Study: NCT00083551

Adverse event: Grade 3 Arrhythmia, NOS
Serious: yes
Organ System: Cardiac disorders
Frequency: 12 affected / 323 at risk

Adverse event: Grade 4 Arrhythmia, NOS
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 323 at risk

Adverse event: Grade 3 Cardiac ischemia/infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 323 at risk

Adverse event: Grade 4 Cardiac ischemia/infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 323 at risk

Adverse event: Grade 3 Cardiovascular-other
Serious: yes
Organ System: Cardiac disorders
Frequency: 7 affected / 323 at risk

Adverse event: Grade 3 Cerebrovascular ischemia
Serious: yes
Organ System: Cardiac disorders
Frequency: 7 affected / 323 at risk

Adverse event: Grade 4 Cerebrovascular ischemia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 323 at risk

Adverse event: Grade 3 Edema
Serious: yes
Organ System: Cardiac disorders
Frequency: 6 affected / 323 at risk

Adverse event: Grade 3 Hypertension
Serious: yes
Organ System: Cardiac disorders
Frequency: 7 affected / 323 at risk

Adverse event: Grade 3 Hypotension
Serious: yes
Organ System: Cardiac disorders
Frequency: 8 affected / 323 at risk

Adverse event: Grade 4 Hypotension
Serious: yes
Organ System: Cardiac disorders
Frequency: 5 affected / 323 at risk

Adverse event: Grade 3 Nodal/junctional dysrhythmia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 323 at risk

Adverse event: Grade 3 Sinus bradycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 6 affected / 323 at risk

Adverse event: Grade 4 Sinus bradycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 323 at risk

Adverse event: Grade 3 Sinus tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 323 at risk

Adverse event: Grade 3 Supraventricular arrhythmia
Serious: yes
Organ System: Cardiac disorders
Frequency: 7 affected / 323 at risk

Adverse event: Grade 3 Syncope
Serious: yes
Organ System: Cardiac disorders
Frequency: 31 affected / 323 at risk

Adverse event: Grade 3 Thrombosis/embolism
Serious: yes
Organ System: Cardiac disorders
Frequency: 69 affected / 323 at risk

Adverse event: Grade 4 Thrombosis/embolism
Serious: yes
Organ System: Cardiac disorders
Frequency: 11 affected / 323 at risk

Adverse event: Grade 3 Valvular heart disease
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 323 at risk

Adverse event: Grade 3 Vasovagal episode
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 323 at risk

Adverse event: Grade 3 Ventricular arrhythmia
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 323 at risk

Adverse event: Grade 4 Ventricular arrhythmia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 323 at risk

Adverse event: Grade 3 Supra Arrhyth: Atrial Fib.
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 323 at risk

Adverse event: Grade 3 Clotting-other
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 323 at risk

Adverse event: Grade 3 Prothrombin time increase
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 323 at risk

Adverse event: Grade 3 Thrombotic microangiopathy
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 323 at risk

Adverse event: Grade 3 Hearing
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 323 at risk

Adverse event: Grade 3 Inner ear - hearing loss
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 8 affected / 323 at risk

Adverse event: Grade 3 Middle ear - hearing loss/otitis
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 2 affected / 323 at risk

Adverse event: Grade 3 Diabetes
Serious: yes
Organ System: Endocrine disorders
Frequency: 1 affected / 323 at risk

Adverse event: Grade 3 Endocrine - other
Serious: yes
Organ System: Endocrine disorders
Frequency: 1 affected / 323 at risk

Adverse event: Grade 3 Blurred vision
Serious: yes
Organ System: Eye disorders
Frequency: 3 affected / 323 at risk

Adverse event: Grade 3 Cataract
Serious: yes
Organ System: Eye disorders
Frequency: 10 affected / 323 at risk

Adverse event: Grade 3 Eye - other
Serious: yes
Organ System: Eye disorders
Frequency: 2 affected / 323 at risk

Adverse event: Grade 4 Retinopathy
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 323 at risk

Adverse event: Grade 3 Fatigue/malaise/lethargy
Serious: yes
Organ System: General disorders
Frequency: 130 affected / 323 at risk

Adverse event: Grade 4 Fatigue/malaise/lethargy
Serious: yes
Organ System: General disorders
Frequency: 40 affected / 323 at risk

Adverse event: Grade 3 Fever without neutropenia
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 323 at risk

Adverse event: Grade 3 Fever, NOS
Serious: yes
Organ System: General disorders
Frequency: 29 affected / 323 at risk

Adverse event: Grade 4 Fever, NOS
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 323 at risk

Adverse event: Grade 3 Flu-like symptoms-other
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 323 at risk

Adverse event: Grade 3 Insomnia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 323 at risk

Adverse event: Grade 3 Weight loss
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 323 at risk

Adverse event: Grade 3 Anal incontinence
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 323 at risk

Adverse event: Grade 3 Anorexia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 94 affected / 323 at risk

Adverse event: Grade 4 Anorexia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 323 at risk

Adverse event: Grade 3 Colitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 323 at risk

Adverse event: Grade 4 Colitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 323 at risk

Adverse event: Grade 3 Constipation/bowel obstruction
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 31 affected / 323 at risk

Adverse event: Grade 4 Constipation/bowel obstruction
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 323 at risk

Adverse event: Grade 3 Dehydration
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 323 at risk

Adverse event: Grade 3 Diarrhea with colostomy
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 323 at risk

Adverse event: Grade 3 Diarrhea without colostomy
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 61 affected / 323 at risk

Adverse event: Grade 4 Diarrhea without colostomy
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 323 at risk

Adverse event: Grade 3 Dyspepsia/heartburn
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 323 at risk

Adverse event: Grade 3 Esophagitis/dysphagia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 26 affected / 323 at risk

Adverse event: Grade 4 Esophagitis/dysphagia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 10 affected / 323 at risk

Adverse event: Grade 3 Dysphagia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 323 at risk

Adverse event: Grade 3 GI Mucositis, NOS
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 20 affected / 323 at risk

Adverse event: Grade 3 GI-other
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 323 at risk

Adverse event: Grade 4 GI-other
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 323 at risk

Adverse event: Grade 3 Mouth Dryness
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 323 at risk

Adverse event: Grade 3 Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 117 affected / 323 at risk

Adverse event: Grade 4 Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 323 at risk

Adverse event: Grade 3 Pancreatitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 323 at risk

Adverse event: Grade 3 Periodontal
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 323 at risk

Adverse event: Grade 3 RT-GI mucositis, NOS
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 323 at risk

Adverse event: Grade 3 Stomatitis/pharyngitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 60 affected / 323 at risk

Adverse event: Grade 4 Stomatitis/pharyngitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 323 at risk

Adverse event: Grade 3 Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 37 affected / 323 at risk

Adverse event: Grade 4 Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 323 at risk

Adverse event: Grade 3 Bladder Spasms
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 4 affected / 323 at risk

Adverse event: Grade 4 Bladder Spasms
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 323 at risk

Adverse event: Grade 3 Creatinine increase
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 12 affected / 323 at risk

Adverse event: Grade 4 Creatinine increase
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 16 affected / 323 at risk

Adverse event: Grade 3 GU-other
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 2 affected / 323 at risk

Adverse event: Grade 3 Renal failure
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 6 affected / 323 at risk

Adverse event: Grade 4 Renal failure
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 8 affected / 323 at risk

Adverse event: Grade 3 Urinary retention
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 323 at risk

Adverse event: Grade 4 Anemia (HGB)
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 27 affected / 323 at risk

Adverse event: Grade 4 Neutropenia/granulocytopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 242 affected / 323 at risk

Adverse event: Grade 4 Platelet transfusion
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 323 at risk

Adverse event: Grade 4 Thrombocytopenia (PLT)
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 159 affected / 323 at risk

Adverse event: Grade 4 Leukopenia (WBC)
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 257 affected / 323 at risk

Adverse event: Grade 3 Hematuria
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 5 affected / 323 at risk

Adverse event: Grade 3 Hemorrhage w/3-4 thrombocytopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 38 affected / 323 at risk

Adverse event: Grade 4 Hemorrhage w/3-4 thrombocytopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 6 affected / 323 at risk

Adverse event: Grade 3 Hemorrhage-other
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 323 at risk

Adverse event: Grade 4 Vaginal bleeding
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 323 at risk

Adverse event: Grade 3 Melena/GI bleeding
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 6 affected / 323 at risk

Adverse event: Grade 4 Melena/GI bleeding
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 323 at risk

Adverse event: Grade 3 Autoimmune reaction
Serious: yes
Organ System: Immune system disorders
Frequency: 4 affected / 323 at risk

Adverse event: Grade 4 Autoimmune reaction
Serious: yes
Organ System: Immune system disorders
Frequency: 4 affected / 323 at risk

