Table 7.
Incidence of treatment-relateda adverse events by primary neurological condition (safety population).
| Preferred term, % | AD/dementia (n = 17) | MS (n = 223) | Stroke/CBVD (n = 51) | TBI (n = 23) | ALS/MND (n = 199) | PD/movement disorders (n = 23) | Other PBA (n = 17) | Total (N = 553) |
|---|---|---|---|---|---|---|---|---|
| Any TRAE | 23.5 | 39.9 | 51.0 | 47.8 | 59.3 | 60.9 | 52.9 | 49.0 |
| Nausea | 0 | 8.1 | 7.8 | 4.3 | 19.1 | 4.3 | 17.6 | 11.8 |
| Dizziness (excluding vertigo) | 0 | 10.3 | 7.8 | 13.0 | 10.1 | 21.7 | 17.6 | 10.5 |
| Headache NOS | 0 | 9.4 | 5.9 | 8.7 | 11.6 | 21.7 | 5.9 | 9.9 |
| Somnolence | 0 | 2.7 | 5.9 | 0 | 13.1 | 13.0 | 11.8 | 7.2 |
| Fatigue | 5.9 | 5.8 | 2.0 | 26.1 | 7.5 | 4.3 | 11.8 | 7.1 |
| Diarrhea NOS | 11.8 | 4.0 | 3.9 | 4.3 | 9.0 | 0 | 23.5 | 6.5 |
| Dry mouth | 0 | 3.1 | 5.9 | 0 | 8.0 | 8.7 | 0 | 5.1 |
Additional TRAEs that occurred in at least 5% of patients and in two or more patients in any disease category were stroke/CBVD: insomnia (not elsewhere classified), n = 3 (5.9%); TBI: lethargy, n = 3 (13.0%), abnormal dreams, n = 2 (8.7%); ALS/MND: constipation, n = 11 (5.5%); PD/movement disorders: confusion, n = 2 (8.7%); other PBA: joint stiffness, n = 2 (11.8%); flatulence, n = 2 (11.8%); dyspepsia, n = 2 (11.8%).
AD: Alzheimer’s disease; ALS: amyotrophic lateral sclerosis; CBVD: cerebrovascular disorders; MND: motor neuron disease; MS: multiple sclerosis; NOS: not otherwise specified; PBA: pseudobulbar affect; PD: Parkinson’s disease; TRAE: treatment-related adverse event.
aTRAEs that occurred in at least 5% of total patients; treatment-related categories included possible, probable, highly probable, and missing.