Grade 3 and grade 4 toxicity during asparaginase-containing courses
| Event type . | Pegaspargase . | Native . | ||||
|---|---|---|---|---|---|---|
| IND . | DI no. 1 . | DI no. 2 . | IND . | DI no. 1 . | DI no. 2 . | |
| CNS thrombosis | 1 | 1 | — | 2 | — | — |
| Other CNS complications5-150 | — | 3 | 3 | — | 2 | 2 |
| Life-threatening infections5-151 | — | 1 | 1 | — | — | 1 |
| Bacteremia | 1 | 6 | 10 | 6 | 2 | 9 |
| Hyperglycemia | 3 | — | — | 1 | 1 | 1 |
| Coagulopathy5-152 | 1 | — | — | 3 | — | — |
| Nausea/vomiting | — | — | — | 2 | 1 | — |
| Abdominal pain | — | — | 3 | — | — | 1 |
| Abnormal LFT5-153 | — | — | — | — | 2 | 2 |
| Pancreatitis | 1 | — | 2 | 1 | — | — |
| Mucositis | — | — | 1 | — | — | — |
| Gastric ulcer | — | — | 1 | — | — | — |
| Hemorrhagic cystitis | — | — | — | — | 1 | — |
| Constipation | — | — | 1 | — | — | — |
| Diarrhea | — | — | 1 | — | — | — |
| Allergy to asparaginase | — | 1 | — | — | — | — |
| Assessable patients | 59 | 54 | 48 | 59 | 53 | 53 |
| Event type . | Pegaspargase . | Native . | ||||
|---|---|---|---|---|---|---|
| IND . | DI no. 1 . | DI no. 2 . | IND . | DI no. 1 . | DI no. 2 . | |
| CNS thrombosis | 1 | 1 | — | 2 | — | — |
| Other CNS complications5-150 | — | 3 | 3 | — | 2 | 2 |
| Life-threatening infections5-151 | — | 1 | 1 | — | — | 1 |
| Bacteremia | 1 | 6 | 10 | 6 | 2 | 9 |
| Hyperglycemia | 3 | — | — | 1 | 1 | 1 |
| Coagulopathy5-152 | 1 | — | — | 3 | — | — |
| Nausea/vomiting | — | — | — | 2 | 1 | — |
| Abdominal pain | — | — | 3 | — | — | 1 |
| Abnormal LFT5-153 | — | — | — | — | 2 | 2 |
| Pancreatitis | 1 | — | 2 | 1 | — | — |
| Mucositis | — | — | 1 | — | — | — |
| Gastric ulcer | — | — | 1 | — | — | — |
| Hemorrhagic cystitis | — | — | — | — | 1 | — |
| Constipation | — | — | 1 | — | — | — |
| Diarrhea | — | — | 1 | — | — | — |
| Allergy to asparaginase | — | 1 | — | — | — | — |
| Assessable patients | 59 | 54 | 48 | 59 | 53 | 53 |
IND indicates induction; DI, delayed intensification; CNS, central nervous system; LFT, liver function tests.
Including seizures, tremors, facial palsy, hemiparesis, peripheral neuropathy, and motor weakness.
Septic shock including hypotension and/or requiring intubation.
Prolonged partial thromboplastin time or hypofibrinogenemia.
Aspartate aminotransferase, alanine aminotransferase, or alkaline phosphatase greater than 1.5 times the normal value, or total bilirubin greater than 1.5 times the normal value.