Baseline characteristics | Saline placebo (n=100) | Bupivacaine HCl 50 mg (n=155) | HTX-011 60 mg/1.8 mg (n=157) |
Age (years) | |||
Mean (SD) | 47.3 (12.83) | 45.5 (14.79) | 48.0 (14.47) |
Min, max | 19, 77 | 18, 77 | 18, 77 |
Sex, n (%) | |||
Female | 86 (86.0) | 132 (85.2) | 138 (87.9) |
Male | 14 (14.0) | 23 (14.8) | 19 (12.1) |
Race, n (%) | |||
American Indian or Alaskan Native | 0 | 2 (1.3) | 1 (0.6) |
Asian | 2 (2.0) | 1 (0.6) | 8 (5.1) |
Black or African descent | 12 (12.0) | 22 (14.2) | 24 (15.3) |
Native Hawaiian or another Pacific Islander | 0 | 1 (0.6) | 0 |
White | 86 (86.0) | 128 (82.6) | 123 (78.3) |
Multiple | 0 | 1 (0.6) | 1 (0.6) |
Ethnicity, n (%) | |||
Hispanic or Latino | 32 (32.0) | 49 (31.6) | 47 (29.9) |
Not Hispanic or Latino | 68 (68.0) | 106 (68.4) | 110 (70.1) |
Body mass index (kg/m2) | |||
Mean (SD) | 27.9 (5.05) | 27.2 (4.38) | 27.3 (4.79) |
Median | 27.3 | 26.7 | 26.8 |
Min, max | 17.5, 38.4 | 17.3, 38.5 | 18.3, 38.6 |
*ITT population includes all subjects who were randomized and received study drug.
HCl, hydrochloride;ITT, intent to treat.