Table 4.
Treatment-emergent adverse events (safety population)
| Methoxyflurane (N=149) | Placebo (N=149) | Total (N=298) | ||||
|---|---|---|---|---|---|---|
| n | N (%) | n | N (%) | n | N (%) | |
| TEAEs | 188 | 88 (59.1%) | 111 | 61 (40.9%) | 299 | 149 (50.0%) |
| Severe TEAEs* | 3 | 2 (1.3%) | 3 | 2 (1.3%) | 6 | 4 (1.3%) |
| Serious TEAEs† | 1 | 1 (0.7%) | 0 | 0 | 1 | 1 (0.3%) |
| Drug-related TEAEs‡ | 85 | 54 (36.2%) | 29 | 20 (13.4%) | 114 | 74 (24.8%) |
| TEAEs leading to withdrawal of study drug§ | 4 | 2 (1.3%) | 4 | 3 (2.0%) | 8 | 5 (1.7%) |
n, number of events; N, number of patients; %, percentage of patients.
*Severity classified as ‘severe’ or missing.
†Serious classified as ‘yes’ or missing.
‡Relationship to study drug classified as ‘related’ or missing; serious drug-related TEAEs were both serious and drug-related, as specified above.
§Action taken that was classified as ‘drug withdrawn’.
TEAE, treatment-emergent adverse event.