Study: NCT01964716

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 250 at risk

Adverse event: Dermatitis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 250 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 250 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 27 affected / 250 at risk

Adverse event: Viral diarrhoea
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 250 at risk

Adverse event: Tinea capitis
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 250 at risk

Adverse event: Viral infection
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 250 at risk

Adverse event: Otitis media
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 250 at risk

Adverse event: Breast abscess
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 250 at risk

Adverse event: Injection site abscess
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 250 at risk

Adverse event: Oral candidiasis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 250 at risk

Adverse event: Otitis media acute
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 250 at risk

Adverse event: Respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 250 at risk

Adverse event: Dermatitis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 8 affected / 250 at risk

Adverse event: Dermatitis diaper
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 250 at risk

Adverse event: Eczema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 250 at risk

Adverse event: Umbilical granuloma
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 2 affected / 250 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 250 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 250 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 250 at risk

Adverse event: Redness: Any
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 248 at risk

Adverse event: Redness: Mild
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 248 at risk

Adverse event: Swelling: Any
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 248 at risk

Adverse event: Swelling: Mild
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 248 at risk

Adverse event: Tenderness: Any
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 42 affected / 248 at risk

Adverse event: Tenderness: Mild
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 32 affected / 248 at risk

Adverse event: Tenderness: Moderate
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 13 affected / 248 at risk

Adverse event: Fever: >=38.0 degree C
Serious: no
Organ System: General disorders
Frequency: 9 affected / 248 at risk

Adverse event: Fever: >=38.0 but <=39.0 degrees C
Serious: no
Organ System: General disorders
Frequency: 9 affected / 248 at risk

Adverse event: Decreased appetite: Any
Serious: no
Organ System: General disorders
Frequency: 17 affected / 248 at risk

Adverse event: Decreased appetite: Moderate
Serious: no
Organ System: General disorders
Frequency: 17 affected / 248 at risk

Adverse event: Irritability: Any
Serious: no
Organ System: General disorders
Frequency: 103 affected / 249 at risk

Adverse event: Irritability: Mild
Serious: no
Organ System: General disorders
Frequency: 86 affected / 249 at risk

Adverse event: Irritability: Moderate
Serious: no
Organ System: General disorders
Frequency: 19 affected / 248 at risk

Adverse event: Increased sleep: Any
Serious: no
Organ System: General disorders
Frequency: 16 affected / 248 at risk

Adverse event: Increased sleep: Mild
Serious: no
Organ System: General disorders
Frequency: 11 affected / 248 at risk

Adverse event: Increased sleep: Moderate
Serious: no
Organ System: General disorders
Frequency: 6 affected / 248 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 250 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 17 affected / 250 at risk

Adverse event: Viral diarrhoea
Serious: no
Organ System: Infections and infestations
Frequency: 10 affected / 250 at risk

Adverse event: Tinea capitis
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 250 at risk

Adverse event: Viral infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 250 at risk

Adverse event: Otitis media
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 250 at risk

Adverse event: Dysentery
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 250 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 250 at risk

Adverse event: Tinea infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 250 at risk

Adverse event: Tinea versicolour
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 250 at risk

Adverse event: Dermatitis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 12 affected / 250 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 250 at risk

Adverse event: Contusion
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 250 at risk

Adverse event: Fall
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 250 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 250 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 2 affected / 250 at risk

Adverse event: Vaccination site swelling
Serious: no
Organ System: General disorders
Frequency: 1 affected / 250 at risk

Adverse event: Tenderness: Any
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 47 affected / 250 at risk

Adverse event: Tenderness: Mild
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 37 affected / 250 at risk

Adverse event: Tenderness: Moderate
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 14 affected / 250 at risk

Adverse event: Fever: >=38.0 degree C
Serious: no
Organ System: General disorders
Frequency: 7 affected / 250 at risk

Adverse event: Fever: >=38.0 but <=39.0 degrees C
Serious: no
Organ System: General disorders
Frequency: 7 affected / 250 at risk

