Table 4. Adverse Effects in FPNS and Placebo Armsa.
| Average Change (SD) | Number of patients with worse scores after the 6MWT (%) | |||
|---|---|---|---|---|
|
| ||||
| Variable | FBT | Placebo | FBT | Placebo |
| Dizzy | -0.4 (1.3) | 0.2 (0.4) | 0 | 2 (18.2) |
| Drowsy | -0.1 (0.3) | 0.6 (2.3) | 0 | 2 (18.2) |
| Nausea | 0 (0) | -0.2 (0.6) | 0 | 0 |
| Itchiness | -0.3 (1) | 0.3 (0.7) | 0 | 2 (18.2) |
Abbreviations: FBT, fentanyl buccal tablet; SD, standard deviation; 6MWT, 6 minute walk test
Each adverse effect was measured using an 11-point numeric rating scale (0=none, 10=worst) immediate before drug administration and immediately after the second walk test (approximately 30 minutes later).