Study: NCT00083382

Adverse event: Pneumonitis/infiltrates
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 83 at risk

Adverse event: Cardiovascular-other
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 83 at risk

Adverse event: Joint, muscle, bone-other
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 83 at risk

Adverse event: Lung-other
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 83 at risk

Adverse event: Respiratory infect w/o neutrop
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 83 at risk

Adverse event: Diarrhea without colostomy
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 83 at risk

Adverse event: Fatigue/malaise/lethargy
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 83 at risk

Adverse event: Syncope
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 83 at risk

Adverse event: Confusional state
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 83 at risk

Adverse event: Speech impairment
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 83 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 83 at risk

Adverse event: GI-other
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 83 at risk

Adverse event: Grade 1 Allergic rhinitis
Serious: no
Organ System: Immune system disorders
Frequency: 7 affected / 83 at risk

Adverse event: Grade 1 Anemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 25 affected / 83 at risk

Adverse event: Grade 2 Anemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 8 affected / 83 at risk

Adverse event: Grade 1 Neutropenia/granulocytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 10 affected / 83 at risk

Adverse event: Grade 2 Neutropenia/granulocytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 17 affected / 83 at risk

Adverse event: Grade 1 Thrombocytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 17 affected / 83 at risk

Adverse event: Grade 2 Thrombocytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 5 affected / 83 at risk

Adverse event: Grade 3 Thrombocytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 5 affected / 83 at risk

Adverse event: Grade 2 Leukopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 20 affected / 83 at risk

Adverse event: Grade 1 Arrhythmia, NOS
Serious: no
Organ System: Cardiac disorders
Frequency: 9 affected / 83 at risk

Adverse event: Grade 4 Cardiovascular - other
Serious: no
Organ System: Cardiac disorders
Frequency: 4 affected / 83 at risk

Adverse event: Grade 1 Edema
Serious: no
Organ System: Cardiac disorders
Frequency: 27 affected / 83 at risk

Adverse event: Grade 2 Edema
Serious: no
Organ System: Cardiac disorders
Frequency: 8 affected / 83 at risk

Adverse event: Grade 1 Hypertension
Serious: no
Organ System: Cardiac disorders
Frequency: 4 affected / 83 at risk

Adverse event: Grade 2 Hypertension
Serious: no
Organ System: Cardiac disorders
Frequency: 4 affected / 83 at risk

Adverse event: Grade 1 Sinus bradycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 7 affected / 83 at risk

Adverse event: Grade 2 Sinus bradycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 5 affected / 83 at risk

Adverse event: Grade 1 Fatigue
Serious: no
Organ System: General disorders
Frequency: 23 affected / 83 at risk

Adverse event: Grade 2 Fatigue
Serious: no
Organ System: General disorders
Frequency: 42 affected / 83 at risk

Adverse event: Grade 3 Fatigue
Serious: no
Organ System: General disorders
Frequency: 9 affected / 83 at risk

Adverse event: Grade 1 Fever without neutropenia
Serious: no
Organ System: General disorders
Frequency: 4 affected / 83 at risk

Adverse event: Grade 2 Fever without neutropenia
Serious: no
Organ System: General disorders
Frequency: 8 affected / 83 at risk

Adverse event: Grade 1 Fever, NOS
Serious: no
Organ System: General disorders
Frequency: 21 affected / 83 at risk

Adverse event: Grade 2 Fever, NOS
Serious: no
Organ System: General disorders
Frequency: 12 affected / 83 at risk

Adverse event: Grade 2 Sweating
Serious: no
Organ System: General disorders
Frequency: 4 affected / 83 at risk

Adverse event: Grade 1 weight gain
Serious: no
Organ System: General disorders
Frequency: 6 affected / 83 at risk

Adverse event: Grade 2 weight gain
Serious: no
Organ System: General disorders
Frequency: 5 affected / 83 at risk

Adverse event: Grade 1 weight loss
Serious: no
Organ System: General disorders
Frequency: 7 affected / 83 at risk

Adverse event: Grade 1 Dry skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 10 affected / 83 at risk

Adverse event: Grade 1 Erythema/rash/eruption/desquamation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 5 affected / 83 at risk

Adverse event: Grade 2 Erythema/rash/eruption/desquamation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 9 affected / 83 at risk

Adverse event: Grade 1 Rash/desquamation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 10 affected / 83 at risk

Adverse event: Grade 2 Rash/desquamation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 7 affected / 83 at risk

Adverse event: Grade 1 Skin - other
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 6 affected / 83 at risk

Adverse event: Grade 2 Skin - other
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 83 at risk

Adverse event: Grade 1 Anorexia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 83 at risk

Adverse event: Grade 2 Anorexia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 83 at risk