Adverse event: Grade 3 Catheter related infection
Serious: yes
Organ System: Infections and infestations
Frequency: 11 affected / 323 at risk

Adverse event: Grade 3 Febrile neutropenia
Serious: yes
Organ System: Infections and infestations
Frequency: 62 affected / 323 at risk

Adverse event: Grade 3 GU infection ABC UTI
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 323 at risk

Adverse event: Grade 3 Infection w/grade 3 or 4 Neutrophils
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 323 at risk

Adverse event: Grade 3 Infection w/o 3-4 Neutropenia
Serious: yes
Organ System: Infections and infestations
Frequency: 29 affected / 323 at risk

Adverse event: Grade 4 Infection w/o 3-4 Neutropenia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 323 at risk

Adverse event: Grade 3 Infection w/3-4 Neutropenia
Serious: yes
Organ System: Infections and infestations
Frequency: 28 affected / 323 at risk

Adverse event: Grade 3 Infection ANC
Serious: yes
Organ System: Infections and infestations
Frequency: 27 affected / 323 at risk

Adverse event: Grade 4 Infection ANC
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 323 at risk

Adverse event: Grade 3 Lung infection 3-4 ANC
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 323 at risk

Adverse event: Grade 3 Lung Infection ANC Bronchus
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 323 at risk

Adverse event: Grade 3 Lung Infection ANC Lung
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 323 at risk

Adverse event: Grade 3 Lung Infection ANC Pharynx
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 323 at risk

Adverse event: Grade 3 Moderate
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 323 at risk

Adverse event: Grade 3 Respiratory infect w/neutrop
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 323 at risk

Adverse event: Grade 3 Muscle infection ANC Bone
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 323 at risk

Adverse event: Grade 3 Respiratory infection w/o neutrop
Serious: yes
Organ System: Infections and infestations
Frequency: 17 affected / 323 at risk

Adverse event: Grade 4 Respiratory infection w/o neutrop
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 323 at risk

Adverse event: Grade 3 Respiratory infection ANC
Serious: yes
Organ System: Infections and infestations
Frequency: 18 affected / 323 at risk

Adverse event: Grade 3 Skin infection 3-4 ANC lip/perior
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 323 at risk

Adverse event: Grade 3 Surgery-wound infection
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 323 at risk

Adverse event: Grade 4 Surgery -wound infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 323 at risk

Adverse event: Grade 3 Uninary tract infection w/o neutrop
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 323 at risk

Adverse event: Grade 3 Urinary tract infection ANC
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 323 at risk

Adverse event: Grade 3 Alkaline phosphatase increase
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 3 affected / 323 at risk

Adverse event: Grade 3 Bilirubin increase
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 8 affected / 323 at risk

Adverse event: Grade 4 Bilirnbin increase
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 4 affected / 323 at risk

Adverse event: Grade 3 Hypoalbuminemia
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 16 affected / 323 at risk

Adverse event: Grade 3 SGOT (AST) increase
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 9 affected / 323 at risk

Adverse event: Grade 3 SGPT (ALT) increase
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 18 affected / 323 at risk

Adverse event: Grade 4 SGPT (ALT) increase
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 323 at risk

Adverse event: Grade 4 Acute respiratory distress syndrome
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 323 at risk

Adverse event: Grade 3 Apnea
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 323 at risk

Adverse event: Grade 4 Apnea
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 323 at risk

Adverse event: Grade 3 Cough
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 6 affected / 323 at risk

Adverse event: Grade 3 Dyspnea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 18 affected / 323 at risk

Adverse event: Grade 4 Dyspnea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 323 at risk

Adverse event: Grade 3 Hiccoughs
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 323 at risk

Adverse event: Grade 3 Hypoxia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 33 affected / 323 at risk

Adverse event: Grade 4 Hypoxia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 7 affected / 323 at risk

Adverse event: Grade 3 Lung Fistula
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 323 at risk

Adverse event: Grade 3 Lung-other
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 6 affected / 323 at risk

Adverse event: Grade 4 Lung-other
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 323 at risk

Adverse event: Grade 3 Pleural effusions
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 323 at risk

Adverse event: Grade 3 Pneumonitis/infilitrates
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 35 affected / 323 at risk

Adverse event: Grade 4 Pneumonitis/infiltrates
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 323 at risk

Adverse event: Grade 3 Pneumothorax
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 323 at risk

Adverse event: Grade 3 Pulmonary edema
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 323 at risk

Adverse event: Grade 3 Bicarbonate decrease
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 8 affected / 323 at risk

Adverse event: Grade 4 Bicarbonate decrease
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 323 at risk

Adverse event: Grade 3 Hypercalcemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 323 at risk

Adverse event: Grade 4 Hypercalcemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 6 affected / 323 at risk

Adverse event: Grade 3 Hyperglycemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 57 affected / 323 at risk

Adverse event: Grade 4 Hyperglycemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 10 affected / 323 at risk

Adverse event: Grade 3 Hyperkalemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 11 affected / 323 at risk

Adverse event: Grade 4 Hyperkalemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 323 at risk

Adverse event: Grade 3 Hypermagnesemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 14 affected / 323 at risk

Adverse event: Grade 4 Hypermagnesemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 323 at risk

Adverse event: Grade 4 Hyperuricemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 323 at risk

Adverse event: Grade 3 Hypocalcemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 61 affected / 323 at risk

Adverse event: Grade 4 Hypocalcemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 20 affected / 323 at risk

Adverse event: Grade 3 Hypokalemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 72 affected / 323 at risk

Adverse event: Grade 4 Hypokalemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 6 affected / 323 at risk

Adverse event: Grade 4 Hypomagnesemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 323 at risk

Adverse event: Grade 3 Hyponatremia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 101 affected / 323 at risk

Adverse event: Grade 4 Hyponatremia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 14 affected / 323 at risk

Adverse event: Grade 3 Hypophosphatemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 183 affected / 323 at risk

Adverse event: Grade 2 Gait/Walking
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 323 at risk

Adverse event: Grade 4 Gait/Walking
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 323 at risk

Adverse event: Grade 3 Joint, muscle, bone
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 19 affected / 323 at risk

Adverse event: Grade 3 Muscle weakness
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 6 affected / 323 at risk

Adverse event: Grade 3 Osteonecrosis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 323 at risk

Adverse event: Grade 3 Anxiety/agitation
Serious: yes
Organ System: Nervous system disorders
Frequency: 8 affected / 323 at risk

Adverse event: Grade 4 Anxiety/agitation
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 323 at risk

Adverse event: Grade 3 Ataxia
Serious: yes
Organ System: Nervous system disorders
Frequency: 10 affected / 323 at risk

Adverse event: Grade 4 CNS ischemia
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 323 at risk

Adverse event: Grade 3 Confusion
Serious: yes
Organ System: Nervous system disorders
Frequency: 25 affected / 323 at risk

Adverse event: Grade 4 Confusion
Serious: yes
Organ System: Nervous system disorders
Frequency: 5 affected / 323 at risk

Adverse event: Grade 3 Depression
Serious: yes
Organ System: Nervous system disorders
Frequency: 32 affected / 323 at risk

Adverse event: Grade 4 Depression
Serious: yes
Organ System: Nervous system disorders
Frequency: 6 affected / 323 at risk

Adverse event: Grade 3 Dizziness/light headedness
Serious: yes
Organ System: Nervous system disorders
Frequency: 35 affected / 323 at risk

Adverse event: Grade 4 Dizziness/light headedness
Serious: yes
Organ System: Nervous system disorders
Frequency: 4 affected / 323 at risk

Adverse event: Grade 3 Dizziness/vertigo
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 323 at risk

Adverse event: Grade 3 Hallucinations
Serious: yes
Organ System: Nervous system disorders
Frequency: 4 affected / 323 at risk

Adverse event: Grade 3 Headache
Serious: yes
Organ System: Nervous system disorders
Frequency: 11 affected / 323 at risk

Adverse event: Grade 3 Insomnia
Serious: yes
Organ System: Nervous system disorders
Frequency: 4 affected / 323 at risk

Adverse event: Grade 3 Involuntary movement/restlessnes
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 323 at risk

Adverse event: Grade 3 Mood/consciousness change
Serious: yes
Organ System: Nervous system disorders
Frequency: 23 affected / 323 at risk

Adverse event: Grade 4 Mood/consciousness change
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 323 at risk

Adverse event: Grade 3 Neuro-other
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 323 at risk

Adverse event: Grade 3 Seizures
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 323 at risk

Adverse event: Grade 3 Sensory/neuropathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 46 affected / 323 at risk

Adverse event: Grade 4 Sensory/neuropathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 323 at risk

Adverse event: Grade 3 Somnolence/consciousness loss
Serious: yes
Organ System: Nervous system disorders
Frequency: 40 affected / 323 at risk

