Study: NCT00918723

Adverse event: Sepsis Grade 5
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 40 at risk

Adverse event: Infusion reaction Grade 3
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 40 at risk

Adverse event: Gastroenteritis Grade 3
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 40 at risk

Adverse event: Dehydration Grade 3
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 40 at risk

Adverse event: Bronchiectasis Grade 3
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 40 at risk

Adverse event: Sepsis Grade 4
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 40 at risk

Adverse event: Diarrhea Grade 3
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 40 at risk

Adverse event: Bradychardia Grade 3
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 40 at risk

Adverse event: Neutropenia Grade 3
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 40 at risk

Adverse event: Pneumonia Grade 3
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 40 at risk

Adverse event: Sepsis Grade 3
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 40 at risk

Adverse event: Venous thromboemoblism Grade 4
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 40 at risk

Adverse event: Drug rash with eosinophilia and systemic symptoms (DRESS) syndrome - Grade 3
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 40 at risk

Adverse event: Rash Grade 3
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 40 at risk

Adverse event: Elective surgery
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 40 at risk

Adverse event: Anemia Grade 3
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 40 at risk

Adverse event: Neutropenia Grade 2
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 10 affected / 40 at risk

Adverse event: Neutropenia Grade 3
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 8 affected / 40 at risk

Adverse event: Leukopenia Grade 3
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 12 affected / 40 at risk

Adverse event: Neutropenia Grade 4
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 16 affected / 40 at risk

Adverse event: Leukopenia Grade 4
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 8 affected / 40 at risk

Adverse event: Thrombocytopenia Grade 2
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 6 affected / 40 at risk

Adverse event: Thrombocytopenia Grade 3
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 6 affected / 40 at risk

Adverse event: Thrombocytopenia Grade 4
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 4 affected / 40 at risk

Adverse event: Nausea Grade 3
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 40 at risk

Adverse event: Vomiting Grade 3
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 40 at risk

Adverse event: Constipation Grade 3
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 40 at risk

Adverse event: Diarrhea Grade 3
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 40 at risk

Adverse event: Gastroenteritis Grade 3
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 40 at risk

Adverse event: Hyperbilirubinemia Grade 2
Serious: no
Organ System: Investigations
Frequency: 4 affected / 40 at risk

Adverse event: Hyperbilirubinemia Grade 3
Serious: no
Organ System: Investigations
Frequency: 1 affected / 40 at risk

Adverse event: Elevated alkaline phosphatase Grade 3
Serious: no
Organ System: Investigations
Frequency: 1 affected / 40 at risk

Adverse event: Elevated AST Grade 4
Serious: no
Organ System: Investigations
Frequency: 1 affected / 40 at risk

Adverse event: Elevated AST Grade 3
Serious: no
Organ System: Investigations
Frequency: 1 affected / 40 at risk

Adverse event: Hypoalbuminemia Grade 3
Serious: no
Organ System: Investigations
Frequency: 1 affected / 40 at risk

Adverse event: Elevated lipase Grade 3
Serious: no
Organ System: Investigations
Frequency: 1 affected / 40 at risk

Adverse event: Cholecystitis Grade 4
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 40 at risk

Adverse event: Hypokalemia Grade 3
Serious: no
Organ System: Investigations
Frequency: 2 affected / 40 at risk

Adverse event: Hypokalemia Grade 4
Serious: no
Organ System: Investigations
Frequency: 1 affected / 40 at risk

Adverse event: Dehydration Grade 3
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 40 at risk

Adverse event: Hypophosphatemia Grade 3
Serious: no
Organ System: Investigations
Frequency: 3 affected / 40 at risk

Adverse event: Renal dysfunction Grade 2
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 40 at risk

Adverse event: Renal dysfunction Grade 3
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 40 at risk

Adverse event: Hyponatremia Grade 3
Serious: no
Organ System: Investigations
Frequency: 1 affected / 40 at risk

Adverse event: Hypouricemia Grade 4
Serious: no
Organ System: Investigations
Frequency: 1 affected / 40 at risk

Adverse event: Hypocalcemia Grade 3
Serious: no
Organ System: Investigations
Frequency: 1 affected / 40 at risk

Adverse event: Hypertension Grade 3
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 40 at risk

Adverse event: Vasovagal episode Grade 3
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 40 at risk

Adverse event: Venous thromboembolism Grade 3
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 40 at risk

Adverse event: Venous thromboembolism Grade 4
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 40 at risk

Adverse event: Pneumonia Grade 3
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 40 at risk

Adverse event: Pneumonia Grade 4
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 40 at risk

Adverse event: Acute respiratory distress syndrome Grade 4
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 40 at risk

Adverse event: Bronchiectasis Grade 3
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 40 at risk

Adverse event: Infusion reaction Grade 2
Serious: no
Organ System: General disorders
Frequency: 14 affected / 40 at risk

Adverse event: Infusion reaction Grade 3
Serious: no
Organ System: General disorders
Frequency: 4 affected / 40 at risk

Adverse event: Infusion reaction Grade 4
Serious: no
Organ System: General disorders
Frequency: 1 affected / 40 at risk

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

Adverse event: Fatigue Grade 3
Serious: no
Organ System: General disorders
Frequency: 4 affected / 40 at risk

Adverse event: Headache Grade 3
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 40 at risk

Adverse event: Back pain Grade 3
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 40 at risk

Adverse event: Inguinal pain Grade 3
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 40 at risk

Adverse event: Squamous cell carcinoma Grade 3
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 40 at risk

Adverse event: Rash Grade 3
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 40 at risk

Adverse event: Drug rash with eosinophilia and systemic symptoms (DRESS) syndrome Grade 3
Serious: no
Organ System: General disorders
Frequency: 1 affected / 40 at risk

Adverse event: Hyperglycemia Grade 3
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 40 at risk

Adverse event: Mood alteration Grade 3
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 40 at risk