Table 2.
Demographics of patients enrolled in phase II/III clinical development program
| Dalbavancin (N = 1778) | Comparator (N = 1224) | |
|---|---|---|
| Age (years) | ||
| N | 1778 | 1224 |
| Mean | 48.3 | 49.2 |
| SD | 16.44 | 16.51 |
| Median | 47.0 | 49.0 |
| Min; max | 16; 93 | 18; 92 |
| Age distribution (years) | ||
| <65 | 1465 (82.4) | 995 (81.3) |
| ≥65 | 313 (17.6) | 229 (18.7) |
| Sex | ||
| Male | 1066 (60.0) | 711 (58.1) |
| Female | 712 (40.0) | 513 (41.9) |
| Race | ||
| Whitea | 1388 (78.1) | 1008 (82.4) |
| Black or African American | 143 (8.0) | 88 (7.2) |
| Asiana | 36 (2.0) | 41 (3.3) |
| American Indian or Alaska Native | 5 (0.3) | 4 (0.3) |
| Native Hawaiian or other Pacific Islander | 1 (0.1) | 1 (0.1) |
| Othera | 205 (11.5) | 82 (6.7) |
| Body mass index (kg/m2) | ||
| N | 1761 | 1218 |
| Mean | 29.9 | 29.4 |
| SD | 8.18 | 7.96 |
| Median | 27.9 | 27.8 |
| Min; max | 14; 98 | 14; 91 |
| Body mass index distribution (kg/m2) | ||
| <18.5 | 23 (1.3) | 18 (1.5) |
| 18.5 to <25 | 465 (26.2) | 359 (29.3) |
| ≥25 | 1273 (71.6) | 841 (68.7) |
| Unknown | 17 (1.0) | 6 (0.5) |
| Indication | ||
| cSSSI/ABSSSIa | 1294 (72.8) | 973 (79.5) |
| uSSSIa | 444 (25.0) | 217 (17.7) |
| Catheter-related bloodstream infections | 40 (2.2) | 34 (2.8) |
| Locationa | ||
| North America | 1143 (64.3) | 689 (56.3) |
| Eastern Europe and South Africa | 395 (22.2) | 389 (31.8) |
| Western Europe | 216 (12.1) | 118 (9.6) |
| Asia–Pacific | 24 (1.3) | 28 (2.3) |
| Temperature ≥38 °C at baselineb, n/N (%) | 549/649 (84.6) | 552/649 (85.0) |
| Median (range)a infection area (cm2) | 324 (26–5100) | 367 (72–3922) |
Data are presented as N (%) unless otherwise indicated
ABSSSI acute bacterial skin and skin structure infection, cSSSI complicated skin and skin structure infection, SD standard deviation, uSSSI uncomplicated skin and skin structure infection
aComparisons with p < 0.05 by Fisher’s exact test
bAmong patients in the ABSSSI studies