TABLE 4.
Baseline and Cycle 4 Adverse Events According to CTCAE Criteria
| Labs | Grade 0 or Grade 1 | Grade 2 | Grade 3 | Grade 4 | No Data | |
|---|---|---|---|---|---|---|
| Baseline | ||||||
| Hypoalbuminemia | ↓Alb | 161 (96.4%) | 4 (2.4%) | 2 (1.2%) | 6 | |
| Elevated alkaline phosphatase* | ↑ALP | 101 (60.1%) | — | — | — | 5 |
| Neutropenia | ↓ANC | 139 (99.3%) | 0 | 0 | 1 (0.7%) | 33 |
| Hyperbilirubinemia† | ↑Bili | 148 (93.1%) | — | — | — | 14 |
| Elevated creatinine | ↑Cr | 163 (99.4%) | 1 (0.6%) | 0 | 0 | 9 |
| Elevated chromogranin A‡ | ↑CgA | 28 (27.7%) | 72 | |||
| Declined renal filtration | ↓eGFR | 147 (86.0%) | 23 (13.5%) | 1 (0.6%) | 0 | 2 |
| Anemia | ↓HgB | 157 (92.4%) | 13 (7.7%) | 0 | 3 | |
| Lymphocytopenia | ↓LYM | 105 (84.7%) | 13 (10.5%) | 6 (4.8%) | 0 | 49 |
| Thrombocytopenia | ↓PLT | 168 (100%) | 0 | 0 | 0 | 32 |
| Leukopenia | ↓WCC | 167 (98.2%) | 3 (1.8%) | 0 | 0 | 3 |
| Following treatment cycles after baseline | ||||||
| Hypoalbuminemia | ↓Alb | 452 (95.4%) | 14 (3.0%) | 8 (1.7%) | 80 | |
| Elevated alkaline phosphatase | ↑ALP | 461 (98.5%) | 4 (0.9%) | 3 (0.6%) | 0 | 85 |
| Neutropenia | ↓ANC | 443 (98.2%) | 8 (1.8%) | 0 | 0 | 113 |
| Hyperbilirubinemia | ↑Bili | 461 (97.9%) | 9 (1.9%) | 1 (0.2%) | 0 | 83 |
| Elevated creatinine | ↑Cr | 469 (98.7%) | 6 (1.3%) | 0 | 0 | 76 |
| Elevated chromogranin A‡ | ↑CgA | 68 (25.6%) | 408 | |||
| Declined renal filtration | ↓eGFR | 377 (80.2%) | 92 (19.6%) | 1 (0.2%) | 0 | 83 |
| Anemia | ↓HgB | 425 (89.3%) | 45 (9.5%) | 6 (1.3%) | 75 | |
| Lymphocytopenia | ↓LYM | 273 (64.2%) | 107 (25.2%) | 44 (10.4%) | 1 (0.2%) | 139 |
| Thrombocytopenia | ↓PLT | 468 (98.5%) | 6 (1.3%) | 1 (0.2%) | 0 | 76 |
| Leukopenia | ↓WCC | 462 (96.7%) | 13 (2.7%) | 1 (0.2%) | 2 (0.4%) | 73 |
Note: The criteria for grade 4 hypoalbuminemia and anemia are not a numeric parameter and therefore are omitted.
Baseline alkaline phosphatase was used to assess if patient values were within normal limits (WNL) or elevated at baseline to determine treatment CTCAE grades [at baseline, 101 patients (60.1%) were WNL, 67 patients (40.0%) were elevated].
Baseline bilirubin (Bili) was used to assess if patient values were WNL or elevated at baseline to determine treatment CTCAE grades [at baseline, 148 patients (93.1%) were WNL, 11 patients (6.9%) were elevated].
Chromogranin A values were determined to be WNL or elevated. At baseline, 73 patients (72.3%) had elevated chromogranin A. During treatment, 198 administrations (74.4%) led to elevated chromogranin A.