Study: NCT00772447

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 131 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 7 affected / 131 at risk

Adverse event: Aspartate aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 6 affected / 131 at risk

Adverse event: Blood creatine phosphokinase increased
Serious: no
Organ System: Investigations
Frequency: 4 affected / 131 at risk

Adverse event: White blood cell count decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 131 at risk

Adverse event: Blood lactate dehydrogenase increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 131 at risk

Adverse event: Red blood cells urine positive
Serious: no
Organ System: Investigations
Frequency: 1 affected / 131 at risk

Adverse event: Blood urine present
Serious: no
Organ System: Investigations
Frequency: 1 affected / 131 at risk

Adverse event: ELECTROCARDIOGRAM QRS COMPLEX PROLONGE0D
Serious: no
Organ System: Investigations
Frequency: 1 affected / 131 at risk

Adverse event: Electrocardiogram T wave abnormal
Serious: no
Organ System: Investigations
Frequency: 1 affected / 131 at risk

Adverse event: White blood cells urine positive
Serious: no
Organ System: Investigations
Frequency: 1 affected / 131 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 131 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 131 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 131 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 2 affected / 131 at risk

Adverse event: Chest discomfort
Serious: no
Organ System: General disorders
Frequency: 1 affected / 131 at risk

Adverse event: Muscular weakness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 131 at risk

Adverse event: Joint swelling
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 131 at risk

Adverse event: Abdominal distension
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 131 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 131 at risk

Adverse event: Muscle contractions involuntary
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 131 at risk

Adverse event: Angina pectoris
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 131 at risk

Adverse event: Ventricular extrasystoles
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 131 at risk

Adverse event: Dysuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 131 at risk

Adverse event: Haematuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 131 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 131 at risk

Adverse event: Pruritus genital
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 131 at risk

Adverse event: Blood phosphorus increased
Serious: no
Organ System: Investigations
Notes: BLOOD PHOSPHORUS INCREASED
Frequency: 1 affected / 131 at risk

Adverse event: Blood potassium increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 131 at risk

Adverse event: Blood uric acid increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 131 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 133 at risk

Adverse event: Tuberculosis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 133 at risk

Adverse event: Hepatic cirrhosis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 133 at risk

Adverse event: Chronic kidney disease
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 133 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 7 affected / 133 at risk

Adverse event: Aspartate aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 6 affected / 133 at risk

Adverse event: White blood cell count decreased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 133 at risk

Adverse event: Blood lactate dehydrogenase increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 133 at risk

Adverse event: Red blood cells urine positive
Serious: no
Organ System: Investigations
Frequency: 1 affected / 133 at risk

Adverse event: Blood alkaline phosphatase increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 133 at risk

Adverse event: Blood creatinine increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 133 at risk

Adverse event: Blood potassium decreased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 133 at risk

Adverse event: Gamma-glutamyltransferase increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 133 at risk

Adverse event: Monocyte percentage increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 133 at risk

Adverse event: Platelet count decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 133 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 133 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 133 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 133 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 133 at risk

Adverse event: Tuberculosis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 133 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 133 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Frequency: 1 affected / 133 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 133 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 133 at risk

Adverse event: Muscular weakness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 133 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 133 at risk

Adverse event: Abdominal discomfort
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 133 at risk

Adverse event: Ascites
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 133 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 133 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 133 at risk

Adverse event: Amnesia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 133 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 133 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 133 at risk

Adverse event: Left ventricular hypertrophy
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 133 at risk

Adverse event: Supraventricular extrasystoles
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 133 at risk

Adverse event: Chronic kidney disease
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 133 at risk

Adverse event: Flushing
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 133 at risk

Adverse event: Hepatic cirrhosis
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 133 at risk