Study: NCT00103207

Adverse event: Hypersensitivity
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 72 at risk

Adverse event: Lymphopenia
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 72 at risk

Adverse event: Fatigue
Serious: yes
Organ System: General disorders
Frequency: 7 affected / 72 at risk

Adverse event: Dry skin
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 72 at risk

Adverse event: Nail disorder
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 72 at risk

Adverse event: Pruritus/itching
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 72 at risk

Adverse event: Rash: acne/acneiform
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 11 affected / 72 at risk

Adverse event: Hand-foot reaction
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 72 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 72 at risk

Adverse event: Diarrhea w/o prior colostomy
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 72 at risk

Adverse event: Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 72 at risk

Adverse event: Infection Gr0-2 neut, skin
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 72 at risk

Adverse event: Infection Gr0-2 neut, ungual
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 72 at risk

Adverse event: Infection Gr0-2 neut, urinary tract
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 72 at risk

Adverse event: Creatinine, increased
Serious: yes
Organ System: Investigations
Frequency: 2 affected / 72 at risk

Adverse event: Hyperglycaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 72 at risk

Adverse event: Hypophosphataemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 72 at risk

Adverse event: Hyperkalaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 72 at risk

Adverse event: Neuropathy-sensory
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 72 at risk

Adverse event: Back, pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 72 at risk

Adverse event: Head/headache
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 72 at risk

Adverse event: Skin, pain
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 72 at risk

Adverse event: Cough
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 72 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 72 at risk

Adverse event: Hypoxia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 72 at risk

Adverse event: Pleural effusion (non-malignant)
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 72 at risk

Adverse event: Pneumonitis/pulmonary infiltrates
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 72 at risk

Adverse event: Thrombosis/thrombus/embolism
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 72 at risk

Adverse event: Hypersensitivity
Serious: no
Organ System: Immune system disorders
Frequency: 4 affected / 72 at risk

Adverse event: Rhinitis allergic
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 72 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 27 affected / 72 at risk

Adverse event: Leukocytes, decreased
Serious: no
Organ System: Investigations
Frequency: 8 affected / 72 at risk

Adverse event: Neutrophils, decreased
Serious: no
Organ System: Investigations
Frequency: 7 affected / 72 at risk

Adverse event: Platelets, decreased
Serious: no
Organ System: Investigations
Frequency: 5 affected / 72 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 44 affected / 72 at risk

Adverse event: Fever w/o neutropenia
Serious: no
Organ System: General disorders
Frequency: 8 affected / 72 at risk

Adverse event: Rigors/chills
Serious: no
Organ System: General disorders
Frequency: 4 affected / 72 at risk

Adverse event: Weight decreased
Serious: no
Organ System: Investigations
Frequency: 12 affected / 72 at risk

Adverse event: Dry skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 19 affected / 72 at risk

Adverse event: Nail disorder
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 10 affected / 72 at risk

Adverse event: Pruritus/itching
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 14 affected / 72 at risk

Adverse event: Rash/desquamation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 22 affected / 72 at risk

Adverse event: Rash: acne/acneiform
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 60 affected / 72 at risk

Adverse event: Hand-foot reaction
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 9 affected / 72 at risk

Adverse event: Skin-other
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 5 affected / 72 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 15 affected / 72 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 16 affected / 72 at risk

Adverse event: Diarrhea w/o prior colostomy
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 22 affected / 72 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 72 at risk

Adverse event: Muco/stomatitis by exam, oral cavity
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 72 at risk

Adverse event: Muco/stomatitis (symptom) oral cavity
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 11 affected / 72 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 23 affected / 72 at risk

Adverse event: Taste disorder
Serious: no
Organ System: Nervous system disorders
Frequency: 9 affected / 72 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 72 at risk

Adverse event: Nose, hemorrhage
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 72 at risk

Adverse event: Edema limb
Serious: no
Organ System: General disorders
Frequency: 4 affected / 72 at risk

Adverse event: Hypoalbuminaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 72 at risk

Adverse event: Blood alkaline phosphatase increased
Serious: no
Organ System: Investigations
Frequency: 8 affected / 72 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 5 affected / 72 at risk

Adverse event: Aspartate aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 6 affected / 72 at risk

Adverse event: Hypocalcaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 72 at risk

Adverse event: Creatinine, increased
Serious: no
Organ System: Investigations
Frequency: 9 affected / 72 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 32 affected / 72 at risk

Adverse event: Hypoglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 72 at risk

Adverse event: Hypomagnesaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 20 affected / 72 at risk

Adverse event: Hypophosphataemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 72 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 6 affected / 72 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 72 at risk

Adverse event: Neuropathy-sensory
Serious: no
Organ System: Nervous system disorders
Frequency: 6 affected / 72 at risk

Adverse event: Dry eye
Serious: no
Organ System: Eye disorders
Frequency: 4 affected / 72 at risk

Adverse event: Head/headache
Serious: no
Organ System: Nervous system disorders
Frequency: 11 affected / 72 at risk

Adverse event: Muscle, pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 72 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 6 affected / 72 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 6 affected / 72 at risk