Study: NCT00186875

Adverse event: Allergic reaction/hypersensitivity (including drug fever)
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 26 at risk

Adverse event: Prolonged QTc interval
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 26 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 26 at risk

Adverse event: Typhlitis (cecal inflammation)
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 26 at risk

Adverse event: Ulcer, GI, Stomach
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 26 at risk

Adverse event: Hemorrhage, GI, Stomach
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 26 at risk

Adverse event: Infection, blood
Serious: yes
Organ System: Infections and infestations
Notes: Documented clinically or microbiologically with Grade 3 or 4 neutrophils (ANC \<1.0 x 10e9/L.
Frequency: 1 affected / 26 at risk

Adverse event: Infection, brain (encephalitis, infectious)
Serious: yes
Organ System: Infections and infestations
Notes: Documented clinically or microbiologically with Grade 3 or 4 neutrophils (ANC \<1.0 x 10e9/L).
Frequency: 1 affected / 26 at risk

Adverse event: Infection, Catheter-related
Serious: yes
Organ System: Infections and infestations
Notes: Documented clinically or microbiologically with Grade 3 or 4 neutrophils (ANC \<1.0 x 10e9/L).
Frequency: 1 affected / 26 at risk

Adverse event: Allergic reaction/hypersensitivity (including drug fever)
Serious: no
Organ System: Immune system disorders
Frequency: 11 affected / 26 at risk

Adverse event: Hypertension
Serious: no
Organ System: Cardiac disorders
Frequency: 5 affected / 26 at risk

Adverse event: Hypotension
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 26 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Notes: In the absence of neutropenia, where neutropenia is defined as ANC \<1.0 x 10e9/L.
Frequency: 8 affected / 26 at risk

Adverse event: Neuroendocrine: ADH secretion abnormality (e.g., SIADH or low ADH)
Serious: no
Organ System: Endocrine disorders
Frequency: 1 affected / 26 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 26 at risk

Adverse event: Colitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 26 at risk

Adverse event: Mucositis/stomatitis (clinical exam), oral cavity
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 26 at risk

Adverse event: Typhlitis (cecal inflammation)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 26 at risk

Adverse event: Febrile neutropenia
Serious: no
Organ System: General disorders
Notes: Fever of unknown origin without clinically or microbiologically documented infection (ANC \<1.0 x 10e9/L).
Frequency: 17 affected / 26 at risk

Adverse event: Infection, blood
Serious: no
Organ System: Infections and infestations
Notes: Documented clinically or microbiologically with Grade 3 or 4 neutrophils (ANC \<1.0 x 10e9/L).
Frequency: 9 affected / 26 at risk

Adverse event: Infection, sinus
Serious: no
Organ System: Infections and infestations
Notes: Documented clinically or microbiologically with Grade 3 or 4 neutrophils (ANC \<1.0 x 10e9/L).
Frequency: 7 affected / 26 at risk

Adverse event: Colitis, infectious (e.g., Clostridium difficile)
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 26 at risk

Adverse event: Infection, catheter-related
Serious: no
Organ System: Infections and infestations
Notes: Documented clinically or microbiologically with Grade 3 or 4 neutrophils (ANC \<1.0 x 10e9/L).
Frequency: 3 affected / 26 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils, upper airway NOS
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 26 at risk

Adverse event: Infection, lung (pneumonia)
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 26 at risk

Adverse event: Infection, upper airway NOS
Serious: no
Organ System: Infections and infestations
Notes: Documented clinically or microbiologically with Grade 3 or 4 neutrophils (ANC \<1.0 x 10e9/L).
Frequency: 4 affected / 26 at risk

Adverse event: Infection, skin (cellulitis)
Serious: no
Organ System: Infections and infestations
Notes: Documented clinically or microbiologically with Grade 3 or 4 neutrophils (ANC \<1.0 x 10e9/L).
Frequency: 3 affected / 26 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils, skin (cellulitis)
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 26 at risk

