Table 9.
Summary of total adverse events for patients receiving >10 days of active or placebo intravenous dosing in DISCOVER
| Number of patients who experienced at least one | Dalbavancin (N = 61) | Vancomycin (N = 54) | p value |
|---|---|---|---|
| TEAE | 18 (29.5) | 25 (46.3) | 0.08 |
| TEAE leading to premature discontinuation of study drug | 1 (1.6) | 0 | 1.0 |
| Drug-related TEAE | 3 (4.9) | 3 (5.6) | 1.00 |
| Serious TEAE | 1 (1.6) | 7 (13.0) | 0.03 |
| Serious TEAE leading to premature study drug discontinuation | 0 | 0 | 1.0 |
| Drug-related serious TEAE | 0 | 0 | 1.0 |
| Serious TEAE leading to death | 0 | 1 (1.9) | 0.23 |
| Nephrotoxicity on therapya | |||
| Safety population | 21/637 (3.3) | 31/638 (4.9) | 0.16 |
| All dalbavancin patients versus IV vancomycin only | 21/637 (3.3) | 5/54 (9.3) | 0.06 |
| Patients who received only IV therapy and no oral therapyb | 1/58 (1.7) | 5/54 (9.3) | 0.21 |
Data are presented as n (%) unless otherwise indicated
IV intravenous, TEAE treatment-emergent adverse event
aNephrotoxicity defined as a 50 % increase from baseline serum creatinine or an absolute increase in serum creatinine of 0.5 mg/dl; p value by Fischer’s exact test
bDalbavancin-active (and IV vancomycin-placebo) versus IV vancomycin-active (and dalbavancin-placebo) without receiving oral linezolid/placebo