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. 2019 Nov 6;6(11):ofz436. doi: 10.1093/ofid/ofz436

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.