Study: NCT01036321

Adverse event: Aspartate aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 3 affected / 36 at risk

Adverse event: Blood bilirubin increased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 36 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 36 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 36 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 36 at risk

Adverse event: Hypocalcaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 36 at risk

Adverse event: Metabolism and nutrition disorders - Other, Low carbon dioxide
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 36 at risk

Adverse event: Metabolism and nutrition disorders - Other, Low protein
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 36 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 36 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 36 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 1 affected / 36 at risk

Adverse event: Flatulence
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 36 at risk

Adverse event: Gastrointestinal disorder - Other, Darkening of stool
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 36 at risk

Adverse event: Gastrointestinal disorders - Other, Soft stool
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 36 at risk

Adverse event: General disorders - Other, Feeling of fullness
Serious: no
Organ System: General disorders
Frequency: 1 affected / 36 at risk

Adverse event: Hypernatraemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 36 at risk

Adverse event: Investigations - Other, Elevated estradiol
Serious: no
Organ System: Investigations
Frequency: 1 affected / 36 at risk

Adverse event: Investigations - Other, Low serum Co2
Serious: no
Organ System: Investigations
Frequency: 1 affected / 36 at risk

Adverse event: Investigations - Other, Low total testosterone
Serious: no
Organ System: Investigations
Frequency: 1 affected / 36 at risk

Adverse event: Metabolism and nutrition disorders - Other, Elevated albumin
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 36 at risk

Adverse event: Metabolism and nutrition disorders - Other, Low creatinine
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 36 at risk

Adverse event: Renal and urinary disorders - Other, Slow stream
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 36 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 36 at risk

Adverse event: Renal and urinary disorders, Other - Frequent urination
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 36 at risk

Adverse event: Renal and urinary disorders, Other - Frequent urination (night)
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 36 at risk

Adverse event: White blood cell count decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 36 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 35 at risk

Adverse event: Inoperative hemorrhage
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 35 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 35 at risk

Adverse event: Aspartate aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 35 at risk

Adverse event: Abdominal distension
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 35 at risk

Adverse event: Blood bilirubin increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 35 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 35 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 35 at risk

Adverse event: Occasional Diarrhea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 35 at risk

Adverse event: Gastrointestinal disorders - Other, Belching
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 35 at risk

Adverse event: Gastrointestinal disorders - Other, GI symptoms
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 35 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 35 at risk

Adverse event: Hypocalcaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 35 at risk

Adverse event: Hyponatraemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 35 at risk

Adverse event: Investigations - Other, Elevated total testosterone
Serious: no
Organ System: Investigations
Frequency: 1 affected / 35 at risk

Adverse event: Investigations - Other, Low hemoglobin
Serious: no
Organ System: Investigations
Frequency: 1 affected / 35 at risk

Adverse event: Investigations - Other, Low RBC
Serious: no
Organ System: Investigations
Frequency: 2 affected / 35 at risk

Adverse event: Metabolism and nutrition disorders - Other, Low carbon dioxide
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 35 at risk

Adverse event: Metabolism and nutrition disorders - Other, Low globulin
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 35 at risk

Adverse event: Metabolism and nutrition disorders - Other, Low protein
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 35 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 35 at risk

Adverse event: Neutrophil count decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 35 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 35 at risk

Adverse event: Renal and urinary disorders - Other, Urination discomfort
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 35 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 35 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 35 at risk

Adverse event: Gastrointestinal disorder - Other, Tender stomach
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 35 at risk

Adverse event: Urticaria
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 35 at risk