Adverse event: Grade 4 Somnolence/consciousness loss
Serious: yes
Organ System: Nervous system disorders
Frequency: 4 affected / 323 at risk

Adverse event: Grade 3 Tremor
Serious: yes
Organ System: Nervous system disorders
Frequency: 32 affected / 323 at risk

Adverse event: Grade4 Tremor
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 323 at risk

Adverse event: Grade 3 Weakness (motor neuropathy)
Serious: yes
Organ System: Nervous system disorders
Frequency: 55 affected / 323 at risk

Adverse event: Grade 4 Weakness (motor neuropathy)
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 323 at risk

Adverse event: Grade 3 Abdominal pain/cramping
Serious: yes
Organ System: General disorders
Frequency: 10 affected / 323 at risk

Adverse event: Grade 3 Arthralgia
Serious: yes
Organ System: General disorders
Frequency: 6 affected / 323 at risk

Adverse event: Grade 3 Bone pain
Serious: yes
Organ System: General disorders
Frequency: 24 affected / 323 at risk

Adverse event: Grade 4 Bone pain
Serious: yes
Organ System: General disorders
Frequency: 4 affected / 323 at risk

Adverse event: Grade 3 Cardiac/heart
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 323 at risk

Adverse event: Grade 3 Chest pain/not cardio or pleural
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 323 at risk

Adverse event: Grade 3 Earache
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 2 affected / 323 at risk

Adverse event: Grade 3 Extremity/limb
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 323 at risk

Adverse event: Grade 3 Hip-left
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 323 at risk

Adverse event: Grade 3 Lower back
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 323 at risk

Adverse event: Grade 3 Myalgia
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 5 affected / 323 at risk

Adverse event: Grade 3 Pain/other
Serious: yes
Organ System: General disorders
Frequency: 53 affected / 323 at risk

Adverse event: Grade 4 Pain/other
Serious: yes
Organ System: General disorders
Frequency: 4 affected / 323 at risk

Adverse event: Grade 3 Pleuritic pain
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 323 at risk

Adverse event: Grade 3 Rectal/perirectal pain
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 323 at risk

Adverse event: Grade 3 Upper Back
Serious: yes
Organ System: General disorders
Frequency: 6 affected / 323 at risk

Adverse event: Grade 4 Second primary
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 6 affected / 323 at risk

Adverse event: Grade 3 Erectile impotence
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 323 at risk

Adverse event: Grade 3 Female sterility
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 323 at risk

Adverse event: Grade 3 Menses changes
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 323 at risk

Adverse event: Grade 3 Decubitus
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 323 at risk

Adverse event: Grade 3 Erythema multifrme/blistering
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 323 at risk

Adverse event: Grade 3 Erythema/rash/eruption/desquamation
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 6 affected / 323 at risk

Adverse event: Grade 3 Pruritis
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 323 at risk

Adverse event: Grade 3 Rash/desquamation
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 34 affected / 323 at risk

Adverse event: Grade 4 Rash/desquamation
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 8 affected / 323 at risk

Adverse event: Grade 3 Skin/other
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 323 at risk

Adverse event: Grade 3 Failure to engraft
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 323 at risk

Adverse event: Grade 4 Stem cell infusion complication
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 323 at risk

Adverse event: Grade 3 Syndrome/other
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 323 at risk

Adverse event: Grade 3 Thrombosis/embolism
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 323 at risk

Adverse event: Grade 1 Arrythmia, NOS
Serious: no
Organ System: Cardiac disorders
Frequency: 70 affected / 323 at risk

Adverse event: Grade 2 Arrythmia, NOS
Serious: no
Organ System: Cardiac disorders
Frequency: 21 affected / 323 at risk

Adverse event: Grade 1 Edema
Serious: no
Organ System: Cardiac disorders
Frequency: 101 affected / 323 at risk

Adverse event: Grade 2 Edema
Serious: no
Organ System: Cardiac disorders
Frequency: 33 affected / 323 at risk

Adverse event: Grade 2 Thrombosis/embolism
Serious: no
Organ System: Cardiac disorders
Frequency: 17 affected / 323 at risk

Adverse event: Grade 1 Hypothyroidism
Serious: no
Organ System: Endocrine disorders
Frequency: 22 affected / 323 at risk

Adverse event: Grade 2 Hypothyroidism
Serious: no
Organ System: Endocrine disorders
Frequency: 30 affected / 323 at risk

Adverse event: Grade 2 Blurred vision
Serious: no
Organ System: Eye disorders
Frequency: 53 affected / 323 at risk

Adverse event: Grade 1 Eye - other
Serious: no
Organ System: Eye disorders
Frequency: 24 affected / 323 at risk

Adverse event: Grade 1 Vision, NOS
Serious: no
Organ System: Eye disorders
Frequency: 16 affected / 323 at risk

Adverse event: Grade 2 Fatigue/malaise/lethargy
Serious: no
Organ System: General disorders
Frequency: 79 affected / 323 at risk

Adverse event: Grade 1 Fever without neutropenia
Serious: no
Organ System: General disorders
Frequency: 48 affected / 323 at risk

Adverse event: Grade 2 Fever without neutropenia
Serious: no
Organ System: General disorders
Frequency: 32 affected / 323 at risk

Adverse event: Grade 1 Fever, NOS
Serious: no
Organ System: General disorders
Frequency: 94 affected / 323 at risk

Adverse event: Grade 2 Fever, NOS
Serious: no
Organ System: General disorders
Frequency: 72 affected / 323 at risk

Adverse event: Grade 1 Flu-like symptoms-other
Serious: no
Organ System: General disorders
Frequency: 35 affected / 323 at risk

Adverse event: Grade 1 Insomnia
Serious: no
Organ System: General disorders
Frequency: 21 affected / 323 at risk

Adverse event: Grade 1 Rigors/chills
Serious: no
Organ System: General disorders
Frequency: 29 affected / 323 at risk

Adverse event: Grade 1 sweating
Serious: no
Organ System: General disorders
Frequency: 37 affected / 323 at risk

Adverse event: Grade 2 sweating
Serious: no
Organ System: General disorders
Frequency: 34 affected / 323 at risk

Adverse event: Grade 1 Weight gain
Serious: no
Organ System: General disorders
Frequency: 36 affected / 323 at risk

Adverse event: Grade 1 Weight loss
Serious: no
Organ System: General disorders
Frequency: 35 affected / 323 at risk

Adverse event: Grade 1 Anorexia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 50 affected / 323 at risk

Adverse event: Grade 2 Anorexia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 42 affected / 323 at risk

Adverse event: Grade 1 Constipation/bowel obstruction
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 55 affected / 323 at risk

Adverse event: Grade 2 Constipation/bowel obstruction
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 143 affected / 323 at risk

Adverse event: Grade 1 Diarrhea without colostomy
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 50 affected / 323 at risk

Adverse event: Grade 2 Diarrhea without colostomy
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 119 affected / 323 at risk

Adverse event: Grade 1 Dyspepsia/heartburn
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 27 affected / 323 at risk

Adverse event: Grade 1 Esophagitis/dysphagia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 70 affected / 323 at risk

Adverse event: Grade 2 Esophagitis/dysphagia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 54 affected / 323 at risk

Adverse event: Grade 1 Mouth Dryness
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 52 affected / 323 at risk

Adverse event: Grade 2 Mouth Dryness
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 73 affected / 323 at risk

Adverse event: Grade 1 Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 46 affected / 323 at risk

Adverse event: Grade 2 Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 83 affected / 323 at risk

Adverse event: Grade 1 Stomatitis/pharyngitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 63 affected / 323 at risk

Adverse event: Grade 2 Stomatitis/pharyngitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 73 affected / 323 at risk

Adverse event: Grade 1 Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 58 affected / 323 at risk

Adverse event: Grade 2 Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 105 affected / 323 at risk

Adverse event: Grade 1 Creatinine increase
Serious: no
Organ System: Renal and urinary disorders
Frequency: 77 affected / 323 at risk

Adverse event: Grade 2 Creatinine increase
Serious: no
Organ System: Renal and urinary disorders
Frequency: 53 affected / 323 at risk

Adverse event: Grade 1 Urinary frequency/urgency
Serious: no
Organ System: Renal and urinary disorders
Frequency: 32 affected / 323 at risk

Adverse event: Grade 2 Anemia (HGB)
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 70 affected / 323 at risk

Adverse event: Grade 3 Anemia (HGB)
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 161 affected / 323 at risk

Adverse event: Grade 3 Neutropenia/ granulocytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 16 affected / 323 at risk

Adverse event: Grade 3 PRBC transfusion
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 25 affected / 323 at risk

Adverse event: Grade 3 Platelet Transfusion
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 16 affected / 323 at risk

Adverse event: Grade 3 Thrombocytopenia (PLT)
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 99 affected / 323 at risk

Adverse event: Grade 1 Hemorrhage w/3-4 thrombocytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 40 affected / 323 at risk

