Table 5.
Adverse Events Related to FPNS - Safety Population (n=84)
| Adverse Events Related to FPNS | ||
|---|---|---|
| Number of AEs | Patients - N (%) | |
| Any FPNS-related AEs | 47 | 23 (27.4) |
| Any FPNS-related SAEs | 0 | 0 (0.0) |
| FPNS-related AEs | 47 | 23 (27.4) |
| Dizziness | 11 | 9 (11) |
| Constipation | 7 | 6 (7) |
| Somnolence | 6 | 6 (7) |
| Nausea | 6 | 5 (6) |
| Nasal intolerance | 8 | 4 (5) |
| Hypotension | 3 | 2 (2) |
| Vomiting | 2 | 2 (2) |
| Tremor | 1 | 1 (1) |
| Headache | 1 | 1 (1) |
| Insomnia | 1 | 1 (1) |
| Fatigue | 1 | 1 (1) |
Abbreviations: AE, adverse event; FPNS, fentanyl pectin nasal spray; SAE, serious adverse event.