Table 2.
Summary of treatment-emergent CRS and neurologic events since start of study.
| Cohort 6 N = 40 | |
|---|---|
| CRS | |
| Any, n (%) | 32 (80) |
| Worst Grade 1, n (%) | 14 (35) |
| Worst Grade 2, n (%) | 18 (45) |
| Worst Grade 3, n (%) | 0 |
| Worst Grade 4, n (%) | 0 |
| Worst Grade 5, n (%) | 0 |
| Worst Grade ≥3, n (%) | 0 |
| Median (range) time to onset of any-grade CRS, days | 5 (1, 15) |
| Median (range) duration, days | 4 (1, 11) |
| Patients for whom events resolved, n/N (%) | 32/32 (100) |
| Neurologic events | |
| Any, n (%) | 23 (58) |
| Worst Grade 1, n (%) | 9 (23) |
| Worst Grade 2, n (%) | 7 (18) |
| Worst Grade 3, n (%) | 3 (8) |
| Worst Grade 4, n (%) | 2 (5) |
| Worst Grade 5, n (%) | 2 (5) |
| Worst Grade ≥3, n (%) | 7 (18) |
| Median (range) time to onset of any-grade neurologic event, days | 6 (2–162) |
| Median (range) duration, days | 19 (1–438) |
| Patients for whom events resolved, n/N (%) | 18/23 (78) |
Severity of CRS was graded per modified Lee 2014 criteria [21]. Neurologic events were identified using a Medical Dictionary for Regulatory Activities version 24.1 search term list that was developed based on a modification of the specific search strategy by Topp et al [22]. The severity of neurologic events was graded with the use of the Common Terminology Criteria for Adverse Events, version 4.03, of the National Cancer Institute.
CRS cytokine release syndrome.