Adverse event: Infection, other
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 26 at risk

Adverse event: Infection, pharynx
Serious: no
Organ System: Infections and infestations
Notes: Documented clinically or microbiologically with Grade 3 or 4 neutrophils (ANC \<1.0 x 10e9/L).
Frequency: 2 affected / 26 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils, lung (pneumonia)
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 26 at risk

Adverse event: Infection, lip/perioral
Serious: no
Organ System: Infections and infestations
Notes: Documented clinically or microbiologically with Grade 3 or 4 neutrophils (ANC \<1.0 x 10e9/L).
Frequency: 1 affected / 26 at risk

Adverse event: Infection, wound
Serious: no
Organ System: Infections and infestations
Notes: Documented clinically or microbiologically with Grade 3 or 4 neutrophils (ANC \<1.0 x 10e9/L).
Frequency: 1 affected / 26 at risk

Adverse event: Potassium, serum-low (hypokalemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 8 affected / 26 at risk

Adverse event: ALT, SGPT (serum glutamic pyruvic transaminase)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 9 affected / 26 at risk

Adverse event: Glucose, serum-high (hyperglycemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 26 at risk

Adverse event: Sodium, serum-low (hyponatremia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 26 at risk

Adverse event: AST, SGOT (serum glutamic oxaloacetic transaminase)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 26 at risk

Adverse event: Bilirubin (hyperbilirubinemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 26 at risk

Adverse event: Phosphate, serum-low (hypophosphatemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 26 at risk

Adverse event: Calcium, serum-low (hypocalcemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 26 at risk

Adverse event: Amylase
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 26 at risk

Adverse event: Lipase
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 26 at risk

Adverse event: Sodium, serum-high (hypernatremia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 26 at risk

Adverse event: Osteonecrosis (avascular necrosis)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 5 affected / 26 at risk

Adverse event: Fracture
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 26 at risk

Adverse event: Neuropathy, motor
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 26 at risk

Adverse event: Encephalopathy
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 26 at risk

Adverse event: Neuropathy, sensory
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 26 at risk

Adverse event: Seizure
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 26 at risk

Adverse event: Somnolence/depressed level of consciousness
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 26 at risk

Adverse event: Pain, neuralgia/peripheral nerve
Serious: no
Organ System: General disorders
Frequency: 8 affected / 26 at risk

Adverse event: Pain, extremity-limb
Serious: no
Organ System: General disorders
Frequency: 5 affected / 26 at risk

Adverse event: Pain, back
Serious: no
Organ System: General disorders
Frequency: 4 affected / 26 at risk

Adverse event: Pain, abdomen NOS
Serious: no
Organ System: General disorders
Frequency: 2 affected / 26 at risk

Adverse event: Pain, head/headache
Serious: no
Organ System: General disorders
Frequency: 2 affected / 26 at risk

Adverse event: Hypoxia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 26 at risk

Adverse event: Pneumonitis/pulmonary infiltrates
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 26 at risk

Adverse event: Thrombosis/thrombus/embolism
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 26 at risk

Adverse event: Thrombosis/embolism (vascular access-related)
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 26 at risk

Adverse event: Iron overload
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 14 at risk

Adverse event: Supraventricular and nodal arrhythmia, supraventricular tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 14 at risk

Adverse event: Ventricular arrhythmia, ventricular arrhythmia NOS
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 14 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 14 at risk

Adverse event: Infection, blood
Serious: yes
Organ System: Infections and infestations
Notes: Documented clinically or microbiologically with Grade 3 or 4 neutrophils (ANC \<1.0 x 10e9/L.
Frequency: 1 affected / 14 at risk

Adverse event: Infection, brain (encephalitis, infectious)
Serious: yes
Organ System: Infections and infestations
Notes: Documented clinically or microbiologically with Grade 3 or 4 neutrophils (ANC \<1.0 x 10e9/L).
Frequency: 1 affected / 14 at risk

