Table 1.
Frequency of adverse and serious adverse events reported by group
| Days 0–10 (During Intervention) | Days 11–180 (Post-Intervention) | |||||
|---|---|---|---|---|---|---|
| Adverse Event | Control | BB-12® | Total | Control | BB-12® | Total |
| Allergies (e.g. seasonal) | 1 | 2 | 3 | 1 | 3 | 4 |
| Broken finger | 1 | 1 | ||||
| Bronchiolitis | 1 | 1 | ||||
| Cold | 2 | 2 | 2 | 1 | 3 | |
| Constipation | 3 | 3 | 2 | 1 | 3 | |
| Cough | 5 | 10 | 15 | 1 | 5 | 6 |
| Croup | 1 | 1 | ||||
| Cut finger | 1 | 1 | ||||
| Diarrhea | 2 | 2 | 4 | 2 | 5 | 7 |
| Ear aches | 1 | 1 | ||||
| Ear infection | 2 | 1 | 3 | |||
| Fever | 2 | 2 | 2 | 3 | 5 | |
| Flatulence | 2 | 2 | 4 | 1 | 1 | 2 |
| Headache | 1 | 1 | ||||
| Hives | 1 | 1 | ||||
| Irritability | 4 | 1 | 5 | 3 | 5 | 8 |
| Laceration | 1 | 1 | ||||
| Lack of/decreased appetite | 2 | 2 | 4 | 3 | 1 | 4 |
| Lethargy | 1 | 5 | 6 | |||
| Loose stool | 2 | 6 | 8 | 3 | 3 | 6 |
| Lump on back of head | 1 | 1 | ||||
| Nasal congestion | 4 | 6 | 10 | 2 | 2 | |
| Pain | 2 | 1 | 3 | 2 | 2 | |
| Physical injury | 1 | 1 | ||||
| Pink eye | 1 | 1 | ||||
| Pneumonia | 1 | 1 | ||||
| Rash | 2 | 2 | 1 | 2 | 3 | |
| Runny nose | 6 | 12 | 18 | 6 | 9 | 15 |
| Skin infection | 1 | 1 | ||||
| Sore foot | 1 | 1 | ||||
| Sore throat | 1 | 2 | 3 | |||
| Strep throat | 1 | 1 | ||||
| Umbilical hernia | 1 | 1 | ||||
| Vomiting | 2 | 2 | 1 | 2 | 3 | |
| Total | 35 | 61 | 96 | 38 | 52 | 90 |
| Serious adverse eventsa | 1 | 1 | 2 | 2 | ||
a
Serious adverse events included: grade 4/potentially life-threatening fever reported on day 2; grade 4/potentially life-threatening bronchiolitis reported at day 180; and grade 4/potentially life-threatening pneumonia reported at day 180. All serious adverse events were unrelated to the interventions and resolved.