Study: NCT00200161

Adverse event: Blood bilirubin
Serious: no
Organ System: Investigations
Frequency: 22 affected / 43 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 34 affected / 43 at risk

Adverse event: Blood alkaline phosphatase
Serious: no
Organ System: Investigations
Frequency: 10 affected / 43 at risk

Adverse event: Alanine aminotransferase
Serious: no
Organ System: Investigations
Frequency: 43 affected / 43 at risk

Adverse event: Lymphopenia
Serious: no
Organ System: Investigations
Frequency: 30 affected / 43 at risk

Adverse event: PTT
Serious: no
Organ System: Investigations
Frequency: 7 affected / 43 at risk

Adverse event: Muscle weakness - right sided
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 43 at risk

Adverse event: Muscle weakness - Left sided
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 43 at risk

Adverse event: Aspartate aminotransferase
Serious: no
Organ System: Investigations
Frequency: 24 affected / 43 at risk

Adverse event: Platelets
Serious: no
Organ System: Investigations
Frequency: 35 affected / 43 at risk

Adverse event: Hypoalbuminaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 34 affected / 43 at risk

Adverse event: Thrombosis
Serious: no
Organ System: Vascular disorders
Frequency: 8 affected / 43 at risk

Adverse event: Hyponatraemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 13 affected / 43 at risk

Adverse event: Haemoglobin
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 33 affected / 43 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 12 affected / 43 at risk

Adverse event: Blood creatinine
Serious: no
Organ System: Investigations
Frequency: 6 affected / 43 at risk

Adverse event: Hyperkalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 6 affected / 43 at risk

Adverse event: Hypermagnesaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 43 at risk

Adverse event: Hypernatraemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 15 affected / 43 at risk

Adverse event: International normalised ratio
Serious: no
Organ System: Investigations
Frequency: 7 affected / 43 at risk

Adverse event: Seizure
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 43 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 43 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 7 affected / 43 at risk

Adverse event: Pollakiuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 43 at risk

Adverse event: Leukocytes
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 16 affected / 43 at risk

Adverse event: ANC
Serious: no
Organ System: Investigations
Frequency: 9 affected / 43 at risk

Adverse event: Hypomagnesmia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 43 at risk

Adverse event: Hypophosphataemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 6 affected / 43 at risk

Adverse event: Hypertriglyceridaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 43 at risk

Adverse event: Amylase
Serious: no
Organ System: Investigations
Frequency: 3 affected / 43 at risk

Adverse event: Lipase
Serious: no
Organ System: Investigations
Frequency: 4 affected / 43 at risk

Adverse event: Infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 43 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 11 affected / 43 at risk

Adverse event: Tremor
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 43 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 1 affected / 43 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 43 at risk

Adverse event: Hypercholesterolaemia
Serious: no
Organ System: Investigations
Frequency: 6 affected / 43 at risk

Adverse event: Speech impairment
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 43 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 43 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 43 at risk

Adverse event: Alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 43 at risk

Adverse event: Vision blurred
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 43 at risk

Adverse event: Blood bilirubin
Serious: no
Organ System: Investigations
Frequency: 18 affected / 42 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 32 affected / 42 at risk

Adverse event: Blood alkaline phosphatase
Serious: no
Organ System: Investigations
Frequency: 8 affected / 42 at risk

Adverse event: Alanine aminotransferase
Serious: no
Organ System: Investigations
Frequency: 36 affected / 42 at risk

Adverse event: Lymphopenia
Serious: no
Organ System: Investigations
Frequency: 27 affected / 42 at risk

Adverse event: PTT
Serious: no
Organ System: Investigations
Frequency: 8 affected / 42 at risk

Adverse event: Muscle weakness - right sided
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 42 at risk

Adverse event: Muscle weakness - Left sided
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 42 at risk

Adverse event: Muscle weakness extremity - lower
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 42 at risk

Adverse event: Aspartate aminotransferase
Serious: no
Organ System: Investigations
Frequency: 14 affected / 42 at risk

Adverse event: Platelets
Serious: no
Organ System: Investigations
Frequency: 27 affected / 42 at risk

Adverse event: Hypoalbuminaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 26 affected / 42 at risk

Adverse event: Thrombosis
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 42 at risk

Adverse event: Hyponatraemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 15 affected / 42 at risk

Adverse event: Haemoglobin
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 23 affected / 42 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 12 affected / 42 at risk

Adverse event: Blood creatinine
Serious: no
Organ System: Investigations
Frequency: 8 affected / 42 at risk

Adverse event: Hyperkalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 42 at risk

Adverse event: Hypernatraemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 14 affected / 42 at risk

Adverse event: International normalised ratio
Serious: no
Organ System: Investigations
Frequency: 11 affected / 42 at risk

Adverse event: Seizure
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 42 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 42 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 6 affected / 42 at risk

Adverse event: Pollakiuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 42 at risk

Adverse event: Leukocytes
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 24 affected / 42 at risk

Adverse event: ANC
Serious: no
Organ System: Investigations
Frequency: 13 affected / 42 at risk

Adverse event: Hypophosphataemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 42 at risk

Adverse event: Hypertriglyceridaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 42 at risk

Adverse event: Amylase
Serious: no
Organ System: Investigations
Frequency: 1 affected / 42 at risk

Adverse event: Infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 42 at risk

Adverse event: Edema: limb
Serious: no
Organ System: General disorders
Frequency: 2 affected / 42 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 20 affected / 42 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 3 affected / 42 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 3 affected / 42 at risk

Adverse event: Hypercholesterolaemia
Serious: no
Organ System: Investigations
Frequency: 5 affected / 42 at risk

Adverse event: Speech impairment
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 42 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 42 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 42 at risk

Adverse event: Alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 42 at risk

Adverse event: Vision blurred
Serious: no
Organ System: Eye disorders
Frequency: 4 affected / 42 at risk

Adverse event: Confusional state
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 42 at risk