Study: NCT00497055

Adverse event: Rhabdomyolysis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 45 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 45 at risk

Adverse event: Cellulitis
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 45 at risk

Adverse event: Skin abrasion
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 45 at risk

Adverse event: Akathisia
Serious: no
Organ System: Nervous system disorders
Frequency: 12 affected / 45 at risk

Adverse event: Abscess
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 45 at risk

Adverse event: Contusion
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 45 at risk

Adverse event: Somnolence
Serious: no
Organ System: General disorders
Frequency: 6 affected / 45 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 8 affected / 45 at risk

Adverse event: Hyperbilirubinaemia
Serious: no
Organ System: General disorders
Frequency: 3 affected / 45 at risk

Adverse event: Toothache
Serious: no
Organ System: General disorders
Frequency: 3 affected / 45 at risk

Adverse event: Viral infection
Serious: no
Organ System: General disorders
Frequency: 1 affected / 45 at risk

Adverse event: Depressed mood
Serious: no
Organ System: Psychiatric disorders
Frequency: 3 affected / 45 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 45 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 45 at risk

Adverse event: Hypernatraemia
Serious: no
Organ System: General disorders
Frequency: 4 affected / 45 at risk

Adverse event: Hypocalcaemia
Serious: no
Organ System: General disorders
Frequency: 3 affected / 45 at risk

Adverse event: Increased Alanine Transaminase (ALT)
Serious: no
Organ System: General disorders
Frequency: 8 affected / 45 at risk

Adverse event: Increased Aspartate Transaminase (AST)
Serious: no
Organ System: General disorders
Frequency: 6 affected / 45 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 45 at risk

Adverse event: Restlessness
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 45 at risk

Adverse event: Skin infection
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 45 at risk

Adverse event: Sleep disorder
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 45 at risk

Adverse event: Upper Respiratory Infection (URI)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 6 affected / 45 at risk

Adverse event: Subdural haematoma
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 45 at risk

Adverse event: metastatic cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 45 at risk

Adverse event: Abscess
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 45 at risk

Adverse event: Skin abrasion
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 45 at risk

Adverse event: Akathisia
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 45 at risk

Adverse event: Abscess
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 45 at risk

Adverse event: Contusion
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 45 at risk

Adverse event: Hyperbilirubinaemia
Serious: no
Organ System: General disorders
Frequency: 4 affected / 45 at risk

Adverse event: Toothache
Serious: no
Organ System: General disorders
Frequency: 4 affected / 45 at risk

Adverse event: Viral infection
Serious: no
Organ System: General disorders
Frequency: 3 affected / 45 at risk

Adverse event: Anxiety
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 45 at risk

Adverse event: Depressed mood
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 45 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 45 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 45 at risk

Adverse event: Hypocalcaemia
Serious: no
Organ System: General disorders
Frequency: 2 affected / 45 at risk

Adverse event: Increased Alanine Transaminase (ALT)
Serious: no
Organ System: General disorders
Frequency: 7 affected / 45 at risk

Adverse event: Increased Aspartate Transaminase (AST)
Serious: no
Organ System: General disorders
Frequency: 4 affected / 45 at risk

Adverse event: Skin laceration
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 45 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 45 at risk

Adverse event: Restlessness
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 45 at risk

Adverse event: Skin infection
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 45 at risk

Adverse event: Sleep disorder
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 45 at risk

Adverse event: Sweats
Serious: no
Organ System: General disorders
Frequency: 4 affected / 45 at risk

Adverse event: Upper Respiratory Infection (URI)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 45 at risk

Adverse event: Urinary Tract Infection (UTI)
Serious: no
Organ System: Renal and urinary disorders
Frequency: 3 affected / 45 at risk