Study: NCT00624585

Adverse event: Anorexia - Grade 3 - *Possibly related
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 18 at risk

Adverse event: Blood/Bone Marrow - Grade 4
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 18 at risk

Adverse event: Cardiac general - Grade 3
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 18 at risk

Adverse event: Cholecystitis - Grade 3 - *Possibly related
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 18 at risk

Adverse event: Confusion - Grade 3
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 18 at risk

Adverse event: Dehydration - Grade 3
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 18 at risk

Adverse event: Diarrhea - Grade 1
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 18 at risk

Adverse event: Diarrhea - Grade 3 - *Possibly related
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 18 at risk

Adverse event: Dyspnea - Grade 2
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 18 at risk

Adverse event: Dyspnea - Grade 2 - *Possibly related
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 18 at risk

Adverse event: Dyspnea - Grade 3
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 18 at risk

Adverse event: Dyspnea - Grade 3 - **Definitely related
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: \*\*"Definitely related to study" events are noted as appropriate
Frequency: 1 affected / 18 at risk

Adverse event: Dyspnea - Grade 3 - *Possibly related
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 18 at risk

Adverse event: Edema: limb - Grade 2
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 18 at risk

Adverse event: Fatigue - Grade 3 - *Possibly related
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 18 at risk

Adverse event: Febrile neutropenia - Grade 3
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 18 at risk

Adverse event: Febrile neutropenia - Grade 3 - *Possibly related
Serious: yes
Organ System: Infections and infestations
Notes: \*"Possibly related to study" events are noted as appropriate
Frequency: 1 affected / 18 at risk

Adverse event: Fever in absence of neutropenia - Grade 2
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 18 at risk

Adverse event: Glucose, serum - low - Grade 4
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 18 at risk

Adverse event: Hematoma - Grade 1
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 18 at risk

Adverse event: Hemoglobin - Grade 3 - *Possibly related
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 18 at risk

Adverse event: Hemoglobin - Grade 4 - *Possibly related
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 18 at risk

Adverse event: Hemorrhage, GI - Lower GI NOS - Grade 3
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 18 at risk

Adverse event: Hemorrhage, GI - Rectum - Grade 3 - *Possibly related
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 18 at risk

Adverse event: Hemorrhage, GI - Upper GI - Grade 3 - *Possibly related
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 18 at risk

Adverse event: Hepatobiliary/Pancreas - Grade 1
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 18 at risk

Adverse event: Hypertension - Grade 3
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 18 at risk

Adverse event: Infection - Grade 3
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 18 at risk

Adverse event: Infection - Grade 3 - *Possibly related
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 18 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils - Lung - Grade 3
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 18 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils - lung - Grade 3 - *Possibly related
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 18 at risk

Adverse event: Mucositis/stomatitis (oral cavity) - Grade 3
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 18 at risk

Adverse event: Nausea - Grade 2
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 18 at risk

Adverse event: Nausea - Grade 3 - *Possibly related
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 18 at risk

Adverse event: Pain - Cardiac/heart - Grade 3
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 18 at risk

Adverse event: Pain - head/headache - Grade 3
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 18 at risk

Adverse event: Pain: abdomen - Grade 2
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 18 at risk

Adverse event: Platelets - Grade 3 - *Possibly related
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 18 at risk

Adverse event: Platelets - Grade 4 - *Possibly related
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 18 at risk

Adverse event: Pleural effusion - Grade 2 - **Definitely related
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 18 at risk

Adverse event: Pleural effusion - Grade 2 - *Possibly related
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 18 at risk

Adverse event: Pleural effusion - Grade 3 - *Possibly related
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 18 at risk

Adverse event: Renal failure - Grade 3
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 18 at risk

Adverse event: Renal failure - Grade 3 - *Possibly related
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 18 at risk

Adverse event: Renal/Genitourinary - Grade 2
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 18 at risk

Adverse event: Vomiting - Grade 1
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 18 at risk

Adverse event: Vomiting - Grade 2
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 18 at risk

Adverse event: Vomiting - Grade 3 - *Possibly related
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 18 at risk

Adverse event: Alergic rhinitis
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 18 at risk

Adverse event: Anorexia - *2 Events possibly related
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 18 at risk

Adverse event: Auditory/Ear
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 18 at risk

Adverse event: Blood/Bone Marrow - *Possibly related
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: \*"Possibly related to study" events are noted as appropriate
Frequency: 1 affected / 18 at risk

Adverse event: Bruising (in absence of Grade 3 or 4 thrombocytopenia) - *2 Events possibly related
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 6 affected / 18 at risk

Adverse event: Calcium, serum-high (hypercalcemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 18 at risk

Adverse event: Cardiac troponia I (cTnl)
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 18 at risk

Adverse event: Constipation - *3 Events possibly related
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 18 at risk

Adverse event: Cough - *3 Events possibly related
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 18 at risk

Adverse event: Dehydration - *Possibly related
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 18 at risk

Adverse event: Dermatology
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 5 affected / 18 at risk

Adverse event: Diarrhea - *5 Events possibly related
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 18 at risk

Adverse event: Dizziness
Serious: no
Organ System: General disorders
Frequency: 1 affected / 18 at risk

Adverse event: Dysgeusia - *4 Events possibly related
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 18 at risk

Adverse event: Dysphagia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 18 at risk

Adverse event: Dyspnea - *6 Events possibly related
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 8 affected / 18 at risk

