Table 5.
Treatment-emergent adverse events (safety population).
| Adverse event, n (%) | PWID (n=211) | Non-PWID (n=484) | ||
|---|---|---|---|---|
|
| ||||
| Dalbavancin Single-dose (n=105) | Dalbavancin 2-dose (n=106) | Dalbavancin Single-dose (n=244) | Dalbavancin 2-dose (n=240) | |
| Patients experiencing ≥1 | ||||
| TEAE | 22 (21.0) | 23 (21.7) | 48 (19.7) | 46 (19.2) |
| Drug-related TEAE | 9 (8.6) | 5 (4.7) | 16 (6.6) | 21 (8.8) |
| Serious TEAE | 2 (1.9) | 1 (0.9) | 5 (2.0) | 4 (1.7) |
| Death | 1 (1.0) | 0 (0) | 0 (0) | 1 (0.4) |
| TEAE leading to premature discontinuation of study drug | 1 (1.0) | 0 (0) | 5 (2.0) | 5 (2.1) |
|
| ||||
| TEAE ≥1% | ||||
| Headache | 4 (3.8) | 3 (2.8) | 2 (0.8) | 1 (0.4) |
| Nausea | 3 (2.9) | 1 (0.9) | 9 (3.7) | 6 (2.5) |
| Hypersensitivity | 2 (1.9) | 0 (0) | 0 (0) | 2 (0.8) |
| Infusion site extravasation | 2 (1.9) | 0 (0) | 0 (0) | 1 (0.4) |
| Skin abrasion | 2 (1.9) | 0 (0) | 0 (0) | 0 (0) |
| Diarrhea | 1 (1.0) | 2 (1.9) | 3 (1.2) | 0 (0) |
| Vomiting | 1 (1.0) | 1 (0.9) | 5 (2.0) | 2 (0.8) |
| Cellulitis | 0 (0) | 3 (2.8) | 1 (0.4) | 2 (0.8) |
| Chills | 0 (0) | 2 (1.9) | 0 (0) | 2 (0.8) |
| Dizziness | 0 (0) | 0 (0) | 4 (1.6) | 0 (0) |
| Localized infection | 0 (0) | 3 (2.8) | 0 (0) | 2 (0.8) |
|
| ||||
| Nephrotoxicity on therapya | ||||
| 48–72 hours | 2/98 (2.0) | 0/97 (0.0) | 3/235 (1.3) | 7/234 (3.0) |
| Day 14 | 0/88 (0.0) | 3/91 (3.3) | 6/219 (2.7) | 6/221 (2.7) |
PWID, persons who inject drugs; TEAE, treatment-emergent adverse event.
a
Nephrotoxicity defined as a 50% increase from baseline serum creatinine or an absolute increase in serum creatinine of 0.5 mg/dL.