Adverse event: Grade 1 Allergic rhinitis
Serious: no
Organ System: Immune system disorders
Frequency: 54 affected / 323 at risk

Adverse event: Grade 1 Autoimmune reaction
Serious: no
Organ System: Immune system disorders
Frequency: 25 affected / 323 at risk

Adverse event: Grade 2 Infection w/Grade 3 or 4 Neutrophils
Serious: no
Organ System: Infections and infestations
Frequency: 21 affected / 323 at risk

Adverse event: Grade 2 Infection w/o 3-4 Neutropenia
Serious: no
Organ System: Infections and infestations
Frequency: 34 affected / 323 at risk

Adverse event: Grade 2 Lung Infection ANC Bronchus
Serious: no
Organ System: Infections and infestations
Frequency: 20 affected / 323 at risk

Adverse event: Grade 2 Respiratory infection w/o neutrop
Serious: no
Organ System: Infections and infestations
Frequency: 33 affected / 323 at risk

Adverse event: Grade 1 Respiratory infection w/o neutrop
Serious: no
Organ System: Infections and infestations
Frequency: 17 affected / 323 at risk

Adverse event: Grade 1 Alkaline phosphatase increase
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 139 affected / 323 at risk

Adverse event: Grade 2 Alkaline phosphatase increase
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 17 affected / 323 at risk

Adverse event: Grade 1 Bilirubin increase
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 52 affected / 323 at risk

Adverse event: Grade 2 Bilirubin increase
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 28 affected / 323 at risk

Adverse event: Grade 1 Hypoalbuminemia
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 86 affected / 323 at risk

Adverse event: Grade 2 Hypoalbuminemia
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 155 affected / 323 at risk

Adverse event: Grade 1 SGOT (AST) increase
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 111 affected / 323 at risk

Adverse event: Grade 2 SGOT (AST) increase
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 25 affected / 323 at risk

Adverse event: Grade 1 SGPT (ALT) increase
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 131 affected / 323 at risk

Adverse event: Grade 2 SGPT (ALT) increase
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 39 affected / 323 at risk

Adverse event: Grade 1 Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 113 affected / 323 at risk

Adverse event: Grade 2 Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 45 affected / 323 at risk

Adverse event: Grade 2 Dyspnea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 97 affected / 323 at risk

Adverse event: Grade 2 Hypoxia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 24 affected / 323 at risk

Adverse event: Grade 2 Pneumonitis/infiltrates
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 20 affected / 323 at risk

Adverse event: Grade 1 Edema-limb
Serious: no
Organ System: General disorders
Frequency: 22 affected / 323 at risk

Adverse event: Grade 1 Lymphedema
Serious: no
Organ System: General disorders
Frequency: 16 affected / 323 at risk

Adverse event: Grade 1 Bicarbonate decrease
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 194 affected / 323 at risk

Adverse event: Grade 2 Bicarbonate decrease
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 28 affected / 323 at risk

Adverse event: Grade 1 Hypercalcemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 34 affected / 323 at risk

Adverse event: Grade 1 Hyperglycemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 48 affected / 323 at risk

Adverse event: Grade 2 Hyperglycemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 152 affected / 323 at risk

Adverse event: Grade 1 Hyperkalemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 78 affected / 323 at risk

Adverse event: Grade 2 Hyperkalemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 29 affected / 323 at risk

Adverse event: Grade 1 Hypermagnesemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 60 affected / 323 at risk

Adverse event: Grade 1 Hypematremia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 80 affected / 323 at risk

Adverse event: Grade 1 Hypocalcemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 35 affected / 323 at risk

Adverse event: Grade 2 Hypocalcemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 146 affected / 323 at risk

Adverse event: Grade 1 Hypokalemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 175 affected / 323 at risk

Adverse event: Grade 1 Hypomagnesemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 142 affected / 323 at risk

Adverse event: Grade 2 Hypomagnesemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 119 affected / 323 at risk

Adverse event: Grade 1 Hyponatremia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 141 affected / 323 at risk

Adverse event: Grade 2 Hypophosphatemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 75 affected / 323 at risk

Adverse event: Grade 1 Joint, muscle, bone
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 44 affected / 323 at risk

Adverse event: Grade 2 Joint, muscle, bone
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 22 affected / 323 at risk

Adverse event: Grade 1 Muscle weakness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 34 affected / 323 at risk

Adverse event: Grade 2 Muscle weakness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 13 affected / 323 at risk

Adverse event: Grade 1 Anxiety/agitation
Serious: no
Organ System: Nervous system disorders
Frequency: 79 affected / 323 at risk

Adverse event: Grade 2 Anxiety/agitation
Serious: no
Organ System: Nervous system disorders
Frequency: 55 affected / 323 at risk

Adverse event: Grade 1 Ataxia
Serious: no
Organ System: Nervous system disorders
Frequency: 45 affected / 323 at risk

Adverse event: Grade 2 Ataxia
Serious: no
Organ System: Nervous system disorders
Frequency: 27 affected / 323 at risk

Adverse event: Grade 1 Confusion
Serious: no
Organ System: Nervous system disorders
Frequency: 84 affected / 323 at risk

Adverse event: Grade 2 Confusion
Serious: no
Organ System: Nervous system disorders
Frequency: 42 affected / 323 at risk

Adverse event: Grade 1 Depression
Serious: no
Organ System: Nervous system disorders
Frequency: 85 affected / 323 at risk

Adverse event: Grade 2 Depression
Serious: no
Organ System: Nervous system disorders
Frequency: 89 affected / 323 at risk

Adverse event: Grade 1 Dizziness/light headedness
Serious: no
Organ System: Nervous system disorders
Frequency: 76 affected / 323 at risk

Adverse event: Grade 2 Dizziness/light headedness
Serious: no
Organ System: Nervous system disorders
Frequency: 53 affected / 323 at risk

Adverse event: Grade 1 Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 48 affected / 323 at risk

Adverse event: Grade 2 Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 37 affected / 323 at risk

Adverse event: Grade 1 Insomnia
Serious: no
Organ System: Nervous system disorders
Frequency: 46 affected / 323 at risk

Adverse event: Grade 2 Insomnia
Serious: no
Organ System: Nervous system disorders
Frequency: 15 affected / 323 at risk

Adverse event: Grade 1 Memory loss
Serious: no
Organ System: Nervous system disorders
Frequency: 20 affected / 323 at risk

Adverse event: Grade 1 Mood/consciousness change
Serious: no
Organ System: Nervous system disorders
Frequency: 51 affected / 323 at risk

Adverse event: Grade 2 Mood/consciousness change
Serious: no
Organ System: Nervous system disorders
Frequency: 35 affected / 323 at risk

Adverse event: Grade 1 Sensory neuropathy
Serious: no
Organ System: Nervous system disorders
Frequency: 72 affected / 323 at risk

Adverse event: Grade 2 Sensory/neuropathy
Serious: no
Organ System: Nervous system disorders
Frequency: 115 affected / 323 at risk

Adverse event: Grade 1 Somnolence/consciousness loss
Serious: no
Organ System: Nervous system disorders
Frequency: 75 affected / 323 at risk

Adverse event: Grade 2 Somnolence/consciousness loss
Serious: no
Organ System: Nervous system disorders
Frequency: 52 affected / 323 at risk

Adverse event: Grade 1 Tremor
Serious: no
Organ System: Nervous system disorders
Frequency: 64 affected / 323 at risk

Adverse event: Grade 2 Tremor
Serious: no
Organ System: Nervous system disorders
Frequency: 45 affected / 323 at risk

Adverse event: Grade 1 Weakness (motor neuropathy)
Serious: no
Organ System: Nervous system disorders
Frequency: 45 affected / 323 at risk

Adverse event: Grade 2 Weakness (motor neuropathy)
Serious: no
Organ System: Nervous system disorders
Frequency: 77 affected / 323 at risk

Adverse event: Grade 1 Abdominal pain/cramping
Serious: no
Organ System: General disorders
Frequency: 20 affected / 323 at risk

Adverse event: Grade 1 Arthralgia
Serious: no
Organ System: General disorders
Frequency: 60 affected / 323 at risk

Adverse event: Grade 2 Arthralgia
Serious: no
Organ System: General disorders
Frequency: 23 affected / 323 at risk

Adverse event: Grade 1 Bone pain
Serious: no
Organ System: General disorders
Frequency: 77 affected / 323 at risk

Adverse event: Grade 2 Bone pain
Serious: no
Organ System: General disorders
Frequency: 55 affected / 323 at risk

Adverse event: Grade 1 Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 40 affected / 323 at risk

Adverse event: Grade 2 Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 26 affected / 323 at risk

Adverse event: Grade 1 Pain/other
Serious: no
Organ System: General disorders
Frequency: 53 affected / 323 at risk

