Study: NCT01148459

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 23 affected / 99 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Frequency: 21 affected / 99 at risk

Adverse event: Febrile convulsion
Serious: yes
Organ System: Nervous system disorders
Frequency: 10 affected / 99 at risk

Adverse event: Malaria
Serious: yes
Organ System: Infections and infestations
Frequency: 5 affected / 99 at risk

Adverse event: Salmonella sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 7 affected / 99 at risk

Adverse event: Malnutrition
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 7 affected / 99 at risk

Adverse event: Oral candidiasis
Serious: yes
Organ System: Infections and infestations
Frequency: 5 affected / 99 at risk

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 99 at risk

Adverse event: Otitis media
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 99 at risk

Adverse event: Pulmonary tuberculosis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 99 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 99 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 99 at risk

Adverse event: Helminthic infection
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 99 at risk

Adverse event: Pneumonia aspiration
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 99 at risk

Adverse event: Tuberculosis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 99 at risk

Adverse event: Abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 99 at risk

Adverse event: Hepatitis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 99 at risk

Adverse event: Kwashiorkor
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 99 at risk

Adverse event: Pneumocystis jirovecii pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 99 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 99 at risk

Adverse event: Varicella
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 99 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 16 affected / 99 at risk

Adverse event: Body tinea
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 99 at risk

Adverse event: Bronchial hyperreactivity
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 8 affected / 99 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Eye disorders
Frequency: 13 affected / 99 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 6 affected / 99 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 33 affected / 99 at risk

Adverse event: Dermatitis diaper
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 99 at risk

Adverse event: Eczema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 19 affected / 99 at risk

Adverse event: Enteritis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 26 affected / 99 at risk

Adverse event: Erythema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 14 affected / 99 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Frequency: 38 affected / 99 at risk

Adverse event: Impetigo
Serious: no
Organ System: Infections and infestations
Frequency: 9 affected / 99 at risk

Adverse event: Irritability
Serious: no
Organ System: Psychiatric disorders
Frequency: 46 affected / 99 at risk

Adverse event: Malaria
Serious: no
Organ System: Infections and infestations
Frequency: 22 affected / 99 at risk

Adverse event: Malnutrition
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 99 at risk

Adverse event: Oral candidiasis
Serious: no
Organ System: Infections and infestations
Frequency: 11 affected / 99 at risk

Adverse event: Otitis media
Serious: no
Organ System: Infections and infestations
Frequency: 14 affected / 99 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 33 affected / 99 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Infections and infestations
Frequency: 25 affected / 99 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 76 affected / 99 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 5 affected / 99 at risk

Adverse event: Rash papular
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 7 affected / 99 at risk

Adverse event: Rash pruritic
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 5 affected / 99 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Infections and infestations
Frequency: 25 affected / 99 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 22 affected / 99 at risk

Adverse event: Swelling
Serious: no
Organ System: General disorders
Frequency: 26 affected / 99 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 74 affected / 99 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 99 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 23 affected / 101 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Frequency: 19 affected / 101 at risk

Adverse event: Febrile convulsion
Serious: yes
Organ System: Nervous system disorders
Frequency: 13 affected / 101 at risk

Adverse event: Malaria
Serious: yes
Organ System: Infections and infestations
Frequency: 10 affected / 101 at risk

Adverse event: Salmonella sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 6 affected / 101 at risk

Adverse event: Malnutrition
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 101 at risk

Adverse event: Oral candidiasis
Serious: yes
Organ System: Infections and infestations
Frequency: 5 affected / 101 at risk

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 7 affected / 101 at risk

Adverse event: Otitis media
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 101 at risk

Adverse event: Pulmonary tuberculosis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 101 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 101 at risk

Adverse event: Measles
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 101 at risk

Adverse event: Pneumococcal sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 101 at risk

Adverse event: Bronchiolitis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 101 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 101 at risk

Adverse event: Pneumonia aspiration
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 101 at risk

Adverse event: Amoebiasis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 101 at risk

Adverse event: Cellulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 101 at risk

Adverse event: Enteritis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 101 at risk

Adverse event: Gastroenteritis salmonella
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 101 at risk

Adverse event: Hypokalaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 101 at risk

Adverse event: Meningitis haemophilus
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 101 at risk

Adverse event: Mycobacterium avium complex infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 101 at risk

Adverse event: Oropharyngeal candidiasis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 101 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 101 at risk

Adverse event: Upper respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 101 at risk

Adverse event: Viral infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 101 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 17 affected / 101 at risk

Adverse event: Body tinea
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 101 at risk

Adverse event: Bronchial hyperreactivity
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 14 affected / 101 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Eye disorders
Frequency: 12 affected / 101 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 101 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 23 affected / 101 at risk

Adverse event: Dermatitis diaper
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 5 affected / 101 at risk

Adverse event: Eczema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 22 affected / 101 at risk

Adverse event: Enteritis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 27 affected / 101 at risk

Adverse event: Erythema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 9 affected / 101 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Frequency: 41 affected / 101 at risk

Adverse event: Impetigo
Serious: no
Organ System: Infections and infestations
Frequency: 7 affected / 101 at risk

Adverse event: Irritability
Serious: no
Organ System: Psychiatric disorders
Frequency: 25 affected / 101 at risk

Adverse event: Malaria
Serious: no
Organ System: Infections and infestations
Frequency: 20 affected / 101 at risk

Adverse event: Malnutrition
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 6 affected / 101 at risk

Adverse event: Oral candidiasis
Serious: no
Organ System: Infections and infestations
Frequency: 19 affected / 101 at risk

Adverse event: Otitis media
Serious: no
Organ System: Infections and infestations
Frequency: 15 affected / 101 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 18 affected / 101 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Infections and infestations
Frequency: 21 affected / 101 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 50 affected / 101 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 9 affected / 101 at risk

Adverse event: Rash papular
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 10 affected / 101 at risk

Adverse event: Rash pruritic
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 9 affected / 101 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Infections and infestations
Frequency: 18 affected / 101 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 15 affected / 101 at risk

Adverse event: Swelling
Serious: no
Organ System: General disorders
Frequency: 13 affected / 101 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 79 affected / 101 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 101 at risk