Study: NCT01500096

Adverse event: Low ANC
Serious: yes
Organ System: Immune system disorders
Notes: Low Absolute Neutrophil Count (ANC)
Frequency: 1 affected / 32 at risk

Adverse event: Bronchitis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Bronchitis
Frequency: 1 affected / 32 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Notes: Anxiety
Frequency: 11 affected / 32 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Cough
Frequency: 3 affected / 32 at risk

Adverse event: Decreased ANC
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Decreased ANC
Frequency: 5 affected / 32 at risk

Adverse event: Decreased Potassium
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 32 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Diarrhea
Frequency: 1 affected / 32 at risk

Adverse event: Diziness
Serious: no
Organ System: Nervous system disorders
Notes: Dizziness
Frequency: 11 affected / 32 at risk

Adverse event: Elevated ALT
Serious: no
Organ System: Hepatobiliary disorders
Notes: Elevated Alanine Aminotransferase (ALT)
Frequency: 7 affected / 32 at risk

Adverse event: Elevated AST
Serious: no
Organ System: Hepatobiliary disorders
Notes: Elevated AST
Frequency: 8 affected / 32 at risk

Adverse event: Elevated Alkaline Phosphatase
Serious: no
Organ System: Hepatobiliary disorders
Notes: Elevated Alkaline Phosphatase
Frequency: 4 affected / 32 at risk

Adverse event: Elevated Bilirubin
Serious: no
Organ System: Hepatobiliary disorders
Notes: Elevated Bilirubin
Frequency: 6 affected / 32 at risk

Adverse event: Elevated Glucose
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Elevated Glucose
Frequency: 1 affected / 32 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: Fatigue
Frequency: 1 affected / 32 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: Headache
Frequency: 11 affected / 32 at risk

Adverse event: Hypertension
Serious: no
Organ System: Cardiac disorders
Notes: Hypertension
Frequency: 3 affected / 32 at risk

Adverse event: Insomnia
Serious: no
Organ System: Nervous system disorders
Notes: Insomnia
Frequency: 11 affected / 32 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Nausea
Frequency: 6 affected / 32 at risk

Adverse event: Nervousness
Serious: no
Organ System: Nervous system disorders
Notes: Nervousness
Frequency: 9 affected / 32 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Notes: Upper Respiratory Infection
Frequency: 4 affected / 32 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Endocrine disorders
Notes: Hyperglycemia
Frequency: 5 affected / 32 at risk

Adverse event: Low ANC
Serious: yes
Organ System: Immune system disorders
Notes: Low Absolute Neutrophil Count (ANC)
Frequency: 1 affected / 17 at risk

Adverse event: Cellulitis
Serious: yes
Organ System: Infections and infestations
Notes: Cellulitis Right Finger
Frequency: 1 affected / 17 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Notes: Anxiety
Frequency: 9 affected / 17 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Cough
Frequency: 1 affected / 17 at risk

Adverse event: Decreased ANC
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Decreased ANC
Frequency: 3 affected / 17 at risk

Adverse event: Decreased Potassium
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 17 at risk

Adverse event: Diziness
Serious: no
Organ System: Nervous system disorders
Notes: Dizziness
Frequency: 7 affected / 17 at risk

Adverse event: Elevated ALT
Serious: no
Organ System: Hepatobiliary disorders
Notes: Elevated Alanine Aminotransferase (ALT)
Frequency: 3 affected / 17 at risk

Adverse event: Elevated AST
Serious: no
Organ System: Hepatobiliary disorders
Notes: Elevated AST
Frequency: 4 affected / 17 at risk

Adverse event: Elevated Alkaline Phosphatase
Serious: no
Organ System: Hepatobiliary disorders
Notes: Elevated Alkaline Phosphatase
Frequency: 4 affected / 17 at risk

Adverse event: Elevated Bilirubin
Serious: no
Organ System: Hepatobiliary disorders
Notes: Elevated Bilirubin
Frequency: 1 affected / 17 at risk

Adverse event: Elevated Glucose
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Elevated Glucose
Frequency: 2 affected / 17 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: Headache
Frequency: 9 affected / 17 at risk

Adverse event: Hypertension
Serious: no
Organ System: Cardiac disorders
Notes: Hypertension
Frequency: 2 affected / 17 at risk

Adverse event: Insomnia
Serious: no
Organ System: Nervous system disorders
Notes: Insomnia
Frequency: 9 affected / 17 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Nausea
Frequency: 6 affected / 17 at risk

Adverse event: Nervousness
Serious: no
Organ System: Nervous system disorders
Notes: Nervousness
Frequency: 6 affected / 17 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Notes: Upper Respiratory Infection
Frequency: 1 affected / 17 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Endocrine disorders
Notes: Hyperglycemia
Frequency: 4 affected / 17 at risk

Adverse event: Hip arthroplasty
Serious: yes
Organ System: Surgical and medical procedures
Notes: Right Hip Replacement
Frequency: 1 affected / 31 at risk

Adverse event: Increased AST
Serious: yes
Organ System: Hepatobiliary disorders
Notes: Increased Aspartate aminotransferase (AST)
Frequency: 1 affected / 31 at risk

Adverse event: Cellulitis
Serious: yes
Organ System: Infections and infestations
Notes: Cellulitis Right Finger
Frequency: 1 affected / 31 at risk

