Study: NCT03301155

Adverse event: Partial cramps
Serious: yes
Organ System: Nervous system disorders
Notes: Partial epilepsy
Frequency: 1 affected / 528 at risk

Adverse event: Intestinal dysfunction
Serious: no
Organ System: Gastrointestinal disorders
Notes: Intestinal dysfunction
Frequency: 1 affected / 528 at risk

Adverse event: Teething
Serious: no
Organ System: Gastrointestinal disorders
Notes: Teething
Frequency: 3 affected / 528 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Notes: Vomiting
Frequency: 1 affected / 528 at risk

Adverse event: Functional gastrointestinal pathology
Serious: no
Organ System: Gastrointestinal disorders
Notes: Functional gastrointestinal pathology
Frequency: 3 affected / 528 at risk

Adverse event: Chicken pox
Serious: no
Organ System: Infections and infestations
Notes: Chicken pox
Frequency: 4 affected / 528 at risk

Adverse event: Respiratory viral infection
Serious: no
Organ System: Infections and infestations
Notes: ARVI, rhinopharyngitis
Frequency: 3 affected / 528 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Infections and infestations
Notes: Purulent conjunctivitis
Frequency: 1 affected / 528 at risk

Adverse event: Purulent rhinitis
Serious: no
Organ System: Infections and infestations
Notes: Purulent rhinitis
Frequency: 1 affected / 528 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Notes: Urinary tract infection
Frequency: 1 affected / 528 at risk

Adverse event: Non-purulent otitis media
Serious: no
Organ System: Infections and infestations
Notes: Non-purulent otitis media
Frequency: 1 affected / 528 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Notes: Obstructive bronchitis
Frequency: 1 affected / 528 at risk

Adverse event: Respiratory tract infection
Serious: no
Organ System: Infections and infestations
Notes: Acute respiratory tract infection
Frequency: 4 affected / 528 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Notes: Acute nasopharyngitis
Frequency: 6 affected / 528 at risk

Adverse event: Tracheitis
Serious: no
Organ System: Infections and infestations
Notes: Acute tracheitis
Frequency: 1 affected / 528 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Infections and infestations
Notes: Acute pharyngitis
Frequency: 1 affected / 528 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Infections and infestations
Notes: Rhinitis
Frequency: 2 affected / 528 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Notes: Rhinosinusitis
Frequency: 1 affected / 528 at risk

Adverse event: Rotavirus infection
Serious: no
Organ System: Infections and infestations
Notes: Rotavirus infection
Frequency: 1 affected / 528 at risk

Adverse event: Acute otitis media
Serious: no
Organ System: Infections and infestations
Notes: Acute otitis media
Frequency: 1 affected / 528 at risk

Adverse event: Pharyngotonsillitis
Serious: no
Organ System: Infections and infestations
Notes: Pharyngotonsillitis
Frequency: 1 affected / 528 at risk

Adverse event: Tracheitis
Serious: no
Organ System: Infections and infestations
Notes: Pharyngotracheitis
Frequency: 1 affected / 528 at risk

Adverse event: Rhinorrhoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Runny nose
Frequency: 6 affected / 528 at risk

Adverse event: Epistaxis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Nasal bleeding
Frequency: 1 affected / 528 at risk

Adverse event: Productive cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Productive cough
Frequency: 5 affected / 528 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Dry cough
Frequency: 2 affected / 528 at risk

Adverse event: Dermatitis allergic
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Allergic dermatitis
Frequency: 1 affected / 528 at risk

Adverse event: Urticaria
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Acute allergic urticaria
Frequency: 1 affected / 528 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Rash on the skin of the face
Frequency: 1 affected / 528 at risk

Adverse event: Partial seizures
Serious: no
Organ System: Nervous system disorders
Notes: Partial epilepsy
Frequency: 1 affected / 528 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Notes: Fervescence
Frequency: 7 affected / 528 at risk

Adverse event: Dysphemia
Serious: no
Organ System: Psychiatric disorders
Notes: Stammering
Frequency: 1 affected / 528 at risk

