TABLE 5.
Adverse events and severe adverse events registered during the study
| Probiotic, n (%) | Placebo, n (%) | |
|---|---|---|
| All subjects with AEs | 188 (42.0) | 184 (40.9) |
| Subjects with AEs not related to the study product | 176 (39.3) | 175 (38.9) |
| Subjects with AEs related to the study product | 12 (2.7) | 9 (2.0) |
| Definite1 | 0 (0) | 0 (0) |
| Probable1 | 2 (0.4) | 0 (0) |
| Possible1 | 7 (1.6) | 8 (1.8) |
| Not assessable1 | 3 (0.7) | 1 (0.2) |
| Subjects with SAEs | 2 (0.4) | 2 (0.4) |
Data are in the intent-to-treat population (including all subjects irrespective of having reported a cold or not). Results show number of participants that reported adverse or severe adverse events in each study group and the corresponding frequency among randomized subjects in the respective group, n (%). Randomized subjects were n = 448 in the probiotic group and n = 450 in the placebo group. Abbreviations: AE, adverse event; SAE, severe adverse event.
1The association of AEs to the study product was either definite, probable, possible, or could not be assessed.