Study: NCT03143101

Adverse event: Tympanic membrane perforation
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 67 at risk

Adverse event: Strabismus
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 67 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 67 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 67 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 67 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Frequency: 1 affected / 67 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 67 at risk

Adverse event: Cellulitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 67 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 67 at risk

Adverse event: Croup infectious
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 67 at risk

Adverse event: Ear infection
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 67 at risk

Adverse event: Folliculitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 67 at risk

Adverse event: Gastroenteritis viral
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 67 at risk

Adverse event: Hand-foot-and-mouth disease
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 67 at risk

Adverse event: Otitis media acute
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 67 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 67 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 67 at risk

Adverse event: Viral pharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 67 at risk

Adverse event: Arthropod bite
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 67 at risk

Adverse event: Skin laceration
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 67 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 67 at risk

Adverse event: Lethargy
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 67 at risk

Adverse event: Irritability
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 67 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 67 at risk

Adverse event: Dysphonia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 67 at risk

Adverse event: Epistaxis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 67 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 67 at risk

Adverse event: Paranasal sinus discomfort
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 67 at risk

Adverse event: Pharyngeal erythema
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 67 at risk

Adverse event: Rhinorrhoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 67 at risk

Adverse event: Dermatitis diaper
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 67 at risk

Adverse event: Eye oedema
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 66 at risk

Adverse event: Ocular hyperaemia
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 66 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 66 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 66 at risk

Adverse event: Mouth haemorrhage
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 66 at risk

Adverse event: Oral discomfort
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 66 at risk

Adverse event: Oral pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 66 at risk

Adverse event: Toothache
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 66 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 66 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 7 affected / 66 at risk

Adverse event: Allergy to arthropod bite
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 66 at risk

Adverse event: Ear infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 66 at risk

Adverse event: Escherichia urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 66 at risk

Adverse event: Otitis media acute
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 66 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 66 at risk

Adverse event: Arthropod bite
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 66 at risk

Adverse event: Radial head dislocation
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 66 at risk

Adverse event: Thermal burn
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 66 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 66 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 66 at risk

Adverse event: Irritability
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 66 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 66 at risk

Adverse event: Epistaxis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 66 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 66 at risk

Adverse event: Pharyngeal erythema
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 66 at risk

Adverse event: Rhinorrhoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 7 affected / 66 at risk

Adverse event: Sneezing
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 66 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 66 at risk

Adverse event: Abdominal discomfort
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 67 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 67 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 67 at risk

Adverse event: Dental caries
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 67 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 67 at risk

Adverse event: Haematochezia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 67 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 67 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 67 at risk

Adverse event: Developmental delay
Serious: no
Organ System: General disorders
Frequency: 1 affected / 67 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 2 affected / 67 at risk

Adverse event: Seasonal allergy
Serious: no
Organ System: Immune system disorders
Frequency: 2 affected / 67 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 67 at risk

Adverse event: Ear infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 67 at risk

Adverse event: Gastroenteritis viral
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 67 at risk

Adverse event: Herpes simplex
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 67 at risk

Adverse event: Localised infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 67 at risk

Adverse event: Otitis media acute
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 67 at risk

Adverse event: Pharyngitis streptococcal
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 67 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 67 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 67 at risk

Adverse event: Viral pharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 67 at risk

Adverse event: Viral upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 67 at risk

Adverse event: Arthropod bite
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 67 at risk

Adverse event: Neck pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 67 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 67 at risk

Adverse event: Irritability
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 67 at risk

Adverse event: Bronchial hyperreactivity
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 67 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 67 at risk

Adverse event: Epistaxis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 67 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 67 at risk

Adverse event: Rhinorrhoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 9 affected / 67 at risk

Adverse event: Sneezing
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 67 at risk

Adverse event: Tonsillar hypertrophy
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 67 at risk

Adverse event: Cold sweat
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 67 at risk

Adverse event: Dermatitis diaper
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 67 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 67 at risk