Table 3.
Laboratory variables
| Variables | Part A | Part B | ||
|---|---|---|---|---|
| Clazakizumab (n=10) | Placebo (n=10) | P Value | Clazakizumab (n=18) | |
| Liver parameters | ||||
| ALT levels (U/L) | ||||
| Highest level, median (IQR) | 29 (23–39) | 24 (18–36) | 0.39 | 30 (23–43) |
| >1–3 ULN, n (%) | 1 (10) | 1 (10) | 1 (5.6) | |
| >3–5 ULN, n (%) | 0 | 0 | 2 (11.1) | |
| >5–8 ULN, n (%) | 0 | 0 | 0 | |
| AST levels (U/L) | ||||
| Highest level, median (IQR) | 26 (22–34) | 28 (25–34) | 0.68 | 28 (24–35) |
| >1–3 ULN, n (%) | 1 (10) | 0 | 2 (11.1) | |
| >3–5 ULN, n (%) | 0 | 0 | 0 | |
| >5–8 ULN, n (%) | 0 | 0 | 0 | |
| Total bilirubin levels (mg/dl) | ||||
| Highest level, median (IQR) | 0.69 (0.41–0.94) | 0.38 (0.31–0.55) | 0.052 | 0.56 (0.43–1.0) |
| >1–3 ULN, n (%) | 0 | 0 | 3 (16.7) | |
| >3–5 ULN, n (%) | 0 | 0 | 0 | |
| >5–8 ULN, n (%) | 0 | 0 | 0 | |
| Blood count | ||||
| Hemoglobin levels (g/dl) | ||||
| Level at nadir, median (IQR) | 11.4 (9.8–12.2) | 9.4 (8.4–10.7) | 0.023 | 9.8 (8.5–11.0) |
| Anemia grade at nadir, n (%)a | ||||
| 0 | 1 (10) | 0 | 1 (5.6) | |
| I | 7 (70) | 3 (30) | 8 (44.4) | |
| II | 1 (10) | 6 (60) | 6 (33.3) | |
| IIII | 1 (10) | 1 (10) | 3 (16.7) | |
| IV | 0 | 0 | 0 | |
| Leukocyte count (x109/L) | ||||
| Level at nadir, median (IQR) | 5.3 (3.8–6.7) | 4.7 (3.3–8.9) | 0.80 | 4.6 (3.3–6.1) |
| Leukopenia grade at nadir, n (%)a | ||||
| 0 | 8 (80) | 5 (50) | 10 (55.6) | |
| I | 2 (20) | 5 (50) | 8 (44.4) | |
| II | 0 | 0 | 0 | |
| IIII | 0 | 0 | 0 | |
| IV | 0 | 0 | 0 | |
| Platelet count (x109/L) | ||||
| Level at nadir, median (IQR) | 172 (131–207) | 226 (130–284) | 0.14 | 162 (136–213) |
| Thrombocytopenia grade at nadir, na (%) | ||||
| 0 | 6 (60) | 7 (70) | 10 (55.6) | |
| I | 4 (40) | 3 (30) | 7 (38.9) | |
| II | 0 | 0 | 1 (5.6) | |
| IIII | 0 | 0 | 0 | |
| IV | 0 | 0 | 0 | |
| Lipids (unfasted) | ||||
| Cholesterol (mg/dl) | ||||
| LDL | ||||
| Level above threshold, n (%) | 4 (40) | 4 (40) | >0.99 | 12 (66.7) |
| Highest level, median (IQR) | 149 (132–166) | 142 (122–209) | 0.97 | 205 (142–253) |
| HDL | ||||
| Level below threshold, n (%) | 8 (80) | 8 (80) | >0.99 | 17 (94.4) |
| Level at nadir, median (IQR) | 45 (30–59) | 49 (39–61) | 0.48 | 47 (41–52) |
| Triglycerides (mg/dl) | ||||
| Level above threshold, n (%) | 9 (90) | 6 (60) | 0.30 | 18 (100) |
| Highest level, median (IQR) | 313 (213–655) | 205 (118–254) | 0.029 | 246 (201–352) |
ALT, alanine aminotransferase; AST, aspartate aminotransferase; ULN, upper limit of normal.
a
For grading of hematologic toxicities we used the National Cancer Institute Common Terminology Criteria for Adverse Events.