Table 3.
Adverse Events.*
| Event | Blinatumomab Group (N = 267) |
Chemotherapy Group (N = 109) |
|---|---|---|
| no. of patients (%) | ||
| Any adverse event | 263 (98.5) | 108 (99.1) |
|
| ||
| Event leading to premature discontinuation of trial treatment | 33 (12.4) | 9 (8.3) |
|
| ||
| Serious adverse event | 165 (61.8) | 49 (45.0) |
|
| ||
| Fatal serious adverse event | 51 (19.1) | 19 (17.4) |
|
| ||
| Any adverse event of grade ≥3 | 231 (86.5) | 100 (91.7) |
|
| ||
| Grade ≥3 adverse event of interest reported in at least 3% of patients in either group | ||
|
| ||
| Neutropenia | 101 (37.8) | 63 (57.8) |
|
| ||
| Infection | 91 (34.1) | 57 (52.3) |
|
| ||
| Elevated liver enzyme | 34 (12.7) | 16 (14.7) |
|
| ||
| Neurologic event | 25 (9.4) | 9 (8.3) |
|
| ||
| Cytokine release syndrome | 13 (4.9) | 0 |
|
| ||
| Infusion reaction | 9 (3.4) | 1 (09) |
|
| ||
| Lymphopenia | 4 (1.5) | 4 (3.7) |
|
| ||
| Any decrease in platelet count | 17 (6.4) | 13 (11.9) |
|
| ||
| Any decrease in white-cell count | 14 (5.2) | 6 (5.5) |
*
Data are summarized for all patients who received at least one dose of trial treatment.