Table 7.
Treatment-related adverse events and treatment-related serious adverse eventsa
| Stroke (N=411) |
MS (N=119) |
CP (N=77) |
TBI (N=45) |
SCI (N=42) |
||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Patients, N (%) |
Events, n | Patients, N (%) |
Events, n | Patients, N (%) |
Events, n | Patients, N (%) |
Events, n | Patients, N (%) |
Events, n | |
| All TRAEsb | ||||||||||
| Muscular weakness | 4 (1.0) | 4 | 3 (2.5) | 3 | – | – | – | – | – | – |
| Dysphagia | 2 (0.5) | 2 | – | – | – | – | – | – | – | – |
| Asthenia | 1 (0.2) | 1 | – | – | – | – | – | – | – | – |
| Drug tolerance | 1 (0.2) | 1 | – | – | – | – | – | – | – | – |
| Dry mouth | – | – | 1 (0.8) | 1 | – | – | – | – | – | – |
| Grip strength decreased | – | – | – | – | – | – | 1 (2.2) | 1 | – | – |
| Influenza-like illness | – | – | 1 (0.8) | 1 | – | – | – | – | – | – |
| Peripheral edema | 1 (0.2) | 1 | – | – | – | – | – | – | – | – |
| Slow speech | 1 (0.2) | 1 | – | – | – | – | – | – | – | – |
| All TRSAEsb | ||||||||||
| Dysphagia | 1 (0.2) | 1 | – | – | – | – | – | – | – | – |
| Muscular weakness | 1 (0.2) | 1 | – | – | – | – | – | – | – | – |
| Slow speech | 1 (0.2) | 1 | – | – | – | – | – | – | – | – |
CP: cerebral palsy, MS: multiple sclerosis, n: number of adverse events, N: number of patients, SCI: spinal cord injury, TBI: traumatic brain injury, TRAE: treatment-related adverse events, TRSAE: treatment-related serious adverse events.
a
All TRAE and TRSAE data are shown.
b
For each TRAE and TRSAE, the number of patients that reported the event were totaled across all etiologies and arranged in descending order.