Adverse event: Grade 2 Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 83 at risk

Adverse event: Grade 1 Constipation/bowel obstruction
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 24 affected / 83 at risk

Adverse event: Grade 2 Constipation/bowel obstruction
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 32 affected / 83 at risk

Adverse event: Grade 3 Constipation/bowel obstruction
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 83 at risk

Adverse event: Grade 1 Diarrhea without colostomy
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 83 at risk

Adverse event: Grade 2 Diarrhea without colostomy
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 83 at risk

Adverse event: Grade 1 GI - other
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 83 at risk

Adverse event: Grade 1 Mouth dryness
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 12 affected / 83 at risk

Adverse event: Grade 2 Mouth dryness
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 83 at risk

Adverse event: Grade 1 Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 11 affected / 83 at risk

Adverse event: Grade 2 Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 83 at risk

Adverse event: Grade 1 Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 83 at risk

Adverse event: Grade 1 Alkaline phosphatase increase
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 4 affected / 83 at risk

Adverse event: Grade 1 Hypoalbuminemia
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 36 affected / 83 at risk

Adverse event: Grade 2 Hypoalbuminemia
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 7 affected / 83 at risk

Adverse event: Grade 1 SGOT (AST) increase
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 12 affected / 83 at risk

Adverse event: Grade 1 SGPT (ALT) increase
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 19 affected / 83 at risk

Adverse event: Grade 1 Infection w/o 3-4 neutropenia
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 83 at risk

Adverse event: Grade 2 Infection w/o 3-4 neutropenia
Serious: no
Organ System: Infections and infestations
Frequency: 9 affected / 83 at risk

Adverse event: Grade 2 Respiratory infect w/o neutrop
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 83 at risk

Adverse event: Grade 1 Bicarbonate decrease
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 19 affected / 83 at risk

Adverse event: Grade 1 Hypercalcemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 83 at risk

Adverse event: Grade 1 Hyperglycemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 32 affected / 83 at risk

Adverse event: Grade 2 Hyperglycemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 11 affected / 83 at risk

Adverse event: Grade 3 Hyperglycemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 6 affected / 83 at risk

Adverse event: Grade 1 Hypocalcemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 39 affected / 83 at risk

Adverse event: Grade 2 Hypocalcemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 9 affected / 83 at risk

Adverse event: Grade 1 Hypokalemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 15 affected / 83 at risk

Adverse event: Grade 1 Hypomagnesemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 47 affected / 83 at risk

Adverse event: Grade 1 Hyponatremia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 24 affected / 83 at risk

Adverse event: Grade 3 Hyponatremia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 83 at risk

Adverse event: Grade 2 Hypophosphatemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 22 affected / 83 at risk

Adverse event: Grade 3 Hypophosphatemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 9 affected / 83 at risk

Adverse event: Grade 2 Arthritis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 6 affected / 83 at risk

Adverse event: Grade 1 Joint, muscle, bone - other
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 21 affected / 83 at risk

Adverse event: Grade 2 Joint, muscle, bone - other
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 16 affected / 83 at risk

Adverse event: Grade 3 Joint, muscle, bone - other
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 83 at risk

Adverse event: Grade 1 Muscle Weakness (not neuro)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 11 affected / 83 at risk

Adverse event: Grade 2 Muscle Weakness (not neuro)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 7 affected / 83 at risk

Adverse event: Grade 1 Anxiety/agitation
Serious: no
Organ System: Psychiatric disorders
Frequency: 10 affected / 83 at risk

Adverse event: Grade 2 Anxiety/agitation
Serious: no
Organ System: Psychiatric disorders
Frequency: 4 affected / 83 at risk

Adverse event: Grade 1 Ataxia
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 83 at risk

Adverse event: Grade 1 Confusion
Serious: no
Organ System: Psychiatric disorders
Frequency: 13 affected / 83 at risk

Adverse event: Grade 2 Confusion
Serious: no
Organ System: Psychiatric disorders
Frequency: 5 affected / 83 at risk

Adverse event: Grade 1 Cranial neuropathy
Serious: no
Organ System: Nervous system disorders
Frequency: 6 affected / 83 at risk

Adverse event: Grade 1 Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 19 affected / 83 at risk

Adverse event: Grade 2 Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 11 affected / 83 at risk

Adverse event: Grade 1 Dizziness/light headedness
Serious: no
Organ System: Nervous system disorders
Frequency: 14 affected / 83 at risk

Adverse event: Grade 2 Dizziness/light headedness
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 83 at risk

Adverse event: Grade 3 Dizziness/light headedness
Serious: no
Organ System: Nervous system disorders
Frequency: 7 affected / 83 at risk

