Study: NCT00639509

Adverse event: Hyperglycaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 24 at risk

Adverse event: ALT, SGPT
Serious: yes
Organ System: Investigations
Frequency: 3 affected / 24 at risk

Adverse event: AST, SGOT
Serious: yes
Organ System: Investigations
Frequency: 4 affected / 24 at risk

Adverse event: Blood alkaline phosphatase
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 24 at risk

Adverse event: Ascites
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 24 at risk

Adverse event: Bilirubin (hyperbilirubinemia)
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 24 at risk

Adverse event: Confusional state
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 24 at risk

Adverse event: Death not assoc w CTCAE term-Disease Progression
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 24 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 24 at risk

Adverse event: Hemorrhage, Rectum
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 24 at risk

Adverse event: Hemorrhage, Varices (esophageal)
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 24 at risk

Adverse event: Pain, Back
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 24 at risk

Adverse event: Platelets
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 24 at risk

Adverse event: Pleural effusion (non-malig)
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 24 at risk

Adverse event: Renal failure
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 24 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 24 at risk

Adverse event: ALT, SGPT
Serious: no
Organ System: Investigations
Frequency: 21 affected / 24 at risk

Adverse event: AST, SGOT
Serious: no
Organ System: Investigations
Frequency: 23 affected / 24 at risk

Adverse event: Hypoalbuminaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 24 affected / 24 at risk

Adverse event: Blood alkaline phosphatase
Serious: no
Organ System: Investigations
Frequency: 17 affected / 24 at risk

Adverse event: Hyperbilirubinaemia
Serious: no
Organ System: Investigations
Frequency: 21 affected / 24 at risk

Adverse event: Hypercholesterolaemia
Serious: no
Organ System: Investigations
Frequency: 3 affected / 24 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 10 affected / 24 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 24 at risk

Adverse event: Blood creatinine
Serious: no
Organ System: Investigations
Frequency: 9 affected / 24 at risk

Adverse event: Skin disorder
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 24 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 24 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 8 affected / 24 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 21 affected / 24 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 24 affected / 24 at risk

Adverse event: Hypoglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 24 at risk

Adverse event: Haemoglobin decreased
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 17 affected / 24 at risk

Adverse event: Haemorrhage
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 24 at risk

Adverse event: International normalised ratio
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 15 affected / 24 at risk

Adverse event: Leukocyte count decrease
Serious: no
Organ System: Investigations
Frequency: 10 affected / 24 at risk

Adverse event: Lymphocyte count decrease
Serious: no
Organ System: Investigations
Frequency: 3 affected / 24 at risk

Adverse event: Serum Magnesium decrease
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 24 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 24 at risk

Adverse event: Neurological disorder
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 24 at risk

Adverse event: Neutrophil count decrease
Serious: no
Organ System: Investigations
Frequency: 3 affected / 24 at risk

Adverse event: Activated partial thromboplastin prolonged time
Serious: no
Organ System: Investigations
Frequency: 3 affected / 24 at risk

Adverse event: Pain-Abdomen NOS
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 24 at risk

Adverse event: Hypophosphataemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 24 at risk

Adverse event: Platelet count decrease
Serious: no
Organ System: Investigations
Frequency: 19 affected / 24 at risk

Adverse event: Potassium, high (hyperkalemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 24 at risk

Adverse event: Sodium, low (hyponatremia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 21 affected / 24 at risk

Adverse event: Vision blurred
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 24 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 24 at risk