Table 6.
Treatment-emergent adverse events occurring in 3 or more patients and effects on liver function, safety population
| TEAE, n (%) | Placebo (n = 27) | Fezolinetant 60 mg (n = 23) | Fezolinetant 180 mg (n = 23) |
|---|---|---|---|
| Any TEAE | 20 (74.1) | 17 (73.9) | 21 (91.3) |
| Treatment-related TEAEs | 13 (48.1) | 12 (52.2) | 13 (56.5) |
| TEAEs of any severity or causality occurring in ≥ 3 patients in any treatment group | |||
| Headache | 7 (25.9) | 5 (21.7) | 9 (39.1) |
| Paresthesia | 0 (0) | 0 (0) | 5 (21.7) |
| Rash | 1 (3.7) | 0 (0) | 3 (13.0) |
| Nasopharyngitis | 5 (18.5) | 3 (13.0) | 2 (8.7) |
| Fatigue | 3 (11.1) | 2 (8.7) | 0 (0) |
| Nausea | 1 (3.7) | 3 (13.0) | 0 (0) |
| Treatment-emergent AST or ALT ≥ 3 × ULNa | 1 | 0 | 1 |
Abbreviations: ALT, alanine aminotransferase; AST, aspartate aminotransferase; TEAE, treatment-emergent adverse event; ULN, upper limit of normal.
a Based on laboratory testing; all increases were transient and resolved spontaneously during treatment.