Table 1.
Baseline demographics of safety and mITT populations
| Safety population | mITT population | |||
|---|---|---|---|---|
| Besifloxacin (n = 344) | Vehicle (n = 170) | Besifloxacin (n = 212) | Vehicle (n = 87) | |
| Age, years | ||||
| Mean (SD) | 29.6 (25.1) | 30.5 (22.5) | 27.8 (25.4) | 28.5 (21.1) |
| Range | 1–97 | 1–92 | 1–97 | 1–74 |
| Distribution of age categories, n (%) | ||||
| ≥1–<2 years | 19 (5.5) | 8 (4.7) | 19 (9.0) | 6 (6.9) |
| 2–11 years | 107 (31.1) | 38 (22.4) | 71 (33.5) | 21 (24.1) |
| 12–17 years | 22 (6.4) | 14 (8.2) | 9 (4.2) | 5 (5.7) |
| 18–29 years | 46 (13.4) | 29 (17.1) | 27 (12.7) | 13 (14.9) |
| 30–39 years | 30 (8.7) | 23 (13.5) | 16 (7.5) | 13 (14.9) |
| 40–49 years | 29 (8.4) | 20 (11.8) | 17 (8.0) | 12 (13.8) |
| 50–59 years | 38 (11.0) | 20 (11.8) | 20 (9.4) | 10 (11.5) |
| ≥60 years | 53 (15.4) | 18 (10.6) | 33 (15.6) | 7 (8.0) |
| Sex, n (%) | ||||
| Male | 140 (40.7) | 75 (44.1) | 87 (41.0) | 38 (43.7) |
| Female | 204 (59.3) | 95 (55.9) | 125 (59.0) | 49 (56.3) |
| Racial background, n (%) | ||||
| American Indian/Alaskan Native | 7 (2.0) | 3 (1.8) | 5 (2.4) | 1 (1.1) |
| Asian | 5 (1.5) | 5 (2.9) | 3 (1.4) | 2 (2.3) |
| Black/African American | 83 (24.1) | 40 (23.5) | 65 (30.7) | 30 (34.5) |
| Native Hawaiian/Pacific Islander | 0 | 1 (0.6) | 0 | 0 |
| White | 210 (61.0) | 102 (60.0) | 121 (57.1) | 49 (56.3) |
| Other | 39 (11.3) | 19 (11.2) | 18 (8.5) | 5 (5.7) |
| Ethnicity, n (%) | ||||
| Not Hispanic and Not Latino | 194 (56.4) | 101 (59.4) | 126 (59.4) | 58 (66.7) |
| Hispanic or Latino | 150 (43.6) | 69 (40.6) | 86 (40.6) | 29 (33.3) |
mITT modified Intent to Treat population