Patient demographics at baseline
| Safety evaluable population | Per protocol population | |||||
|---|---|---|---|---|---|---|
| Levofloxacin | Placebo | p Value* | Levofloxacin | Placebo | p Value* | |
| *Based on analysis of variance for age and Mantel-Haenszel χ2 test for sex and race. | ||||||
| Patients (n) | 124 | 120 | 60 | 57 | ||
| Age (years) | ||||||
| Mean (SD) | 34.5 (20.2) | 33.8 (21.6) | 0.810 | 31.4 (22.3) | 31.6 (23.0) | 0.959 |
| Range | 2–91 | 2–86 | 2–91 | 2–76 | ||
| Subgroups; n (%) | ||||||
| >16 years | 98 (79.0) | 89 (74.2) | 41 (68.3) | 37 (64.9) | ||
| 12–16 years | 7 (5.6) | 9 (7.5) | 3 (5.0) | 3 (5.3) | ||
| 2–11 years | 19 (15.3) | 22 (18.3) | 16 (26.7) | 17 (29.8) | ||
| Sex: n (%) | ||||||
| Female | 78 (62.9) | 61 (50.8) | 0.058 | 38 (63.3) | 25 (43.9) | 0.036 |
| Male | 46 (37.1) | 59 (49.2) | 22 (36.7) | 32 (56.1) | ||
| Race: n (%) | ||||||
| White | 94 (75.8) | 94 (78.3) | 44 (73.3) | 46 (80.7) | ||
| Black | 30 (24.2) | 26 (21.7) | 10 (16.7) | 6 (10.5) | ||
| Hispanic | 15 (12.1) | 6 (5.0) | 0.258 | 5 (8.3) | 3 (5.3) | 0.654 |
| Asian | 1 (0.8) | 1 (0.8) | 0 (0) | 1 (1.8) | ||
| Other | 2 (1.6) | 1 (0.8) | 1 (1.7) | 1 (1.8) | ||