Study: NCT04595513

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Notes: Total Reported: 4; Grade 1: 4; Relatedness: Unrelated 100%
Frequency: 2 affected / 5 at risk

Adverse event: Flatulence
Serious: no
Organ System: Gastrointestinal disorders
Notes: Total Reported: 4; Grade 1: 1; Grade 2: 3; Relatedness: Unrelated 100%
Frequency: 2 affected / 5 at risk

Adverse event: Emesis (vomiting)
Serious: no
Organ System: Gastrointestinal disorders
Notes: Total Reported: 5; Grade 1: 5; Relatedness: Unrelated 100%
Frequency: 1 affected / 5 at risk

Adverse event: Hematochezia (Bloody stool)
Serious: no
Organ System: Gastrointestinal disorders
Notes: Total Reported: 1; Grade 2: 1; Relatedness: Possibly related 100%
Frequency: 1 affected / 5 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Total Reported: 1; Grade 2: 1; Relatedness: Possibly related 100%
Frequency: 1 affected / 5 at risk

Adverse event: Stomatitis (mouth sores/ulcers)
Serious: no
Organ System: Gastrointestinal disorders
Notes: Total Reported: 5; Grade 1: 2; Grade 2: 3; Relatedness: Probable 60%, Definite 40%
Frequency: 2 affected / 5 at risk

Adverse event: Pyrexia (fever)
Serious: no
Organ System: General disorders
Notes: Total Reported: 8; Grade 2: 8; Relatedness: Unrelated 100%
Frequency: 2 affected / 5 at risk

Adverse event: Fussiness
Serious: no
Organ System: General disorders
Notes: Total Reported: 13; Grade 1: 1, Grade 2: 12; Relatedness: Unrelated 100%
Frequency: 1 affected / 5 at risk

Adverse event: Discomfort/Pain due to Teething
Serious: no
Organ System: General disorders
Notes: Total Reported: 3; Grade 2: 3; Relatedness: Unrelated 100%
Frequency: 1 affected / 5 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: Total Reported: 1; Grade 1: 1; Relatedness: Unrelated 100%
Frequency: 1 affected / 5 at risk

Adverse event: Rash (Allergic reaction)
Serious: no
Organ System: Immune system disorders
Notes: Total Reported: 1; Grade 2: 1; Relatedness: Unrelated 100%
Frequency: 1 affected / 5 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Infections and infestations
Notes: Total Reported: 4; Grade 1: 4; Relatedness: Unrelated 50%, Possible 50%
Frequency: 3 affected / 5 at risk

Adverse event: Otitis media
Serious: no
Organ System: Infections and infestations
Notes: Total Reported: 3; Grade 2: 3; Relatedness: Possible 66.7%, Probable 33.3%
Frequency: 3 affected / 5 at risk

Adverse event: Rhinosinusitis (Sinus infection)
Serious: no
Organ System: Infections and infestations
Notes: Total Reported: 1; Grade 2: 1; Relatedness: Probable 100%
Frequency: 1 affected / 5 at risk

Adverse event: Abscess w/Infection
Serious: no
Organ System: Infections and infestations
Notes: Total Reported: 1; Grade 2: 1; Relatedness: Unlikely 100%
Frequency: 1 affected / 5 at risk

Adverse event: Croup w/Stridor
Serious: no
Organ System: Infections and infestations
Notes: Total Reported: 1; Grade 2: 1; Relatedness: Possible 100%
Frequency: 1 affected / 5 at risk

Adverse event: Respiratory Syncytial Virus (RSV)
Serious: no
Organ System: Infections and infestations
Notes: Total Reported: 1; Grade 2: 1; Relatedness: Possible 100%
Frequency: 1 affected / 5 at risk

Adverse event: Hand-Foot-Mouth Disease
Serious: no
Organ System: Infections and infestations
Notes: Total Reported: 1; Grade 2; Relatedness: Possible 100%
Frequency: 1 affected / 5 at risk

Adverse event: Hypertriglyceridaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Total Reported: 4; Grade 1: 2, Grade 3: 2; Relatedness: Definite 100%
Frequency: 4 affected / 5 at risk

Adverse event: Hypercholesterolaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Total Reported: 4; Grade 1: 4; Relatedness: Definite 100%
Frequency: 3 affected / 5 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Notes: Total Reported: 2; Grade 1: 1, Grade 2: 1; Relatedness: Unrelated 100%
Frequency: 2 affected / 5 at risk

Adverse event: Tussis (cough)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Total Reported: 3; Grade 1: 2, Grade 2: 1; Relatedness: Unrelated: 66.7%, Possible: 33.3%
Frequency: 3 affected / 5 at risk

Adverse event: Rhinorrhea (Congestion)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Total Reported: 8; Grade 1: 4, Grade 2: 4; Relatedness: Unrelated 50%, Possible 50%
Frequency: 2 affected / 5 at risk

Adverse event: Lip Lesion
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Total Reported: 4; Grade 2: 4; Relatedness: Possible 100%
Frequency: 1 affected / 5 at risk

Adverse event: Dermatitis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Total Reported: 5; Grade 1: 4, Grade 2: 1; Relatedness: Unrelated 80%, Possible 20%
Frequency: 1 affected / 5 at risk

Adverse event: Eczema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Total Reported: 2; Grade 1: 2; Relatedness: Unrelated 100%
Frequency: 1 affected / 5 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Notes: Total Reported: 1; Grade 2: 1; Relatedness: Unrelated 100%
Frequency: 1 affected / 5 at risk