Study: NCT03039621

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Diarrhoea
Frequency: 2 affected / 143 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Notes: Vomiting
Frequency: 1 affected / 143 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Notes: Abdominal pain
Frequency: 1 affected / 143 at risk

Adverse event: Condition aggravated
Serious: no
Organ System: General disorders
Notes: Condition worsened
Frequency: 1 affected / 143 at risk

Adverse event: Adenoiditis
Serious: no
Organ System: Infections and infestations
Notes: Adenoiditis
Frequency: 1 affected / 143 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Notes: Acute gastroenteritis
Frequency: 1 affected / 143 at risk

Adverse event: Tracheitis
Serious: no
Organ System: Infections and infestations
Notes: Acute laryngotracheitis
Frequency: 1 affected / 143 at risk

Adverse event: Otitis media acute
Serious: no
Organ System: Infections and infestations
Notes: Otitis media acute
Frequency: 1 affected / 143 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Infections and infestations
Notes: Acute rhinitis
Frequency: 1 affected / 143 at risk

Adverse event: Infectious mononucleosis
Serious: no
Organ System: Infections and infestations
Notes: Infectious mononucleosis
Frequency: 1 affected / 143 at risk

Adverse event: Muscle twitching
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Muscle twitching
Frequency: 1 affected / 143 at risk

Adverse event: Urticaria
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Urticaria
Frequency: 1 affected / 143 at risk

Adverse event: Exfoliative rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Rash desquamating
Frequency: 1 affected / 143 at risk

Adverse event: Lymphadenitis
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Bilateral cervical lymphadenitis
Frequency: 1 affected / 144 at risk

Adverse event: Tachycardia
Serious: no
Organ System: Cardiac disorders
Notes: Tachycardia NOS
Frequency: 1 affected / 144 at risk

Adverse event: Eyelid oedema
Serious: no
Organ System: Eye disorders
Notes: Eyelid oedema
Frequency: 1 affected / 144 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Diarrhoea
Frequency: 1 affected / 144 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Notes: Vomiting
Frequency: 1 affected / 144 at risk

Adverse event: Teething
Serious: no
Organ System: Gastrointestinal disorders
Notes: Teething syndrome
Frequency: 1 affected / 144 at risk

Adverse event: Hyperthermia
Serious: no
Organ System: General disorders
Notes: Hyperthermia sudden
Frequency: 1 affected / 144 at risk

Adverse event: Condition aggravated
Serious: no
Organ System: General disorders
Notes: Condition worsened
Frequency: 3 affected / 144 at risk

Adverse event: Adenoiditis
Serious: no
Organ System: Infections and infestations
Notes: Adenoiditis
Frequency: 8 affected / 144 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Notes: Obstructive bronchitis
Frequency: 4 affected / 144 at risk

Adverse event: Otitis media acute
Serious: no
Organ System: Infections and infestations
Notes: Acute mucoid otitis media
Frequency: 2 affected / 144 at risk

Adverse event: Otitis media acute
Serious: no
Organ System: Infections and infestations
Notes: Otitis media acute
Frequency: 2 affected / 144 at risk

Adverse event: Adenoviral upper respiratory infection
Serious: no
Organ System: Infections and infestations
Notes: Adenoviral upper respiratory infection
Frequency: 1 affected / 144 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Notes: Gastroenterocolitis
Frequency: 1 affected / 144 at risk

Adverse event: Oral herpes
Serious: no
Organ System: Infections and infestations
Notes: Herpes labialis
Frequency: 1 affected / 144 at risk

Adverse event: Pharyngotonsillitis
Serious: no
Organ System: Infections and infestations
Notes: Pharyngotonsillitis
Frequency: 2 affected / 144 at risk

Adverse event: Procedural vomiting
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Post procedural vomiting
Frequency: 1 affected / 144 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Myalgia
Frequency: 1 affected / 144 at risk

Adverse event: Torticollis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Acute torticollis
Frequency: 1 affected / 144 at risk

Adverse event: Rhinorrhoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Nasal discharge
Frequency: 1 affected / 144 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Cough aggravated
Frequency: 2 affected / 144 at risk

Adverse event: Dermatitis atopic
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Dermatitis atopic aggravated
Frequency: 1 affected / 144 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Localised rash
Frequency: 1 affected / 144 at risk