Table 5.
Incidence and exposure-adjusted event rate of NEs by dose
| Blinatumomab 9 μg/day (n = 189) | Blinatumomab 28 μg/day (n = 178) | |||
|---|---|---|---|---|
| Total crude exposure, 281.3 weeks | Total crude exposure, 1017.0 weeks | |||
| Eventsa | Any NE n (%) | Serious NE n (%) | Any NE n (%) | Serious NE n (%) |
| Any NEb | 58 (20.6) | 4 (1.4) | 179 (17.6) | 35 (3.4) |
| Tremor | 15 (5.3) | 0 | 32 (3.1) | 5 (0.5) |
| Dizziness | 9 (3.2) | 0 | 20 (2.0) | 1 (0.1) |
| Paresthesia | 7 (2.5) | 1 (0.4) | 0 | 0 |
| Confusional state | 5 (1.8) | 0 | 11 (1.1) | 5 (0.5) |
| Encephalopathy | 3 (1.1) | 2 (0.7) | 7 (0.7) | 3 (0.3) |
| Somnolence | 3 (1.1) | 0 | 10 (1.0) | 0 |
| Ataxia | 2 (0.7) | 0 | 7 (0.7) | 3 (0.3) |
| Mental status changes | 2 (0.7) | 0 | 6 (0.6) | 1 (0.1) |
| Lethargy | 2 (0.7) | 0 | 3 (0.3) | 0 |
| Aphasia | 1 (0.4) | 1 (0.4) | 6 (0.6) | 1 (0.1) |
| Dysarthria | 1 (0.4) | 0 | 6 (0.6) | 1 (0.1) |
| Hypoesthesia | 1 (0.4) | 0 | 5 (0.5) | 0 |
| Neurotoxicityc | 1 (0.4) | 0 | 4 (0.4) | 3 (0.3) |
| Nervous system disorder | 1 (0.4) | 0 | 2 (0.2) | 1 (0.1) |
| Disorientation | 0 | 0 | 8 (0.8) | 0 |
| Convulsion | 0 | 0 | 4 (0.4) | 2 (0.2) |
| Dysesthesia | 0 | 0 | 4 (0.4) | 2 (0.2) |
| Memory impairment | 0 | 0 | 4 (0.4) | 0 |
| Cognitive disorder | 0 | 0 | 3 (0.3) | 3 (0.3) |
| Amnesia | 0 | 0 | 2 (0.2) | 0 |
| Bradyphrenia | 0 | 0 | 2 (0.2) | 0 |
| Delirium | 0 | 0 | 2 (0.2) | 0 |
| Hyperreflexia | 0 | 0 | 2 (0.2) | 0 |
| Nystagmus | 0 | 0 | 2 (0.2) | 0 |
| Reflexes abnormal | 0 | 0 | 2 (0.2) | 0 |
| Restless legs syndrome | 0 | 0 | 2 (0.2) | 0 |
NE neurologic event
aEvent incidence rate per 100 weeks of exposure
bAEs of any grade reported in ≥ 2 patients in either group
cEvent reported by the investigators without further specification