Table 7.
Patients with adverse events of special interest in phase II/III clinical development program
| Dalbavancin | Comparator | |
|---|---|---|
| Infusion-associated AEs | 40/1778 (2.2) | 38/1224 (3.1) |
| Number of infusion-associated events | 48 | 55 |
| Number of events on day of active infusion | 12 | 53 |
| Renal-associated AEs | 33/1778 (1.9) | 24/1224 (2.0) |
| Treatment-related renal-associated AEs | 3 (0.2) | 5 (0.4) |
| Serious renal-associated AEs | 3 (0.2) | 6 (0.5) |
| Treatment-related serious renal-associated AEs | 0 | 3 (0.2) |
| Hepatobiliary AEs | 19/1778 (1.1) | 9/1224 (0.7) |
| Treatment-related treatment-emergent hepatobiliary AEs | 6 (0.3) | 1 (0.1) |
| Serious treatment-emergent hepatobiliary AEs | ||
| All treatment-emergent hepatobiliary AEs | 3 (0.2) | 2 (0.2) |
| Treatment-related hepatobiliary AEs | 0 | 0 |
| TEAE by age, sex, or race | ||
| <65 years of age | 641/1465 (43.8) | 465/995 (46.7) |
| ≥65 years of age | 158/313 (50.5) | 108/229 (47.2) |
| Male | 449/1066 (42.1) | 308/711 (43.3) |
| Female | 350/712 (49.2) | 265/513 (51.7) |
| White | 579/1388 (41.7) | 448/1008 (44.4) |
| Black | 90/143 (62.9) | 58/88 (65.9) |
| Other | 130/247 (52.6) | 67/127 (52.8) |
Data are presented as n (%) or n/N (%) unless otherwise indicated
AE adverse event, TEAE treatment-emergent adverse event