Table 3.
Adverse events (safety population)
| Number (%) of patients | Methoxyflurane (N = 135) | Standard analgesic treatment (N = 135) | ||
|---|---|---|---|---|
| All AEs | Related AEsa | All AEs | Related AEsa | |
| Any adverse event | 23 (17.0) | 17 (12.6) | 4 (3.0) | 2 (1.5) |
| Euphoric mood | 5 (3.7) | 5 (3.7) | 0 | 0 |
| Somnolence | 4 (3.0) | 4 (3.0) | 0 | 0 |
| Nausea | 3 (2.2) | 3 (2.2) | 1 (0.7) | 0 |
| Dysgeusia | 3 (2.2) | 3 (2.2) | 0 | 0 |
| Feeling abnormal | 3 (2.2) | 3 (2.2) | 0 | 0 |
| Pyrexia | 2 (1.5) | 0 | 0 | 0 |
| Vertigo | 2 (1.5) | 2 (1.5) | 0 | 0 |
| Presyncope | 1 (0.7) | 0 | 2 (1.5) | 1 (0.7) |
| Bronchitis | 1 (0.7) | 0 | 0 | 0 |
| Diplopia | 1 (0.7) | 1 (0.7) | 0 | 0 |
| Dizziness | 1 (0.7) | 1 (0.7) | 0 | 0 |
| Feeling drunk | 1 (0.7) | 1 (0.7) | 0 | 0 |
| Headache | 1 (0.7) | 0 | 0 | 0 |
| Oral discomfort | 1 (0.7) | 1 (0.7) | 0 | 0 |
| Sedation | 1 (0.7) | 1 (0.7) | 0 | 0 |
| Vomiting | 0 | 0 | 2 (1.5) | 1 (0.7) |
| Constipation | 0 | 0 | 1 (0.7) | 0 |
| Hyperhidrosis | 0 | 0 | 1 (0.7) | 0 |
| Hypotension | 0 | 0 | 1 (0.7) | 1 (0.7) |
| Pruritis | 0 | 0 | 1 (0.7) | 0 |
Data are presented as number (%) of patients. Adverse events (AEs) are presented by MedDRA preferred term in decreasing order of frequency in the methoxyflurane group, followed by the standard analgesic treatment group
aEvents considered possibly or probably related to study treatment by the investigator