Study: NCT03205371

Adverse event: Bronchitis viral
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 103 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 103 at risk

Adverse event: Hand-foot-and-mouth disease
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 103 at risk

Adverse event: Respiratory syncytial virus bronchiolitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 103 at risk

Adverse event: Tonsillitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 103 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 103 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Notes: Vomiting events that occurred after 7 days post-vaccination were considered as unsolicited AE.
Frequency: 7 affected / 103 at risk

Adverse event: Crying
Serious: no
Organ System: General disorders
Notes: Crying/Abnormal crying events that occurred after 7 days post-vaccination were considered as unsolicited AE.
Frequency: 21 affected / 103 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 35 affected / 103 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 31 affected / 103 at risk

Adverse event: Injection site swelling
Serious: no
Organ System: General disorders
Frequency: 25 affected / 103 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Notes: Pyrexia/Fever events that occurred after 7 days post-vaccination were considered as unsolicited AE.
Frequency: 21 affected / 103 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 103 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 29 affected / 103 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 103 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 103 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 29 affected / 103 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 17 affected / 103 at risk

Adverse event: Irritability
Serious: no
Organ System: Psychiatric disorders
Frequency: 31 affected / 103 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 103 at risk

Adverse event: Rhinorrhoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 103 at risk

Adverse event: Bronchiolitis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 52 at risk

Adverse event: Bronchitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 52 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 52 at risk

Adverse event: Hand-foot-and-mouth disease
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 52 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 52 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Notes: Vomiting events that occurred after 7 days post-vaccination were considered as unsolicited AE.
Frequency: 3 affected / 52 at risk

Adverse event: Crying
Serious: no
Organ System: General disorders
Notes: Crying/Abnormal crying events that occurred after 7 days post-vaccination were considered as unsolicited AE.
Frequency: 9 affected / 52 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 20 affected / 52 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 15 affected / 52 at risk

Adverse event: Injection site swelling
Serious: no
Organ System: General disorders
Frequency: 14 affected / 52 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Notes: Pyrexia/Fever events that occurred after 7 days post-vaccination were considered as unsolicited AE.
Frequency: 11 affected / 52 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 52 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 17 affected / 52 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 52 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 52 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 52 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 10 affected / 52 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 8 affected / 52 at risk

Adverse event: Irritability
Serious: no
Organ System: Psychiatric disorders
Frequency: 12 affected / 52 at risk

Adverse event: Rhinorrhoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 52 at risk

Adverse event: Otitis media viral
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 53 at risk

Adverse event: Pneumonia viral
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 53 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Notes: Vomiting events that occurred after 7 days post-vaccination were considered as unsolicited AE.
Frequency: 2 affected / 53 at risk

Adverse event: Crying
Serious: no
Organ System: General disorders
Notes: Crying/Abnormal crying events that occurred after 7 days post-vaccination were considered as unsolicited AE.
Frequency: 6 affected / 53 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 8 affected / 53 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 12 affected / 53 at risk

Adverse event: Injection site swelling
Serious: no
Organ System: General disorders
Frequency: 3 affected / 53 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Notes: Pyrexia/Fever events that occurred after 7 days post-vaccination were considered as unsolicited AE.
Frequency: 10 affected / 53 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 53 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 13 affected / 53 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 53 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 8 affected / 53 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 9 affected / 53 at risk

Adverse event: Irritability
Serious: no
Organ System: Psychiatric disorders
Frequency: 11 affected / 53 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 53 at risk

Adverse event: Rhinorrhoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 53 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 86 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Notes: Vomiting events that occurred after 7 days post-vaccination were considered as unsolicited AE.
Frequency: 6 affected / 86 at risk

Adverse event: Crying
Serious: no
Organ System: General disorders
Notes: Crying/Abnormal crying events that occurred after 7 days post-vaccination were considered as unsolicited AE.
Frequency: 15 affected / 86 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 36 affected / 86 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 31 affected / 86 at risk

Adverse event: Injection site swelling
Serious: no
Organ System: General disorders
Frequency: 18 affected / 86 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Notes: Pyrexia/Fever events that occurred after 7 days post-vaccination were considered as unsolicited AE.
Frequency: 6 affected / 86 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 86 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 86 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 86 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 86 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 11 affected / 86 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 8 affected / 86 at risk

Adverse event: Irritability
Serious: no
Organ System: Psychiatric disorders
Frequency: 14 affected / 86 at risk

Adverse event: Croup infectious
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 42 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Notes: Vomiting events that occurred after 7 days post-vaccination were considered as unsolicited AE.
Frequency: 4 affected / 42 at risk

Adverse event: Crying
Serious: no
Organ System: General disorders
Notes: Crying/Abnormal crying events that occurred after 7 days post-vaccination were considered as unsolicited AE.
Frequency: 17 affected / 42 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 13 affected / 42 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 17 affected / 42 at risk

Adverse event: Injection site swelling
Serious: no
Organ System: General disorders
Frequency: 7 affected / 42 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Notes: Pyrexia/Fever events that occurred after 7 days post-vaccination were considered as unsolicited AE.
Frequency: 3 affected / 42 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 42 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 42 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 42 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 12 affected / 42 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 7 affected / 42 at risk

Adverse event: Irritability
Serious: no
Organ System: Psychiatric disorders
Frequency: 11 affected / 42 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Notes: Vomiting events that occurred after 7 days post-vaccination were considered as unsolicited AE.
Frequency: 6 affected / 42 at risk

Adverse event: Crying
Serious: no
Organ System: General disorders
Notes: Crying/Abnormal crying events that occurred after 7 days post-vaccination were considered as unsolicited AE.
Frequency: 12 affected / 42 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 16 affected / 42 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 19 affected / 42 at risk

