Table 4.
Adverse events in phase II/III clinical development program
| Dalbavancin (N = 1778) | Comparator (N = 1224) | p value | |
|---|---|---|---|
| Patients with the AE | |||
| TEAEa | 799 (44.9) | 573 (46.8) | 0.012 |
| Treatment-related TEAEa | 328 (18.4) | 246 (20.1) | 0.014 |
| Serious AEs | 109 (6.1) | 80 (6.5) | 0.266 |
| Serious treatment-related AEs | 3 (0.2) | 9 (0.7) | 0.021 |
| Discontinuation due to a TEAEa | 53 (3.0) | 35 (2.9) | 0.857 |
| Discontinuation due to a serious TEAEa | 22 (1.2) | 13 (1.1) | 0.660 |
| Death | 10 (0.6) | 14 (1.1) | 0.087 |
| Number of AEs | |||
| AEs, N (N/patient) | 2386 (1.34) | 1739 (1.42) | |
| Treatment-related AEsb (N, % of total) | 566 (23.7) | 459 (26.4) | 0.0004 |
| Serious AEs (N, % of total) | 135 (5.7) | 100 (5.8) | NS |
| Serious treatment-related AEsc (N, % of total) | 3 (0.1) | 9 (0.5) | 0.036 |
Data are presented as N (%) unless otherwise indicated
AE adverse event, NS not significant, TEAE treatment-emergent adverse event
aCochran–Mantel–Haenszel analysis, adjusted for study
bLog-normal, Poisson regression model adjusted by study on total number of treatment-related adverse events per patient
cFisher’s exact test