk

Adverse event: Platelet count decreased
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 14 affected / 33 at risk

Adverse event: Atrial tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 33 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 22 affected / 33 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 8 affected / 33 at risk

Adverse event: Weight decreased
Serious: no
Organ System: General disorders
Frequency: 5 affected / 33 at risk

Adverse event: Alopecia (Hair loss)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 33 at risk

Adverse event: Palmar-plantar erythrodysaesthesia syndrome
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 33 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 6 affected / 33 at risk

Adverse event: Acne
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 9 affected / 33 at risk

Adverse event: Desquamating rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 9 affected / 33 at risk

Adverse event: Abdominal distention
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 33 at risk

Adverse event: Anorexia (Loss of appetite)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 10 affected / 33 at risk

Adverse event: Ascites (Accumulation of fluid in the abdomen)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 33 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 33 at risk

Adverse event: Dehydration
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 33 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 18 affected / 33 at risk

Adverse event: Gastritis (Stomach lining inflammation)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 33 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 16 affected / 33 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 11 affected / 33 at risk

Adverse event: Epistaxis (Nosebleed)
Serious: no
Organ System: General disorders
Frequency: 3 affected / 33 at risk

Adverse event: Febrile neutropenia
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 33 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 33 at risk

Adverse event: Edema: limbs
Serious: no
Organ System: General disorders
Frequency: 3 affected / 33 at risk

Adverse event: Edema: trunk/genital
Serious: no
Organ System: General disorders
Frequency: 2 affected / 33 at risk

Adverse event: Blood alkaline phosphatase increased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 33 at risk

Adverse event: Aspartate aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 33 at risk

Adverse event: Hyperbilirubinemia (High level of bilirubin)
Serious: no
Organ System: Investigations
Frequency: 6 affected / 33 at risk

Adverse event: Hyperglycemia (High glucose level in blood)
Serious: no
Organ System: Investigations
Frequency: 3 affected / 33 at risk

Adverse event: Hypoalbuminemia (Low level of albumin in blood)
Serious: no
Organ System: Investigations
Frequency: 4 affected / 33 at risk

Adverse event: Hypocalcemia (Low calcium level in blood)
Serious: no
Organ System: Investigations
Frequency: 3 affected / 33 at risk

Adverse event: ypocalcemia (Low calcium level in blood)
Serious: no
Organ System: Investigations
Frequency: 3 affected / 33 at risk

Adverse event: Hypokalemia (Low potassium level in blood)
Serious: no
Organ System: Investigations
Frequency: 5 affected / 33 at risk

Adverse event: Hypomagnesemia (Low magnesium level in blood)
Serious: no
Organ System: Investigations
Frequency: 3 affected / 33 at risk

Adverse event: Hyponatremia (Low sodium level in blood)
Serious: no
Organ System: Investigations
Frequency: 4 affected / 33 at risk

Adverse event: Anxiety
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 33 at risk

Adverse event: Confusional state
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 33 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 33 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 33 at risk

Adverse event: Insomnia
Serious: no
Organ System: Nervous system disorders
Frequency: 7 affected / 33 at risk

Adverse event: Peripheral motor neuropathy
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 33 at risk

Adverse event: Peripheral sensory neuropathy
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 33 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: General disorders
Frequency: 5 affected / 33 at risk

Adverse event: Extremity - Limb pain
Serious: no
Organ System: General disorders
Frequency: 2 affected / 33 at risk

Adverse event: Neck pain
Serious: no
Organ System: General disorders
Frequency: 2 affected / 33 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 33 at risk

Adverse event: Dyspnea (Shortness of breath)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 33 at risk

Adverse event: Hiccups
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 33 at risk