Adverse event: Grade 2 Pain/other
Serious: no
Organ System: General disorders
Frequency: 74 affected / 323 at risk

Adverse event: Grade 1 Upper back
Serious: no
Organ System: General disorders
Frequency: 40 affected / 323 at risk

Adverse event: Grade 2 Upper back
Serious: no
Organ System: General disorders
Frequency: 35 affected / 323 at risk

Adverse event: Grade 2 Alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 73 affected / 323 at risk

Adverse event: Grade 1 Bruising
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 25 affected / 323 at risk

Adverse event: Grade 1 Dry skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 60 affected / 323 at risk

Adverse event: Grade 2 Dry skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 19 affected / 323 at risk

Adverse event: Erythema/rash/eruption/desquamation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 37 affected / 323 at risk

Adverse event: Grade 2 Erythema/rash/eruption/desquamation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 18 affected / 323 at risk

Adverse event: Grade 1 Rash/desquamation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 73 affected / 323 at risk

Adverse event: Grade 2 Rash/desquamation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 82 affected / 323 at risk

Adverse event: Grade 4 Skin/other
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 21 affected / 323 at risk

Adverse event: Grade 3 Arrhythmia, NOS
Serious: yes
Organ System: Cardiac disorders
Frequency: 21 affected / 345 at risk

Adverse event: Grade 4 Arrhythmia, NOS
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 345 at risk

Adverse event: Grade 3 Cardiac ischemia/infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 345 at risk

Adverse event: Grade 4 Cardiac ischemia/infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 345 at risk

Adverse event: Grade 3 Cardiovascular-other
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 345 at risk

Adverse event: Grade 4 Cardiovascular-other
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 345 at risk

Adverse event: Grade 3 Cerebrovascular ischemia
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 345 at risk

Adverse event: Grade 3 Conduction abnormality/block
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 345 at risk

Adverse event: Grade 4 Conduction abnormality/block
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 345 at risk

Adverse event: Grade 3 Edema
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 345 at risk

Adverse event: Grade 3 Hypertension
Serious: yes
Organ System: Cardiac disorders
Frequency: 7 affected / 345 at risk

Adverse event: Grade 3 Hypotension
Serious: yes
Organ System: Cardiac disorders
Frequency: 8 affected / 345 at risk

Adverse event: Grade 3 LVEF decrease/CHF
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 345 at risk

Adverse event: Grade 3 Sinus bradycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 345 at risk

Adverse event: Grade 3 Sinus tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 345 at risk

Adverse event: Grade 3 Supraventricular arrhythmia
Serious: yes
Organ System: Cardiac disorders
Frequency: 7 affected / 345 at risk

Adverse event: Grade 4 Supraventricular arrhythmia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 345 at risk

Adverse event: Grade 3 Surgery-injury of vein/artery
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 345 at risk

Adverse event: Grade 3 Syncope
Serious: yes
Organ System: Cardiac disorders
Frequency: 12 affected / 345 at risk

Adverse event: Grade 3 Thrombosis/embolism
Serious: yes
Organ System: Cardiac disorders
Frequency: 47 affected / 345 at risk

Adverse event: Grade 4 Thrombosis/embolism
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 345 at risk

Adverse event: Grade 3 Ventricular arrhythmia
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 345 at risk

Adverse event: Grade 3 Hearing
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 345 at risk

Adverse event: Grade 3 Middle ear - hearing loss/otitis
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 345 at risk

Adverse event: Grade 3 Diabetes
Serious: yes
Organ System: Endocrine disorders
Frequency: 1 affected / 345 at risk

Adverse event: Grade 3 SIADH
Serious: yes
Organ System: Endocrine disorders
Frequency: 1 affected / 345 at risk

Adverse event: Grade 3 Blurred vision
Serious: yes
Organ System: Eye disorders
Frequency: 2 affected / 345 at risk

Adverse event: Grade 3 Cataract
Serious: yes
Organ System: Eye disorders
Frequency: 4 affected / 345 at risk

Adverse event: Grade 3 Double vision
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 345 at risk

Adverse event: Grade 3 Eye - other
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 345 at risk

Adverse event: Grade 3 Keratitis
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 345 at risk

Adverse event: Grade 3 Photophobia
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 345 at risk

Adverse event: Grade 3 Fatigue/malaise/lethargy
Serious: yes
Organ System: General disorders
Frequency: 139 affected / 345 at risk

Adverse event: Grade 4 Fatigue/malaise/lethargy
Serious: yes
Organ System: General disorders
Frequency: 52 affected / 345 at risk

Adverse event: Grade 3 Fever without neutropenia
Serious: yes
Organ System: General disorders
Frequency: 8 affected / 345 at risk

Adverse event: Grade 4 Fever without neutropenia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 345 at risk

Adverse event: Grade 3 Fever, NOS
Serious: yes
Organ System: General disorders
Frequency: 25 affected / 345 at risk

Adverse event: Grade 4 Fever, NOS
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 345 at risk

Adverse event: Grade 3 Flu-like symptoms-other
Serious: yes
Organ System: General disorders
Frequency: 4 affected / 345 at risk

Adverse event: Grade 3 Obesity
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 345 at risk

Adverse event: Grade 3 Rigors/chills
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 345 at risk

Adverse event: Grade 4 Sweating
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 345 at risk

Adverse event: Grade 3 Weight loss
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 345 at risk

Adverse event: Grade 3 Anorexia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 99 affected / 345 at risk

Adverse event: Grade 4 Anorexia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 345 at risk

Adverse event: Grade 3 Colitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 345 at risk

Adverse event: Grade 4 Colitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 345 at risk

Adverse event: Grade 3 Constipation/bowel obstruction
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 17 affected / 345 at risk

Adverse event: Grade 4 Constipation/bowel obstruction
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 345 at risk

Adverse event: Grade 3 Dehydration
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 345 at risk

Adverse event: Grade 3 Diarrhea with colostomy
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 345 at risk

Adverse event: Grade 3 Diarrhea without colostomy
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 80 affected / 345 at risk

Adverse event: Grade 4 Diarrhea without colostomy
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 345 at risk

Adverse event: Grade 3 Dyspepsia/heartburn
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 345 at risk

Adverse event: Grade 3 Esophagitis/dysphagia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 35 affected / 345 at risk

Adverse event: Grade 4 Esophagitis/dysphagia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 345 at risk

Adverse event: Grade 3 GI Mucositis, NOS
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 10 affected / 345 at risk

Adverse event: Grade 4 GI Mucositis, NOS
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 345 at risk

Adverse event: Grade 3 GI-other
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 345 at risk

Adverse event: Grade 4 GI-other
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 345 at risk

Adverse event: Grade 3 Ileus
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 345 at risk

Adverse event: Grade 3 Mouth Dryness
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 345 at risk

Adverse event: Grade 4 Mouth Dryness
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 345 at risk

Adverse event: Grade 3 Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 118 affected / 345 at risk

Adverse event: Grade 4 Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 345 at risk

Adverse event: Grade 3 Stomatitis/pharyngitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 41 affected / 345 at risk

Adverse event: Grade 4 Stomatitis/pharyngitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 12 affected / 345 at risk

Adverse event: Grade 3 Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 42 affected / 345 at risk

Adverse event: Grade 4 Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 345 at risk

Adverse event: Grade 3 Bladder Spasms
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 2 affected / 345 at risk

Adverse event: Grade 4 Bladder Spasms
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 345 at risk

Adverse event: Grade 3 Creatinine increase
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 8 affected / 345 at risk

Adverse event: Grade 4 Creatinine increase
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 15 affected / 345 at risk

Adverse event: Grade 3 GU-other
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 345 at risk

Adverse event: Grade 3 incontinence
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 345 at risk

Adverse event: Grade 3 Renal failure
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 6 affected / 345 at risk

Adverse event: Grade 4 Renal failure
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 5 affected / 345 at risk

Adverse event: Grade 3 Urinary frequency/urgency
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 2 affected / 345 at risk

Adverse event: Grade 4 Anemia (HGB)
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 34 affected / 345 at risk

Adverse event: Grade 4 Neutropenia/granulocytopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 259 affected / 345 at risk

Adverse event: Grade 4 Thrombocytopenia (PLT)
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 168 affected / 345 at risk

Adverse event: Grade 4 Leukopenia (WBC)
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 279 affected / 345 at risk

Adverse event: Grade 3 Hematuria
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 4 affected / 345 at risk

Adverse event: Grade 4 Hematuria
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 345 at risk

Adverse event: Grade 3 Hemorrhage w/3-4 thrombocytopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 37 affected / 345 at risk

Adverse event: Grade 4 Hemorrhage w/3-4 thrombocytopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 10 affected / 345 at risk

Adverse event: Grade 3 Hemorrhage w/o 3-4 thrombocytopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 345 at risk

Adverse event: Grade 3 Petechiae/purpura
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 345 at risk

