Table 8.
Selected laboratory measurements (phase II/III clinical development program)
| Organ system | Parameter | Criteria, post-baseline | Dalbavancin | Comparator |
|---|---|---|---|---|
| Renal | Creatinine | ≥1.5 × ULN and ≥twofold ↑ | 3 (0.2) | 6 (0.6) |
| >ULN but normal at baseline* | 51 (3.6) | 63 (6.6) | ||
| >ULN but high at baseline | 69 (46.3) | 63 (52.5) | ||
| Hematologic | Hematocrit | ≤0.8 × LLN and ≥0.25-fold ↓ | 5 (0.3) | 4 (0.4) |
| Platelets | ≤0.6 × LLN and ≥0.4-fold ↓ | 2 (0.1) | 4 (0.4) | |
| WBC | ≤0.5 × LLN and ≥0.75-fold ↓ | 1 (0.1) | 1 (0.1) | |
| Hepatic | ||||
| All patients | ALT | Total | 1707 | 1186 |
| >ULN** | 417 (24.4) | 307 (25.9) | ||
| >3 × ULN | 44 (2.6) | 31 (2.6) | ||
| >5 × ULN | 9 (0.5) | 9 (0.8) | ||
| >10 × ULN | 4 (0.2) | 2 (0.2) | ||
| Normal baseline | ALT | Total | 1437 | 975 |
| >ULN** | 218 (15.2) | 139 (14.3) | ||
| >3 × ULN | 12 (0.8) | 2 (0.2) | ||
| >5 × ULN | 5 (0.3) | 1 (0.1) | ||
| >10 × ULN | 3 (0.2) | 0 | ||
| Elevated baseline | ALT | Total | 237 | 197 |
| >ULN** | 173 (73.0) | 155 (78.7) | ||
| >3 × ULN | 30 (12.7) | 28 (14.2) | ||
| >5 × ULN | 4 (1.7) | 8 (4.1) | ||
| >10 × ULN | 1(0.4) | 2 (1.0) | ||
ALT alanine aminotransferase, LLN lower limit of normal, ULN upper limit of normal, WBC white blood cell
* p = 0.001, ** p > 0.05