Study: NCT01702454

Adverse event: Thermal burn
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 241 at risk

Adverse event: Bronchitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 241 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 241 at risk

Adverse event: Laryngitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 241 at risk

Adverse event: Otitis media
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 241 at risk

Adverse event: Otitis media acute
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 241 at risk

Adverse event: Rhinitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 241 at risk

Adverse event: Sinusitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 241 at risk

Adverse event: Arthralgia
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 241 at risk

Adverse event: Upper respiratory tract inflammation
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 241 at risk

Adverse event: Urticaria
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 241 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 96 affected / 239 at risk

Adverse event: Erythema
Serious: no
Organ System: General disorders
Frequency: 82 affected / 239 at risk

Adverse event: Swelling
Serious: no
Organ System: General disorders
Frequency: 49 affected / 239 at risk

Adverse event: Somnolence
Serious: no
Organ System: General disorders
Frequency: 54 affected / 238 at risk

Adverse event: Irritability/Fussiness
Serious: no
Organ System: General disorders
Frequency: 77 affected / 238 at risk

Adverse event: Loss of Appetite
Serious: no
Organ System: General disorders
Frequency: 51 affected / 238 at risk

Adverse event: Temperature
Serious: no
Organ System: General disorders
Frequency: 13 affected / 238 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 9 affected / 241 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 229 at risk

Adverse event: Inguinal hernia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 229 at risk

Adverse event: Bronchiolitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 229 at risk

Adverse event: Lymphadenitis bacterial
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 229 at risk

Adverse event: Pharyngitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 229 at risk

Adverse event: Pneumonia bacterial
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 229 at risk

Adverse event: Adenoidal hypertrophy
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 229 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 61 affected / 228 at risk

Adverse event: Erythema
Serious: no
Organ System: General disorders
Frequency: 48 affected / 228 at risk

Adverse event: Swelling
Serious: no
Organ System: General disorders
Frequency: 25 affected / 228 at risk

Adverse event: Somnolence
Serious: no
Organ System: General disorders
Frequency: 44 affected / 224 at risk

Adverse event: Irritability/Fussiness
Serious: no
Organ System: General disorders
Frequency: 59 affected / 224 at risk

Adverse event: Loss of Appetite
Serious: no
Organ System: General disorders
Frequency: 46 affected / 224 at risk

Adverse event: Temperature
Serious: no
Organ System: General disorders
Frequency: 26 affected / 224 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 13 affected / 229 at risk