Study: NCT01313897

Adverse event: Grade 4 Anemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 8 at risk

Adverse event: Grade 4 Thrombocytopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 6 affected / 8 at risk

Adverse event: Grade 4 Leukopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 6 affected / 8 at risk

Adverse event: Grade 3 Constitutional Symptoms - Other
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 8 at risk

Adverse event: Grade 2 Fever
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 8 at risk

Adverse event: Grade 2 Rigors/Chills
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 8 at risk

Adverse event: Grade 3 Skin Rash
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 8 at risk

Adverse event: Grade 3 Diarrhea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 8 at risk

Adverse event: Grade 3 Mucositis/Stomatitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 8 at risk

Adverse event: Grade 2 Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 8 at risk

Adverse event: Grade 5 Sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 8 at risk

Adverse event: Grade 3 Infection - other
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 8 at risk

Adverse event: Grade 5 Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 8 at risk

Adverse event: Grade 1 Rhinitis
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 8 at risk

Adverse event: Grade 2 Rhinitis
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 8 at risk

Adverse event: Grade 1 Anemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 7 affected / 8 at risk

Adverse event: Grade 2 Anemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 8 affected / 8 at risk

Adverse event: Grade 3 Anemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 6 affected / 8 at risk

Adverse event: Grade 1 Blood - Other
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 8 at risk

Adverse event: Grade 2 Blood - Other
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 8 at risk

Adverse event: Grade 1 Thrombocytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 4 affected / 8 at risk

Adverse event: Grade 2 Thrombocytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 5 affected / 8 at risk

Adverse event: Grade 3 Thrombocytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 7 affected / 8 at risk

Adverse event: Grade 2 Leukopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 8 affected / 8 at risk

Adverse event: Grade 3 Leukopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 7 affected / 8 at risk

Adverse event: Grade 2 Cardiac General - Other
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 8 at risk

Adverse event: Grade 2 Hypotension
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 8 at risk

Adverse event: Grade 1 Fatigue
Serious: no
Organ System: General disorders
Frequency: 3 affected / 8 at risk

Adverse event: Grade 2 Fatigue
Serious: no
Organ System: General disorders
Frequency: 4 affected / 8 at risk

Adverse event: Grade 1 Fever
Serious: no
Organ System: General disorders
Frequency: 3 affected / 8 at risk

Adverse event: Grade 2 Fever
Serious: no
Organ System: General disorders
Frequency: 2 affected / 8 at risk

Adverse event: Grade 1 Rigors/Chills
Serious: no
Organ System: General disorders
Frequency: 3 affected / 8 at risk

Adverse event: Grade 2 Rigors/Chills
Serious: no
Organ System: General disorders
Frequency: 1 affected / 8 at risk

Adverse event: Grade 1 Sweating
Serious: no
Organ System: General disorders
Frequency: 1 affected / 8 at risk

Adverse event: Grade 1 Weight Loss
Serious: no
Organ System: General disorders
Frequency: 1 affected / 8 at risk

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

Adverse event: Grade 2 Alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 8 at risk

Adverse event: Grade 1 Dermatology - Other
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 8 at risk

Adverse event: Grade 2 Dermatology - Other
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 8 at risk

Adverse event: Grade 2 Dry Skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 8 at risk

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

Adverse event: Grade 2 Hypothyroidism
Serious: no
Organ System: Endocrine disorders
Frequency: 1 affected / 8 at risk

Adverse event: Grade 1 Anorexia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 8 at risk

Adverse event: Grade 2 Anorexia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 8 at risk

Adverse event: Grade 1 Diarrhea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 8 at risk

Adverse event: Grade 2 Diarrhea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 8 at risk

Adverse event: Grade 1 Dry Mouth
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 8 at risk

Adverse event: Grade 1 Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 8 at risk

Adverse event: Grade 2 Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 8 at risk

Adverse event: Grade 1 Alkaline Phosphatase Increase
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 4 affected / 8 at risk

Adverse event: Grade 1 Bilirubin Increase
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 3 affected / 8 at risk

Adverse event: Grade 2 Bilirubin Increase
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 2 affected / 8 at risk

Adverse event: Grade 3 Bilirubin Increase
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 8 at risk

Adverse event: Grade 1 Hypoalbuminemia
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 7 affected / 8 at risk

Adverse event: Grade 2 Hypoalbuminemia
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 6 affected / 8 at risk

Adverse event: Grade 1 SGOT (AST) Increase
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 4 affected / 8 at risk

Adverse event: Grade 2 SGOT (AST) Increase
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 8 at risk

Adverse event: Grade 4 SGOT (AST) Increase
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 8 at risk

Adverse event: Grade 1 SGPT (ALT) Increase
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 3 affected / 8 at risk

Adverse event: Grade 2 SGPT (ALT) Increase
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 8 at risk

