Study: NCT00792909

Adverse event: Gastritis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 51 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 51 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 51 at risk

Adverse event: Irritability
Serious: no
Organ System: Psychiatric disorders
Frequency: 20 affected / 51 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 51 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 41 affected / 51 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 7 affected / 51 at risk

Adverse event: Swelling
Serious: no
Organ System: General disorders
Frequency: 28 affected / 51 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 51 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 51 at risk

Adverse event: Erythema
Serious: no
Organ System: General disorders
Frequency: 34 affected / 51 at risk

Adverse event: Somnolence
Serious: no
Organ System: General disorders
Frequency: 20 affected / 51 at risk

Adverse event: Fever (Rectally, ≥ 38.0°C)
Serious: no
Organ System: General disorders
Frequency: 9 affected / 51 at risk

Adverse event: Loss of appetite
Serious: no
Organ System: General disorders
Frequency: 12 affected / 51 at risk

Adverse event: Pyelonephritis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 59 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 59 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 59 at risk

Adverse event: Irritability
Serious: no
Organ System: Psychiatric disorders
Frequency: 27 affected / 59 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 59 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 44 affected / 59 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 8 affected / 59 at risk

Adverse event: Swelling
Serious: no
Organ System: General disorders
Frequency: 27 affected / 59 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 59 at risk

Adverse event: Viral infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 59 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 59 at risk

Adverse event: Erythema
Serious: no
Organ System: General disorders
Frequency: 35 affected / 59 at risk

Adverse event: Somnolence
Serious: no
Organ System: General disorders
Frequency: 23 affected / 59 at risk

Adverse event: Fever (Rectally, ≥ 38.0°C)
Serious: no
Organ System: General disorders
Frequency: 5 affected / 59 at risk

Adverse event: Loss of appetite
Serious: no
Organ System: General disorders
Frequency: 13 affected / 59 at risk

Adverse event: Bronchitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 62 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 62 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 62 at risk

Adverse event: Irritability
Serious: no
Organ System: Psychiatric disorders
Frequency: 21 affected / 62 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 12 affected / 62 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 49 affected / 62 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 7 affected / 62 at risk

Adverse event: Swelling
Serious: no
Organ System: General disorders
Frequency: 30 affected / 62 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 62 at risk

Adverse event: Viral infection
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 62 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 62 at risk

Adverse event: Erythema
Serious: no
Organ System: General disorders
Frequency: 41 affected / 62 at risk

Adverse event: Somnolence
Serious: no
Organ System: General disorders
Frequency: 17 affected / 62 at risk

Adverse event: Fever (Rectally, ≥ 38.0°C)
Serious: no
Organ System: General disorders
Frequency: 8 affected / 62 at risk

Adverse event: Loss of appetite
Serious: no
Organ System: General disorders
Frequency: 14 affected / 62 at risk