Study: NCT00587054

Adverse event: Adult respiratory disorder
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 129 at risk

Adverse event: Left ventricular failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 129 at risk

Adverse event: Constitutional symptoms, other
Serious: yes
Organ System: General disorders
Frequency: 4 affected / 129 at risk

Adverse event: Hemorrhage, other
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 129 at risk

Adverse event: Hypoxia
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 129 at risk

Adverse event: infection unknown absolut neutriphil counts
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 129 at risk

Adverse event: Infection without neutropenia
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 129 at risk

Adverse event: Leukoencephalopathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 129 at risk

Adverse event: Rash
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 129 at risk

Adverse event: Renal failure
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 129 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 129 at risk

Adverse event: Vision-double vision
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 129 at risk

Adverse event: Blood alkaline phosphatase
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 23 affected / 129 at risk

Adverse event: Blood bilirubin
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 31 affected / 129 at risk

Adverse event: Blood creatinine
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 13 affected / 129 at risk

Adverse event: Hemoglobin (Hgb)
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 117 affected / 129 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 58 affected / 129 at risk

Adverse event: Hyperkalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 26 affected / 129 at risk

Adverse event: Hypocalcaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 35 affected / 129 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 60 affected / 129 at risk

Adverse event: Hyponatraemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 35 affected / 129 at risk

Adverse event: Hypophosphataemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 48 affected / 129 at risk

Adverse event: Leukocytes
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 125 affected / 129 at risk

Adverse event: Lymphopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 125 affected / 129 at risk

Adverse event: Neutrophil count
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 123 affected / 129 at risk

Adverse event: Platelets
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 124 affected / 129 at risk

Adverse event: Prothrombin time (PT)
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 11 affected / 129 at risk

Adverse event: Partial thromboplastin time (PTT)
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 22 affected / 129 at risk

Adverse event: SGOT (AST)
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 28 affected / 129 at risk

Adverse event: SGPT (ALT)
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 42 affected / 129 at risk