Table 2.
Treatment-emergent adverse events
| 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) | ||
| Any TEAEs | 1 (100) | 3 (100) | 3 (100) | 5 (100) | 3 (100) | 6 (100) | 4 (100) | 5 (100) | 5 (100) | 4 (100 | 39 (100) |
| Related | 1 (100) | 3 (100) | 3 (100) | 5 (100) | 3 (100) | 6 (100) | 4 (100) | 5 (100) | 5 (100) | 4 (100) | 39 (100) |
| Grade 3–4 | 0 | 1 (33.3) | 1 (33.3) | 4 (80.0) | 0 | 2 (33.3) | 2 (50.0) | 4 (80.0) | 2 (40.0) | 1 (25.0) | 17 (43.6) |
| Most common TEAEs (>40% in total group) | |||||||||||
| Pyrexia | 0 | 1 (33.3) | 1 (33.3) | 3 (60.0) | 2 (66.7) | 4 (66.7) | 4 (100) | 3 (60.0) | 5 (100) | 4 (100) | 27 (69.2) |
| 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) |
| Injection site erythema | 0 | 0 | 0 | 0 | 1 (33.3) | 5 (83.3) | 3 (75.0) | 4 (80.0) | 5 (100) | 4 (100) | 22 (56.4) |
| Chills | 0 | 3 (100) | 1 (33.3) | 3 (60.0) | 0 | 4 (66.7) | 1 (25.0) | 1 (20.0) | 2 (40.0) | 3 (75.0) | 18 (46.2) |
| Fatigue | 1 (100) | 1 (33.3) | 2 (66.7) | 4 (80.0) | 0 | 3 ( 50.0) | 1 (25.0) | 2 (40.0) | 2 (40.0) | 0 | 16 (41.0) |
| Serious TEAEs | 0 | 1 (33.3) | 1 (33.3) | 3 (60.0) | 0 | 2 (33.3) | 3 (75.0) | 3 (60.0) | 3 (60.0) | 2 (50.0) | 18 (46.2) |
| Related | 0 | 1 (33.3) | 0 | 3 (60.0) | 0 | 0 | 2 (50.0) | 1 (20.0) | 3 (60.0) | 2 (50.0) | 12 (30.8) |
| AEs leading to discontinuation | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 (20.0) | 0 | 1 (25.0) | 2 (5.1) |
| Related | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 (25.0) | 1 (2.6) |
CRS, cytokine release syndrome; IV, intravenous; SC, subcutaneous; TEAE, treatment-emergent adverse event.
Database captured both the syndrome term CRS and individual signs and symptoms of CRS. Signs and symptoms of CRS are presented in Table 3 in addition to the report of CRS.