Table III.
Frequency of Selected Toxicities by Cycle: Targeted Asparaginase‐Associated Toxicities and Most Commonly‐Reported Adverse Events
| Adverse event, N (%) | Cycle 1 (N = 30) | Cycle 2 (N = 21) | Cycle 3 (N = 15) | Cycle 4 (N = 10) | Cycle 5 (N = 6) | Cycle 6 (N = 1) | Overall a (N = 30) |
|---|---|---|---|---|---|---|---|
| ≥1 Adverse event, any grade | 15 (50) | 11 (52) | 6 (40) | 2 (20) | 1 (17) | 1 (100) | 23 (77) |
| ≥1 Grade 3–4 adverse event b | 5 (17) | 4 (19) | 4 (27) | 1 (10) | 1 (17) | 0 | 10 (33) |
| Hypersensitivity/infusion reaction c | 5 (17) | 2 (10) | 2 (13) | 0 | 1 (17) | 1 (100) | 11 (37) |
| Pancreatitis | 1 (3) | 0 | 0 | 1 d (10) | 0 | 0 | 2 (7) |
| Thrombosis | 1 (3) | 0 | 0 | 0 | 0 | 0 | 1 (3) |
| Hyperglycemia | 2 (7) | 4 (19) | 0 | 0 | 0 | 0 | 5 (17) |
| Nausea and/or vomiting | 7 (23) | 2 (10) | 0 | 1 (10) | 0 | 0 | 7 (23) |
| Transaminase increase | 0 | 1 (5) | 0 | 0 | 0 | 0 | 1 (3) |
| Fever ± neutropenia | 1 (3) | 1 (5) | 2 (13) | 0 | 0 | 0 | 4 (13) |
| Infection/sepsis | 1 b (3) | 1 (5) | 0 | 0 | 0 | 0 | 2 (7) |
a
Each patient is counted only once for a given toxicity.
b
The only grade 4 adverse event was an occurrence of sepsis; all other adverse events were grade 1–3.
c
Included is one event reported as urticaria (grade 3); all other reactions were ≤ grade 2.
d
Pancreatitis occurred after six doses administered with every 48 hr dosing.