Study: NCT01621672

Adverse event: Grade 3 Allergic reaction/Hypersensitivity
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 25 at risk

Adverse event: Grade 4 Neutropenia/granulocytopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 25 at risk

Adverse event: Grade 4 Thrombocyopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 25 at risk

Adverse event: Grade 4 Leukopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 25 at risk

Adverse event: Grade 3 Skin Rash/desquamation
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 25 at risk

Adverse event: Grade 3 Dysphagia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 25 at risk

Adverse event: Grade 4 Hypocalcemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 25 at risk

Adverse event: Grade 3 Hypokalemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 25 at risk

Adverse event: Grade 3 Hypophosphatemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 25 at risk

Adverse event: Grade 3 Gait/ walking
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 25 at risk

Adverse event: Grade 3 CNS Ischemia
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 25 at risk

Adverse event: Grade 3 Mood alteration
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 25 at risk

Adverse event: Grade 3 Sensory/Neuropathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 25 at risk

Adverse event: Grade 3 Extremity/limb
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 25 at risk

Adverse event: Grade 1 Rhinitis
Serious: no
Organ System: Immune system disorders
Frequency: 2 affected / 25 at risk

Adverse event: Grade 1 Anemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 8 affected / 25 at risk

Adverse event: Grade 3 Anemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 25 at risk

Adverse event: Grade 1 Thrombocytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 13 affected / 25 at risk

Adverse event: Grade 2 Leukopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 9 affected / 25 at risk

Adverse event: Grade 1 Fatigue
Serious: no
Organ System: General disorders
Frequency: 2 affected / 25 at risk

Adverse event: Grade 2 Hypothyroidism
Serious: no
Organ System: Endocrine disorders
Frequency: 2 affected / 25 at risk

Adverse event: Grade 1 Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 25 at risk

Adverse event: Grade 1 Diarrhea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 25 at risk

Adverse event: Grade 2 Diarrhea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 25 at risk

Adverse event: Grade 1 Alkaline phosphatase increase
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 3 affected / 25 at risk

Adverse event: Grade 1 Bilirubin increase
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 4 affected / 25 at risk

Adverse event: Grade 1 Hypoalbuminemia
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 17 affected / 25 at risk

Adverse event: Grade 2 Hypoalbuminemia
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 2 affected / 25 at risk

Adverse event: Grade 1 SGOT (AST) increase
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 5 affected / 25 at risk

Adverse event: Grade 1 SGPT (ALT) increase
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 6 affected / 25 at risk

Adverse event: Grade 1 Hyperglycemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 25 at risk

Adverse event: Grade 2 Hypocalcemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 25 at risk

Adverse event: Grade 1 Hypokalemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 25 at risk

Adverse event: Grade 1 Hyponatremia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 25 at risk

Adverse event: Grade 2 Hypophosphatemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 25 at risk

Adverse event: Grade 1 Sensory/Neuropathy
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 25 at risk

Adverse event: Grade 2 Sensory/Neuropathy
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 25 at risk

Adverse event: Grade 1 Joint
Serious: no
Organ System: General disorders
Frequency: 2 affected / 25 at risk

Adverse event: Grade 2 Upper Back
Serious: no
Organ System: General disorders
Frequency: 2 affected / 25 at risk

Adverse event: Grade 1 Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 25 at risk

Adverse event: Grade 1 Creatinine increase
Serious: no
Organ System: Renal and urinary disorders
Frequency: 7 affected / 25 at risk

Adverse event: Grade 2 Creatinine increase
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 25 at risk

Adverse event: Grade 4 Thrombocyopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 17 at risk

Adverse event: Grade 4 Leukopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 17 at risk

Adverse event: Grade 4 Hypocalcemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 17 at risk

Adverse event: Grade 3 Hypophosphatemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 17 at risk

Adverse event: Grade 3 Sensory/Neuropathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 17 at risk

Adverse event: Gade 3 Hypertension
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 17 at risk