Adverse event: Decreased appetite: Any
Serious: no
Organ System: General disorders
Frequency: 26 affected / 250 at risk

Adverse event: Decreased appetite: Moderate
Serious: no
Organ System: General disorders
Frequency: 26 affected / 250 at risk

Adverse event: Irritability: Any
Serious: no
Organ System: General disorders
Frequency: 93 affected / 250 at risk

Adverse event: Irritability: Mild
Serious: no
Organ System: General disorders
Frequency: 77 affected / 250 at risk

Adverse event: Irritability: Moderate
Serious: no
Organ System: General disorders
Frequency: 17 affected / 250 at risk

Adverse event: Increased sleep: Any
Serious: no
Organ System: General disorders
Frequency: 14 affected / 250 at risk

Adverse event: Increased sleep: Mild
Serious: no
Organ System: General disorders
Frequency: 10 affected / 250 at risk

Adverse event: Increased sleep: Moderate
Serious: no
Organ System: General disorders
Frequency: 4 affected / 250 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 249 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 17 affected / 249 at risk

Adverse event: Viral diarrhoea
Serious: no
Organ System: Infections and infestations
Frequency: 8 affected / 249 at risk

Adverse event: Tinea capitis
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 249 at risk

Adverse event: Viral infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 249 at risk

Adverse event: Otitis media
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 249 at risk

Adverse event: Breast abscess
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 249 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 249 at risk

Adverse event: Injection site abscess
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 249 at risk

Adverse event: Otitis media acute
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 249 at risk

Adverse event: Respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 249 at risk

Adverse event: Rash pustular
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 249 at risk

Adverse event: Tinea faciei
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 249 at risk

Adverse event: Dermatitis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 5 affected / 249 at risk

Adverse event: Eczema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 249 at risk

Adverse event: Bronchial hyperreactivity
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 249 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 249 at risk

Adverse event: Redness: Any
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 247 at risk

Adverse event: Redness: Mild
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 247 at risk

Adverse event: Swelling: Any
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 247 at risk

Adverse event: Swelling: Mild
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 247 at risk

Adverse event: Swelling: Moderate
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 247 at risk

Adverse event: Tenderness: Any
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 34 affected / 248 at risk

Adverse event: Tenderness: Mild
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 27 affected / 248 at risk

Adverse event: Tenderness: Moderate
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 7 affected / 247 at risk

Adverse event: Fever: >=38.0 degree C
Serious: no
Organ System: General disorders
Frequency: 7 affected / 247 at risk

Adverse event: Fever: >=38.0 but <=39.0 degrees C
Serious: no
Organ System: General disorders
Frequency: 7 affected / 247 at risk

Adverse event: Fever: >39.0 but <=40.0 degrees C
Serious: no
Organ System: General disorders
Frequency: 1 affected / 247 at risk

Adverse event: Decreased appetite: Any
Serious: no
Organ System: General disorders
Frequency: 28 affected / 247 at risk

Adverse event: Decreased appetite: Moderate
Serious: no
Organ System: General disorders
Frequency: 28 affected / 247 at risk

Adverse event: Irritability: Any
Serious: no
Organ System: General disorders
Frequency: 93 affected / 248 at risk

Adverse event: Irritability: Mild
Serious: no
Organ System: General disorders
Frequency: 75 affected / 248 at risk

Adverse event: Irritability: Moderate
Serious: no
Organ System: General disorders
Frequency: 23 affected / 247 at risk

Adverse event: Increased sleep: Any
Serious: no
Organ System: General disorders
Frequency: 24 affected / 247 at risk

Adverse event: Increased sleep: Mild
Serious: no
Organ System: General disorders
Frequency: 20 affected / 247 at risk

Adverse event: Increased sleep: Moderate
Serious: no
Organ System: General disorders
Frequency: 4 affected / 247 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 248 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 248 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 10 affected / 248 at risk

Adverse event: Viral diarrhoea
Serious: no
Organ System: Infections and infestations
Frequency: 10 affected / 248 at risk

