Study: NCT00345293

Adverse event: Chest pain
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 13 at risk

Adverse event: Arrhythmia
Serious: yes
Organ System: Cardiac disorders
Notes: hospitalization for pacemaker placement
Frequency: 1 affected / 13 at risk

Adverse event: absolute lymphocyte, low
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: G1
Frequency: 1 affected / 13 at risk

Adverse event: acid phosphatase, high
Serious: no
Organ System: General disorders
Notes: G1
Frequency: 1 affected / 13 at risk

Adverse event: albumin, low
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: G1
Frequency: 1 affected / 13 at risk

Adverse event: albumin, trace, urine
Serious: no
Organ System: General disorders
Notes: G1
Frequency: 2 affected / 13 at risk

Adverse event: alkaline phosphatase, high
Serious: no
Organ System: General disorders
Notes: G1
Frequency: 1 affected / 13 at risk

Adverse event: ALT, high
Serious: no
Organ System: Gastrointestinal disorders
Notes: G2
Frequency: 1 affected / 13 at risk

Adverse event: ANA, high
Serious: no
Organ System: General disorders
Notes: G1
Frequency: 2 affected / 13 at risk

Adverse event: ANC, low
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: G2
Frequency: 1 affected / 13 at risk

Adverse event: AST, high
Serious: no
Organ System: Hepatobiliary disorders
Notes: G1 and G3
Frequency: 2 affected / 13 at risk

Adverse event: bacteria, urine, few
Serious: no
Organ System: General disorders
Notes: G1
Frequency: 1 affected / 13 at risk

Adverse event: basophil, high
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: G1
Frequency: 1 affected / 13 at risk

Adverse event: bilirubin, urine, small
Serious: no
Organ System: General disorders
Notes: G1
Frequency: 1 affected / 13 at risk

Adverse event: blood, urine, trace
Serious: no
Organ System: Renal and urinary disorders
Notes: G1
Frequency: 2 affected / 13 at risk

Adverse event: BUN, high
Serious: no
Organ System: General disorders
Notes: G1
Frequency: 1 affected / 13 at risk

Adverse event: calcium, ionized, low
Serious: no
Organ System: General disorders
Notes: G1
Frequency: 1 affected / 13 at risk

Adverse event: chloride, high
Serious: no
Organ System: General disorders
Notes: G1
Frequency: 4 affected / 13 at risk

Adverse event: CO2, high
Serious: no
Organ System: General disorders
Notes: G1
Frequency: 7 affected / 13 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: G1
Frequency: 1 affected / 13 at risk

Adverse event: creatinine, high
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: G1 and G2
Frequency: 3 affected / 13 at risk

Adverse event: crystals, urine
Serious: no
Organ System: Renal and urinary disorders
Notes: G1
Frequency: 2 affected / 13 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: G1
Frequency: 1 affected / 13 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: G1 and G2
Frequency: 2 affected / 13 at risk

Adverse event: glucose, high
Serious: no
Organ System: General disorders
Notes: G1 and G2
Frequency: 3 affected / 13 at risk

Adverse event: glucose, low
Serious: no
Organ System: General disorders
Notes: G1 and G2
Frequency: 2 affected / 13 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Notes: G1
Frequency: 1 affected / 13 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Notes: G1 and G2
Frequency: 2 affected / 13 at risk

Adverse event: hematocrit, low
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: G1
Frequency: 3 affected / 13 at risk

Adverse event: Haematoma
Serious: no
Organ System: General disorders
Notes: G1
Frequency: 1 affected / 13 at risk

Adverse event: hemoglobin, low
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: G1
Frequency: 2 affected / 13 at risk

Adverse event: hemorrhage, GU, bladder
Serious: no
Organ System: Renal and urinary disorders
Notes: G1 and G2
Frequency: 1 affected / 13 at risk

Adverse event: Epistaxis
Serious: no
Organ System: General disorders
Notes: G1
Frequency: 1 affected / 13 at risk

Adverse event: Injection site reaction
Serious: no
Organ System: General disorders
Notes: G1 and G2
Frequency: 11 affected / 13 at risk

Adverse event: INR, low
Serious: no
Organ System: General disorders
Notes: G1
Frequency: 1 affected / 13 at risk

Adverse event: ketones, urine, high
Serious: no
Organ System: General disorders
Notes: G1
Frequency: 2 affected / 13 at risk

