Table 6.
Treatment-emergent adverse events (TEAEs) registered in the study.
| Overall (n=228) |
High product dose (n=76) |
Low product dose (n=76) |
Low product dose (n=76) |
||||||||||
| |
N |
P |
% |
N |
P |
% |
N |
P |
% |
N |
P |
% |
|
| Relationship to study product | Unlikely | 3 | 2 | 0.9 | 0 | 0 | 0 | 2 | 1 | 1.3 | 1 | 1 | 1.3 |
| Unrelated | 63 | 49 | 21.5 | 24 | 19 | 25.0 | 14 | 12 | 15.8 | 25 | 18 | 23.7 | |
| Maximum intensity | Mild | 1 | 1 | 0.4 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 1 | 1.3 |
| Moderate | 57 | 43 | 18.9 | 21 | 17 | 22.4 | 15 | 11 | 14.5 | 21 | 15 | 19.7 | |
| Severe | 8 | 7 | 3.1 | 3 | 2 | 2.6 | 1 | 1 | 1.3 | 4 | 4 | 5.3 | |
High-dose group, 1 × 1010 CFU of HN019/day; low-dose group 1 × 109 CFU of HN019/day; n; number of participants by product or overall; N, number of TEAEs; P, number of participants with at least 1 TEAE; %, incidence (P/n)*100.