Study: NCT00539695

Adverse event: Decreased appetite
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 22 at risk

Adverse event: Colitis, infectious (e.g., Clostridium difficile)
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 22 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 22 at risk

Adverse event: Dry skin
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 22 at risk

Adverse event: Fatigue (lethargy, malaise, asthenia)
Serious: yes
Organ System: General disorders
Notes: constitutional symptoms
Frequency: 1 affected / 22 at risk

Adverse event: Febrile neutropenia (fever of unknown origin without clinically or microbiologically documented infe
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 22 at risk

Adverse event: Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L)
Serious: yes
Organ System: General disorders
Notes: Constitutional Symptoms
Frequency: 3 affected / 22 at risk

Adverse event: Gastrointestinal - Other: Gall Bladder
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 22 at risk

Adverse event: Hemorrhage, CNS
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 22 at risk

Adverse event: Hypoxia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 22 at risk

Adverse event: Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils (ANC <1.0 x 10e
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 22 at risk

Adverse event: Infection - Other: GNR Line Infection (B Cepacia complex)
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 22 at risk

Adverse event: Infection - Other: Gastrointestinal_Abdomen
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 22 at risk

Adverse event: Infection - Other: Parainfluenza
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 22 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils - Upper airway NOS
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 22 at risk

Adverse event: Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 22 at risk

Adverse event: Rash/desquamation
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 22 at risk

Adverse event: Rash: erythema multiforme (e.g., Stevens-Johnson syndrome, toxic epidermal necrolysis)
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 22 at risk

Adverse event: Thrombosis/thrombus/embolism
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 22 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 22 at risk

Adverse event: ALT, SGPT (serum glutamic pyruvic transaminase)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 9 affected / 22 at risk

Adverse event: AST, SGOT(serum glutamic oxaloacetic transaminase)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 13 affected / 22 at risk

Adverse event: Albumin, serum-low (hypoalbuminemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 12 affected / 22 at risk

Adverse event: Blood alkaline phosphatase
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 22 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 22 at risk

Adverse event: Bicarbonate, serum-low
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 22 at risk

Adverse event: Bilirubin (hyperbilirubinemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 22 at risk

Adverse event: Calcium, serum-low (hypocalcemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 14 affected / 22 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 22 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 22 at risk

Adverse event: Blood creatinine
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 22 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 11 affected / 22 at risk

Adverse event: Dry skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 8 affected / 22 at risk

Adverse event: Dyspnea (shortness of breath)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 22 at risk

Adverse event: Edema: head and neck
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 22 at risk

Adverse event: Edema: limb
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 22 at risk

Adverse event: Fatigue (asthenia, lethargy, malaise)
Serious: no
Organ System: General disorders
Frequency: 6 affected / 22 at risk

Adverse event: Fatigue (lethargy, malaise, asthenia)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 22 at risk

Adverse event: Febrile neutropenia (fever of unknown origin without clinically or microbiologically documented infe
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 22 at risk

Adverse event: Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L)
Serious: no
Organ System: General disorders
Frequency: 9 affected / 22 at risk

Adverse event: GGT (gamma-Glutamyl transpeptidase)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 7 affected / 22 at risk

Adverse event: Glucose, serum-high (hyperglycemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 22 at risk

Adverse event: Glucose, serum-low (hypoglycemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 22 at risk

Adverse event: Hyperpigmentation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 22 at risk

Adverse event: Hypertension
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 22 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils - Catheter-related
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 22 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: 2 affected / 22 at risk

Adverse event: Injection site reaction/extravasation changes
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 22 at risk

Adverse event: Insomnia
Serious: no
Organ System: General disorders
Frequency: 2 affected / 22 at risk

Adverse event: Magnesium, serum-high (hypermagnesemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 22 at risk

Adverse event: Magnesium, serum-low (hypomagnesemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 9 affected / 22 at risk

Adverse event: Mood alteration - Anxiety
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 22 at risk

Adverse event: Mood alteration - Depression
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 22 at risk

Adverse event: Mucositis/stomatitis (clinical exam) - Oral cavity
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 22 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 18 affected / 22 at risk

Adverse event: Neuropathy: sensory
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 22 at risk

Adverse event: PTT (Partial Thromboplastin Time)
Serious: no
Organ System: General disorders
Frequency: 3 affected / 22 at risk

Adverse event: Pain - Abdomen NOS
Serious: no
Organ System: General disorders
Frequency: 8 affected / 22 at risk

Adverse event: Pain - Back
Serious: no
Organ System: General disorders
Frequency: 3 affected / 22 at risk

Adverse event: Pain - Bone
Serious: no
Organ System: General disorders
Frequency: 3 affected / 22 at risk

Adverse event: Pain - Head/headache
Serious: no
Organ System: General disorders
Frequency: 10 affected / 22 at risk

Adverse event: Pain - Joint
Serious: no
Organ System: General disorders
Frequency: 2 affected / 22 at risk

Adverse event: Pain - Other: Abdomen
Serious: no
Organ System: General disorders
Frequency: 2 affected / 22 at risk

Adverse event: Pain - Other: Dysuria
Serious: no
Organ System: General disorders
Frequency: 2 affected / 22 at risk

Adverse event: Phosphate, serum-low (hypophosphatemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 22 at risk

Adverse event: Potassium, serum-low (hypokalemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 22 at risk

Adverse event: Pruritus/itching
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 22 at risk

Adverse event: Pulmonary/Upper Respiratory - Other: Rhinorrhea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 22 at risk

Adverse event: Rash/desquamation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 13 affected / 22 at risk

Adverse event: Renal/Genitourinary - Other: Dysuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 22 at risk

Adverse event: Rigors/chills
Serious: no
Organ System: General disorders
Frequency: 3 affected / 22 at risk

Adverse event: Sodium, serum-high (hypernatremia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 22 at risk

Adverse event: Sodium, serum-low (hyponatremia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 8 affected / 22 at risk

Adverse event: Tremor
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 22 at risk

Adverse event: Triglyceride, serum-high (hypertriglyceridemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 22 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 12 affected / 22 at risk