Adverse event: Grade 3 Melena/GI bleeding
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 9 affected / 345 at risk

Adverse event: Grade 4 Melena/GI bleeding
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 345 at risk

Adverse event: Grade 3 Allergic/hypersensitivity
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 345 at risk

Adverse event: Grade 3 Autoimmune reaction
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 345 at risk

Adverse event: Grade 3 Catheter related infection
Serious: yes
Organ System: Infections and infestations
Frequency: 18 affected / 345 at risk

Adverse event: Grade 3 Ear infection ANC mid ear
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 345 at risk

Adverse event: Grade 3 Febrile neutropenia
Serious: yes
Organ System: Infections and infestations
Frequency: 80 affected / 345 at risk

Adverse event: Grade 4 Febrile neutropenia
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 345 at risk

Adverse event: Grade 3 GI infection 3-4 ANC abdomen
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 345 at risk

Adverse event: Grade 3 GI infection 3-4 ANC appendix
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 345 at risk

Adverse event: Grade 3 GI Infection 3-4 ANC tooth
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 345 at risk

Adverse event: Grade 3 GI infection ANC abdomen
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 345 at risk

Adverse event: Grade 3 Infection w/grade 3 or 4 Neutrophils
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 345 at risk

Adverse event: Grade 3 Infection w/o 3-4 Neutropenia
Serious: yes
Organ System: Infections and infestations
Frequency: 38 affected / 345 at risk

Adverse event: Grade 4 Infection w/o 3-4 Neutropenia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 345 at risk

Adverse event: Grade 3 Infection w/3-4 Neutropenia
Serious: yes
Organ System: Infections and infestations
Frequency: 27 affected / 345 at risk

Adverse event: Grade 4 Infection w/3-4 Neutropenia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 345 at risk

Adverse event: Grade 3 Infection ANC
Serious: yes
Organ System: Infections and infestations
Frequency: 25 affected / 345 at risk

Adverse event: Grade 3 Moderate
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 345 at risk

Adverse event: Grade 3 Respiratory infect w/neutrop
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 345 at risk

Adverse event: Grade 3 Respiratory infection w/o neutrop
Serious: yes
Organ System: Infections and infestations
Frequency: 10 affected / 345 at risk

Adverse event: Grade 4 Respiratory infection w/o neutrop
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 345 at risk

Adverse event: Grade 3 Respiratory infection ANC
Serious: yes
Organ System: Infections and infestations
Frequency: 11 affected / 345 at risk

Adverse event: Grade 3 Urinary tract infectiob w/neutrop
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 345 at risk

Adverse event: Grade 3 Uninary tract infection w/o neutrop
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 345 at risk

Adverse event: Grade 4 Urinary tract infection w/o neutrop
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 345 at risk

Adverse event: Grade 3 Urinary tract infection ANC
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 345 at risk

Adverse event: Grade 3 Alkaline phosphatase increase
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 4 affected / 345 at risk

Adverse event: Grade 3 Bilirubin increase
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 9 affected / 345 at risk

Adverse event: Grade 4 Bilirnbin increase
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 2 affected / 345 at risk

Adverse event: Grade 3 Hypoalbuminemia
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 18 affected / 345 at risk

Adverse event: Grade 3 Liver enlargement
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 345 at risk

Adverse event: Grade 3 SGOT (AST) increase
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 7 affected / 345 at risk

Adverse event: Grade 4 SGOT (AST) increase
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 3 affected / 345 at risk

Adverse event: Grade 3 SGPT (ALT) increase
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 19 affected / 345 at risk

Adverse event: Grade 4 SGPT (ALT) increase
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 345 at risk

Adverse event: Grade 4 Acute respiratory distress syndrome
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 345 at risk

Adverse event: Grade 3 Cough
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 345 at risk

Adverse event: Grade 3 Dyspnea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 12 affected / 345 at risk

Adverse event: Grade 4 Dyspnea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 345 at risk

Adverse event: Grade 3 Hiccoughs
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 345 at risk

Adverse event: Grade 3 Hypoxia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 37 affected / 345 at risk

Adverse event: Grade 4 Hypoxia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 345 at risk

Adverse event: Grade 3 Lung-other
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 6 affected / 345 at risk

Adverse event: Grade 3 Pleural effusions
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 345 at risk

Adverse event: Grade 3 Pneumonitis/infilitrates
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 30 affected / 345 at risk

Adverse event: Grade 4 Pneumonitis/infiltrates
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 345 at risk

Adverse event: Grade 3 Pulmonary edema
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 345 at risk

Adverse event: Grade 3 Voice charge /stridor/larynx
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 345 at risk

Adverse event: Grade 3 Bicarbonate decrease
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 345 at risk

Adverse event: Grade 4 Bicarbonate decrease
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 345 at risk

Adverse event: Grade 3 Hypercalcemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 345 at risk

Adverse event: Grade 4 Hypercalcemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 345 at risk

Adverse event: Grade 3 Hyperglycemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 84 affected / 345 at risk

Adverse event: Grade 4 Hyperglycemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 10 affected / 345 at risk

Adverse event: Grade 3 Hyperkalemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 18 affected / 345 at risk

Adverse event: Grade 4 Hyperkalemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 345 at risk

Adverse event: Grade 3 Hypermagnesemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 21 affected / 345 at risk

Adverse event: Grade 4 Hypermagnesemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 345 at risk

Adverse event: Grade 3 Hypermatremia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 345 at risk

Adverse event: Grade 3 Hypocalcemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 75 affected / 345 at risk

Adverse event: Grade 4 Hypocalcemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 17 affected / 345 at risk

Adverse event: Grade 3 Hypokalemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 89 affected / 345 at risk

Adverse event: Grade 4 Hypokalemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 345 at risk

Adverse event: Grade 3 Hypomagnesemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 10 affected / 345 at risk

Adverse event: Grade 3 Hyponatremia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 95 affected / 345 at risk

Adverse event: Grade 4 Hyponatremia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 8 affected / 345 at risk

Adverse event: Grade 3 Hypophosphatemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 214 affected / 345 at risk

Adverse event: Grade 4 Hypophosphatemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 345 at risk

Adverse event: Grade 3 Fracture
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 345 at risk

Adverse event: Grade 3 Joint, muscle, bone
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 6 affected / 345 at risk

Adverse event: Grade 3 Muscle weakness
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 5 affected / 345 at risk

Adverse event: Grade 3 Osteonecrosis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 345 at risk

Adverse event: Grade 3 Anxiety/agitation
Serious: yes
Organ System: Nervous system disorders
Frequency: 16 affected / 345 at risk

Adverse event: Grade 4 Anxiety/agitation
Serious: yes
Organ System: Nervous system disorders
Frequency: 5 affected / 345 at risk

Adverse event: Grade 3 Ataxia
Serious: yes
Organ System: Nervous system disorders
Frequency: 6 affected / 345 at risk

Adverse event: Grade 3 Confusion
Serious: yes
Organ System: Nervous system disorders
Frequency: 23 affected / 345 at risk

Adverse event: Grade 4 Confusion
Serious: yes
Organ System: Nervous system disorders
Frequency: 8 affected / 345 at risk

Adverse event: Grade 3 Depression
Serious: yes
Organ System: Nervous system disorders
Frequency: 28 affected / 345 at risk

Adverse event: Grade 4 Depression
Serious: yes
Organ System: Nervous system disorders
Frequency: 6 affected / 345 at risk

Adverse event: Grade 3 Dizziness/light headedness
Serious: yes
Organ System: Nervous system disorders
Frequency: 15 affected / 345 at risk

Adverse event: Grade 4 Dizziness/light headedness
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 345 at risk

Adverse event: Grade 3 Hallucinations
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 345 at risk

Adverse event: Grade 3 Headache
Serious: yes
Organ System: Nervous system disorders
Frequency: 19 affected / 345 at risk

Adverse event: Grade 3 Insomnia
Serious: yes
Organ System: Nervous system disorders
Frequency: 4 affected / 345 at risk

Adverse event: Grade 3 Mood/consciousness change
Serious: yes
Organ System: Nervous system disorders
Frequency: 17 affected / 345 at risk

Adverse event: Grade 4 Mood/consciousness change
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 345 at risk

Adverse event: Grade 3 Neuro-other
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 345 at risk

Adverse event: Grade 4 Neuro-other
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 345 at risk

Adverse event: Grade 3 Seizures
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 345 at risk

Adverse event: Grade 4 Seizures
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 345 at risk

Adverse event: Grade 3 Sensory/neuropathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 13 affected / 345 at risk

Adverse event: Grade 3 Somnolence/consciousness loss
Serious: yes
Organ System: Nervous system disorders
Frequency: 32 affected / 345 at risk

Adverse event: Grade 4 Somnolence/consciousness loss
Serious: yes
Organ System: Nervous system disorders
Frequency: 4 affected / 345 at risk

