Table 2.
Distribution and outcome of patients with severe neurotoxicity in the LTI and HR-NBL1 (R2 and R4) study.
| Patients, n | LTI Study | HR-NBL1 (R2) | HR-NBL1 (R4) | Total |
|---|---|---|---|---|
| Enrolled | 288 | 406 | 408 | 1102 |
| Gr 3/4 neurotoxicity * | 15 | 21 | 8 | 44 |
| with DB | 0 | 4 | 5 | 9 |
| with DB + scIL-2 | 15 | 17 | 3 | 35 |
| Severe CNS neurotoxicity # | 10 | 9 | 8 | 27 |
| with DB | 0 | 1 | 5 | 6 |
| with DB + scIL-2 | 10 | 8 | 3 | 19 |
| Recovery | 10 | 17 | 6 | 33 † |
| Persistent severe neurotoxicity | 3 | 2 | 0 | 5 |
* All neurotoxicity events reported according to CTCAE. # Severe neurotoxicity according to the definition outlined in Table 1; † Data were missing for 6 patients with severe CNS neurotoxicity. DB, dinutuximab beta; CNS, central nervous system; CTCAE, Common Terminology Criteria for Adverse Events; Gr, grade; R, randomisation; scIL-2, subcutaneous interleukin-2.