Study: NCT00258960

Adverse event: Cerebrovascular ischemia
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 48 at risk

Adverse event: Febrile neutropenia grade 3
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 48 at risk

Adverse event: Hemorrhage CNS grade 5
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 48 at risk

Adverse event: Infection with normal ANC (skin celluties grade 3)
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 48 at risk

Adverse event: Acute respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 48 at risk

Adverse event: Catheter - related infection grade 3
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 48 at risk

Adverse event: Holocraneal cephalea
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 48 at risk

Adverse event: Neutropenia grade 3
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 48 at risk

Adverse event: Subarachnoid haemorrhage
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 48 at risk

Adverse event: Hypersensibility reaction grade 3
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 48 at risk

Adverse event: Palmoplantar erythrodysesthesia grade 3, stomatitis grade 3
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 48 at risk

Adverse event: Progression disease
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 48 at risk

Adverse event: Neutropenia grade 4, fever grade 1, oral mucositis grade 3
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 48 at risk

Adverse event: Leukocytes
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Grade 4
Frequency: 1 affected / 48 at risk

Adverse event: Neutrophils / Granulocytes
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Grade 4
Frequency: 5 affected / 48 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: Grade 4
Frequency: 1 affected / 48 at risk

Adverse event: Mucositis / Stomatitis
Serious: no
Organ System: Gastrointestinal disorders
Notes: Grade 4
Frequency: 1 affected / 48 at risk

Adverse event: Dyspnea (shortness of breath)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Grade 4
Frequency: 2 affected / 48 at risk

Adverse event: Pneumonitis/Pulmonary infiltrates
Serious: no
Organ System: Reproductive system and breast disorders
Notes: Grade 5
Frequency: 1 affected / 48 at risk

Adverse event: Leukocytes
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Grade 3
Frequency: 9 affected / 48 at risk

Adverse event: Leukocytes
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Grade 2
Frequency: 10 affected / 48 at risk

Adverse event: Haemoglobin
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Grade 2
Frequency: 10 affected / 48 at risk

Adverse event: Rash: Hand-foot skin reaction
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Grade 3
Frequency: 14 affected / 48 at risk

Adverse event: Mucositis / Stomatitis
Serious: no
Organ System: Gastrointestinal disorders
Notes: Grade 3
Frequency: 10 affected / 48 at risk

Adverse event: Lymphopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Grade 2
Frequency: 9 affected / 48 at risk

Adverse event: Lymphopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Grade 3
Frequency: 7 affected / 48 at risk

Adverse event: Neutrophils / Granulocytes
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Grade 3
Frequency: 5 affected / 48 at risk

Adverse event: Neutrophils / Granulocytes
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Grade 2
Frequency: 9 affected / 48 at risk

Adverse event: Left ventricular dysfunction
Serious: no
Organ System: Cardiac disorders
Notes: Grade 2
Frequency: 8 affected / 48 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: Grade 2
Frequency: 16 affected / 48 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: Grade 1
Frequency: 12 affected / 48 at risk

Adverse event: Rash/desquamation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Grade 2
Frequency: 11 affected / 48 at risk

Adverse event: Rash/desquamation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Grade 1
Frequency: 8 affected / 48 at risk

Adverse event: Rash: Hand-foot skin reaction
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Grade 2
Frequency: 10 affected / 48 at risk

Adverse event: Rash: Hand-foot skin reaction
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Grade 1
Frequency: 13 affected / 48 at risk

Adverse event: Heartburn/dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Notes: Grade 2
Frequency: 20 affected / 48 at risk

Adverse event: Haemoglobin
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Grade 1
Frequency: 27 affected / 48 at risk

Adverse event: Leukocytes
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Grade 1
Frequency: 14 affected / 48 at risk

Adverse event: Left ventricular dysfunction
Serious: no
Organ System: Cardiac disorders
Notes: Grade 1
Frequency: 19 affected / 48 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Notes: Grade 1
Frequency: 9 affected / 48 at risk

Adverse event: Hair loss/alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Grade 1
Frequency: 12 affected / 48 at risk

Adverse event: Hyperpigmentation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Grade 1
Frequency: 8 affected / 48 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Gastrointestinal disorders
Notes: Grade 1
Frequency: 8 affected / 48 at risk

Adverse event: Mucositis / Stomatitis
Serious: no
Organ System: Gastrointestinal disorders
Notes: Grade 1
Frequency: 9 affected / 48 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Grade 1
Frequency: 16 affected / 48 at risk

Adverse event: Infection with normal ANC or G1 or 2 neutrophils
Serious: no
Organ System: Infections and infestations
Notes: Grade 2
Frequency: 10 affected / 48 at risk

Adverse event: Blood alkaline phosphatase
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Grade 1
Frequency: 10 affected / 48 at risk

Adverse event: ALT, SGPT
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Grade 1
Frequency: 20 affected / 48 at risk

Adverse event: AST, SGOT
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Grade 1
Frequency: 18 affected / 48 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Grade 1
Frequency: 8 affected / 48 at risk