Adverse event: Pain Right Index Finger
Serious: yes
Organ System: General disorders
Notes: Pain Right Index Finger
Frequency: 1 affected / 31 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Notes: Anxiety
Frequency: 7 affected / 31 at risk

Adverse event: Decreased ANC
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Decreased ANC
Frequency: 5 affected / 31 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Diarrhea
Frequency: 3 affected / 31 at risk

Adverse event: Diziness
Serious: no
Organ System: Nervous system disorders
Notes: Dizziness
Frequency: 6 affected / 31 at risk

Adverse event: Elevated ALT
Serious: no
Organ System: Hepatobiliary disorders
Notes: Elevated Alanine Aminotransferase (ALT)
Frequency: 6 affected / 31 at risk

Adverse event: Elevated AST
Serious: no
Organ System: Hepatobiliary disorders
Notes: Elevated AST
Frequency: 6 affected / 31 at risk

Adverse event: Elevated Alkaline Phosphatase
Serious: no
Organ System: Hepatobiliary disorders
Notes: Elevated Alkaline Phosphatase
Frequency: 4 affected / 31 at risk

Adverse event: Elevated Bilirubin
Serious: no
Organ System: Hepatobiliary disorders
Notes: Elevated Bilirubin
Frequency: 1 affected / 31 at risk

Adverse event: Elevated Creatinine
Serious: no
Organ System: Renal and urinary disorders
Notes: Elevated Creatinine
Frequency: 5 affected / 31 at risk

Adverse event: Elevated Glucose
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Elevated Glucose
Frequency: 4 affected / 31 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: Fatigue
Frequency: 2 affected / 31 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: Headache
Frequency: 7 affected / 31 at risk

Adverse event: Hypertension
Serious: no
Organ System: Cardiac disorders
Notes: Hypertension
Frequency: 1 affected / 31 at risk

Adverse event: Insomnia
Serious: no
Organ System: Nervous system disorders
Notes: Insomnia
Frequency: 7 affected / 31 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Nausea
Frequency: 7 affected / 31 at risk

Adverse event: Nervousness
Serious: no
Organ System: Nervous system disorders
Notes: Nervousness
Frequency: 5 affected / 31 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Notes: Upper Respiratory Infection
Frequency: 1 affected / 31 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Endocrine disorders
Notes: Hyperglycemia
Frequency: 8 affected / 31 at risk

Adverse event: Low ANC
Serious: yes
Organ System: Immune system disorders
Notes: Low Absolute Neutrophil Count (ANC)
Frequency: 1 affected / 16 at risk

Adverse event: Nephrolithiasis
Serious: yes
Organ System: Renal and urinary disorders
Notes: Kidney Stone
Frequency: 1 affected / 16 at risk

Adverse event: Abdominal pain
Serious: yes
Organ System: General disorders
Notes: Abdominal Pain
Frequency: 1 affected / 16 at risk

Adverse event: Ureterolithiasis
Serious: yes
Organ System: Renal and urinary disorders
Notes: Ureterolithiasis
Frequency: 1 affected / 16 at risk

Adverse event: Right Flank Pain
Serious: yes
Organ System: General disorders
Notes: Right Flank Pain
Frequency: 1 affected / 16 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Notes: Anxiety
Frequency: 5 affected / 16 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Cough
Frequency: 1 affected / 16 at risk

Adverse event: Decreased ANC
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Decreased ANC
Frequency: 3 affected / 16 at risk

Adverse event: Decreased Potassium
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 16 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Diarrhea
Frequency: 1 affected / 16 at risk

Adverse event: Diziness
Serious: no
Organ System: Nervous system disorders
Notes: Dizziness
Frequency: 5 affected / 16 at risk

Adverse event: Elevated ALT
Serious: no
Organ System: Hepatobiliary disorders
Notes: Elevated Alanine Aminotransferase (ALT)
Frequency: 3 affected / 16 at risk

Adverse event: Elevated AST
Serious: no
Organ System: Hepatobiliary disorders
Notes: Elevated AST
Frequency: 4 affected / 16 at risk

Adverse event: Elevated Alkaline Phosphatase
Serious: no
Organ System: Hepatobiliary disorders
Notes: Elevated Alkaline Phosphatase
Frequency: 1 affected / 16 at risk

Adverse event: Elevated Bilirubin
Serious: no
Organ System: Hepatobiliary disorders
Notes: Elevated Bilirubin
Frequency: 2 affected / 16 at risk

Adverse event: Elevated Creatinine
Serious: no
Organ System: Renal and urinary disorders
Notes: Elevated Creatinine
Frequency: 1 affected / 16 at risk

Adverse event: Elevated Glucose
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Elevated Glucose
Frequency: 3 affected / 16 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: Fatigue
Frequency: 2 affected / 16 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: Headache
Frequency: 5 affected / 16 at risk

Adverse event: Insomnia
Serious: no
Organ System: Nervous system disorders
Notes: Insomnia
Frequency: 5 affected / 16 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Nausea
Frequency: 5 affected / 16 at risk

Adverse event: Nervousness
Serious: no
Organ System: Nervous system disorders
Notes: Nervousness
Frequency: 5 affected / 16 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Notes: Upper Respiratory Infection
Frequency: 2 affected / 16 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Endocrine disorders
Notes: Hyperglycemia
Frequency: 4 affected / 16 at risk