Adverse event: leuko est, urine, high
Serious: no
Organ System: General disorders
Notes: G1
Frequency: 2 affected / 13 at risk

Adverse event: Dizziness
Serious: no
Organ System: General disorders
Notes: G1
Frequency: 1 affected / 13 at risk

Adverse event: Back pain
Serious: no
Organ System: General disorders
Notes: G1
Frequency: 2 affected / 13 at risk

Adverse event: LUC, high
Serious: no
Organ System: General disorders
Notes: G1
Frequency: 1 affected / 13 at risk

Adverse event: lymphocytes, %, low
Serious: no
Organ System: General disorders
Notes: G1
Frequency: 3 affected / 13 at risk

Adverse event: MCHC, high
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: G1
Frequency: 6 affected / 13 at risk

Adverse event: monocytes, %, high
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: G1
Frequency: 2 affected / 13 at risk

Adverse event: neutrophils, %, high
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: G1
Frequency: 3 affected / 13 at risk

Adverse event: neutrophils, %, low
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: G1
Frequency: 1 affected / 13 at risk

Adverse event: numbness/tingling
Serious: no
Organ System: General disorders
Notes: G1
Frequency: 2 affected / 13 at risk

Adverse event: Chest pain
Serious: no
Organ System: Cardiac disorders
Notes: G3
Frequency: 1 affected / 13 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Notes: G1
Frequency: 6 affected / 13 at risk

Adverse event: pH, urine, high
Serious: no
Organ System: General disorders
Notes: G1
Frequency: 3 affected / 13 at risk

Adverse event: platelet, high
Serious: no
Organ System: General disorders
Frequency: 1 affected / 13 at risk

Adverse event: platelets, low
Serious: no
Organ System: General disorders
Frequency: 1 affected / 13 at risk

Adverse event: potassium, high
Serious: no
Organ System: General disorders
Notes: G1
Frequency: 2 affected / 13 at risk

Adverse event: Presyncope
Serious: no
Organ System: General disorders
Notes: G2
Frequency: 1 affected / 13 at risk

Adverse event: Prolonged QTc interval
Serious: no
Organ System: Cardiac disorders
Notes: G2
Frequency: 1 affected / 13 at risk

Adverse event: pulmonary nodules
Serious: no
Organ System: General disorders
Frequency: 1 affected / 13 at risk

Adverse event: Rash
Serious: no
Organ System: General disorders
Notes: G1
Frequency: 2 affected / 13 at risk

Adverse event: RBC, low
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: G1
Frequency: 3 affected / 13 at risk

Adverse event: RBC, urine, high
Serious: no
Organ System: Renal and urinary disorders
Notes: G1
Frequency: 6 affected / 13 at risk

Adverse event: RDW, high
Serious: no
Organ System: General disorders
Frequency: 1 affected / 13 at risk

Adverse event: rheumatoid factor, positive
Serious: no
Organ System: General disorders
Notes: G1
Frequency: 1 affected / 13 at risk

Adverse event: rosecea
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: G1
Frequency: 1 affected / 13 at risk

Adverse event: seasonal allergies
Serious: no
Organ System: Immune system disorders
Notes: G1
Frequency: 1 affected / 13 at risk

Adverse event: specific gravity, urine, high
Serious: no
Organ System: Renal and urinary disorders
Frequency: 5 affected / 13 at risk

Adverse event: specific gravity, urine, low
Serious: no
Organ System: Renal and urinary disorders
Notes: G1
Frequency: 4 affected / 13 at risk

Adverse event: Lymphadenopathy
Serious: no
Organ System: General disorders
Notes: G1
Frequency: 1 affected / 13 at risk

Adverse event: thyroid nodules
Serious: no
Organ System: General disorders
Frequency: 1 affected / 13 at risk

Adverse event: total bilirubin, high
Serious: no
Organ System: General disorders
Frequency: 2 affected / 13 at risk

Adverse event: total protein, low
Serious: no
Organ System: General disorders
Notes: G1
Frequency: 1 affected / 13 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: General disorders
Notes: G1
Frequency: 1 affected / 13 at risk

Adverse event: vasovagal episode
Serious: no
Organ System: General disorders
Notes: G2
Frequency: 1 affected / 13 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 13 at risk

Adverse event: WBC, low
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: G1
Frequency: 3 affected / 13 at risk