Table 1.
Proportion of Patients With Positive Result From Central Laboratory ELISA for Clostridioides (Clostridium) difficile Toxin A/B in Stool, by Study Visit (mFAS)
| Visit | EPFX (N = 177) | Vancomycin (N = 179) | Total (N = 356) | |
|---|---|---|---|---|
| Screening | n | 165 | 164 | 329 |
| Positive, n (%) | 116 (70.3) | 114 (69.5) | 230 (69.9) | |
| Negative, n (%) | 49 (29.7) | 50 (30.5) | 99 (30.1) | |
| Day 5 | n | 27 | 21 | 48 |
| Positive, n (%) | 5 (18.5) | 5 (23.8) | 10 (20.8) | |
| Negative, n (%) | 22 (81.5) | 16 (76.2) | 38 (79.2) | |
| Day 12 | n | 24 | 20 | 44 |
| Positive, n (%) | 1 (4.2) | 0 | 1 (2.3) | |
| Negative, n (%) | 23 (95.8) | 20 (100.0) | 43 (97.7) | |
| Day 27 | n | 20 | 17 | 37 |
| Positive, n (%) | 1 (5.0) | 3 (17.6) | 4 (10.8) | |
| Negative, n (%) | 19 (95.0) | 14 (82.4) | 33 (89.2) | |
| Day 40 | n | 21 | 16 | 37 |
| Positive, n (%) | 1 (4.8) | 3 (18.8) | 4 (10.8) | |
| Negative, n (%) | 20 (95.2) | 13 (81.3) | 33 (89.2) | |
| Day 55 | n | 19 | 14 | 33 |
| Positive, n (%) | 3 (15.8) | 2 (14.3) | 5 (15.2) | |
| Negative, n (%) | 16 (84.2) | 12 (85.7) | 28 (84.8) | |
| Treatment failure (unscheduled visit) | n | 2 | 3 | 5 |
| Positive, n (%) | 0 | 0 | 0 | |
| Negative, n (%) | 2 (100.0) | 3 (100.0) | 5 (100.0) | |
| Recurrence (unscheduled visit) | n | 9 | 25 | 34 |
| Positive, n (%) | 8 (88.9) | 18 (72.0) | 26 (76.5) | |
| Negative, n (%) | 1 (11.1) | 7 (28.0) | 8 (23.5) |
Abbreviations: ELISA, enzyme-linked immunosorbent assay; 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 1 dose of study medication).