TABLE 1.
Demographics and baseline characteristics (safety population)
| Parameter | Data by patient group (omadacycline dose)a: |
|||
|---|---|---|---|---|
| 1 (i.v. 200 mg → p.o. 300 mg [n = 11]) |
2 (p.o. 300 mg [n = 10]) |
3 (p.o. 450 mg [n = 10]) |
All patients (N = 31) |
|
| Race (n [%]) | ||||
| White | 4 (36.4) | 3 (30.0) | 4 (40.0) | 11 (35.5) |
| Black or African American | 6 (54.5) | 7 (70.0) | 6 (60.0) | 19 (61.3) |
| Asian | 1 (9.1) | 0 | 0 | 1 (3.2) |
| Female (n [%]) | 11 (100.0) | 10 (100.0) | 10 (100.0) | 31 (100.0) |
| Age (yrs) (median [range]) | 51 (20–60) | 31 (25–54) | 41 (19–75) | 38 (19–75) |
| Wt (kg) (median [range]) | 72 (47–95) | 75 (54–121) | 69 (51–111) | 72 (47–121) |
| Body mass index (kg/m2) (median [range]) | 27 (20–39) | 28 (20–43) | 27 (21–41) | 27 (20–43) |
| Medical history (n [%]) | ||||
| Postmenopausal | 5 (45.5) | 1 (10.0) | 3 (30.0) | 9 (29.0) |
| Diabetes mellitus | 0 | 1 (10.0) | 2 (20.0) | 3 (9.7) |
a
Omadacycline doses are given in parentheses after each group. i.v., intravenous; p.o., oral.