Table 3.
Subgroup analyses for primary endpoint (mITT Set)
| Subgroup | Clinical cure, n/N (%) | Rate difference (%), 95% CI | P value | |
|---|---|---|---|---|
| Ibrexafungerp | Placebo | |||
| Body mass index | ||||
| < 28 kg/m2 | 120/228 (52.6) | 29/110 (26.4) | 26.3 (15.01, 37.09) | < 0.001 |
| ≥ 28 kg/m2 | 2/11 (18.2) | 2/11 (18.2) | 0.0 (− 43.56, 43.56) | 1.000 |
| Diagnosis of diabetes | ||||
| Yes | 6/7 (85.7) | 2/3 (66.7) | 19.0 (− 47.08, 78.59) | 0.490 |
| No | 116/232 (50.0) | 29/118 (24.6) | 25.4 (14.49, 36.06) | < 0.001 |
| Severity of VVC | ||||
| Mild-to-moderate (VSS score < 7) | 102/195 (52.3) | 29/106 (27.4) | 24.9 (13.27, 36.15) | < 0.001 |
| Severe (VSS score ≥ 7) | 20/44 (45.5) | 2/15 (13.3) | 32.1 (2.14, 58.12) | 0.026 |
| Candida species at screeninga | ||||
| C. albicans | 88/161 (54.7) | 15/75 (20.0) | 34.7 (21.31, 47.17) | < 0.001 |
| C. glabrata | 26/60 (43.3) | 13/38 (34.2) | 9.1 (− 11.21, 28.95) | 0.369 |
| C. krusei | 3/9 (33.3) | 2/4 (50.0) | − 16.7 (− 70.15, 43.30) | 0.569 |
CI confidence interval, VVC vulvovaginal candidiasis, VSS vulvovaginal signs and symptoms
aSubgroup analyses would not be performed for subgroups containing fewer than ten patients