Adverse event: Grade 1 Headache
Serious: no
Organ System: General disorders
Frequency: 10 affected / 83 at risk

Adverse event: Grade 2 Headache
Serious: no
Organ System: General disorders
Frequency: 7 affected / 83 at risk

Adverse event: Grade 1 Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 5 affected / 83 at risk

Adverse event: Grade 2 Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 5 affected / 83 at risk

Adverse event: Grade 1 Memory loss
Serious: no
Organ System: Psychiatric disorders
Frequency: 6 affected / 83 at risk

Adverse event: Grade 1 Mood/consciousness change, NOS
Serious: no
Organ System: Psychiatric disorders
Frequency: 9 affected / 83 at risk

Adverse event: Grade 1 Neuro - other
Serious: no
Organ System: Nervous system disorders
Frequency: 13 affected / 83 at risk

Adverse event: Grade 2 Neuro - other
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 83 at risk

Adverse event: Grade 1 Sensory neuropathy
Serious: no
Organ System: Nervous system disorders
Frequency: 39 affected / 83 at risk

Adverse event: Grade 2 Sensory neuropathy
Serious: no
Organ System: Nervous system disorders
Frequency: 32 affected / 83 at risk

Adverse event: Grade 3 Sensory neuropathy
Serious: no
Organ System: Nervous system disorders
Frequency: 9 affected / 83 at risk

Adverse event: Grade 1 Somnolence/consciousness loss
Serious: no
Organ System: General disorders
Frequency: 9 affected / 83 at risk

Adverse event: Grade 2 Somnolence/consciousness loss
Serious: no
Organ System: General disorders
Frequency: 5 affected / 83 at risk

Adverse event: Grade 3 Somnolence/consciousness loss
Serious: no
Organ System: General disorders
Frequency: 4 affected / 83 at risk

Adverse event: Grade 1 Tremor
Serious: no
Organ System: Nervous system disorders
Frequency: 12 affected / 83 at risk

Adverse event: Grade 2 Tremor
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 83 at risk

Adverse event: Grade 1 Weakness (motor neuropathy)
Serious: no
Organ System: Nervous system disorders
Frequency: 15 affected / 83 at risk

Adverse event: Grade 2 Weakness (motor neuropathy)
Serious: no
Organ System: Nervous system disorders
Frequency: 11 affected / 83 at risk

Adverse event: Grade 3 Weakness (motor neuropathy)
Serious: no
Organ System: Nervous system disorders
Frequency: 6 affected / 83 at risk

Adverse event: Grade 2 Blurred vision
Serious: no
Organ System: Eye disorders
Frequency: 12 affected / 83 at risk

Adverse event: Grade 1 Eye - other
Serious: no
Organ System: Eye disorders
Frequency: 8 affected / 83 at risk

Adverse event: Grade 1 Bone Pain
Serious: no
Organ System: General disorders
Frequency: 14 affected / 83 at risk

Adverse event: Grade 2 Bone Pain
Serious: no
Organ System: General disorders
Frequency: 13 affected / 83 at risk

Adverse event: Grade 3 Bone Pain
Serious: no
Organ System: General disorders
Frequency: 6 affected / 83 at risk

Adverse event: Grade 1 Chest pain, not cardio or pleural
Serious: no
Organ System: General disorders
Frequency: 4 affected / 83 at risk

Adverse event: Grade 2 Lower Back
Serious: no
Organ System: General disorders
Frequency: 4 affected / 83 at risk

Adverse event: Grade 1 Pain - other
Serious: no
Organ System: General disorders
Frequency: 10 affected / 83 at risk

Adverse event: Grade 2 Pain - other
Serious: no
Organ System: General disorders
Frequency: 10 affected / 83 at risk

Adverse event: Grade 3 Pain - other
Serious: no
Organ System: General disorders
Frequency: 5 affected / 83 at risk

Adverse event: Grade 1 Upper Back
Serious: no
Organ System: General disorders
Frequency: 6 affected / 83 at risk

Adverse event: Grade 1 Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 7 affected / 83 at risk

Adverse event: Grade 2 Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 6 affected / 83 at risk

Adverse event: Grade 2 Dyspnea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 19 affected / 83 at risk

Adverse event: Grade 3 Dyspnea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 83 at risk

Adverse event: Grade 3 Pneumonitis/infiltrates
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 83 at risk

Adverse event: Grade 1 Creatinine increase
Serious: no
Organ System: Renal and urinary disorders
Frequency: 14 affected / 83 at risk

Adverse event: Grade 2 Creatinine increase
Serious: no
Organ System: Renal and urinary disorders
Frequency: 5 affected / 83 at risk

Adverse event: Grade 1 GU - other
Serious: no
Organ System: Renal and urinary disorders
Frequency: 4 affected / 83 at risk