Study: NCT00597038

Adverse event: Hemoglobin - Grade 4
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 16 at risk

Adverse event: Neutrophils/granulocytes - Grade 4
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 16 at risk

Adverse event: Platelets - Grade 3
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 16 at risk

Adverse event: Death not associated with CTCAE term - Disease progression not otherwise specified (NOS) - Grade 5
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 16 at risk

Adverse event: Hemorrhage, GI - Lower GI NOS - Grade 4
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 16 at risk

Adverse event: Febrile neutropenia - Grade 3
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 16 at risk

Adverse event: Infection with Grade 3 or 4 neutrophils - skin - Grade 3
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 16 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils - skin - Grade 3
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 16 at risk

Adverse event: Infection with unknown ANC - Joint - Grade 3
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 16 at risk

Adverse event: Pain - Abdomen NOS - Grade 4
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 16 at risk

Adverse event: Allergic reaction/hypersensitivity - Grade 2
Serious: no
Organ System: General disorders
Frequency: 1 affected / 16 at risk

Adverse event: Infection - Grade 2
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 16 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils - Skin - Grade 2
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 16 at risk

Adverse event: Pain - Chest wall - Grade 2
Serious: no
Organ System: General disorders
Frequency: 1 affected / 16 at risk

Adverse event: Blood/Bone Marrow - Grade 3
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 34 at risk

Adverse event: Platelets - Grade 4
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 34 at risk

Adverse event: Cardiac general - Grade 3
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 34 at risk

Adverse event: Cardiac ischemia/infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 34 at risk

Adverse event: Death not associated with CTCAE term - Disease progression not otherwise specified (NOS) - Grade 5
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 34 at risk

Adverse event: Diarrhea - Grade 3
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 34 at risk

Adverse event: Hemorrhage, GI - Lower GI NOS - Grade 3
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 34 at risk

Adverse event: Febrile neutropenia - Grade 3
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 34 at risk

Adverse event: Edema - limb - Grade 3
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 34 at risk

Adverse event: Mental status - Grade 4
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 34 at risk

Adverse event: Pain - Abdomen NOS - Grade 3
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 34 at risk

Adverse event: Dyspnea - Grade 3
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 34 at risk

Adverse event: Dyspnea - Grade 5
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 34 at risk

Adverse event: Hemoglobin - Grade 2
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 34 at risk

Adverse event: Ascites (non-malignant) - Grade 2
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 34 at risk

Adverse event: Diarrhea - Grade 2
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 34 at risk

Adverse event: Pleural effusion (non-malignant) - Grade 2
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 34 at risk