Table 7.
Liver safety assessments
| 12-Week double-blind period (SAF)a | |||
|---|---|---|---|
| Category, n/N (%)b | Placebo (n = 167) | Fezolinetant 30 mg (n = 166) | Fezolinetant 45 mg (n = 167) |
| ALT | |||
| >3 times ULN | 1/161 (0.6) | 2/164 (1.2) | 3/164 (1.8) |
| >5 times ULN | 0/161 | 1/164 (0.6) | 0/164 |
| >8 times ULN | 0/161 | 0/164 | 0/164 |
| AST | |||
| >3 times ULN | 1/161 (0.6) | 1/164 (0.6) | 0/164 |
| >5 times ULN | 0/161 | 0/164 | 0/164 |
| ALT or AST | |||
| ALT or AST > 3 times ULN | 1/161 (0.6) | 2/164 (1.2) | 3/164 (1.8) |
| ALT or AST > 5 times ULN | 0/161 | 1/164 (0.6) | 0/164 |
| ALT or AST > 8 times ULN | 0/161 | 0/164 | 0/164 |
| ALP | |||
| >1.5 times ULN | 4/162 (2.5) | 0/164 | 1/164 (0.6) |
| Total bilirubin >2 times ULN | 0/161 | 0/161 | 0/161 |
| ALT or AST > 3 times ULN and bilirubin > 2 times ULN | 0/161 | 0/161 | 0/161 |
| ALT or AST > 3 times ULN, ALP < 2 times ULN, and bilirubin > 2 times ULN | 0/161 | 0/161 | 0/161 |
| Start of fezolinetant treatment (SAF-fezolinetant exposure)c | ||||
|---|---|---|---|---|
| Category, n/N (%)b | Fezolinetant 30 mg (n = 166) | Fezolinetant 45 mg (n = 167) | Placebo/Fezolinetant 30 mg (n = 76) | Placebo/Fezolinetant 45 mg (n = 75) |
| ALT | ||||
| >3 times ULN | 3/164 (1.8) | 6/164 (3.7) | 0/76 | 2/74 (2.7) |
| >5 times ULN | 1/164 (0.6) | 1/164 (0.6) | 0/76 | 0/74 |
| >8 times ULN | 0/164 | 0/164 | 0/76 | 0/74 |
| AST | ||||
| >3 times ULN | 1/164 (0.6) | 2/164 (1.2) | 0/76 | 0/74 |
| >5 times ULN | 0/164 | 0/164 | 0/76 | 0/74 |
| ALT or AST | ||||
| ALT or AST > 3 times ULN | 3/164 (1.8) | 7/164 (4.3) | 0/76 | 2/74 (2.7) |
| ALT or AST > 5 times ULN | 1/164 (0.6) | 1/164 (0.6) | 0/76 | 0/74 |
| ALT or AST > 8 times ULN | 0/164 | 0/164 | 0/76 | 0/74 |
| ALP | ||||
| >1.5 times ULN | 3/164 (1.8) | 2/164 (1.2) | 3/76 (3.9) | 3/74 (4.1) |
| Total bilirubin >2 times ULN | 0/164 | 0/164 | 0/76 | 0/74 |
| (ALT or AST > 3 times ULN) and bilirubin > 2 times ULN | 0/164 | 0/164 | 0/76 | 0/74 |
| (ALT or AST > 3 times ULN) and ALP < 2 times ULN and bilirubin > 2 times ULN | 0/164 | 0/164 | 0/76 | 0/74 |
Data shown for the safety analysis set (randomized participants who took ≥ 1 dose of study drug; a participant receiving a treatment different from their randomized treatment was assigned to the treatment group received as first dose). A participant could be counted in multiple categories as they were included in all that apply (eg, if a participant had a level > 8 times ULN they were also included in the > 3 times ULN and > 5 times ULN categories). The denominator is the number of participants who had at least one nonmissing value during the 12-week double-blind treatment period.
Abbreviations: ALP, alkaline phosphatase; ALT, alanine aminotransferase; AST, aspartate aminotransferase; SAF, safety analysis set; ULN, upper limit of normal.
For the double-blind period, data were collected from the first dose of study drug until week 12.
Others were analyzed but are not included due to no events.
For the extension period, data were collected from the first dose of study drug until week 52 for the fezolinetant groups and from week 13 to week 52 for the placebo/fezolinetant groups.