Study: NCT01444781

Adverse event: Adverse drug reaction
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 416 at risk

Adverse event: Cellulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 416 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 416 at risk

Adverse event: Kawasaki's disease
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 416 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 5 affected / 416 at risk

Adverse event: Febrile convulsion
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 416 at risk

Adverse event: Asthma
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 416 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 27 affected / 416 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 232 affected / 416 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 112 affected / 413 at risk

Adverse event: Injection site swelling
Serious: no
Organ System: General disorders
Frequency: 60 affected / 412 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 114 affected / 413 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 34 affected / 413 at risk

Adverse event: Crying
Serious: no
Organ System: Psychiatric disorders
Frequency: 148 affected / 413 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 124 affected / 413 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 118 affected / 413 at risk

Adverse event: Irritability
Serious: no
Organ System: Psychiatric disorders
Frequency: 201 affected / 413 at risk

Adverse event: Immune thrombocytopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 415 at risk

Adverse event: Acute sinusitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 415 at risk

Adverse event: Osteomyelitis acute
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 415 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 415 at risk

Adverse event: Pyelonephritis acute
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 415 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 415 at risk

Adverse event: Viral infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 415 at risk

Adverse event: Arthropathy
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 415 at risk

Adverse event: Febrile convulsion
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 415 at risk

Adverse event: Haematuria
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 415 at risk

Adverse event: Asthma
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 415 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 23 affected / 415 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 205 affected / 412 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 100 affected / 412 at risk

Adverse event: Injection site swelling
Serious: no
Organ System: General disorders
Frequency: 56 affected / 412 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 99 affected / 412 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 39 affected / 412 at risk

Adverse event: Crying
Serious: no
Organ System: Psychiatric disorders
Frequency: 139 affected / 412 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 113 affected / 412 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 121 affected / 412 at risk

Adverse event: Irritability
Serious: no
Organ System: Psychiatric disorders
Frequency: 176 affected / 412 at risk

Adverse event: Cellulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 275 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 275 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 5 affected / 275 at risk

Adverse event: Subcutaneous abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 275 at risk

Adverse event: Febrile convulsion
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 275 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 12 affected / 275 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 160 affected / 272 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 86 affected / 272 at risk

Adverse event: Injection site swelling
Serious: no
Organ System: General disorders
Frequency: 49 affected / 272 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 91 affected / 272 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 19 affected / 272 at risk

Adverse event: Crying
Serious: no
Organ System: Psychiatric disorders
Frequency: 102 affected / 272 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 85 affected / 272 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 90 affected / 272 at risk

Adverse event: Irritability
Serious: no
Organ System: Psychiatric disorders
Frequency: 146 affected / 272 at risk