Table 3.
Treatment-emergent adverse events of CRS and IRR/ISR
| n (%) | Weekly IV | Weekly SC (without priming) | Weekly SC (with priming) | Total (n=39) | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| 0.1 μg/kg (n=1) | 0.3 μg/kg (n=3) | 1 μg/kg (n=3) | 3 μg/kg (n=5) | 3 μg/kg (n=3) | 10 μg/kg (n=6) | 30 μg/kg (n=4) | 10 then 30 μg/kg (n=5) | 10 then 55 μg/kg (n=5) | 5 and 20, then 60 μg/kg (n=4) | ||
| CRS | 0 | 0 | 1 (33.3) | 3 (60.0) | 2 (66.7) | 4 (66.7) | 4 (100) | 3 (60.0) | 5 (100) | 4 (100) | 26 (66.7) |
| Grade 2 | 0 | 0 | 0 | 3 (60.0) | 0 | 1 (16.7) | 3 (75.0) | 1 (20.0) | 4 (80.0) | 1 (25.0 | 13 (33.3) |
| Most common CRS symptoms * | |||||||||||
| Pyrexia | 0 | 0 | 1 (33.3) | 3 (60.0) | 2 (66.7) | 4 (66.7) | 4 (100) | 3 (60.0) | 5 (100) | 4 (100) | 26 (66.7) |
| Hypotension | 0 | 0 | 0 | 2 (40.0) | 0 | 1 (16.7) | 2 (50.0) | 1 (20.0) | 4 (80.0) | 1 (25.0) | 11 (28.2) |
| Chills | 0 | 0 | 0 | 0 | 0 | 3 (50.0) | 1 (25.0) | 1 (20.0) | 2 (40.0) | 3 (75.0) | 10 (25.6) |
| Tachycardia | 0 | 0 | 0 | 2 (40.0) | 0 | 1 (16.7) | 1 (25.0) | 0 | 1 (20.0) | 1 (25.0) | 6 (15.4) |
| Hypoxia | 0 | 0 | 0 | 2 (40.0) | 0 | 0 | 0 | 1 (20.0) | 1 (20.0) | 1 (25.0) | 5 (12.8) |
| IRR/ISR | 0 | 2 (66.7) | 0 | 4 (80.0) | 3 (100) | 6 (100) | 4 (100) | 5 (100) | 5 (100) | 4 (100) | 33 (84.6) |
| Most common IRR/ISR symptoms * | |||||||||||
| Injection site erythema | 0 | 0 | 0 | 0 | 1 (33.3) | 5 (83.3) | 3 (75.0) | (80.0) | 5 (100) | 4 (100.0) | 22 (56.4) |
| Injection site pruritus | 0 | 0 | 0 | 0 | 0 | 4 (66.7) | 2 (50.0) | 2 (40.0) | 1 (20.0) | 1 (25.0) | 10 (25.6) |
| Injection site pain | 0 | 0 | 0 | 0 | 1 (33.3) | 3 (50.0) | 0 | 0 | 2 (40.0) | 1 (25.0) | 7 (17.9) |
| Chills | 0 | 1 (33.3) | 0 | 3 (60.0) | 0 | C | 0 | 0 | 0 | 0 | 4 (10.3) |
*
More than 10% of patients in total group, as reported by the investigator. CRS, cytokine release syndrome; ISR, infusion/injection site reaction; IRR, infusion/injection related reaction; IV, intravenous; SC, subcutaneous; TEAE, treatment-emergent adverse event.