Adverse event: Grade 3 SGPT (ALT) increase
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 17 at risk

Adverse event: Grade 3 Skin Infection UNK ANC
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 17 at risk

Adverse event: Grade 3 Hyperglycemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 17 at risk

Adverse event: Grade 3 Hyponatremia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 17 at risk

Adverse event: Grade 3 Apnea
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 17 at risk

Adverse event: Grade 1 Anemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 17 at risk

Adverse event: Grade 1 Fatigue
Serious: no
Organ System: General disorders
Frequency: 1 affected / 17 at risk

Adverse event: Grade 1 Alkaline phosphatase increase
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 2 affected / 17 at risk

Adverse event: Grade 1 Bilirubin increase
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 17 at risk

Adverse event: Grade 1 Hypoalbuminemia
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 8 affected / 17 at risk

Adverse event: Grade 2 Hypoalbuminemia
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 2 affected / 17 at risk

Adverse event: Grade 1 SGOT (AST) increase
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 4 affected / 17 at risk

Adverse event: Grade 1 SGPT (ALT) increase
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 4 affected / 17 at risk

Adverse event: Grade 1 Hyperglycemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 17 at risk

Adverse event: Grade 2 Hypocalcemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 17 at risk

Adverse event: Grade 1 Hypokalemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 7 affected / 17 at risk

Adverse event: Grade 2 Hypophosphatemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 17 at risk

Adverse event: Grade 1 Sensory/Neuropathy
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 17 at risk

Adverse event: Grade 2 Sensory/Neuropathy
Serious: no
Organ System: Nervous system disorders
Frequency: 6 affected / 17 at risk

Adverse event: Grade 2 Upper Back
Serious: no
Organ System: General disorders
Frequency: 1 affected / 17 at risk

Adverse event: Grade 1 Creatinine increase
Serious: no
Organ System: Renal and urinary disorders
Frequency: 7 affected / 17 at risk

Adverse event: Grade 1 Allergic reaction/Hypersensitivity
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 17 at risk

Adverse event: Grade 1 Hearing (monitoring program)
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 17 at risk

Adverse event: Grade 2 Hearing (w/o monitoring program)
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 17 at risk

Adverse event: Grade 2 Anemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 17 at risk

Adverse event: Grade 2 Fatigue
Serious: no
Organ System: General disorders
Frequency: 2 affected / 17 at risk

Adverse event: Grade 1 Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 17 at risk

Adverse event: Grade 2 Bilirubin increase
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 3 affected / 17 at risk

Adverse event: Grade 2 SGOT (AST) increase
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 17 at risk

Adverse event: Grade 2 Infection , normal ANC lung
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 17 at risk

Adverse event: Grade 2 Lung infection UNK ANC
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 17 at risk

Adverse event: Grade 1 Bicarbonate decrease
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 17 at risk

Adverse event: Grade 2 Hyperglycemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 17 at risk

Adverse event: Grade 1 Hypermagnesemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 17 at risk

Adverse event: Grade 1 Hypomagnesemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 17 at risk

Adverse event: Grade 2 Hypomagnesemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 17 at risk

Adverse event: Grade 1 Hypophosphatemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 17 at risk

Adverse event: Grade 2 Fracture
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 17 at risk

Adverse event: Grade 1 Gait/walking
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 17 at risk

Adverse event: Grade 2 Dry eye
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 17 at risk

Adverse event: Grade 2 Extremity/limb
Serious: no
Organ System: General disorders
Frequency: 1 affected / 17 at risk

Adverse event: Grade 1 Muscle
Serious: no
Organ System: General disorders
Frequency: 1 affected / 17 at risk

Adverse event: Grade 1 Neuralgia/peripheral
Serious: no
Organ System: General disorders
Frequency: 2 affected / 17 at risk

Adverse event: Grade 1 Dyspnea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 17 at risk

Adverse event: Grade 2 Dyspnea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 17 at risk

Adverse event: Grade 2 Pulmonary/other
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 17 at risk