Table 3.
Adverse events of interest (N = 239)
| Adverse events | Any grade | Grade 1-2 | Grade ≥3 |
|---|---|---|---|
| Cytokine release syndrome (evaluable; n = 236) | 94 (40) | 86 (36) | 8 (3) |
| Neurological adverse events (evaluable; n = 236) | 55 (23) | 36 (15) | 17 (7) |
| Encephalopathy | 22 (9) | 10 (4) | 12 (5) |
| Headache | 27 (11) | 24 (10) | 3 (1) |
| Seizure | 3 (1) | 2 (1) | 1 (0.4) |
| Stroke | 3 (1) | 0 | 1 (0.4) |
| Hepatotoxicity (evaluable; n = 238) | 83 (35) | 58 (24) | 26 (10) |
| Transaminases | 62 (26) | 40 (17) | 22 (9) |
| Hyperbilirubinemia | 20 (8) | 17 (7) | 3 (1) |
| Veno-occlusive disease | 2 (1) | 1 (0.4) | 1 (0.4) |
| Dose interruptions | |||
| Total no. of patients with dose interruptions | 50 (21) | ||
| 1 | 36 (15) | ||
| 2 | 9 (4) | ||
| 3 | 5 (2) | ||
| Discontinuation of blinatumomab because of AE | 17 (7) | ||
| Neurotoxicity | 8 (3) | ||
| Hepatoxicity | 4 (2) | ||
| Cytokine release syndrome | 3 (1) | ||
| Infections | 3 (1) | ||
| Pain | 1 (0.4) | ||