Adverse event: Tinea capitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 248 at risk

Adverse event: Viral infection
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 248 at risk

Adverse event: Otitis media
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 248 at risk

Adverse event: Respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 248 at risk

Adverse event: Dermatitis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 7 affected / 248 at risk

Adverse event: Eczema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 248 at risk

Adverse event: Dermatitis atopic
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 248 at risk

Adverse event: Rash papular
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 248 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 248 at risk

Adverse event: Ulcer
Serious: no
Organ System: General disorders
Frequency: 1 affected / 248 at risk

Adverse event: Tenderness: Any
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 32 affected / 247 at risk

Adverse event: Tenderness: Mild
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 28 affected / 247 at risk

Adverse event: Tenderness: Moderate
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 5 affected / 247 at risk

Adverse event: Fever: >=38.0 degree C
Serious: no
Organ System: General disorders
Frequency: 7 affected / 247 at risk

Adverse event: Fever: >=38.0 but <=39.0 degrees C
Serious: no
Organ System: General disorders
Frequency: 7 affected / 247 at risk

Adverse event: Decreased appetite: Any
Serious: no
Organ System: General disorders
Frequency: 18 affected / 247 at risk

Adverse event: Decreased appetite: Moderate
Serious: no
Organ System: General disorders
Frequency: 18 affected / 247 at risk

Adverse event: Irritability: Any
Serious: no
Organ System: General disorders
Frequency: 83 affected / 247 at risk

Adverse event: Irritability: Mild
Serious: no
Organ System: General disorders
Frequency: 67 affected / 247 at risk

Adverse event: Irritability: Moderate
Serious: no
Organ System: General disorders
Frequency: 17 affected / 247 at risk

Adverse event: Irritability: Severe
Serious: no
Organ System: General disorders
Frequency: 3 affected / 247 at risk

Adverse event: Increased sleep: Any
Serious: no
Organ System: General disorders
Frequency: 14 affected / 247 at risk

Adverse event: Increased sleep: Mild
Serious: no
Organ System: General disorders
Frequency: 12 affected / 247 at risk

Adverse event: Increased sleep: Moderate
Serious: no
Organ System: General disorders
Frequency: 1 affected / 247 at risk

Adverse event: Increased sleep: Severe
Serious: no
Organ System: General disorders
Frequency: 1 affected / 247 at risk

Adverse event: Sudden infant death syndrome
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 247 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 247 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 247 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 19 affected / 247 at risk

Adverse event: Viral diarrhoea
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 247 at risk

Adverse event: Tinea capitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 247 at risk

Adverse event: Otitis media
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 247 at risk

Adverse event: Oral candidiasis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 247 at risk

Adverse event: Respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 247 at risk

Adverse event: Tinea infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 247 at risk

Adverse event: Furuncle
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 247 at risk

Adverse event: Impetigo
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 247 at risk

Adverse event: Gastroenteritis viral
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 247 at risk

Adverse event: Atypical pneumonia
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 247 at risk

Adverse event: Chest wall abscess
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 247 at risk

Adverse event: Varicella
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 247 at risk

Adverse event: Musculoskeletal pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 247 at risk

Adverse event: Dermatitis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 247 at risk

Adverse event: Dermatitis diaper
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 247 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 247 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 247 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 247 at risk

Adverse event: Tenderness: Any
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 37 affected / 246 at risk

Adverse event: Tenderness: Mild
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 30 affected / 246 at risk

Adverse event: Tenderness: Moderate
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 9 affected / 246 at risk

Adverse event: Fever: >=38.0 degree C
Serious: no
Organ System: General disorders
Frequency: 3 affected / 246 at risk

Adverse event: Fever: >=38.0 but <=39.0 degrees C
Serious: no
Organ System: General disorders
Frequency: 3 affected / 246 at risk

Adverse event: Decreased appetite: Any
Serious: no
Organ System: General disorders
Frequency: 24 affected / 246 at risk

Adverse event: Decreased appetite: Moderate
Serious: no
Organ System: General disorders
Frequency: 24 affected / 246 at risk

