Study: NCT00980005

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 1055 at risk

Adverse event: Herpangina
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1055 at risk

Adverse event: Oral candidiasis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1055 at risk

Adverse event: Abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1055 at risk

Adverse event: Affective disorder
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 1055 at risk

Adverse event: Appendicitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1055 at risk

Adverse event: Attention deficit hyperactivity disorder
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 1055 at risk

Adverse event: Cellulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1055 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 1055 at risk

Adverse event: Forearm fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1055 at risk

Adverse event: H1N1 influenza
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1055 at risk

Adverse event: Oppositional defiant disorder
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 1055 at risk

Adverse event: Respiratory distress
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 1055 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1055 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Unsolicited AE
Frequency: 129 affected / 1055 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Notes: Unsolicited AE
Frequency: 62 affected / 1055 at risk

Adverse event: Arthralgia
Serious: no
Organ System: General disorders
Notes: Solicited general AE: Subjects of 5 years of age and above
Frequency: 70 affected / 750 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: Solicited general AE: Subjects of 5 years of age and above
Frequency: 138 affected / 750 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Notes: Solicited general AE: Subjects of 5 years of age and above
Frequency: 141 affected / 750 at risk

Adverse event: Muscle aches
Serious: no
Organ System: General disorders
Notes: Solicited general AE: Subjects of 5 years of age and above
Frequency: 200 affected / 750 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Notes: Solicited general AE: Subjects of 5 years of age and above
Frequency: 45 affected / 750 at risk

Adverse event: Somnolence
Serious: no
Organ System: General disorders
Notes: Solicited general AE: Subjects below 5 years of age
Frequency: 61 affected / 293 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Notes: Solicited general AE: Subjects below 5 years of age
Frequency: 86 affected / 293 at risk

Adverse event: Loss of appetite
Serious: no
Organ System: General disorders
Notes: Solicited general AE: Subjects below 5 years of age
Frequency: 52 affected / 293 at risk

Adverse event: Temperature
Serious: no
Organ System: General disorders
Notes: Solicited general AE: Subjects below 5 years of age. Temperature = axillary temperature equal to or above 38.0 degrees Celsius (°C).
Frequency: 15 affected / 293 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Notes: Solicited local AE
Frequency: 615 affected / 1043 at risk

Adverse event: Erythema
Serious: no
Organ System: General disorders
Notes: Solicited local AE
Frequency: 57 affected / 1043 at risk

Adverse event: Swelling
Serious: no
Organ System: General disorders
Notes: Solicited local AE
Frequency: 51 affected / 1043 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1061 at risk

Adverse event: Herpangina
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1061 at risk

Adverse event: Oral candidiasis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1061 at risk

Adverse event: Asthma
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 1061 at risk

Adverse event: Bronchiolitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1061 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1061 at risk

Adverse event: Hypoxia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 1061 at risk

Adverse event: Sinus polyp
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 1061 at risk

Adverse event: Type 1 diabetes mellitus
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 1061 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Unsolicited AE
Frequency: 115 affected / 1061 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Notes: Unsolicited AE
Frequency: 60 affected / 1061 at risk

Adverse event: Arthralgia
Serious: no
Organ System: General disorders
Notes: Solicited general AE: Subjects of 5 years of age and above
Frequency: 80 affected / 747 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: Solicited general AE: Subjects of 5 years of age and above
Frequency: 137 affected / 747 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Notes: Solicited general AE: Subjects of 5 years of age and above
Frequency: 131 affected / 747 at risk

Adverse event: Muscle aches
Serious: no
Organ System: General disorders
Notes: Solicited general AE: Subjects of 5 years of age and above
Frequency: 189 affected / 747 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Notes: Solicited general AE: Subjects of 5 years of age and above
Frequency: 40 affected / 747 at risk

Adverse event: Somnolence
Serious: no
Organ System: General disorders
Notes: Solicited general AE: Subjects below 5 years of age
Frequency: 63 affected / 279 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Notes: Solicited general AE: Subjects below 5 years of age
Frequency: 87 affected / 279 at risk

Adverse event: Loss of appetite
Serious: no
Organ System: General disorders
Notes: Solicited general AE: Subjects below 5 years of age
Frequency: 47 affected / 279 at risk

Adverse event: Temperature
Serious: no
Organ System: General disorders
Notes: Solicited general AE: Subjects below 5 years of age. Temperature = axillary temperature equal to or above 38.0 degrees Celsius (°C).
Frequency: 10 affected / 279 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Notes: Solicited local AE
Frequency: 584 affected / 1026 at risk

Adverse event: Erythema
Serious: no
Organ System: General disorders
Notes: Solicited local AE
Frequency: 53 affected / 1026 at risk

Adverse event: Swelling
Serious: no
Organ System: General disorders
Notes: Solicited local AE
Frequency: 59 affected / 1026 at risk