Study: NCT00450801

Adverse event: Neutropenia (Grade 3-4)
Serious: yes
Organ System: Infections and infestations
Frequency: 12 affected / 22 at risk

Adverse event: Anemia (Grade 3-4)
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 7 affected / 22 at risk

Adverse event: Thrombocytopenia (Grade 3-4)
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 8 affected / 22 at risk

Adverse event: Febrile neutropenia (Grade 3-4)
Serious: yes
Organ System: Infections and infestations
Frequency: 9 affected / 22 at risk

Adverse event: Infection (Grade 3-4)
Serious: yes
Organ System: Infections and infestations
Frequency: 5 affected / 22 at risk

Adverse event: Bacteremia (Grade 3-4)
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 22 at risk

Adverse event: Mucositis (Grade 3-4)
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 22 at risk

Adverse event: Diarrhea (Grade 3-4)
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 22 at risk

Adverse event: Dyspnea (Grade 3-4)
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 22 at risk

Adverse event: Pleural effusion (Grade 3-4)
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 22 at risk

Adverse event: Neutropenia (Grade 1-2)
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 22 at risk

Adverse event: Anemia (Grade 1-2)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 10 affected / 22 at risk

Adverse event: Thrombocytopenia (Grade 1-2)
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 7 affected / 22 at risk

Adverse event: Infection (Grade 1-2)
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 22 at risk

Adverse event: Hyperglycemia (Grade 1-2)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 10 affected / 22 at risk

Adverse event: Hypokalemia (Grade 1-2)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 8 affected / 22 at risk

Adverse event: Elevated creatinine (Grade 1-2)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 6 affected / 22 at risk

Adverse event: Nausea (Grade 1-2)
Serious: no
Organ System: General disorders
Frequency: 9 affected / 22 at risk

Adverse event: Vomiting (Grade 1-2)
Serious: no
Organ System: General disorders
Frequency: 4 affected / 22 at risk

Adverse event: Mucositis (Grade 1-2)
Serious: no
Organ System: Infections and infestations
Frequency: 11 affected / 22 at risk

Adverse event: Diarrhea (Grade 1-2)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 22 at risk

Adverse event: Constipation (Grade 1-2)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 22 at risk

Adverse event: Dyspnea (Grade 1-2)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 22 at risk

Adverse event: Edema (Grade 1-2)
Serious: no
Organ System: General disorders
Frequency: 6 affected / 22 at risk

Adverse event: Pleural Effusion (Grade 1-2)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 22 at risk

Adverse event: Headache (Grade 1-2)
Serious: no
Organ System: General disorders
Frequency: 9 affected / 22 at risk

Adverse event: Dizziness (Grade 1-2)
Serious: no
Organ System: General disorders
Frequency: 2 affected / 22 at risk

Adverse event: Rash (Grade 1-2)
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 22 at risk

Adverse event: Neutropenia (Grade 3-4)
Serious: yes
Organ System: Infections and infestations
Frequency: 13 affected / 22 at risk

Adverse event: Anemia (Grade 3-4)
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 19 affected / 22 at risk

Adverse event: Thrombocytopenia (Grade 3-4)
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 21 affected / 22 at risk

Adverse event: Febrile neutropenia (Grade 3-4)
Serious: yes
Organ System: Infections and infestations
Frequency: 20 affected / 22 at risk

Adverse event: Infection (Grade 3-4)
Serious: yes
Organ System: Infections and infestations
Frequency: 11 affected / 22 at risk

Adverse event: Bacteremia (Grade 3-4)
Serious: yes
Organ System: Infections and infestations
Frequency: 12 affected / 22 at risk

Adverse event: Diarrhea (Grade 3-4)
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 22 at risk

Adverse event: Dyspnea (Grade 3-4)
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 22 at risk

Adverse event: Pleural effusion (Grade 3-4)
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 22 at risk

Adverse event: Neutropenia (Grade 1-2)
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 22 at risk

Adverse event: Anemia (Grade 1-2)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 22 at risk

Adverse event: Infection (Grade 1-2)
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 22 at risk

Adverse event: Hyperglycemia (Grade 1-2)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 9 affected / 22 at risk

Adverse event: Hypokalemia (Grade 1-2)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 11 affected / 22 at risk

Adverse event: Elevated creatinine (Grade 1-2)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 22 at risk

Adverse event: Nausea (Grade 1-2)
Serious: no
Organ System: General disorders
Frequency: 15 affected / 22 at risk

Adverse event: Vomiting (Grade 1-2)
Serious: no
Organ System: General disorders
Frequency: 10 affected / 22 at risk

Adverse event: Mucositis (Grade 1-2)
Serious: no
Organ System: Infections and infestations
Frequency: 8 affected / 22 at risk

Adverse event: Diarrhea (Grade 1-2)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 22 at risk

Adverse event: Constipation (Grade 1-2)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 22 at risk

Adverse event: Dyspnea (Grade 1-2)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 22 at risk

Adverse event: Edema (Grade 1-2)
Serious: no
Organ System: General disorders
Frequency: 3 affected / 22 at risk

Adverse event: Pleural Effusion (Grade 1-2)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 22 at risk

Adverse event: Headache (Grade 1-2)
Serious: no
Organ System: General disorders
Frequency: 4 affected / 22 at risk

Adverse event: Dizziness (Grade 1-2)
Serious: no
Organ System: General disorders
Frequency: 4 affected / 22 at risk

Adverse event: Rash (Grade 1-2)
Serious: no
Organ System: Infections and infestations
Frequency: 8 affected / 22 at risk

Adverse event: Neutropenia (Grade 3-4)
Serious: yes
Organ System: Infections and infestations
Frequency: 7 affected / 20 at risk

Adverse event: Infection (Grade 3-4)
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 20 at risk

Adverse event: Diarrhea (Grade 3-4)
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 20 at risk

Adverse event: Dizziness (Grade 3-4)
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 20 at risk

Adverse event: Peripheral Neuropathy (Grade 3-4)
Serious: yes
Organ System: Nervous system disorders
Frequency: 8 affected / 20 at risk

Adverse event: Erectile Dysfunction (Grade 3-4)
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 20 at risk

Adverse event: Infection (Grade 1-2)
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 20 at risk

Adverse event: Constipation (Grade 1-2)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 20 at risk

Adverse event: Edema (Grade 1-2)
Serious: no
Organ System: General disorders
Frequency: 4 affected / 20 at risk

Adverse event: Dizziness (Grade 1-2)
Serious: no
Organ System: General disorders
Frequency: 2 affected / 20 at risk

Adverse event: Somnolence (Grade 1-2)
Serious: no
Organ System: General disorders
Frequency: 3 affected / 20 at risk

Adverse event: Peripheral Neuropathy (Grade 1-2)
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 20 at risk

Adverse event: Erectile Dysfunction (Grade 1-2)
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 20 at risk

Adverse event: Bradycardia (Grade 1-2)
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 20 at risk