Table 3.
Summary of Changes in Renal Function of the Safety Population
| Change in Renal Function | Day 4 | Day 7 | End of Therapy | Lowest CrCla | ||||
|---|---|---|---|---|---|---|---|---|
| TLV Group (n = 592) | VAN Group (n = 610) | TLV Group (n = 420) | VAN Group (n = 430) | TLV Group (n = 684) | VAN Group (n = 698) | TLV Group (n = 696) | VAN Group (n = 703) | |
| Positive shift, no. (%) | 135 (22.8) | 179 (29.3) | 93 (22.1) | 146 (34.0) | 133 (19.4) | 205 (29.4) | 92 (13.2) | 122 (17.4) |
| % difference (95% CI) | −6.5 (−11.5, −1.6)b | −11.8 (−17.7, −5.8)b | −9.9 (−14.4, −5.4)b | −4.1 (−7.9, −0.4)b | ||||
| No shift, no. (%) | 343 (57.9) | 380 (62.3) | 247 (58.8) | 231 (53.7) | 394 (57.6) | 358 (51.3) | 380 (54.6) | 392 (55.8) |
| % difference (95% CI) | −4.4 (−9.9, 1.2) | 5.1 (−1.6, 11.7) | 6.3 (1.1, 11.5)b | −1.2 (−6.4, 4.0) | ||||
| Negative shift, no. (%) | 114 (19.3) | 51 (8.4) | 80 (19.0) | 53 (12.3) | 157 (23.0) | 135 (19.3) | 224 (32.2) | 189 (26.9) |
| % difference (95% CI) | 10.9 (7.0, 14.8)b | 6.7 (1.8, 11.6)b | 3.6 (−0.7, 7.9) | 5.3 (0.5, 10.0)b | ||||
% difference = %TLV–%VAN * 100; TLV = telavancin; VAN = vancomycin; CrCl = creatinine clearance; CI = confidence interval.
a
Lowest CrCl was estimated from serum creatinine concentration measured at any time after baseline (including times not reported in this analysis).
b
Statistically significant difference (95% CI does not include zero).