TABLE 2.
Efficacy Results
| Parameter | SsK12 (n = 71) | Placebo (n = 72) | P |
|---|---|---|---|
| SOM (grade 3 or 4) incidence through RT, %a | 36.6 | 54.2 | .0351 |
| SOM duration, days, median/mean(SD)b | 0.0/8.9 (15.0) | 7.0/18.3 (22.5) | .0084 |
| SOM onset, days, medianc | NE | 42.0 | .0123 |
| Grade 4 OM incidence through RT, %a | 2.8 | 15.3 | .0169 |
| OM incidence through RT, %a | 62.0 | 83.3 | .0049 |
| OM duration, days, medianb | 10.5 | 40.3 | .0010 |
| OM onset, days, medianc | 28.0 | 17.5 | <.0001 |
| RT treatment breaks >five consecutive fractions, No. (%) | 1 (1.4) | 2 (2.8) |
Abbreviations: NE, not estimable; OM, oral mucositis; RT, radiotherapy; SD, standard deviation; SOM, severe OM; SsK12, S. salivarius K12.
a
χ2 test or Fisher's exact test.
b
Wilcoxon rank-sum test.
c
Log-rank test.