Adverse event: Irritability: Any
Serious: no
Organ System: General disorders
Frequency: 83 affected / 246 at risk

Adverse event: Irritability: Mild
Serious: no
Organ System: General disorders
Frequency: 71 affected / 246 at risk

Adverse event: Irritability: Moderate
Serious: no
Organ System: General disorders
Frequency: 15 affected / 246 at risk

Adverse event: Irritability: Severe
Serious: no
Organ System: General disorders
Frequency: 1 affected / 246 at risk

Adverse event: Increased sleep: Any
Serious: no
Organ System: General disorders
Frequency: 12 affected / 246 at risk

Adverse event: Increased sleep: Mild
Serious: no
Organ System: General disorders
Frequency: 10 affected / 246 at risk

Adverse event: Increased sleep: Moderate
Serious: no
Organ System: General disorders
Frequency: 2 affected / 246 at risk

Adverse event: Increased sleep: Severe
Serious: no
Organ System: General disorders
Frequency: 1 affected / 246 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 244 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 244 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 25 affected / 244 at risk

Adverse event: Viral diarrhoea
Serious: no
Organ System: Infections and infestations
Frequency: 10 affected / 244 at risk

Adverse event: Tinea capitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 244 at risk

Adverse event: Viral infection
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 244 at risk

Adverse event: Otitis media
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 244 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 244 at risk

Adverse event: Respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 244 at risk

Adverse event: Impetigo
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 244 at risk

Adverse event: Gastroenteritis viral
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 244 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 244 at risk

Adverse event: Failure to thrive
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 244 at risk

Adverse event: Dermatitis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 6 affected / 244 at risk

Adverse event: Dermatitis diaper
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 244 at risk

Adverse event: Skin ulcer
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 244 at risk

Adverse event: Burns first degree
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 244 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 244 at risk

Adverse event: Tenderness: Any
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 35 affected / 241 at risk

Adverse event: Tenderness: Mild
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 32 affected / 241 at risk

Adverse event: Tenderness: Moderate
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 241 at risk

Adverse event: Fever: >=38.0 degree C
Serious: no
Organ System: General disorders
Frequency: 8 affected / 241 at risk

Adverse event: Fever: >=38.0 but <=39.0 degrees C
Serious: no
Organ System: General disorders
Frequency: 7 affected / 241 at risk

Adverse event: Fever: >39.0 but <=40.0 degrees C
Serious: no
Organ System: General disorders
Frequency: 1 affected / 241 at risk

Adverse event: Decreased appetite: Any
Serious: no
Organ System: General disorders
Frequency: 20 affected / 242 at risk

Adverse event: Decreased appetite: Moderate
Serious: no
Organ System: General disorders
Frequency: 19 affected / 242 at risk

Adverse event: Decreased appetite: Severe
Serious: no
Organ System: General disorders
Frequency: 1 affected / 241 at risk

Adverse event: Irritability: Any
Serious: no
Organ System: General disorders
Frequency: 92 affected / 243 at risk

Adverse event: Irritability: Mild
Serious: no
Organ System: General disorders
Frequency: 74 affected / 242 at risk

Adverse event: Irritability: Moderate
Serious: no
Organ System: General disorders
Frequency: 18 affected / 242 at risk

Adverse event: Irritability: Severe
Serious: no
Organ System: General disorders
Frequency: 5 affected / 241 at risk

Adverse event: Increased sleep: Any
Serious: no
Organ System: General disorders
Frequency: 12 affected / 241 at risk

Adverse event: Increased sleep: Mild
Serious: no
Organ System: General disorders
Frequency: 11 affected / 241 at risk

Adverse event: Increased sleep: Moderate
Serious: no
Organ System: General disorders
Frequency: 1 affected / 241 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 26 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 26 at risk

Adverse event: Failure to thrive
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 26 at risk

Adverse event: Heart disease congenital
Serious: no
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 26 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 26 at risk

Adverse event: Growth retardation
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 26 at risk