Adverse event: Grade 3 SGPT (ALT) Increase
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 8 at risk

Adverse event: Grade 4 SGPT (ALT) Increase
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 8 at risk

Adverse event: Grade 3 Febrile Neutropenia
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 8 at risk

Adverse event: Grade 3 Urinary Tract Infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 8 at risk

Adverse event: Grade 2 Pneumonia
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 8 at risk

Adverse event: Grade 2 Edema - Trunk/Genital
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 8 at risk

Adverse event: Grade 1 Bicarbonate Decrease
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 8 at risk

Adverse event: Grade 2 Bicarbonate Decrease
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 8 at risk

Adverse event: Grade 3 Bicarbonate Disease
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 8 at risk

Adverse event: Grade 1 Hyperglycemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 7 affected / 8 at risk

Adverse event: Grade 2 Hyperglycemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 8 at risk

Adverse event: Grade 3 Hyperglycemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 8 at risk

Adverse event: Grade 1 Hyperkalemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 8 at risk

Adverse event: Grade 2 Hyperkalemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 8 at risk

Adverse event: Grade 3 Hyperkalemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 8 at risk

Adverse event: Grade 1 Hypermagnesemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 6 affected / 8 at risk

Adverse event: Grade 3 Hypermagnesemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 8 at risk

Adverse event: Grade 1 Hypernatremia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 8 at risk

Adverse event: Grade 2 Hypocalcemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 7 affected / 8 at risk

Adverse event: Grade 3 Hypocalcemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 8 at risk

Adverse event: Grade 4 Hypocalcemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 8 at risk

Adverse event: Grade 1 Hypokalemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 7 affected / 8 at risk

Adverse event: Grade 3 Hypokalemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 8 at risk

Adverse event: Grade 1 Hypomagnesemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 8 at risk

Adverse event: Grade 2 Hypomagnesemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 8 at risk

Adverse event: Grade 1 Hyponatremia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 7 affected / 8 at risk

Adverse event: Grade 3 Hyponatremia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 8 at risk

Adverse event: Grade 1 Hypophosphatemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 8 at risk

Adverse event: Grade 2 Hypophosphatemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 7 affected / 8 at risk

Adverse event: Grade 3 Hypophosphatemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 6 affected / 8 at risk

Adverse event: Grade 4 Hypophosphatemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 8 at risk

Adverse event: Grade 1 Gait/Walking
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 8 at risk

Adverse event: Grade 2 Muscle Weakness: Whole Body
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 8 at risk

Adverse event: Grade 3 Muscle Weakness: Whole Body
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 8 at risk

Adverse event: Grade 1 Confusion
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 8 at risk

Adverse event: Grade 2 Confusion
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 8 at risk

Adverse event: Grade 3 Confusion
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 8 at risk

Adverse event: Grade 4 Confusion
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 8 at risk

Adverse event: Grade 1 Dizziness
Serious: no
Organ System: General disorders
Frequency: 2 affected / 8 at risk

Adverse event: Grade 1 Memory Impairment
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 8 at risk

Adverse event: Grade 1 Mood Alteration
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 8 at risk

Adverse event: Grade 2 Mood Alteration
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 8 at risk

Adverse event: Grade 1 Sensory Neuropathy
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 8 at risk

Adverse event: Grade 2 Sensory Neuropathy
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 8 at risk

Adverse event: Grade 3 Pain: Abdomen - NOS
Serious: no
Organ System: General disorders
Frequency: 1 affected / 8 at risk

Adverse event: Grade 1 Headache
Serious: no
Organ System: General disorders
Frequency: 1 affected / 8 at risk

Adverse event: Grade 2 Pain: Joint
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 8 at risk

Adverse event: Grade 1 Pain: Lower Back
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 8 at risk

Adverse event: Grade 2 Pain: Middle Back
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 8 at risk

Adverse event: Grade 1 Pain - NOS
Serious: no
Organ System: General disorders
Frequency: 1 affected / 8 at risk

Adverse event: Grade 2 Pain: Upper Back
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 8 at risk

Adverse event: Grade 2 Bronchospasm
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 8 at risk

Adverse event: Grade 1 Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 8 at risk

Adverse event: Grade 2 Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 8 at risk

Adverse event: Grade 1 Dyspnea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 8 at risk

Adverse event: Grade 2 Dyspnea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 8 at risk

Adverse event: Grade 3 Dyspnea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 8 at risk

Adverse event: Grade 1 Nasal/Paranasal Reactions
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 8 at risk

Adverse event: Grade 2 Pulmonary - Other
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 8 at risk

Adverse event: Grade 1 Creatinine Increase
Serious: no
Organ System: Renal and urinary disorders
Frequency: 4 affected / 8 at risk

Adverse event: Grade 2 Creatinine Increase
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 8 at risk

Adverse event: Grade 2 Thrombosis/Embolism
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 8 at risk