Table 2.
Summary of demographics and baseline characteristics (safety population)
| Characteristic | DUR001-301 | DUR001-302 | DUR001-303 | ||
|---|---|---|---|---|---|
| Dalbavancin (n = 284) | Comparator (n = 284) | Dalbavancin (n = 368) | Comparator (n = 367) | Dalbavancin (n = 695) | |
| Demographics | |||||
| Mean (SD) age, years | 48.8 (15.4) | 48.9 (15.1) | 49.0 (16.5) | 51.4 (16.2) | 48.2 (14.8) |
| Male, n (%) | 168 (59.2) | 173 (60.9) | 220 (59.8) | 201 (54.8) | 406 (58.4) |
| Race, n (%)a | |||||
| White | 261 (91.9) | 259 (91.2) | 326 (88.6) | 319 (86.9) | 621 (89.4) |
| Black/African American | 15 (5.3) | 18 (6.3) | 13 (3.5) | 17 (4.6) | 59 (8.5) |
| Asian | 1 (0.4) | 2 (0.7) | 26 (7.1) | 30 (8.2) | 4 (0.6) |
| Mean (SD) BMI, kg/m2 | 29.9 (8.1) | 29.0 (7.0) | 28.8 (6.4) | 29.1 (7.3) | 28.9 (7.4) |
| Prior medical history related to renal function, n (%) | |||||
| Diabetes mellitusa | 42 (14.8) | 30 (10.5) | 34 (9.2) | 62 (16.9) | 78 (11.2) |
| Acute renal failure | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
| Chronic renal failure | 1 (0.4) | 1 (0.4) | 1 (0.3) | 1 (0.3) | 0 (0.0) |
| Acute kidney injury | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 1 (0.1) |
| Hypertension | 69 (24.3) | 81 (28.5) | 93 (25.3) | 101 (27.5) | 183 (26.3) |
| Anemia | 9 (3.2) | 5 (1.8) | 9 (2.4) | 12 (3.3) | 11 (1.6) |
| CrCl | |||||
| < 30 mL/min, n (%) | 11 (3.9) | 8 (2.8) | 9 (2.4) | 7 (1.9) | 9 (1.3) |
| Mean (SD), mL/min | 89.3 (37.1) | 91.8 (36.7) | 89.3 (35.8) | 92.5 (39.2) | 95.9 (36.3) |
| Prior (within 30 days of study start) medications known to affect renal function, n (%) | |||||
| Aminoglycoside antibiotics | 0 (0.0) | 0 (0.0) | 0 (0.0) | 1 (0.3) | 0 (0.0) |
| Beta lactam antibiotics | 1 (0.4) | 3 (1.1) | 7 (1.9) | 9 (2.5) | 22 (3.2) |
| Ibuprofen | 8 (2.8) | 8 (2.8) | 12 (3.3) | 8 (2.2) | 14 (2.0) |
| Metformin | 0 (0.0) | 1 (0.4) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
BMI body mass index, CrCl creatinine clearance
aDiabetes mellitus based on the following preferred terms: diabetes mellitus, diabetes mellitus inadequate control, diabetic foot, diabetic nephropathy, gestational diabetes, type 1 diabetes mellitus, type 2 diabetes mellitus