Table 1.
Demographic and baseline characteristics
| Characteristic [statistic]a | ITT population |
CE population |
||
|---|---|---|---|---|
| Solithromycin 800/400 mg (N = 65) | Levofloxacin 750 mg (N = 67) | Solithromycin 800/400 mg (N = 55) | Levofloxacin 750 mg (N = 58) | |
| Patients in each country [n (%)] | ||||
| United States | 63 (96.9) | 63 (94.0) | 54 (98.2) | 54 (93.1) |
| Canada | 2 (3.1) | 4 (6.0) | 1 (1.8) | 4 (6.9) |
| Age (yr) | ||||
| Mean ± SD | 56.0 ± 13.0 | 55.2 ± 14.1 | 56.5 ± 13.2 | 54.8 ± 14.4 |
| Range | 25–87 | 18–79 | 25–87 | 18–79 |
| ≥65 [n (%)] | 19 (29.2) | 17 (25.4) | 16 (29.1) | 15 (25.9) |
| Race [n (%)] | ||||
| White | 55 (84.6) | 54 (80.6) | 45 (81.8) | 46 (79.3) |
| Asian | 5 (7.7) | 6 (9.0) | 5 (9.1) | 5 (8.6) |
| Black | 3 (4.6) | 6 (9.0) | 3 (5.5) | 6 (10.3) |
| American Indian or Alaskan Native | 1 (1.5) | 0 (0.0) | 1 (1.8) | 0 (0.0) |
| Native Hawaiian/other Pacific Islander | 1 (1.5) | 0 (0.0) | 1 (1.8) | 0 (0.0) |
| Other | 0 (0.0) | 1 (1.5) | 0 (0.0) | 1 (1.7) |
| Ethnicity [n (%)] | ||||
| Non-Hispanic or Latino | 54 (83.1) | 56 (83.6) | 46 (83.6) | 48 (82.8) |
| Hispanic or Latino | 11 (16.9) | 11 (16.4) | 9 (16.4) | 10 (17.2) |
| Gender [n (%)] | ||||
| Male | 28 (43.1) | 39 (58.2) | 25 (45.5) | 34 (58.6) |
| Female | 37 (56.9) | 28 (41.8) | 30 (54.5) | 24 (41.4) |
| BMIb (kg/m2) | ||||
| Mean ± SD | 30.4 ± 7.5 | 28.6 ± 6.6 | 30.5 ± 7.3 | 27.9 ± 6.1 |
| Range | 14.1, 64.5 | 15.5, 52.6 | 14.1, 64.5 | 15.5, 46.2 |
| PORT score risk class [n (%)] | ||||
| I (0–50) | 2 (3.1) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
| II (51–70) | 47 (72.3) | 50 (74.6) | 39 (70.9) | 44 (75.9) |
| III (71–90) | 12 (18.5) | 15 (22.4) | 12 (21.8) | 13 (22.4) |
| IV (91–105) (IVa + IVb) | 4 (6.2) | 2 (3.0) | 4 (7.3) | 1 (1.7) |
| IVa (91–98) | 3 (4.6) | 1 (1.5) | 3 (5.5) | 0 (0.0) |
| IVb (99–105) | 1 (1.5) | 1 (1.5) | 1 (1.8) | 1 (1.7) |
| Enrolled as a prior treatment failure [n (%)] | 6 (9.2) | 4 (6.0) | 6 (10.9) | 4 (6.9) |
a
n, number of patients with characteristic; N, number of patients in the specified population; %, 100 × (n/N).
b
BMI, body mass index.