Adverse event: Aphthous ulcer
Serious: no
Organ System: Gastrointestinal disorders
Notes: Aphthous stomatitis
Frequency: 1 affected / 508 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Loose stool
Frequency: 1 affected / 508 at risk

Adverse event: Teething
Serious: no
Organ System: Gastrointestinal disorders
Notes: Teething
Frequency: 1 affected / 508 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Notes: Functional dyspepsia
Frequency: 1 affected / 508 at risk

Adverse event: Functional gastrointestinal pathology
Serious: no
Organ System: Gastrointestinal disorders
Notes: Functional gastrointestinal pathology
Frequency: 1 affected / 508 at risk

Adverse event: Enteritis
Serious: no
Organ System: Gastrointestinal disorders
Notes: Enteritis
Frequency: 1 affected / 508 at risk

Adverse event: Chicken pox
Serious: no
Organ System: Infections and infestations
Notes: Chicken pox
Frequency: 8 affected / 508 at risk

Adverse event: Respiratory viral infection
Serious: no
Organ System: Infections and infestations
Notes: ARVI, rhinopharyngitis
Frequency: 4 affected / 508 at risk

Adverse event: Gastroenteritis caused by norovirus
Serious: no
Organ System: Infections and infestations
Notes: Gastroenteritis caused by norovirus
Frequency: 1 affected / 508 at risk

Adverse event: Herpes on the lips
Serious: no
Organ System: Infections and infestations
Notes: Herpes on the lips
Frequency: 1 affected / 508 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Infections and infestations
Notes: Purulent conjunctivitis
Frequency: 1 affected / 508 at risk

Adverse event: Purulent rhinitis
Serious: no
Organ System: Infections and infestations
Notes: Purulent rhinitis
Frequency: 1 affected / 508 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Notes: Obstructive bronchitis
Frequency: 1 affected / 508 at risk

Adverse event: Respiratory tract infection
Serious: no
Organ System: Infections and infestations
Notes: Acute respiratory tract infection
Frequency: 4 affected / 508 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Notes: Acute nasopharyngitis
Frequency: 3 affected / 508 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Infections and infestations
Notes: Acute rhinitis
Frequency: 1 affected / 508 at risk

Adverse event: Tracheitis
Serious: no
Organ System: Infections and infestations
Notes: Acute tracheitis
Frequency: 2 affected / 508 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Infections and infestations
Notes: Acute pharyngitis
Frequency: 1 affected / 508 at risk

Adverse event: Ear infection
Serious: no
Organ System: Infections and infestations
Notes: Otitis
Frequency: 1 affected / 508 at risk

Adverse event: Paronychia
Serious: no
Organ System: Infections and infestations
Notes: Panaritium
Frequency: 1 affected / 508 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Infections and infestations
Notes: Rhinitis
Frequency: 1 affected / 508 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Notes: Rhinopharyngitis
Frequency: 2 affected / 508 at risk

Adverse event: Rotavirus infection
Serious: no
Organ System: Infections and infestations
Notes: Rotavirus infection
Frequency: 1 affected / 508 at risk

Adverse event: Viral otitis media
Serious: no
Organ System: Infections and infestations
Notes: Viral otitis media
Frequency: 1 affected / 508 at risk

Adverse event: Acute otitis media
Serious: no
Organ System: Infections and infestations
Notes: Acute otitis media
Frequency: 1 affected / 508 at risk

Adverse event: Throat hyperemia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Throat hyperemia
Frequency: 1 affected / 508 at risk

Adverse event: Rhinorrhoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Runny nose
Frequency: 2 affected / 508 at risk

Adverse event: Productive cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Productive cough
Frequency: 2 affected / 508 at risk

Adverse event: Dermatitis allergic
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Allergic rash
Frequency: 3 affected / 508 at risk

Adverse event: Skin itch
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Skin itch
Frequency: 1 affected / 508 at risk

Adverse event: Urticaria
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Acute allergic urticaria
Frequency: 1 affected / 508 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: Headache
Frequency: 1 affected / 508 at risk

Adverse event: Foreign body aspiration
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Aspiration of a foreign matter
Frequency: 1 affected / 508 at risk