Table 2.
Toxicities during DLT observation period
| Dose level (MBq) | N | Fever | Vomiting | Anxiety | Pruritus | Hypothermia | ALT | Bilirubin | AST | Platelets | ANC | Lymphopenia | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Grade | 1 | 1 | 2 | 1 | 1 | 2 | 1 | 2 | 3 | 1 | 1 | 2 | 3 | 1 | 2 | 3 | 4 | 1 | 2 | 3 | 4 | 3 | ||
| 370 | 3 | 1 | 1 | 1 | ||||||||||||||||||||
| 740 | 3 | 1 | 1 | 1 | 1 | |||||||||||||||||||
| 1110 | 6 | 1 | 2 | 1 | 2 | 1 | 1 | 2 | 1 | 1 | 1 | 1 | 1 | 2 | ||||||||||
| 1480 | 3 | 1 | 1 | 1 | 1 | 0 | 1 | |||||||||||||||||
| 1850 | 6 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 2 | 1 | ||||||||||||||
| 2220 | 4 | 1 | 1 | 3 | 1 | 3 | 1 | 2 | 1 | 1 | 1 | |||||||||||||
| 2590 | 6 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | ||||||||||||||
| 2960 | 5 | 1 | 1 | 1 | 1 | 1 | ||||||||||||||||||
| Total | 36 | 2 | 6 | 2 | 1 | 1 | 1 | 8 | 2 | 1 | 1 | 8 | 2 | 1 | 4 | 1 | 4 | 6 | 0 | 3 | 3 | 4 | 7 | |
DLT dose-limiting toxicity, ALT alanine transaminase, AST aspartate aminotransferase, ANC absolute neutrophil count,
N: number receiving at least one therapeutic dose of radioiodinated omburtamab