Table 3.
Clostridioides (Clostridium) difficile Infection Relapse and Reinfection Results at Day 90 (mFAS)
| Treatment arm | EPFX | Vancomycin | Total |
|---|---|---|---|
| Patients with CDI recurrence | n = 11 | n = 34 | n = 45 |
| Patients in mFAS | 177 | 179 | 356 |
| Tested pairs, n (%)a | 7 (15.6) | 19 (42.2) | 26 (57.8) |
| Relapse (≤2 SNV) | 1 (2.2) | 3 (6.7) | 4 (8.9) |
| Reinfection (>10 SNV) | 5 (11.1) | 15 (33.3) | 20 (44.4) |
| Indeterminate (>2 but ≤10 SNV) | 1 (2.2) | 1 (2.2) | 2 (4.4) |
| No SNV results available, n (%) | 4 (8.9) | 15 (33.3) | 19 (42.2) |
Abbreviations: CDI, C difficile infection; EPFX, extended-pulsed fidaxomicin; mFAS, modified full analysis set (all randomized patients with positive local laboratory test for C difficile toxin A/B at screening who received at least one dose of study medication); SNV, single nucleotide variant.
aPercentages are calculated over the total number of patients who experienced CDI recurrence in both treatment arms.