Adverse event: Hypoxia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 14 at risk

Adverse event: Renal failure
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 14 at risk

Adverse event: Hypertension
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 14 at risk

Adverse event: Hypotension
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 14 at risk

Adverse event: Neuroendocrine: ADH secretion abnormality (e.g., SIADH or low ADH)
Serious: no
Organ System: Endocrine disorders
Frequency: 1 affected / 14 at risk

Adverse event: Colitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 14 at risk

Adverse event: Febrile neutropenia
Serious: no
Organ System: General disorders
Notes: Fever of unknown origin without clinically or microbiologically documented infection (ANC \<1.0 x 10e9/L).
Frequency: 7 affected / 14 at risk

Adverse event: Infection, blood
Serious: no
Organ System: Infections and infestations
Notes: Documented clinically or microbiologically with Grade 3 or 4 neutrophils (ANC \<1.0 x 10e9/L).
Frequency: 2 affected / 14 at risk

Adverse event: Infection, catheter-related
Serious: no
Organ System: Infections and infestations
Notes: Documented clinically or microbiologically with Grade 3 or 4 neutrophils (ANC \<1.0 x 10e9/L).
Frequency: 3 affected / 14 at risk

Adverse event: Infection, lung (pneumonia)
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 14 at risk

Adverse event: Infection, skin (cellulitis)
Serious: no
Organ System: Infections and infestations
Notes: Documented clinically or microbiologically with Grade 3 or 4 neutrophils (ANC \<1.0 x 10e9/L).
Frequency: 1 affected / 14 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils, skin (cellulitis)
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 14 at risk

Adverse event: Infection, other
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 14 at risk

Adverse event: Infection, lip/perioral
Serious: no
Organ System: Infections and infestations
Notes: Documented clinically or microbiologically with Grade 3 or 4 neutrophils (ANC \<1.0 x 10e9/L).
Frequency: 1 affected / 14 at risk

Adverse event: Infection, wound
Serious: no
Organ System: Infections and infestations
Notes: Documented clinically or microbiologically with Grade 3 or 4 neutrophils (ANC \<1.0 x 10e9/L).
Frequency: 1 affected / 14 at risk

Adverse event: Potassium, serum-low (hypokalemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 6 affected / 14 at risk

Adverse event: ALT, SGPT (serum glutamic pyruvic transaminase)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 14 at risk

Adverse event: Glucose, serum-high (hyperglycemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 14 at risk

Adverse event: Sodium, serum-low (hyponatremia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 14 at risk

Adverse event: AST, SGOT (serum glutamic oxaloacetic transaminase)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 14 at risk

Adverse event: Bilirubin (hyperbilirubinemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 14 at risk

Adverse event: Phosphate, serum-low (hypophosphatemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 14 at risk

Adverse event: Calcium, serum-low (hypocalcemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 14 at risk

Adverse event: Amylase
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 14 at risk

Adverse event: Lipase
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 14 at risk

Adverse event: Sodium, serum-high (hypernatremia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 14 at risk

Adverse event: Albumin, serum-low (hypoalbuminemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 14 at risk

Adverse event: Osteonecrosis (avascular necrosis)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 14 at risk

Adverse event: Encephalopathy
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 14 at risk

Adverse event: Neuropathy, sensory
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 14 at risk

Adverse event: Seizure
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 14 at risk

Adverse event: Somnolence/depressed level of consciousness
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 14 at risk

Adverse event: Pain, neuralgia/peripheral nerve
Serious: no
Organ System: General disorders
Frequency: 1 affected / 14 at risk

Adverse event: Pain, extremity-limb
Serious: no
Organ System: General disorders
Frequency: 1 affected / 14 at risk

Adverse event: Hypoxia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 14 at risk

Adverse event: Adult Respiratory Distress Syndrome (ARDS)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 14 at risk

Adverse event: Thrombosis/thrombus/embolism
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 14 at risk