Table A3.
Summary of AEs After Bolus rhIL-15
| AE | 3 μg/kg (n = 5) |
1 μg/kg (n = 4) |
0.3 μg/kg (n = 9) |
|||
|---|---|---|---|---|---|---|
| Grade 1 or 2 | Grade 3 or 4 | Grade 1 or 2 | Grade 3 or 4 | Grade 1 or 2 | Grade 3 or 4 | |
| Fever | 3 | 1 | 3 | 3 | ||
| Chills/rigors | 4 | 4 | 7 | |||
| Capillary leak syndrome | 4 | 3 | ||||
| Nausea | 4 | 2 | 4 | |||
| Vomiting | 2 | 1 | 1 | |||
| Hypotension | 3 | 2* | 1 | 4 | ||
| Fatigue | 3 | 2 | 8 | |||
| Edema | 4 | 2 | 1 | |||
| Pain | 2 | 2 | 5 | |||
| Diarrhea | 1 | 1 | ||||
| Hypoxia | 3† | |||||
| Pleural effusion | 2 | 2 | ||||
| Albumin | 5 | 4 | 1 | |||
| AST | 5 | 2 | 1‡ | 3 | 1 | |
| ALT | 1 | 2 | 2‡ | 5 | ||
| Alkaline phosphatase | 4 | 3 | ||||
| Bilirubin | 2 | 1 | ||||
| Leukopenia | 1 | 2 | 5 | 1 | ||
| Lymphopenia | 3 | 2 | 3 | 3 | 3 | |
| Thrombocytopenia | 2 | 1‡ | 1 | 8 | ||
| Neutropenia | 3 | 3 | 5 | |||
| Anemia | 2 | 1 | 2 | 6 | 1 | |
| Calcium | 1 | |||||
| Phosphate | 2 | 1 | 1 | |||
| Creatinine | 1 | 1 | ||||
Abbreviations: AE, adverse event; DLT, dose-limiting toxicity; rhIL-15, recombinant human interleukin-15.
*
One event was asymptomatic, transient, and not DLT. Other event was symptomatic, recurrent, and assessed as DLT.
†
Transient asymptomatic decrease in transcutaneous pulse oximeter reading.
‡
DLT at this dose level.