Study: NCT00853749

Adverse event: Lymphadenopathy
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 50 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 50 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 50 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 50 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 50 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 50 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 50 at risk

Adverse event: Epistaxis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 50 at risk

Adverse event: Urticaria
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 50 at risk

Adverse event: Tenderness (Any)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 44 affected / 50 at risk

Adverse event: Tenderness (Significant)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 6 affected / 50 at risk

Adverse event: Redness (Any)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 25 affected / 50 at risk

Adverse event: Redness (Mild)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 5 affected / 50 at risk

Adverse event: Redness (Moderate)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 20 affected / 50 at risk

Adverse event: Redness (Severe)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 5 affected / 50 at risk

Adverse event: Swelling (Any)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 22 affected / 50 at risk

Adverse event: Swelling (Mild)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 8 affected / 49 at risk

Adverse event: Swelling (Moderate)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 14 affected / 49 at risk

Adverse event: Swelling (Severe)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 49 at risk

Adverse event: Fever ≥ 38°C but ≤ 39°C
Serious: no
Organ System: General disorders
Frequency: 1 affected / 49 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: General disorders
Frequency: 6 affected / 49 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Frequency: 9 affected / 49 at risk

Adverse event: Increased sleep
Serious: no
Organ System: General disorders
Frequency: 2 affected / 50 at risk

Adverse event: Rash
Serious: no
Organ System: General disorders
Frequency: 3 affected / 50 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 39 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 39 at risk

Adverse event: Viral infection
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 39 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 39 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 39 at risk

Adverse event: Fall
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 39 at risk

Adverse event: Tenderness (Any)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 30 affected / 39 at risk

Adverse event: Tenderness (Significant)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 8 affected / 39 at risk

Adverse event: Redness (Any)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 26 affected / 39 at risk

Adverse event: Redness (Mild)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 6 affected / 38 at risk

Adverse event: Redness (Moderate)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 20 affected / 38 at risk

Adverse event: Redness (Severe)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 8 affected / 38 at risk

Adverse event: Swelling (Any)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 23 affected / 39 at risk

Adverse event: Swelling (Mild)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 10 affected / 38 at risk

Adverse event: Swelling (Moderate)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 17 affected / 38 at risk

Adverse event: Swelling (Severe)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 38 at risk

Adverse event: Fever ≥ 38°C but ≤ 39°C
Serious: no
Organ System: General disorders
Frequency: 1 affected / 36 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: General disorders
Frequency: 4 affected / 39 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Frequency: 4 affected / 35 at risk

Adverse event: Increased sleep
Serious: no
Organ System: General disorders
Frequency: 5 affected / 39 at risk

Adverse event: Decreased sleep
Serious: no
Organ System: General disorders
Frequency: 2 affected / 39 at risk

Adverse event: Rash
Serious: no
Organ System: General disorders
Frequency: 1 affected / 39 at risk