Adverse event: Grade 3 Speech impairment
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 345 at risk

Adverse event: Grade 3 Tremor
Serious: yes
Organ System: Nervous system disorders
Frequency: 15 affected / 345 at risk

Adverse event: Grade4 Tremor
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 345 at risk

Adverse event: Grade 3 Weakness (motor neuropathy)
Serious: yes
Organ System: Nervous system disorders
Frequency: 36 affected / 345 at risk

Adverse event: Grade 4 Weakness (motor neuropathy)
Serious: yes
Organ System: Nervous system disorders
Frequency: 5 affected / 345 at risk

Adverse event: Grade 3 Abdominal pain/cramping
Serious: yes
Organ System: General disorders
Frequency: 8 affected / 345 at risk

Adverse event: Grade 4 Abdominal pain/cramping
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 345 at risk

Adverse event: Grade 3 Arthralgia
Serious: yes
Organ System: General disorders
Frequency: 8 affected / 345 at risk

Adverse event: Grade 4 Arthralgia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 345 at risk

Adverse event: Grade 3 Bone pain
Serious: yes
Organ System: General disorders
Frequency: 18 affected / 345 at risk

Adverse event: Grade 4 Bone pain
Serious: yes
Organ System: General disorders
Frequency: 4 affected / 345 at risk

Adverse event: Grade 3 Chest/thorax
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 345 at risk

Adverse event: Grade 3 Chest pain/not cardio or pleural
Serious: yes
Organ System: General disorders
Frequency: 4 affected / 345 at risk

Adverse event: Grade 3 Extremity/limb
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 345 at risk

Adverse event: Grade 3 Eye
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 345 at risk

Adverse event: Grade 3 Hepatic pain
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 345 at risk

Adverse event: Grade 3 Lower back
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 345 at risk

Adverse event: Grade 3 Muscle
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 345 at risk

Adverse event: Grade 3 Myalgia
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 345 at risk

Adverse event: Grade 3 Myalgia/arthralgia
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 345 at risk

Adverse event: Grade 3 Neuropathic pain
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 345 at risk

Adverse event: Grade 3 Pain NOS
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 345 at risk

Adverse event: Grade 3 Pain/other
Serious: yes
Organ System: General disorders
Frequency: 47 affected / 345 at risk

Adverse event: Grade 3 Pelvic
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 345 at risk

Adverse event: Grade 3 Rectal/perirectal pain
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 345 at risk

Adverse event: Grade 3 Rib
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 345 at risk

Adverse event: Grade 3 Tumor pain
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 345 at risk

Adverse event: Grade 3 Upper Back
Serious: yes
Organ System: General disorders
Frequency: 4 affected / 345 at risk

Adverse event: Grade 4 Second primary
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 6 affected / 345 at risk

Adverse event: Grade 3 Erythema/rash/eruption/desquamation
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 6 affected / 345 at risk

Adverse event: Grade 3 Pruritis
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 345 at risk

Adverse event: Grade 3 Rash/desquamation
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 36 affected / 345 at risk

Adverse event: Grade 4 Rash/desquamation
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 5 affected / 345 at risk

Adverse event: Grade 3 Skin/other
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 345 at risk

Adverse event: Grade 3 Failure to engraft
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 345 at risk

Adverse event: Grade 3 Stem cell infusion complication
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 345 at risk

Adverse event: Grade 4 Stem cell infusion complication
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 345 at risk

Adverse event: Grade 3 Thrombosis/embolism
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 345 at risk

Adverse event: Grade 1 Arrythmia, NOS
Serious: no
Organ System: Cardiac disorders
Frequency: 88 affected / 345 at risk

Adverse event: Grade 2 Arrythmia, NOS
Serious: no
Organ System: Cardiac disorders
Frequency: 29 affected / 345 at risk

Adverse event: Grade 1 Edema
Serious: no
Organ System: Cardiac disorders
Frequency: 83 affected / 345 at risk

Adverse event: Grade 2 Edema
Serious: no
Organ System: Cardiac disorders
Frequency: 28 affected / 345 at risk

Adverse event: Grade 1 Sinus tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 16 affected / 345 at risk

Adverse event: Grade 2 Thrombosis/embolism
Serious: no
Organ System: Cardiac disorders
Frequency: 21 affected / 345 at risk

Adverse event: Grade 1 Hypothyroidism
Serious: no
Organ System: Endocrine disorders
Frequency: 21 affected / 345 at risk

Adverse event: Grade 2 Blurred vision
Serious: no
Organ System: Eye disorders
Frequency: 47 affected / 345 at risk

Adverse event: Grade 2 Fatigue/malaise/lethargy
Serious: no
Organ System: General disorders
Frequency: 76 affected / 345 at risk

Adverse event: Grade 1 Fever without neutropenia
Serious: no
Organ System: General disorders
Frequency: 45 affected / 345 at risk

Adverse event: Grade 2 Fever without neutropenia
Serious: no
Organ System: General disorders
Frequency: 21 affected / 345 at risk

Adverse event: Grade 1 Fever, NOS
Serious: no
Organ System: General disorders
Frequency: 112 affected / 345 at risk

Adverse event: Grade 2 Fever, NOS
Serious: no
Organ System: General disorders
Frequency: 59 affected / 345 at risk

Adverse event: Grade 1 Flu-like symptoms-other
Serious: no
Organ System: General disorders
Frequency: 27 affected / 345 at risk

Adverse event: Grade 1 Rigors/chills
Serious: no
Organ System: General disorders
Frequency: 14 affected / 345 at risk

Adverse event: Grade 1 sweating
Serious: no
Organ System: General disorders
Frequency: 31 affected / 345 at risk

Adverse event: Grade 2 sweating
Serious: no
Organ System: General disorders
Frequency: 36 affected / 345 at risk

Adverse event: Grade 1 Weight gain
Serious: no
Organ System: General disorders
Frequency: 31 affected / 345 at risk

Adverse event: Grade 1 Weight loss
Serious: no
Organ System: General disorders
Frequency: 37 affected / 345 at risk

Adverse event: Grade 1 Anorexia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 62 affected / 345 at risk

Adverse event: Grade 2 Anorexia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 44 affected / 345 at risk

Adverse event: Grade 2 Colitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 24 affected / 345 at risk

Adverse event: Grade 1 Constipation/bowel obstruction
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 69 affected / 345 at risk

Adverse event: Grade 2 Constipation/bowel obstruction
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 112 affected / 345 at risk

Adverse event: Grade 1 Diarrhea without colostomy
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 51 affected / 345 at risk

Adverse event: Grade 2 Diarrhea without colostomy
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 127 affected / 345 at risk

Adverse event: Grade 1 Dyspepsia/heartburn
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 19 affected / 345 at risk

Adverse event: Grade 1 Esophagitis/dysphagia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 56 affected / 345 at risk

Adverse event: Grade 2 Esophagitis/dysphagia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 81 affected / 345 at risk

Adverse event: Grade 1 Mouth Dryness
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 46 affected / 345 at risk

Adverse event: Grade 2 Mouth Dryness
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 48 affected / 345 at risk

Adverse event: Grade 1 Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 37 affected / 345 at risk

Adverse event: Grade 2 Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 118 affected / 345 at risk

Adverse event: Grade 1 Stomatitis/pharyngitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 66 affected / 345 at risk

Adverse event: Grade 2 Stomatitis/pharyngitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 90 affected / 345 at risk

Adverse event: Grade 1 Taste Disturbance
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 17 affected / 345 at risk

Adverse event: Grade 1 Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 65 affected / 345 at risk

Adverse event: Grade 2 Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 122 affected / 345 at risk

Adverse event: Grade 1 Bladder Spasms
Serious: no
Organ System: Renal and urinary disorders
Frequency: 21 affected / 345 at risk

Adverse event: Grade 1 Creatinine increase
Serious: no
Organ System: Renal and urinary disorders
Frequency: 91 affected / 345 at risk

Adverse event: Grade 2 Creatinine increase
Serious: no
Organ System: Renal and urinary disorders
Frequency: 62 affected / 345 at risk

Adverse event: Grade 1 Urinary frequency/urgency
Serious: no
Organ System: Renal and urinary disorders
Frequency: 22 affected / 345 at risk

Adverse event: Grade 2 Anemia (HGB)
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 76 affected / 345 at risk

Adverse event: Grade 3 Anemia (HGB)
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 174 affected / 345 at risk

Adverse event: Grade 3 Neutropenia/ granulocytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 20 affected / 345 at risk

Adverse event: Grade 3 Thrombocytopenia (PLT)
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 112 affected / 345 at risk

Adverse event: Grade 2 Hematuria
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 16 affected / 345 at risk

Adverse event: Grade 1 Hemorrhage w/3-4 thrombocytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 63 affected / 345 at risk

