Study: NCT00499408

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

Adverse event: Hyperglycaemia
Serious: yes
Organ System: Investigations
Frequency: 2 affected / 26 at risk

Adverse event: Hypoglycaemia
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 26 at risk

Adverse event: Partial Thromboplastin Time
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 26 at risk

Adverse event: Lymphopenia
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 26 at risk

Adverse event: Syncope (fainting)
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 26 at risk

Adverse event: Skin Infection with high grade neutropenia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 26 at risk

Adverse event: Low WBC
Serious: no
Organ System: Investigations
Frequency: 8 affected / 26 at risk

Adverse event: Platelet count decreased
Serious: no
Organ System: Investigations
Frequency: 6 affected / 26 at risk

Adverse event: Low Hemoglobin
Serious: no
Organ System: Investigations
Frequency: 14 affected / 26 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 26 at risk

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

Adverse event: Decreased appetite
Serious: no
Organ System: General disorders
Frequency: 2 affected / 26 at risk

Adverse event: Blood alkaline phosphatase
Serious: no
Organ System: Investigations
Frequency: 2 affected / 26 at risk

Adverse event: Blood creatinine
Serious: no
Organ System: Investigations
Frequency: 3 affected / 26 at risk

Adverse event: "Incontinence, urinary"
Serious: no
Organ System: General disorders
Frequency: 2 affected / 26 at risk

Adverse event: Hypertension
Serious: no
Organ System: General disorders
Frequency: 2 affected / 26 at risk

Adverse event: Taste disorder
Serious: no
Organ System: General disorders
Frequency: 2 affected / 26 at risk

Adverse event: Rigors/chills
Serious: no
Organ System: General disorders
Frequency: 2 affected / 26 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 7 affected / 26 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Investigations
Frequency: 14 affected / 26 at risk

Adverse event: Hypoglycaemia
Serious: no
Organ System: Investigations
Frequency: 2 affected / 26 at risk

Adverse event: Hypocalcaemia
Serious: no
Organ System: Investigations
Frequency: 2 affected / 26 at risk

Adverse event: Hyponatraemia
Serious: no
Organ System: Investigations
Frequency: 4 affected / 26 at risk

Adverse event: Hypoalbuminaemia
Serious: no
Organ System: Investigations
Frequency: 2 affected / 26 at risk

Adverse event: Hyperbilirubinaemia
Serious: no
Organ System: Investigations
Frequency: 2 affected / 26 at risk

Adverse event: Hypophosphataemia
Serious: no
Organ System: Investigations
Frequency: 4 affected / 26 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 26 at risk

Adverse event: Pain: Head/headache
Serious: no
Organ System: General disorders
Frequency: 3 affected / 26 at risk

Adverse event: Fever without neutropenia
Serious: no
Organ System: General disorders
Frequency: 2 affected / 26 at risk

Adverse event: Erectile dysfunction
Serious: no
Organ System: General disorders
Frequency: 3 affected / 26 at risk

Adverse event: Urinary frequency/urgency
Serious: no
Organ System: General disorders
Frequency: 14 affected / 26 at risk

Adverse event: Renal/Genitourinary - Other
Serious: no
Organ System: General disorders
Frequency: 2 affected / 26 at risk

Adverse event: Edema: limb
Serious: no
Organ System: Vascular disorders
Frequency: 3 affected / 26 at risk

Adverse event: Dry mouth
Serious: no
Organ System: General disorders
Frequency: 2 affected / 26 at risk

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

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

Adverse event: Arthritis (non-septic)
Serious: no
Organ System: General disorders
Frequency: 2 affected / 26 at risk

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

Adverse event: Flatulence
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 26 at risk

Adverse event: Glomerular filtration rate
Serious: no
Organ System: Investigations
Frequency: 2 affected / 26 at risk

Adverse event: "Cholesterol, serum-high"
Serious: no
Organ System: Investigations
Frequency: 2 affected / 26 at risk

Adverse event: Libido
Serious: no
Organ System: General disorders
Frequency: 8 affected / 26 at risk

Adverse event: Lymphopenia
Serious: no
Organ System: Investigations
Frequency: 5 affected / 26 at risk

Adverse event: Pain: Muscle
Serious: no
Organ System: General disorders
Frequency: 6 affected / 26 at risk

Adverse event: Pain: Extremity-limb
Serious: no
Organ System: General disorders
Frequency: 2 affected / 26 at risk

Adverse event: Rhinitis allergic
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 11 affected / 26 at risk

Adverse event: "Muscle weakness, generalized or specific area (not due to neuropathy): Extremity-lower"
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 26 at risk