Study: NCT00289341

Adverse event: ALT, serum, high
Serious: no
Organ System: General disorders
Frequency: 3 affected / 12 at risk

Adverse event: Antinuclear antibody
Serious: no
Organ System: General disorders
Frequency: 1 affected / 12 at risk

Adverse event: BUN, serum, high
Serious: no
Organ System: General disorders
Frequency: 1 affected / 12 at risk

Adverse event: CO2, serum, low
Serious: no
Organ System: General disorders
Frequency: 4 affected / 12 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 12 at risk

Adverse event: albumin, urine, high
Serious: no
Organ System: General disorders
Frequency: 1 affected / 12 at risk

Adverse event: chloride, serum, high
Serious: no
Organ System: General disorders
Frequency: 4 affected / 12 at risk

Adverse event: creatinine, serum, high
Serious: no
Organ System: General disorders
Frequency: 1 affected / 12 at risk

Adverse event: diarrhea/loose stools
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 12 at risk

Adverse event: edema, lower extremities
Serious: no
Organ System: General disorders
Frequency: 2 affected / 12 at risk

Adverse event: eosinophils, high
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 12 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 5 affected / 12 at risk

Adverse event: glucose, serum, high, non-fasting
Serious: no
Organ System: General disorders
Frequency: 5 affected / 12 at risk

Adverse event: ketones, urine, high
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 12 at risk

Adverse event: potassium, serum, high
Serious: no
Organ System: General disorders
Frequency: 4 affected / 12 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 12 at risk

Adverse event: Hospitalization: cardioversion for atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 12 at risk

Adverse event: ALT, serum, high
Serious: no
Organ System: General disorders
Frequency: 2 affected / 12 at risk

Adverse event: Antinuclear antibody
Serious: no
Organ System: General disorders
Frequency: 1 affected / 12 at risk

Adverse event: BUN, serum, high
Serious: no
Organ System: General disorders
Frequency: 3 affected / 12 at risk

Adverse event: CO2, serum, low
Serious: no
Organ System: General disorders
Frequency: 2 affected / 12 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 12 at risk

Adverse event: albumin, serum, low
Serious: no
Organ System: General disorders
Frequency: 1 affected / 12 at risk

Adverse event: albumin, urine, high
Serious: no
Organ System: General disorders
Frequency: 3 affected / 12 at risk

Adverse event: chloride, serum, high
Serious: no
Organ System: General disorders
Frequency: 1 affected / 12 at risk

Adverse event: creatinine, serum, high
Serious: no
Organ System: General disorders
Frequency: 2 affected / 12 at risk

Adverse event: diarrhea/loose stools
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 12 at risk

Adverse event: eosinophils, high
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 12 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 5 affected / 12 at risk

Adverse event: glucose, serum, high, non-fasting
Serious: no
Organ System: General disorders
Frequency: 6 affected / 12 at risk

Adverse event: ketones, urine, high
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 12 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 12 at risk

Adverse event: ALT, serum, high
Serious: no
Organ System: General disorders
Frequency: 1 affected / 12 at risk

Adverse event: Antinuclear antibody
Serious: no
Organ System: General disorders
Frequency: 3 affected / 12 at risk

Adverse event: BUN, serum, high
Serious: no
Organ System: General disorders
Frequency: 2 affected / 12 at risk

Adverse event: CO2, serum, low
Serious: no
Organ System: General disorders
Frequency: 2 affected / 12 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 12 at risk

Adverse event: albumin, serum, low
Serious: no
Organ System: General disorders
Frequency: 3 affected / 12 at risk

Adverse event: creatinine, serum, high
Serious: no
Organ System: General disorders
Frequency: 2 affected / 12 at risk

Adverse event: edema, lower extremities
Serious: no
Organ System: General disorders
Frequency: 1 affected / 12 at risk

Adverse event: eosinophils, high
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 12 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 4 affected / 12 at risk

Adverse event: glucose, serum, high, non-fasting
Serious: no
Organ System: General disorders
Frequency: 1 affected / 12 at risk

Adverse event: ketones, urine, high
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 12 at risk

Adverse event: potassium, serum, high
Serious: no
Organ System: General disorders
Frequency: 5 affected / 12 at risk

Adverse event: Elective Hospitalization: inguinal hernia repair
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 24 at risk

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

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

Adverse event: ALT, serum, high
Serious: no
Organ System: General disorders
Frequency: 2 affected / 24 at risk

Adverse event: Antinuclear antibody
Serious: no
Organ System: General disorders
Frequency: 4 affected / 24 at risk

Adverse event: BUN, serum, high
Serious: no
Organ System: General disorders
Frequency: 1 affected / 24 at risk

Adverse event: CO2, serum, low
Serious: no
Organ System: General disorders
Frequency: 1 affected / 24 at risk

Adverse event: albumin, urine, high
Serious: no
Organ System: General disorders
Frequency: 3 affected / 24 at risk

Adverse event: chloride, serum, high
Serious: no
Organ System: General disorders
Frequency: 2 affected / 24 at risk

Adverse event: creatinine, serum, high
Serious: no
Organ System: General disorders
Frequency: 2 affected / 24 at risk

Adverse event: edema, lower extremities
Serious: no
Organ System: General disorders
Frequency: 1 affected / 24 at risk

Adverse event: eosinophils, high
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 24 at risk

Adverse event: glucose, serum, high, non-fasting
Serious: no
Organ System: General disorders
Frequency: 6 affected / 24 at risk

Adverse event: ketones, urine, high
Serious: no
Organ System: Renal and urinary disorders
Frequency: 3 affected / 24 at risk

Adverse event: potassium, serum, high
Serious: no
Organ System: General disorders
Frequency: 1 affected / 24 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 24 at risk