Study: NCT00482391

Adverse event: Cholesterol,high(hypercholestremia)
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 95 at risk

Adverse event: Cough
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 95 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 95 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 95 at risk

Adverse event: Dyspnea (shortness of breath)
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 6 affected / 95 at risk

Adverse event: Edema: limb
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 95 at risk

Adverse event: Fatigue (asthenia, lethargy, malaise)
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 95 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 4 affected / 95 at risk

Adverse event: Flu-like syndrome
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 95 at risk

Adverse event: Gastrointestinal, other
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 95 at risk

Adverse event: Haematoma
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 95 at risk

Adverse event: Haemoglobin
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 95 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 95 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 95 at risk

Adverse event: Inf norm ANC/gr1/2 neut-Cellulitis(skin)
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 95 at risk

Adverse event: Inf norm ANC/gr1/2 neut-Gingivitis(oral-gums)
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 95 at risk

Adverse event: Inf unknown ANC-Cellulitis(skin)
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 95 at risk

Adverse event: Inf unknown ANC-Pneumonia(lung)
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 95 at risk

Adverse event: Infection w/ Gr 3/4 neut, Catheter-related
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 95 at risk

Adverse event: Infection w/ Gr 3/4 neut, Skin (cellulites)
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 95 at risk

Adverse event: Infection, other
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 95 at risk

Adverse event: Left ventricular dysfunction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 95 at risk

Adverse event: Leukocytes (total WBC)
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 95 at risk

Adverse event: Liver dysfunction/failure
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 95 at risk

Adverse event: Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 95 at risk

Adverse event: Neutrophils/granulocytes (ANC/AGC)
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 95 at risk

Adverse event: Ocular/Visual - Other (specify)
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 95 at risk

Adverse event: Pain - Head/headache
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 95 at risk

Adverse event: Pain - Muscle
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 95 at risk

Adverse event: Pain - Other (specify)
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 95 at risk

Adverse event: Pleural effusion (non-malig)
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 95 at risk

Adverse event: Pneumonitis/pulm infiltrates
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 95 at risk

Adverse event: Prolonged QTc interval
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 95 at risk

Adverse event: Rigors/chills
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 95 at risk

Adverse event: Sinus tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 95 at risk

Adverse event: Thrombosis/embolism (vascular access-related)
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 95 at risk

Adverse event: ALT, SGPT
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 22 affected / 95 at risk

Adverse event: AST, SGOT
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 10 affected / 95 at risk

Adverse event: Bilirubin (hyperbilirubinemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 6 affected / 95 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 95 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 95 at risk

Adverse event: Dermatology/Skin, other
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 8 affected / 95 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 50 affected / 95 at risk

Adverse event: Dyspnea (shortness of breath)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 6 affected / 95 at risk

Adverse event: Fatigue (asthenia, lethargy, malaise)
Serious: no
Organ System: General disorders
Frequency: 49 affected / 95 at risk

Adverse event: Glucose, high (hyperglycemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 29 affected / 95 at risk

Adverse event: Hair loss/alopecia (scalp or body)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 24 affected / 95 at risk

Adverse event: Haemoglobin
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 50 affected / 95 at risk

Adverse event: Hot flashes/flushes
Serious: no
Organ System: Endocrine disorders
Frequency: 7 affected / 95 at risk

Adverse event: Infection
Serious: no
Organ System: Infections and infestations
Frequency: 16 affected / 95 at risk

Adverse event: Irregular menses (change from baseline)
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 9 affected / 95 at risk

Adverse event: Leukocytes (total WBC)
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 37 affected / 95 at risk

Adverse event: Lymphopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 38 affected / 95 at risk

Adverse event: Mucositis (Clin exam)- Oral cavity
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 12 affected / 95 at risk

Adverse event: Nail disorder
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 7 affected / 95 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 18 affected / 95 at risk

Adverse event: Neuropathy: sensory
Serious: no
Organ System: Nervous system disorders
Frequency: 16 affected / 95 at risk

Adverse event: Neutrophils/granulocytes (ANC/AGC)
Serious: no
Organ System: Infections and infestations
Frequency: 26 affected / 95 at risk

Adverse event: Pain - Head/headache
Serious: no
Organ System: General disorders
Frequency: 7 affected / 95 at risk

Adverse event: Pain - Other (specify)
Serious: no
Organ System: General disorders
Frequency: 7 affected / 95 at risk

Adverse event: Rash/desquamation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 8 affected / 95 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 95 at risk