Table 3.
Demographic and Other Baseline Characteristics (All Participants as Treated)
| Characteristic | Bezlotoxumab (N = 107) | Placebo (N = 36) | Total (N = 143) | |||
|---|---|---|---|---|---|---|
| Sex, n (%) | ||||||
| Male | 57 | (53.3) | 18 | (50.0) | 75 | (52.4) |
| Female | 50 | (46.7) | 18 | (50.0) | 68 | (47.6) |
| Age (years) | ||||||
| 1 to <6 | 37 | (34.6) | 13 | (36.1) | 50 | (35.0) |
| 6 to <12 | 26 | (24.3) | 7 | (19.4) | 33 | (23.1) |
| 12 to <18 | 44 | (41.1) | 16 | (44.4) | 60 | (42.0) |
| Median (range) | 10.0 | (1-17) | 8.0 | (1-17) | 9.0 | (1-17) |
| Race, n (%) | ||||||
| American Indian/Alaska Native | 2 | (1.9) | 0 | (0.0) | 2 | (1.4) |
| Asian | 3 | (2.8) | 2 | (5.6) | 5 | (3.5) |
| Black or African American | 6 | (5.6) | 1 | (2.8) | 7 | (4.9) |
| Multiraciala | 9 | (8.4) | 1 | (2.8) | 10 | (7.0) |
| White | 83 | (77.6) | 32 | (88.9) | 115 | (80.4) |
| Hispanic or Latino, n (%) | 28 | (26.2) | 8 | (22.2) | 36 | (25.2) |
| Weight (kg), median (range) | 30.1 | (7.8-108.0) | 24.2 | (8.8-116.9) | 27.0 | (7.8-116.9) |
| Primary treatment for baseline CDI episode, n (%) | ||||||
| Vancomycin—enteral/oral | 44 | (41.1) | 15 | (41.7) | 59 | (41.3) |
| Fidaxomicin—enteral/oral | 14 | (13.1) | 5 | (13.9) | 19 | (13.3) |
| Metronidazole—enteral/oral | 47 | (43.9) | 16 | (44.4) | 63 | (44.1) |
Abbreviation: CDI, Clostridioides difficile infection.
aAll multiracial participants were Black/African American and White.