Study: NCT00632411

Adverse event: Hospitalisation
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 16 affected / 649 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 14 affected / 649 at risk

Adverse event: Rash
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 88 affected / 649 at risk

Adverse event: Sleep disorder
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 64 affected / 649 at risk

Adverse event: Respiratory illness/ Sinus/ Sore throat/ Cold/Flu/Seasonal allergies
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 55 affected / 649 at risk

Adverse event: Stomach illness/Nausea/Diarrhea
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 30 affected / 649 at risk

Adverse event: Pain/Joint Pain/Muscle Aches/ Back Pain
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 23 affected / 649 at risk

Adverse event: Anxiety/Irritability
Serious: no
Organ System: Psychiatric disorders
Frequency: 7 affected / 649 at risk

Adverse event: Fatigue/Lethargy
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 649 at risk

Adverse event: Increased Heart Rate/Heart Palpitations
Serious: no
Organ System: Cardiac disorders
Frequency: 4 affected / 649 at risk

Adverse event: Injury: knee/foot
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 4 affected / 649 at risk

Adverse event: Hernia
Serious: no
Organ System: Renal and urinary disorders
Frequency: 4 affected / 649 at risk

Adverse event: Gall bladder surgery
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 649 at risk

Adverse event: Urinary Tract Infection, Bladder problems
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 649 at risk

Adverse event: Tooth extraction
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 649 at risk

Adverse event: Elevated Blood Pressure
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 649 at risk

Adverse event: Tinnitus
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 649 at risk

Adverse event: Ear infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 649 at risk

Adverse event: Biopsy skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 649 at risk

Adverse event: Hospitalisation
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 6 affected / 649 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 4 affected / 649 at risk

Adverse event: Rash
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 26 affected / 649 at risk

Adverse event: Sleep disorder
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 19 affected / 649 at risk

Adverse event: Respiratory illness/ Sinus/ Sore throat/ Cold/Flu/Seasonal allergies
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 13 affected / 649 at risk

Adverse event: Stomach illness/Nausea/Diarrhea
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 14 affected / 649 at risk

Adverse event: Pain/Joint Pain/Muscle Aches/ Back Pain
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 6 affected / 649 at risk

Adverse event: Anxiety/Irritability
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 649 at risk

Adverse event: Fatigue/Lethargy
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 649 at risk

Adverse event: Increased Heart Rate/Heart Palpitations
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 649 at risk

Adverse event: Gall bladder surgery
Serious: no
Organ System: Surgical and medical procedures
Frequency: 2 affected / 649 at risk

Adverse event: Urinary Tract Infection, Bladder problems
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 649 at risk

Adverse event: Tooth extraction
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 649 at risk

Adverse event: Elevated Blood Pressure
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 649 at risk

Adverse event: Tinnitus
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 649 at risk

Adverse event: Ear infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 649 at risk