Table 3.
Adverse event and nephrotoxicity rates across the 3 clinical trials in patients with acute bacterial skin and skin structure infections
| Patients | Dalbavancin | Vancomycinc | P valued | ||
|---|---|---|---|---|---|
| Single dosea (N = 349) n/N1 (%) |
Two dosesb (N = 998) n/N1 (%) |
Totalb (N = 1347) n/N1 (%) |
(N = 651) n/N2 (%) |
||
| Patients (safety population) experiencing a TEAE (n/N) | 70/349 (20.1) | 283/998 (28.4) | 353/1347 (26.2) | 247/651 (37.9) | < 0.0001 |
| All patients experiencing a TEAE | 69/345 (20.0) | 278/980 (28.4) | 347/1325 (26.2) | 25/54 (46.3) | 0.0011 |
| TEAE leading to premature discontinuation of study drug | 5/345 (1.4) | 18/980 (1.8) | 23/1325 (1.7) | 0 | 0.3291 |
| Drug-related TEAE | 24/345 (7.0) | 104/980 (10.6) | 128/1325 (9.7) | 3/54 (5.6) | 0.3134 |
| Serious TEAE | 7/345 (2.0) | 21/980 (2.1) | 28/1325 (2.1) | 7/54 (13.0) | < 0.0001 |
| Nephrotoxicity on therapye | |||||
| All dalbavancin patients vs patients intravenously administered vancomycin only | 15/345 (4.3) | 34/980 (3.5) | 49/1325 (3.7) | 5/54 (9.3) | 0.039 |
| Patients receiving IV treatment onlyf | NA | 1/58 (1.7) | 1/58 (1.7) | 5/54 (9.3) | 0.0781 |
IV intravenous, N safety population, N1 safety population with all creatinine values available, N2 safety population with all creatinine values available in patients who received vancomycin for at least 10 days, NA not applicable, ND not determined, TEAE treatment-emergent adverse event
aDUR001-303
bDISCOVER trials and DUR001-303
cDISCOVER trials
dP value for total dalbavancin vs vancomycin
eNephrotoxicity was defined as a 50% increase in serum creatinine levels from baseline or an absolute increase in serum creatinine of 0.5 mg/dL; Cochran–Mantel–Haenszel test for significance
fPatients who received only intravenously administered vancomycin with a duration ≥ 10 days and did not receive blinded oral therapy