Table 6.
Incidence of NEs occurring in ≥ 2% of patients with or without prior NEs
| Patients with events | Patients with prior NEs (n = 66) | Patients without prior NEs (n = 123) |
|---|---|---|
| Any NE, n (%) | 43 (65) | 55 (45) |
| Dizziness | 16 (24) | 10 (8) |
| Tremor | 12 (18) | 21 (17) |
| Confusional state | 10 (15) | 4 (3) |
| Encephalopathy | 6 (9) | 4 (3) |
| Ataxia | 6 (9) | 3 (2) |
| Neurotoxicity | 4 (6) | 1 (1) |
| Lethargy | 4 (6) | 1 (1) |
| Convulsion | 4 (6) | 0 |
| Aphasia | 3 (5) | 4 (3) |
| Dysarthria | 3 (5) | 3 (2) |
| Somnolence | 2 (3) | 7 (6) |
| Paresthesia | 2 (3) | 5 (4) |
| Disorientation | 2 (3) | 5 (4) |
| Mental status changes | 2 (3) | 5 (4) |
| Hypoesthesia | 2 (3) | 4 (3) |
| Memory impairment | 2 (3) | 1 (1) |
| Dysesthesia | 2 (3) | 1 (1) |
| Delirium | 2 (3) | 0 |
| Reflexes abnormal | 2 (3) | 0 |
| Amnesia | 1 (2) | 1 (1) |
| Depressed level of consciousness | 1 (2) | 0 |
| Febrile delirium | 1 (2) | 0 |
| Hemiparesis | 1 (2) | 1 (1) |
| Hyperreflexia | 1 (2) | 1 (1) |
| Facial nerve disorder | 1 (2) | 0 |
| Leukoencephalopathy | 1 (2) | 0 |
| Myoclonus | 1 (2) | 0 |
| Postural dizziness | 1 (2) | 0 |
| Restless legs syndrome | 1 (2) | 1 (1) |
| Bradyphrenia | 0 | 2 (2) |
| Nervous system disorder | 0 | 3 (2) |
| Cognitive disorder | 0 | 3 (2) |
| Nystagmus | 0 | 2 (2) |
NE neurologic event