Study: NCT00674583

Adverse event: Abdominal injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 311 at risk

Adverse event: Accidental poisoning
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 311 at risk

Adverse event: Head injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 311 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 311 at risk

Adverse event: Gastrooesophageal reflux disease
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 311 at risk

Adverse event: Appendicitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 311 at risk

Adverse event: Nasopharyngitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 311 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 110 affected / 310 at risk

Adverse event: Erythema
Serious: no
Organ System: General disorders
Frequency: 115 affected / 310 at risk

Adverse event: Swelling
Serious: no
Organ System: General disorders
Frequency: 87 affected / 310 at risk

Adverse event: Drowsiness (< 6 years)
Serious: no
Organ System: General disorders
Notes: This solicited general symptom was assessed for subjects between 2 to 5 years of age, from the two groups.
Frequency: 23 affected / 162 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 19 affected / 310 at risk

Adverse event: Irritability (< 6 years)
Serious: no
Organ System: General disorders
Notes: This solicited general symptom was assessed only for subjects between 2 to 5 years of age, from the two groups.
Frequency: 25 affected / 162 at risk

Adverse event: Loss of appetite (< 6 years)
Serious: no
Organ System: General disorders
Notes: This solicited general symptom was assessed only for subjects between 2 to 5 years of age, from the two groups.
Frequency: 17 affected / 162 at risk

Adverse event: Fatigue (≥ 6 years)
Serious: no
Organ System: General disorders
Notes: This solicited general symptom was assessed only for subjects between 6 to 10 years of age, from the two groups.
Frequency: 33 affected / 148 at risk

Adverse event: Gastrointestinal (≥ 6 years)
Serious: no
Organ System: General disorders
Notes: This solicited general symptom was assessed only for subjects between 6 to 10 years of age, from the two groups.
Frequency: 22 affected / 148 at risk

Adverse event: Headache (≥ 6 years)
Serious: no
Organ System: General disorders
Notes: This solicited general symptom was assessed only for subjects between 6 to 10 years of age, from the two groups.
Frequency: 30 affected / 148 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 103 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 42 affected / 103 at risk

Adverse event: Erythema
Serious: no
Organ System: General disorders
Frequency: 40 affected / 103 at risk

Adverse event: Swelling
Serious: no
Organ System: General disorders
Frequency: 28 affected / 103 at risk

Adverse event: Drowsiness (< 6 years)
Serious: no
Organ System: General disorders
Notes: This solicited general symptom was assessed for subjects between 2 to 5 years of age, from the two groups.
Frequency: 6 affected / 53 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 4 affected / 103 at risk

Adverse event: Irritability (< 6 years)
Serious: no
Organ System: General disorders
Notes: This solicited general symptom was assessed only for subjects between 2 to 5 years of age, from the two groups.
Frequency: 6 affected / 53 at risk

Adverse event: Loss of appetite (< 6 years)
Serious: no
Organ System: General disorders
Notes: This solicited general symptom was assessed only for subjects between 2 to 5 years of age, from the two groups.
Frequency: 5 affected / 53 at risk

Adverse event: Fatigue (≥ 6 years)
Serious: no
Organ System: General disorders
Notes: This solicited general symptom was assessed only for subjects between 6 to 10 years of age, from the two groups.
Frequency: 11 affected / 50 at risk

Adverse event: Gastrointestinal (≥ 6 years)
Serious: no
Organ System: General disorders
Notes: This solicited general symptom was assessed only for subjects between 6 to 10 years of age, from the two groups.
Frequency: 4 affected / 50 at risk

Adverse event: Headache (≥ 6 years)
Serious: no
Organ System: General disorders
Notes: This solicited general symptom was assessed only for subjects between 6 to 10 years of age, from the two groups.
Frequency: 4 affected / 50 at risk