Study: NCT00243841

Adverse event: Confusional state
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 3 at risk

Adverse event: Leukocytes (total WBC)
Serious: no
Organ System: Investigations
Frequency: 1 affected / 3 at risk

Adverse event: Platelets
Serious: no
Organ System: Investigations
Frequency: 1 affected / 3 at risk

Adverse event: INR (international normalized ratio of prothrobin time)
Serious: no
Organ System: Investigations
Frequency: 3 affected / 3 at risk

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

Adverse event: Albumin, Serum-low(hypoalbuminemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 3 at risk

Adverse event: ALT, SGPT
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Serum Glutamic Pyruvic Transaminase
Frequency: 2 affected / 3 at risk

Adverse event: AST, SGOT
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Serum Glutamic oxaloacetic Transaminase
Frequency: 2 affected / 3 at risk

Adverse event: Blood bilirubin
Serious: no
Organ System: Investigations
Notes: Hyperbilirubinemia
Frequency: 3 affected / 3 at risk

Adverse event: Gamma-glutamyltransferase
Serious: no
Organ System: Investigations
Notes: Gamma-Glutamyl Transpeptidase
Frequency: 3 affected / 3 at risk

Adverse event: Pain
Serious: no
Organ System: Gastrointestinal disorders
Notes: Abdomen pain
Frequency: 1 affected / 3 at risk

Adverse event: Urinary frequency/urgency
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 3 at risk

Adverse event: Blood creatinine
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 6 at risk

Adverse event: Haemoglobin
Serious: no
Organ System: Investigations
Frequency: 5 affected / 6 at risk

Adverse event: Leukocytes (total WBC)
Serious: no
Organ System: Investigations
Frequency: 3 affected / 6 at risk

Adverse event: Platelets
Serious: no
Organ System: Investigations
Frequency: 4 affected / 6 at risk

Adverse event: INR (international normalized ratio of prothrobin time)
Serious: no
Organ System: Investigations
Frequency: 3 affected / 6 at risk

Adverse event: PTT (partial thromboplastin time)
Serious: no
Organ System: Investigations
Frequency: 2 affected / 6 at risk

Adverse event: Ascites (non-malignant)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 6 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 6 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 6 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 6 at risk

Adverse event: Albumin, Serum-low(hypoalbuminemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 6 affected / 6 at risk

Adverse event: Alkaline Phosphate
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 6 at risk

Adverse event: ALT, SGPT
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Serum Glutamic Pyruvic Transaminase
Frequency: 1 affected / 6 at risk

Adverse event: AST, SGOT
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Serum Glutamic oxaloacetic Transaminase
Frequency: 5 affected / 6 at risk

Adverse event: Blood bilirubin
Serious: no
Organ System: Investigations
Notes: Hyperbilirubinemia
Frequency: 5 affected / 6 at risk

Adverse event: Calcuim, Serum-Low
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: hypocalcemia
Frequency: 1 affected / 6 at risk

Adverse event: Gamma-glutamyltransferase
Serious: no
Organ System: Investigations
Notes: Gamma-Glutamyl Transpeptidase
Frequency: 5 affected / 6 at risk

Adverse event: Blood sodium
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Serum-low hypokalemia
Frequency: 2 affected / 6 at risk

Adverse event: Pain
Serious: no
Organ System: Gastrointestinal disorders
Notes: Abdomen pain
Frequency: 2 affected / 6 at risk

Adverse event: Haemoglobin
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 5 at risk

Adverse event: Platelets
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 5 at risk

Adverse event: Albumin, serum-low (hypoalbuminemia)
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 5 at risk

Adverse event: ALT, SGPT (serum glutamic pyruvic transaminase)
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 5 at risk

Adverse event: AST, SGOT (serum glutamic oxaloacetic transaminase)
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 5 at risk

Adverse event: Bilirubin (hyperbilirubinemia)
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 5 at risk

Adverse event: GGT (gamma-glutamyl transpeptidase)
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 5 at risk

Adverse event: Sodium, serum-low (hyponatremia)
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 5 at risk

Adverse event: INR (International Normalized Ratio of Prothrombin time)
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 5 at risk

