Study: NCT01218308

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Frequency: 6 affected / 2584 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 2584 at risk

Adverse event: Animal bite
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 2584 at risk

Adverse event: Dengue fever
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 2584 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 2584 at risk

Adverse event: Upper respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 2584 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 2584 at risk

Adverse event: Amoebiasis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 2584 at risk

Adverse event: Bronchitis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 2584 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 2584 at risk

Adverse event: Drowning
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 2584 at risk

Adverse event: Influenza like illness
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 2584 at risk

Adverse event: Animal scratch
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 2584 at risk

Adverse event: Appendicitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 2584 at risk

Adverse event: Asthma
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 2584 at risk

Adverse event: Bronchial obstruction
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 2584 at risk

Adverse event: Bronchiolitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 2584 at risk

Adverse event: Bronchospasm
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 2584 at risk

Adverse event: Croup infectious
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 2584 at risk

Adverse event: Diarrhoea infectious
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 2584 at risk

Adverse event: Gastritis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 2584 at risk

Adverse event: Gastroenteritis viral
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 2584 at risk

Adverse event: Head injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 2584 at risk

Adverse event: Herpes zoster
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 2584 at risk

Adverse event: Joint injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 2584 at risk

Adverse event: Pneumonitis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 2584 at risk

Adverse event: Respiratory distress
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 2584 at risk

Adverse event: Urinary retention
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 2584 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 213 affected / 2584 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 145 affected / 2584 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 1215 affected / 2546 at risk

Adverse event: Somnolence
Serious: no
Organ System: General disorders
Notes: Symptom reported for subjects below 5 years of age.
Frequency: 100 affected / 899 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Notes: Symptom reported for subjects below 5 years of age.
Frequency: 102 affected / 899 at risk

Adverse event: Loss of appetite
Serious: no
Organ System: General disorders
Notes: Symptom reported for subjects below 5 years of age.
Frequency: 119 affected / 899 at risk

Adverse event: Temperature
Serious: no
Organ System: General disorders
Notes: Symptom reported for subjects below 5 years of age.
Frequency: 74 affected / 899 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: Symptom reported for subjects of 5 years of age and above
Frequency: 188 affected / 1648 at risk

Adverse event: Gastro.
Serious: no
Organ System: General disorders
Notes: Symptom reported for subjects of 5 years of age and above
Frequency: 133 affected / 1648 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Notes: Symptom reported for subjects of 5 years of age and above
Frequency: 243 affected / 1648 at risk

Adverse event: Arthralgia
Serious: no
Organ System: General disorders
Notes: Symptom reported for subjects of 5 years of age and above
Frequency: 143 affected / 1648 at risk

Adverse event: Muscle aches
Serious: no
Organ System: General disorders
Notes: Symptom reported for subjects of 5 years of age and above
Frequency: 257 affected / 1648 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 2584 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 2584 at risk

Adverse event: Animal bite
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 2584 at risk

Adverse event: Dengue fever
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 2584 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 2584 at risk

Adverse event: Upper respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 2584 at risk

Adverse event: Amoebiasis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 2584 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 2584 at risk

Adverse event: Drowning
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 2584 at risk

Adverse event: Influenza like illness
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 2584 at risk

Adverse event: Tonsillitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 2584 at risk

Adverse event: Amoebic dysentery
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 2584 at risk

Adverse event: Bronchial hyperreactivity
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 2584 at risk

Adverse event: Cellulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 2584 at risk

Adverse event: Endocarditis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 2584 at risk

Adverse event: Herpangina
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 2584 at risk

Adverse event: Nasopharyngitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 2584 at risk

Adverse event: Optic glioma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 2584 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 2584 at risk

Adverse event: Respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 2584 at risk

Adverse event: Tonsillitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 2584 at risk

Adverse event: Visceral leishmaniasis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 2584 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 231 affected / 2584 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 137 affected / 2584 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 888 affected / 2551 at risk

Adverse event: Somnolence
Serious: no
Organ System: General disorders
Notes: Symptom reported for subjects below 5 years of age.
Frequency: 93 affected / 896 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Notes: Symptom reported for subjects below 5 years of age.
Frequency: 91 affected / 896 at risk

Adverse event: Loss of appetite
Serious: no
Organ System: General disorders
Notes: Symptom reported for subjects below 5 years of age.
Frequency: 120 affected / 896 at risk

Adverse event: Temperature
Serious: no
Organ System: General disorders
Notes: Symptom reported for subjects below 5 years of age.
Frequency: 74 affected / 896 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: Symptom reported for subjects of 5 years of age and above
Frequency: 145 affected / 1654 at risk

Adverse event: Gastro.
Serious: no
Organ System: General disorders
Notes: Symptom reported for subjects of 5 years of age and above
Frequency: 146 affected / 1654 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Notes: Symptom reported for subjects of 5 years of age and above
Frequency: 217 affected / 1654 at risk

Adverse event: Arthralgia
Serious: no
Organ System: General disorders
Notes: Symptom reported for subjects of 5 years of age and above
Frequency: 93 affected / 1654 at risk

Adverse event: Muscle aches
Serious: no
Organ System: General disorders
Notes: Symptom reported for subjects of 5 years of age and above
Frequency: 194 affected / 1654 at risk