Table 9.
Morbidities that occurred with a frequency greater than 1%.
| MedDRA Dictionary Version 21.0 (MedDRA, 2018) | BFD (n = 70) | STD (n = 70) | INN (n = 70) | |||
|---|---|---|---|---|---|---|
| Cases | % | Cases | % | Cases | % | |
| Cold | 42 | 18.50 | 47 | 16.15 | 38 | 13.48 |
| Pyrexia | 16 | 7.05 | 24 | 8.25 | 11 | 3.90 |
| Bronchitis/Bronchiolitis* | 13 | 5.7 | 34 | 11.7 | 17 | 6.00 |
| Upper respiratory tract infection | 11 | 4.85 | 11 | 3.78 | 15 | 5.32 |
| Infantile colic | 14 | 6.17 | 9 | 3.09 | 10 | 3.55 |
| Conjunctivitis | 5 | 2.20 | 11 | 3.78 | 15 | 5.32 |
| Neonatal constipation | 6 | 2.64 | 10 | 3.44 | 9 | 3.19 |
| Acute otitis media | 4 | 1.76 | 6 | 2.06 | 13 | 4.61 |
| Rhinorrhea | 9 | 3.96 | 5 | 1.72 | 6 | 2.13 |
| Gastroenteritis | 4 | 1.76 | 8 | 2.75 | 8 | 2.84 |
| Cough | 9 | 3.96 | 7 | 2.41 | 5 | 1.77 |
| Vaccination complication | 1 | 0.44 | 10 | 3.44 | 7 | 2.48 |
| Laryngitis | 1 | 0.44 | 9 | 3.09 | 7 | 2.48 |
| Atopic dermatitis * | 1 | 0.44 | 11 | 3.78 | 2 | 0.71 |
| Seborrheic dermatitis | 2 | 0.88 | 4 | 1.37 | 5 | 1.77 |
| Neonatal diarrhea | 2 | 0.88 | 3 | 1.03 | 5 | 1.77 |
| Oral candidiasis | 4 | 1.76 | 3 | 1.03 | 2 | 0.71 |
| Nasopharyngitis | 1 | 0.44 | 2 | 0.69 | 6 | 2.13 |
| Infantile eczema | 1 | 0.44 | 5 | 1.72 | 2 | 0.71 |
| Diaper dermatitis | 2 | 0.88 | 2 | 0.69 | 4 | 1.42 |
| Rash | 3 | 1.32 | 2 | 0.69 | 2 | 0.71 |
| Neonatal disorder | 2 | 0.88 | 1 | 0.34 | 4 | 1.42 |
| Upper respiratory tract infection | 2 | 0.88 | 1 | 0.34 | 3 | 1.06 |
| Wheezing | 2 | 0.88 | 3 | 1.03 | 1 | 0.35 |
| Infant reflux | 1 | 0.44 | 2 | 0.69 | 3 | 1.06 |
| Otitis media | 4 | 1.76 | 1 | 0.34 | 1 | 0.35 |
| Gastroesophageal reflux disease | 4 | 1.76 | 0 | 0.00 | 1 | 0.35 |
| Heart murmur | 4 | 1.76 | 1 | 0.34 | 0 | 0.00 |
| Diarrhea | 1 | 0.44 | 0 | 0.00 | 4 | 1.42 |
| Atopic Dermatitis* | 1 | 0.44 | 3 | 1.03 | 0 | 0.00 |
| Traumatic head injury | 0 | 0.00 | 1 | 0.34 | 4 | 1.42 |
| Abdominal pain | 0 | 0.00 | 1 | 0.34 | 3 | 1.06 |
| Bronchial hyperreactivity | 0 | 0.00 | 3 | 1.03 | 0 | 0.00 |
| Decreased appetite | 0 | 0.00 | 3 | 1.03 | 0 | 0.00 |
| Pharyngotonsillitis | 0 | 0.00 | 1 | 0.34 | 3 | 1.06 |
| Umbilical hernia | 0 | 0.00 | 1 | 0.34 | 3 | 1.06 |
| Viral rash | 0 | 0.00 | 1 | 0.34 | 3 | 1.06 |
| Traumatic injury to the mouth | 1 | 0.44 | 0 | 0.00 | 3 | 1.06 |
| Total | 173 | 246 | 225 | |||
Data are expressed as counts and percentages, * p < 0.05 BFD and INN vs. STD group. For the analysis, the Chi-square test was used with the Yates correction where appropriate. Bronchitis/bronchiolitis showed a p-value of 0.029 (BFD vs. STD), 1.0 (BFD vs. INN), and 0.026 (STD vs. INN). Atopic dermatitis exhibited a p-value of 0.027 (BFD vs. STD), 1.0 (BFD vs. INN), and 0.029 (STD vs. INN).