Adverse event: Injection site swelling
Serious: no
Organ System: General disorders
Frequency: 5 affected / 42 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Notes: Pyrexia/Fever events that occurred after 7 days post-vaccination were considered as unsolicited AE.
Frequency: 4 affected / 42 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 42 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 42 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 42 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 42 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 42 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 42 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 7 affected / 42 at risk

Adverse event: Irritability
Serious: no
Organ System: Psychiatric disorders
Frequency: 14 affected / 42 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 12 affected / 200 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Notes: Vomiting events that occurred after 7 days post-vaccination were considered as unsolicited AE.
Frequency: 16 affected / 200 at risk

Adverse event: Crying
Serious: no
Organ System: General disorders
Notes: Crying/Abnormal crying events that occurred after 7 days post-vaccination were considered as unsolicited AE.
Frequency: 46 affected / 200 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 67 affected / 200 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 87 affected / 200 at risk

Adverse event: Injection site swelling
Serious: no
Organ System: General disorders
Frequency: 52 affected / 200 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Notes: Pyrexia/Fever events that occurred after 7 days post-vaccination were considered as unsolicited AE.
Frequency: 35 affected / 200 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 29 affected / 200 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 9 affected / 200 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 200 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 51 affected / 200 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 31 affected / 200 at risk

Adverse event: Irritability
Serious: no
Organ System: Psychiatric disorders
Frequency: 64 affected / 200 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 200 at risk

Adverse event: Rhinorrhoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 200 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 100 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Notes: Vomiting events that occurred after 7 days post-vaccination were considered as unsolicited AE.
Frequency: 7 affected / 100 at risk

Adverse event: Crying
Serious: no
Organ System: General disorders
Notes: Crying/Abnormal crying events that occurred after 7 days post-vaccination were considered as unsolicited AE.
Frequency: 25 affected / 100 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 15 affected / 100 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 27 affected / 100 at risk

Adverse event: Injection site swelling
Serious: no
Organ System: General disorders
Frequency: 8 affected / 100 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Notes: Pyrexia/Fever events that occurred after 7 days post-vaccination were considered as unsolicited AE.
Frequency: 8 affected / 100 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 18 affected / 100 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 100 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 100 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 25 affected / 100 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 15 affected / 100 at risk

Adverse event: Irritability
Serious: no
Organ System: Psychiatric disorders
Frequency: 34 affected / 100 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 100 at risk

Adverse event: Febrile convulsion
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 100 at risk

Adverse event: Asthma
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 100 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 100 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Notes: Vomiting events that occurred after 7 days post-vaccination were considered as unsolicited AE.
Frequency: 9 affected / 100 at risk

Adverse event: Crying
Serious: no
Organ System: General disorders
Notes: Crying/Abnormal crying events that occurred after 7 days post-vaccination were considered as unsolicited AE.
Frequency: 26 affected / 100 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 37 affected / 100 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 54 affected / 100 at risk

Adverse event: Injection site swelling
Serious: no
Organ System: General disorders
Frequency: 30 affected / 100 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Notes: Pyrexia/Fever events that occurred after 7 days post-vaccination were considered as unsolicited AE.
Frequency: 17 affected / 100 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 15 affected / 100 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 100 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 20 affected / 100 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 17 affected / 100 at risk

Adverse event: Irritability
Serious: no
Organ System: Psychiatric disorders
Frequency: 33 affected / 100 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 100 at risk

Adverse event: Rhinorrhoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 100 at risk

Adverse event: Crying
Serious: no
Organ System: General disorders
Notes: Crying/Abnormal crying events that occurred after 7 days post-vaccination were considered as unsolicited AE.
Frequency: 8 affected / 200 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 55 affected / 200 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 37 affected / 200 at risk

Adverse event: Injection site swelling
Serious: no
Organ System: General disorders
Frequency: 21 affected / 200 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Notes: Pyrexia/Fever events that occurred after 7 days post-vaccination were considered as unsolicited AE.
Frequency: 13 affected / 200 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 200 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 200 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 200 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 19 affected / 200 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 25 affected / 200 at risk

Adverse event: Irritability
Serious: no
Organ System: Psychiatric disorders
Frequency: 26 affected / 200 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 200 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 100 at risk

Adverse event: Crying
Serious: no
Organ System: General disorders
Notes: Crying/Abnormal crying events that occurred after 7 days post-vaccination were considered as unsolicited AE.
Frequency: 4 affected / 100 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 17 affected / 100 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 8 affected / 100 at risk

Adverse event: Injection site swelling
Serious: no
Organ System: General disorders
Frequency: 7 affected / 100 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Notes: Pyrexia/Fever events that occurred after 7 days post-vaccination were considered as unsolicited AE.
Frequency: 3 affected / 100 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 100 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 100 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 12 affected / 100 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 6 affected / 100 at risk

Adverse event: Irritability
Serious: no
Organ System: Psychiatric disorders
Frequency: 16 affected / 100 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 100 at risk

Adverse event: Crying
Serious: no
Organ System: General disorders
Notes: Crying/Abnormal crying events that occurred after 7 days post-vaccination were considered as unsolicited AE.
Frequency: 2 affected / 99 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 8 affected / 99 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 9 affected / 99 at risk

Adverse event: Injection site swelling
Serious: no
Organ System: General disorders
Frequency: 2 affected / 99 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Notes: Pyrexia/Fever events that occurred after 7 days post-vaccination were considered as unsolicited AE.
Frequency: 2 affected / 99 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 99 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 99 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 7 affected / 99 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 99 at risk

Adverse event: Irritability
Serious: no
Organ System: Psychiatric disorders
Frequency: 9 affected / 99 at risk