Study: NCT03649659

Adverse event: Hospitalization for Dental Abscess
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Hospitalization due to infection and pain with dental abscess resulting in tooth extraction
Frequency: 1 affected / 414 at risk

Adverse event: Hospitalization for Appendix Removal
Serious: yes
Organ System: Surgical and medical procedures
Notes: Inpatient stay for surgical removal of appendix due to diagnosis of appendicitis.
Frequency: 1 affected / 414 at risk

Adverse event: Hospitalization for Febrile Seizure
Serious: yes
Organ System: General disorders
Notes: Cough and fever and subsquent febrile seizure resulting in hospital admission for two nights to stabilize.
Frequency: 1 affected / 414 at risk

Adverse event: Abscess
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 35 affected / 414 at risk

Adverse event: Hypersensitivity
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 414 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 414 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 6 affected / 414 at risk

Adverse event: Dental Trauma
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 414 at risk

Adverse event: Dental care
Serious: no
Organ System: Surgical and medical procedures
Frequency: 22 affected / 414 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 414 at risk

Adverse event: Ear infection
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 414 at risk

Adverse event: Extraoral Staining
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 5 affected / 414 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 9 affected / 414 at risk

Adverse event: Gastrointestinal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 414 at risk

Adverse event: Intraoral Staining
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 414 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 414 at risk

Adverse event: Oral Erythema
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 414 at risk

Adverse event: Oral pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 414 at risk

Adverse event: Mouth ulceration
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 414 at risk

Adverse event: Other
Serious: no
Organ System: General disorders
Notes: COVID-19, heatstroke, dog bite, halitosis, muscle pain, congestion, cheek swelling, seasonal allergies, self-reported flu, stye, helicobacter pylori
Frequency: 15 affected / 414 at risk

Adverse event: Other Surgical Procedure
Serious: no
Organ System: Surgical and medical procedures
Notes: Tonsillectomies, ear tube surgeries, staples, stitches
Frequency: 1 affected / 414 at risk

Adverse event: Pulpal Exposure
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 414 at risk

Adverse event: Respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 7 affected / 414 at risk

Adverse event: Skin and Tissue Disorders
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 6 affected / 414 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 414 at risk

Adverse event: Toothache
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 33 affected / 414 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 414 at risk

Adverse event: Hospitalization due to Asthma
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Abnormal breathing resulting in hospital admission for two nights to diagnose and stabilize. Diagnosis of chronic asthma.
Frequency: 1 affected / 416 at risk

Adverse event: Abscess
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 34 affected / 416 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 416 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 416 at risk

Adverse event: Dental Trauma
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 416 at risk

Adverse event: Dental care
Serious: no
Organ System: Surgical and medical procedures
Frequency: 18 affected / 416 at risk

Adverse event: Ear infection
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 416 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 16 affected / 416 at risk

Adverse event: Gastrointestinal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 416 at risk

Adverse event: Intraoral Staining
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 416 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 416 at risk

Adverse event: Oral Erythema
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 416 at risk

Adverse event: Oral pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 416 at risk

Adverse event: Mouth ulceration
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 416 at risk

Adverse event: Other
Serious: no
Organ System: General disorders
Notes: COVID-19, heatstroke, dog bite, halitosis, muscle pain, congestion, cheek swelling, seasonal allergies, self-reported flu, stye, helicobacter pylori
Frequency: 6 affected / 416 at risk

Adverse event: Other Surgical Procedure
Serious: no
Organ System: Surgical and medical procedures
Notes: Tonsillectomies, ear tube surgeries, staples, stitches
Frequency: 2 affected / 416 at risk

Adverse event: Pulpal Exposure
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 416 at risk

Adverse event: Respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 8 affected / 416 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 416 at risk

Adverse event: Toothache
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 26 affected / 416 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 416 at risk