Table 4.
Objective Responder at 48–72 Hours by Subgroup: Pooled Phase III Intent to Treat Analysis Set
| Delafloxacin | Vancomycin/Aztreonam | |
|---|---|---|
| (n = 754) | (n = 756) | |
| Subpopulation | [n/N1 (%)]a | [n/N1 (%)]a |
| Age | ||
| ≤65 | 538/653 (82.4) | 543/661 (82.1) |
| >65 | 75/101 (74.3) | 67/95 (70.5) |
| Gender | ||
| Male | 381/468 (81.4) | 397/485 (81.9) |
| Female | 232/286 (81.1) | 213/271 (78.6) |
| Ethnicity, N1 | ||
| Hispanic or Latino, n/N1 (%) | 201/233 (86.3) | 170/202 (84.2) |
| Not Hispanic or Latino | 412/521 (79.1) | 440/554 (79.4) |
| Race | ||
| American Indian or Alaska Native | 13/17 (76.5) | 9/9 (100.0) |
| Asian | 6/12 (50.0) | 11/16 (68.8) |
| Black or African American | 32/40 (80.0) | 33/37 (89.2) |
| Native Hawaiian or Other Pacific Islander | 3/3 (100.0) | 2/4 (50.0) |
| White | 530/645 (82.2) | 537/659 (81.5) |
| Other | 29/37 (78.4) | 18/31 (58.1) |
| Region, n (%) | ||
| Asia | 4/9 (44.4) | 9/14 (64.3) |
| Europe | 178/228 (78.1) | 174/228 (76.3) |
| Latin America | 38/47 (80.9) | 31/44 (70.5) |
| North America | 393/473 (83.6) | 396/470 (84.3) |
| Diabetes | ||
| Yes | 63/83 (75.9) | 63.81 (77.8) |
| No | 550/671 (82.0) | 547/675 (81.0) |
| Baseline infection type | ||
| Abscess | 166/190 (87.4) | 165/189 (87.3) |
| Cellulitis/Erysipelas | 244/330 (73.9) | 246/334 (73.7) |
| Wound | 198/227 (87.2) | 196/228 (86.0) |
| Burn | 5/7 (71.4) | 3/5 (60.0) |
| Prior antibiotic use | ||
| Yes | 104/141 (73.8) | 142/182 (78.0) |
| No | 509/613 (83.0) | 468/574 (81.5) |
| Bacteremia at baseline | ||
| Yes | 12/17 (70.6) | 10/17 (58.8) |
| No | 601/737 (81.5) | 600/739 (81.2) |
| Baseline erythema areab | ||
| Quartile 1 | 164/188 (87.2) | 164/186 (88.2) |
| Quartile 2 | 152/184 (82.6) | 157/190 (82.6) |
| Quartile 3 | 164/196 (83.7) | 142/178 (79.8) |
| Quartile 4 | 133/175 (76.0) | 147/199 (73.9) |
| Surgical procedure ≤72 hours from start of study drug | ||
| With surgical procedure | 35/45 (77.8) | 37/48 (77.1) |
| Without surgical procedure | 578/709 (81.5) | 573/708 (80.9) |
Results are based on data closest to and through 72 hours within a window of 48–72 hours (+/- 2 hour window for each visit).
aN1 = number of intent-to-treat patients in each subgroup.
bOnly subjects with baseline erythema area information were included. Baseline erythema size is defined as area of erythema from the digital planimetry prior/closest to first dose. The total baseline erythema size is divided into quartiles, with quartile 1 0-25%, quartile 2 > 25–50%, quartile 3 > 50–75%, and quartile 4 > 75–100%. Quartiles were calculated for individual studies and pool analysis respectively.