Adverse event: Haemoglobin
Serious: no
Organ System: Investigations
Frequency: 4 affected / 5 at risk

Adverse event: Leukocytes (total WBC)
Serious: no
Organ System: Investigations
Frequency: 2 affected / 5 at risk

Adverse event: Neutrophils/Granulocytes (ANC/AGC)
Serious: no
Organ System: Investigations
Frequency: 1 affected / 5 at risk

Adverse event: Platelets
Serious: no
Organ System: Investigations
Frequency: 4 affected / 5 at risk

Adverse event: INR (international normalized ratio of prothrobin time)
Serious: no
Organ System: Investigations
Frequency: 5 affected / 5 at risk

Adverse event: Albumin, Serum-low(hypoalbuminemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 5 at risk

Adverse event: Alkaline Phosphate
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 5 at risk

Adverse event: ALT, SGPT
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Serum Glutamic Pyruvic Transaminase
Frequency: 3 affected / 5 at risk

Adverse event: AST, SGOT
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Serum Glutamic oxaloacetic Transaminase
Frequency: 5 affected / 5 at risk

Adverse event: Blood bilirubin
Serious: no
Organ System: Investigations
Notes: Hyperbilirubinemia
Frequency: 5 affected / 5 at risk

Adverse event: Blood creatinine
Serious: no
Organ System: Investigations
Frequency: 2 affected / 5 at risk

Adverse event: Gamma-glutamyltransferase
Serious: no
Organ System: Investigations
Notes: Gamma-Glutamyl Transpeptidase
Frequency: 3 affected / 5 at risk

Adverse event: Blood sodium
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Serum-low hypokalemia
Frequency: 1 affected / 5 at risk

Adverse event: Blood potassium
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Serum-Low- Hypokalemia
Frequency: 1 affected / 5 at risk

Adverse event: Muscular weakness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Whole body- generalized
Frequency: 1 affected / 5 at risk

Adverse event: Pain
Serious: no
Organ System: Gastrointestinal disorders
Notes: Abdomen pain
Frequency: 1 affected / 5 at risk

Adverse event: Leukocytes (total WBC)
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 3 at risk

Adverse event: Platelets
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 3 at risk

Adverse event: Cardiac arhythmia - other
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 3 at risk

Adverse event: Gastrointestinal - other
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3 at risk

Adverse event: Albumin, serum-low (hypoalbuminemia)
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 3 at risk

Adverse event: AST, SGOT (serum glutamic oxaloacetic transaminase)
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 3 at risk

Adverse event: Haemoglobin
Serious: no
Organ System: Investigations
Frequency: 2 affected / 3 at risk

Adverse event: Leukocytes (total WBC)
Serious: no
Organ System: Investigations
Frequency: 2 affected / 3 at risk

Adverse event: Neutrophils/Granulocytes (ANC/AGC)
Serious: no
Organ System: Investigations
Frequency: 1 affected / 3 at risk

Adverse event: Platelets
Serious: no
Organ System: Investigations
Frequency: 2 affected / 3 at risk

Adverse event: INR (international normalized ratio of prothrobin time)
Serious: no
Organ System: Investigations
Frequency: 2 affected / 3 at risk

Adverse event: PTT (partial thromboplastin time)
Serious: no
Organ System: Investigations
Frequency: 1 affected / 3 at risk

Adverse event: Albumin, Serum-low(hypoalbuminemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 3 at risk

Adverse event: Alkaline Phosphate
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 3 at risk

Adverse event: ALT, SGPT
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Serum Glutamic Pyruvic Transaminase
Frequency: 2 affected / 3 at risk

Adverse event: AST, SGOT
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Serum Glutamic oxaloacetic Transaminase
Frequency: 3 affected / 3 at risk

Adverse event: Blood bilirubin
Serious: no
Organ System: Investigations
Notes: Hyperbilirubinemia
Frequency: 3 affected / 3 at risk

Adverse event: Gamma-glutamyltransferase
Serious: no
Organ System: Investigations
Notes: Gamma-Glutamyl Transpeptidase
Frequency: 3 affected / 3 at risk

Adverse event: Haemoglobin
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 39 at risk

