Table 3.
Adverse Events (Severe Pain Subgroup, Safety Population)
| Number (%) of Patients | Methoxyflurane (N=49) | IV Morphine (N=42) |
|---|---|---|
| Any adverse event | 10 (20.4) | 2 (4.8) |
| Nausea | 2 (4.1) | 0 |
| Feeling abnormal | 2 (4.1) | 0 |
| Dysgeusia | 2 (4.1) | 0 |
| Vertigo | 1 (2.0) | 0 |
| Oral discomfort | 1 (2.0) | 0 |
| Feeling drunk | 1 (2.0) | 0 |
| Pyrexia | 1 (2.0) | 0 |
| Bronchitis | 1 (2.0) | 0 |
| Presyncope | 1 (2.0) | 0 |
| Sedation | 1 (2.0) | 0 |
| Euphoric mood | 1 (2.0) | 0 |
| Vomiting | 0 | 1 (2.4) |
| Pruritus | 0 | 1 (2.4) |
Notes: AEs are presented by MedDRA preferred term in decreasing order of frequency in the methoxyflurane group, followed by the standard analgesic treatment (IV morphine) group.
Abbreviations: AE, adverse event; MedDRA, Medical Dictionary for Regulatory Activities; IV, intravenous.