Adverse event: Grade 1 Allergic rhinitis
Serious: no
Organ System: Immune system disorders
Frequency: 42 affected / 345 at risk

Adverse event: Grade 1 Autoimmune reaction
Serious: no
Organ System: Immune system disorders
Frequency: 28 affected / 345 at risk

Adverse event: Grade 2 Infection w/o 3-4 Neutropenia
Serious: no
Organ System: Infections and infestations
Frequency: 33 affected / 345 at risk

Adverse event: Grade 2 Lung Infection ANC Bronchus
Serious: no
Organ System: Infections and infestations
Frequency: 15 affected / 345 at risk

Adverse event: Grade 2 Respiratory infection w/o neutrop
Serious: no
Organ System: Infections and infestations
Frequency: 46 affected / 345 at risk

Adverse event: Grade 1 Alkaline phosphatase increase
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 149 affected / 345 at risk

Adverse event: Grade 2 Alkaline phosphatase increase
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 21 affected / 345 at risk

Adverse event: Grade 1 Bilirubin increase
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 62 affected / 345 at risk

Adverse event: Grade 2 Bilirubin increase
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 24 affected / 345 at risk

Adverse event: Grade 1 Hypoalbuminemia
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 93 affected / 345 at risk

Adverse event: Grade 2 Hypoalbuminemia
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 179 affected / 345 at risk

Adverse event: Grade 1 SGOT (AST) increase
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 124 affected / 345 at risk

Adverse event: Grade 2 SGOT (AST) increase
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 30 affected / 345 at risk

Adverse event: Grade 1 SGPT (ALT) increase
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 140 affected / 345 at risk

Adverse event: Grade 2 SGPT (ALT) increase
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 57 affected / 345 at risk

Adverse event: Grade 1 Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 103 affected / 345 at risk

Adverse event: Grade 2 Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 31 affected / 345 at risk

Adverse event: Grade 2 Dyspnea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 92 affected / 345 at risk

Adverse event: Grade 2 Hypoxia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 24 affected / 345 at risk

Adverse event: Grade 2 Pneumonitis/infiltrates
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 22 affected / 345 at risk

Adverse event: Grade 1 Bicarbonate decrease
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 217 affected / 345 at risk

Adverse event: Grade 2 Bicarbonate decrease
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 41 affected / 345 at risk

Adverse event: Grade 1 Hypercalcemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 37 affected / 345 at risk

Adverse event: Grade 1 Hyperglycemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 48 affected / 345 at risk

Adverse event: Grade 2 Hyperglycemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 151 affected / 345 at risk

Adverse event: Grade 1 Hyperkalemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 82 affected / 345 at risk

Adverse event: Grade 2 Hyperkalemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 15 affected / 345 at risk

Adverse event: Grade 1 Hypermagnesemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 52 affected / 345 at risk

Adverse event: Grade 1 Hypematremia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 74 affected / 345 at risk

Adverse event: Grade 1 Hypocalcemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 41 affected / 345 at risk

Adverse event: Grade 2 Hypocalcemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 160 affected / 345 at risk

Adverse event: Grade 1 Hypokalemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 182 affected / 345 at risk

Adverse event: Grade 1 Hypomagnesemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 158 affected / 345 at risk

Adverse event: Grade 2 Hypomagnesemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 116 affected / 345 at risk

Adverse event: Grade 1 Hyponatremia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 179 affected / 345 at risk

Adverse event: Grade 2 Hypophosphatemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 65 affected / 345 at risk

Adverse event: Grade 1 Joint, muscle, bone
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 40 affected / 345 at risk

Adverse event: Grade 1 Muscle weakness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 22 affected / 345 at risk

Adverse event: Grade 2 Muscle weakness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 20 affected / 345 at risk

Adverse event: Grade 1 Anxiety/agitation
Serious: no
Organ System: Nervous system disorders
Frequency: 93 affected / 345 at risk

Adverse event: Grade 2 Anxiety/agitation
Serious: no
Organ System: Nervous system disorders
Frequency: 44 affected / 345 at risk

Adverse event: Grade 1 Ataxia
Serious: no
Organ System: Nervous system disorders
Frequency: 27 affected / 345 at risk

Adverse event: Grade 1 Confusion
Serious: no
Organ System: Nervous system disorders
Frequency: 92 affected / 345 at risk

Adverse event: Grade 2 Confusion
Serious: no
Organ System: Nervous system disorders
Frequency: 35 affected / 345 at risk

Adverse event: Grade 1 Depression
Serious: no
Organ System: Nervous system disorders
Frequency: 101 affected / 345 at risk

Adverse event: Grade 2 Depression
Serious: no
Organ System: Nervous system disorders
Frequency: 94 affected / 345 at risk

Adverse event: Grade 1 Dizziness/light headedness
Serious: no
Organ System: Nervous system disorders
Frequency: 76 affected / 345 at risk

Adverse event: Grade 2 Dizziness/light headedness
Serious: no
Organ System: Nervous system disorders
Frequency: 41 affected / 345 at risk

Adverse event: Grade 1 Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 51 affected / 345 at risk

Adverse event: Grade 2 Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 29 affected / 345 at risk

Adverse event: Grade 1 Insomnia
Serious: no
Organ System: Nervous system disorders
Frequency: 42 affected / 345 at risk

Adverse event: Grade 1 Mood/consciousness change
Serious: no
Organ System: Nervous system disorders
Frequency: 36 affected / 345 at risk

Adverse event: Grade 2 Mood/consciousness change
Serious: no
Organ System: Nervous system disorders
Frequency: 31 affected / 345 at risk

Adverse event: Grade 1 Sensory neuropathy
Serious: no
Organ System: Nervous system disorders
Frequency: 134 affected / 345 at risk

Adverse event: Grade 2 Sensory/neuropathy
Serious: no
Organ System: Nervous system disorders
Frequency: 62 affected / 345 at risk

Adverse event: Grade 1 Somnolence/consciousness loss
Serious: no
Organ System: Nervous system disorders
Frequency: 78 affected / 345 at risk

Adverse event: Grade 2 Somnolence/consciousness loss
Serious: no
Organ System: Nervous system disorders
Frequency: 34 affected / 345 at risk

Adverse event: Grade 1 Tremor
Serious: no
Organ System: Nervous system disorders
Frequency: 51 affected / 345 at risk

Adverse event: Grade 2 Tremor
Serious: no
Organ System: Nervous system disorders
Frequency: 32 affected / 345 at risk

Adverse event: Grade 1 Weakness (motor neuropathy)
Serious: no
Organ System: Nervous system disorders
Frequency: 52 affected / 345 at risk

Adverse event: Grade 2 Weakness (motor neuropathy)
Serious: no
Organ System: Nervous system disorders
Frequency: 54 affected / 345 at risk

Adverse event: Grade 1 Abdominal pain/cramping
Serious: no
Organ System: General disorders
Frequency: 26 affected / 345 at risk

Adverse event: Grade 1 Arthralgia
Serious: no
Organ System: General disorders
Frequency: 59 affected / 345 at risk

Adverse event: Grade 2 Arthralgia
Serious: no
Organ System: General disorders
Frequency: 27 affected / 345 at risk

Adverse event: Grade 1 Bone pain
Serious: no
Organ System: General disorders
Frequency: 70 affected / 345 at risk

Adverse event: Grade 2 Bone pain
Serious: no
Organ System: General disorders
Frequency: 65 affected / 345 at risk

Adverse event: Grade 1 Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 53 affected / 345 at risk

Adverse event: Grade 2 Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 14 affected / 345 at risk

Adverse event: Grade 1 Pain/other
Serious: no
Organ System: General disorders
Frequency: 77 affected / 345 at risk

Adverse event: Grade 2 Pain/other
Serious: no
Organ System: General disorders
Frequency: 62 affected / 345 at risk

Adverse event: Grade 1 Upper back
Serious: no
Organ System: General disorders
Frequency: 27 affected / 345 at risk

Adverse event: Grade 2 Upper back
Serious: no
Organ System: General disorders
Frequency: 19 affected / 345 at risk

Adverse event: Grade 2 Alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 79 affected / 345 at risk

Adverse event: Grade 1 Bruising
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 27 affected / 345 at risk

Adverse event: Grade 1 Dry skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 43 affected / 345 at risk

Adverse event: Erythema/rash/eruption/desquamation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 37 affected / 345 at risk

Adverse event: Grade 2 Erythema/rash/eruption/desquamation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 12 affected / 345 at risk

Adverse event: Grade 1 Rash/desquamation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 86 affected / 345 at risk

Adverse event: Grade 2 Rash/desquamation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 93 affected / 345 at risk

Adverse event: Grade 4 Skin/other
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 17 affected / 345 at risk

Adverse event: Grade 1 Stem cell infusion complication
Serious: no
Organ System: General disorders
Frequency: 17 affected / 345 at risk