Adverse event: Haemoglobin
Serious: no
Organ System: Investigations
Frequency: 29 affected / 39 at risk

Adverse event: Leukocytes (total WBC)
Serious: no
Organ System: Investigations
Frequency: 31 affected / 39 at risk

Adverse event: Neutrophils/Granulocytes (ANC/AGC)
Serious: no
Organ System: Investigations
Frequency: 19 affected / 39 at risk

Adverse event: Platelets
Serious: no
Organ System: Investigations
Frequency: 35 affected / 39 at risk

Adverse event: INR (international normalized ratio of prothrobin time)
Serious: no
Organ System: Investigations
Frequency: 20 affected / 39 at risk

Adverse event: PTT (partial thromboplastin time)
Serious: no
Organ System: Investigations
Frequency: 11 affected / 39 at risk

Adverse event: Albumin, Serum-low(hypoalbuminemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 30 affected / 39 at risk

Adverse event: Alkaline Phosphate
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 21 affected / 39 at risk

Adverse event: ALT, SGPT
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Serum Glutamic Pyruvic Transaminase
Frequency: 29 affected / 39 at risk

Adverse event: AST, SGOT
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Serum Glutamic oxaloacetic Transaminase
Frequency: 38 affected / 39 at risk

Adverse event: Blood bilirubin
Serious: no
Organ System: Investigations
Notes: Hyperbilirubinemia
Frequency: 33 affected / 39 at risk

Adverse event: Blood creatinine
Serious: no
Organ System: Investigations
Frequency: 12 affected / 39 at risk

Adverse event: Gamma-glutamyltransferase
Serious: no
Organ System: Investigations
Notes: Gamma-Glutamyl Transpeptidase
Frequency: 35 affected / 39 at risk

Adverse event: Blood sodium
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Serum-low hypokalemia
Frequency: 12 affected / 39 at risk

Adverse event: Blood potassium
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Serum-Low- Hypokalemia
Frequency: 5 affected / 39 at risk

Adverse event: Blood potassium
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 21 at risk

Adverse event: Haemoglobin
Serious: no
Organ System: Investigations
Frequency: 15 affected / 21 at risk

Adverse event: Leukocytes (total WBC)
Serious: no
Organ System: Investigations
Frequency: 16 affected / 21 at risk

Adverse event: Neutrophils/Granulocytes (ANC/AGC)
Serious: no
Organ System: Investigations
Frequency: 5 affected / 21 at risk

Adverse event: Platelets
Serious: no
Organ System: Investigations
Frequency: 21 affected / 21 at risk

Adverse event: INR (international normalized ratio of prothrobin time)
Serious: no
Organ System: Investigations
Frequency: 18 affected / 21 at risk

Adverse event: PTT (partial thromboplastin time)
Serious: no
Organ System: Investigations
Frequency: 7 affected / 21 at risk

Adverse event: Albumin, Serum-low(hypoalbuminemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 21 affected / 21 at risk

Adverse event: Alkaline Phosphate
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 15 affected / 21 at risk

Adverse event: ALT, SGPT
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Serum Glutamic Pyruvic Transaminase
Frequency: 14 affected / 21 at risk

Adverse event: AST, SGOT
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Serum Glutamic oxaloacetic Transaminase
Frequency: 21 affected / 21 at risk

Adverse event: Blood bilirubin
Serious: no
Organ System: Investigations
Notes: Hyperbilirubinemia
Frequency: 21 affected / 21 at risk

Adverse event: Blood creatinine
Serious: no
Organ System: Investigations
Frequency: 4 affected / 21 at risk

Adverse event: Gamma-glutamyltransferase
Serious: no
Organ System: Investigations
Notes: Gamma-Glutamyl Transpeptidase
Frequency: 18 affected / 21 at risk

Adverse event: Blood potassium
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Serum high Hyperkalemia
Frequency: 1 affected / 21 at risk

Adverse event: Blood sodium
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Serum-low hypokalemia
Frequency: 6 affected / 21 at risk

Adverse event: Blood potassium
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Serum-Low- Hypokalemia
Frequency: 2 affected / 21 at risk