Study: NCT00546156

Adverse event: Neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 104 at risk

Adverse event: Leukopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 104 at risk

Adverse event: Cellulitis
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 104 at risk

Adverse event: paranasal sinus reaction
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 104 at risk

Adverse event: ALT-SGPT
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 48 affected / 104 at risk

Adverse event: AST-SGOT
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 48 affected / 104 at risk

Adverse event: Abdomen-pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 10 affected / 104 at risk

Adverse event: Blood alkaline phosphatase
Serious: no
Organ System: Investigations
Frequency: 36 affected / 104 at risk

Adverse event: Hypersensitivity
Serious: no
Organ System: Immune system disorders
Frequency: 10 affected / 104 at risk

Adverse event: Alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 39 affected / 104 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 20 affected / 104 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 18 affected / 104 at risk

Adverse event: Back-pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 22 affected / 104 at risk

Adverse event: Blood bicarbonate
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 19 affected / 104 at risk

Adverse event: Bone-pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 16 affected / 104 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 47 affected / 104 at risk

Adverse event: Constitutional-other
Serious: no
Organ System: General disorders
Frequency: 6 affected / 104 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 26 affected / 104 at risk

Adverse event: Blood creatinine
Serious: no
Organ System: Renal and urinary disorders
Frequency: 34 affected / 104 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 6 affected / 104 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 34 affected / 104 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 9 affected / 104 at risk

Adverse event: Dry skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 9 affected / 104 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 21 affected / 104 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 21 affected / 104 at risk

Adverse event: Erythema multiforme
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 7 affected / 104 at risk

Adverse event: Extremity-limb-pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 13 affected / 104 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 91 affected / 104 at risk

Adverse event: Febrile neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 6 affected / 104 at risk

Adverse event: fever w/o neutropenia
Serious: no
Organ System: General disorders
Frequency: 22 affected / 104 at risk

Adverse event: Flushing
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 8 affected / 104 at risk

Adverse event: GI-other
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 20 affected / 104 at risk

Adverse event: Hand-foot reaction
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 6 affected / 104 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 57 affected / 104 at risk

Adverse event: Hematologic-other
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 38 affected / 104 at risk

Adverse event: Haemoglobin
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 86 affected / 104 at risk

Adverse event: Haemorrhoids
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 12 affected / 104 at risk

Adverse event: Hot flush
Serious: no
Organ System: Endocrine disorders
Frequency: 15 affected / 104 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Endocrine disorders
Frequency: 79 affected / 104 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 27 affected / 104 at risk

Adverse event: Hypoalbuminaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 7 affected / 104 at risk

Adverse event: Hypocalcaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 13 affected / 104 at risk

Adverse event: Hypoglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 7 affected / 104 at risk

Adverse event: Hyponatraemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 11 affected / 104 at risk

Adverse event: Infection Gr0-2 neut-upper airway
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 10 affected / 104 at risk

Adverse event: Infection-other
Serious: no
Organ System: Infections and infestations
Frequency: 7 affected / 104 at risk

Adverse event: Insomnia
Serious: no
Organ System: General disorders
Frequency: 19 affected / 104 at risk

Adverse event: Joint-pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 31 affected / 104 at risk

Adverse event: Leukocytes
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 24 affected / 104 at risk

Adverse event: Lymphopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 56 affected / 104 at risk

Adverse event: Metabolic/laboratory-other
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 37 affected / 104 at risk

Adverse event: Muco/stomatitis (symptom) oral cavity
Serious: no
Organ System: Infections and infestations
Frequency: 23 affected / 104 at risk

Adverse event: Muco/stomatitis by exam-oral cavity
Serious: no
Organ System: Infections and infestations
Frequency: 18 affected / 104 at risk

Adverse event: Muscle-pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 53 affected / 104 at risk

Adverse event: Nail disorder
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 9 affected / 104 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 76 affected / 104 at risk

Adverse event: Neuropathy-motor
Serious: no
Organ System: Nervous system disorders
Frequency: 9 affected / 104 at risk

Adverse event: Neuropathy-sensory
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 64 affected / 104 at risk

Adverse event: Neutrophil count
Serious: no
Organ System: Eye disorders
Frequency: 20 affected / 104 at risk

Adverse event: Nose-hemorrhage
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 33 affected / 104 at risk

Adverse event: Oral cavity-pain
Serious: no
Organ System: General disorders
Frequency: 6 affected / 104 at risk

Adverse event: Pain-other
Serious: no
Organ System: General disorders
Frequency: 27 affected / 104 at risk

Adverse event: Platelets
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 30 affected / 104 at risk

Adverse event: Proteinuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 30 affected / 104 at risk

Adverse event: Pulmonary-Upper Respiratory-other
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 19 affected / 104 at risk

Adverse event: Rash/desquamation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 25 affected / 104 at risk

Adverse event: Rigors/chills
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 6 affected / 104 at risk

Adverse event: Skin-other
Serious: no
Organ System: Vascular disorders
Frequency: 8 affected / 104 at risk

Adverse event: Hyperhidrosis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 6 affected / 104 at risk

Adverse event: Taste disorder
Serious: no
Organ System: General disorders
Frequency: 6 affected / 104 at risk

Adverse event: Throat/pharynx/larynx-pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 30 affected / 104 at risk

Adverse event: Voice changes/dysarthria
Serious: no
Organ System: General disorders
Frequency: 15 affected / 104 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 25 affected / 104 at risk

Adverse event: Weight decreased
Serious: no
Organ System: General disorders
Frequency: 7 affected / 104 at risk