Adverse event: Edema: limb - *3 Events possbily related
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 4 affected / 18 at risk

Adverse event: Fatigue - *13 Events possibly related
Serious: no
Organ System: General disorders
Frequency: 12 affected / 18 at risk

Adverse event: Febrile neutropenia - *3 Events possibly related
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 18 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 18 at risk

Adverse event: Flushing - *Possibly related
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 18 at risk

Adverse event: Gastrointestinal - other - *3 Events possibly related
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 18 at risk

Adverse event: Glucose, serum-high (hyperglycemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 18 at risk

Adverse event: Hair loss/alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 18 at risk

Adverse event: Heartburn/dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 18 at risk

Adverse event: Hemoglobin - *11 Events possibly related
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 6 affected / 18 at risk

Adverse event: Hemorrhage, GI - Oral cavity
Serious: no
Organ System: General disorders
Frequency: 1 affected / 18 at risk

Adverse event: Hemorrhage, GI - Rectum - *1 Event possibly related
Serious: no
Organ System: General disorders
Frequency: 2 affected / 18 at risk

Adverse event: Hemorrhage, pulmonary/upper respiratory - Lung - *Possibly related
Serious: no
Organ System: General disorders
Frequency: 1 affected / 18 at risk

Adverse event: Hypertension
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 18 at risk

Adverse event: Hypoxia - *Possibly related
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 18 at risk

Adverse event: Infection - other - *2 Events possibly related
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 18 at risk

Adverse event: Infection with Grade 3 or 4 neutrophils - Urinary tract - *Possibly related
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 18 at risk

Adverse event: Infection with Grade 3 or 4 neutrophils - Skin - *Possibly related
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 18 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils - Sinus - *1 Event possibly related
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 18 at risk

Adverse event: Insomnia
Serious: no
Organ System: General disorders
Frequency: 2 affected / 18 at risk

Adverse event: Iron overload
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 18 at risk

Adverse event: Leukocytes (total WBC) - *Possibly related
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 18 at risk

Adverse event: Lymphatics
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 18 at risk

Adverse event: Mood alteration - Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 18 at risk

Adverse event: Mucositis/stomatitis - Oral cavity - *Possibly related
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 18 at risk

Adverse event: Muscle weakness - *2 Events possibly related
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 18 at risk

Adverse event: Nausea - *Possibly related
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 18 at risk

Adverse event: Neuropathy - *Possibly related
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 18 at risk

Adverse event: Neutrophils/granulocytes (ANC/AGC) - *Possibly related
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 18 at risk

Adverse event: Ocular/Visual - *1 Event possibly related
Serious: no
Organ System: Eye disorders
Frequency: 4 affected / 18 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 3 affected / 18 at risk

Adverse event: Pain - Abdomen - *2 Events possibly related
Serious: no
Organ System: General disorders
Frequency: 3 affected / 18 at risk

Adverse event: Pain - Back
Serious: no
Organ System: General disorders
Frequency: 2 affected / 18 at risk

Adverse event: Pain - Breast
Serious: no
Organ System: General disorders
Frequency: 1 affected / 18 at risk

Adverse event: Pain - Chest wall - *1 Event possibly related
Serious: no
Organ System: General disorders
Frequency: 2 affected / 18 at risk

Adverse event: Pain - Extremity: limb
Serious: no
Organ System: General disorders
Frequency: 1 affected / 18 at risk

Adverse event: Pain - Head/headache - *4 Events possibly related
Serious: no
Organ System: General disorders
Frequency: 3 affected / 18 at risk

Adverse event: Pain - Joint - *Possibly related
Serious: no
Organ System: General disorders
Frequency: 1 affected / 18 at risk

Adverse event: Pain - Oral cavity
Serious: no
Organ System: General disorders
Frequency: 2 affected / 18 at risk

Adverse event: Pain - Throat/pharynx/larynx - *1 Event possibly related
Serious: no
Organ System: General disorders
Frequency: 2 affected / 18 at risk

Adverse event: Platelets - *6 Events possibly related
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 6 affected / 18 at risk

Adverse event: Pleural effusion - *Possibly related
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 18 at risk

Adverse event: Potassium, serum-low (hypokalemia) - *1 Event possibly related
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 18 at risk

Adverse event: Pruritus/itching
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 18 at risk

Adverse event: Pulmonary/Upper Respiratory - other
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 18 at risk

Adverse event: Rash/desquamation - *Possibly related
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 18 at risk

Adverse event: Rash: acne/acneiform
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 18 at risk

Adverse event: Rash: hand-foot skin reaction - *Possibly related
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 18 at risk

Adverse event: Renal failure - *Possibly related
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 18 at risk

Adverse event: Rigors/chills - *1 Event possibly related
Serious: no
Organ System: General disorders
Frequency: 3 affected / 18 at risk

Adverse event: Supraventricular and nodal arrhythmia - Supraventricular tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 18 at risk

Adverse event: Sweating (diaphoresis) - *1 Event possibly related
Serious: no
Organ System: General disorders
Frequency: 3 affected / 18 at risk

Adverse event: Ulcer
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 18 at risk

Adverse event: Urinary frequency/urgency
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 18 at risk

Adverse event: Vomiting - *Possibly related
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 18 at risk

Adverse event: Weight loss - *Possibly related
Serious: no
Organ System: General disorders
Frequency: 3 affected / 18 at risk