TABLE 3.
Primary efficacy outcomes: frequency of moderate/severe VMS and severity per 24 hours, full analysis set
| Frequency of moderate/severe VMS per 24 ha | Severity of moderate/severe VMS per 24 ha | ||||||||
| Change from baseline | Difference from placebo | Change from baseline | Difference from placebo | ||||||
| Wk | Treatment group (n) | LS Mean (SE) | LS Mean (SE) | 95% CI | P valueb | LS Mean(SE) | LS Mean (SE) | 95% CI | P valueb |
| 4 | Placebo (n = 42) | −4.2 (0.65) | – | – | – | −0.3 (0.15) | – | – | – |
| Fezolinetant | |||||||||
| 15 mg BID (n = 40) | −6.1 (0.61) | −1.9 (0.84) | −3.56 to −0.25 | 0.024 | −0.8 (0.14) | −0.5 (0.2) | −0.84 to −0.07 | 0.0215 | |
| 30 mg BID (n = 41) | −7.2 (0.64) | −3 (0.84) | −4.68 to −1.38 | 0.0004 | −0.9 (0.15) | −0.6 (0.2) | −1.01 to −0.24 | 0.0017 | |
| 60 mg BID (n = 40) | −7.0 (0.62) | −2.8 (0.84) | −4.44 to −1.14 | 0.0010 | −1.2 (0.14) | −0.8 (0.2) | −1.21 to −0.44 | <0.0001 | |
| 90 mg BID (n = 37) | −7.7 (0.65) | −3.5 (0.84) | −5.20 to −1.89 | <0.0001 | −1.3 (0.15) | −1 (0.2) | −1.37 to −0.59 | <0.0001 | |
| 30 mg QD (n = 40) | −6.5 (0.65) | −2.3 (0.84) | −4.00 to −0.68 | 0.0058 | −0.7 (0.15) | −0.4 (0.2) | −0.81 to −0.04 | 0.0322 | |
| 60 mg QD (n = 43) | −7.2 (0.61) | −3 (0.82) | −4.65 to −1.41 | 0.0003 | −0.9 (0.14) | −0.6 (0.19) | −0.99 to −0.23 | 0.0017 | |
| 120 mg QD (n = 42) | −6.6 (0.63) | −2.4 (0.84) | −4.06 to −0.76 | 0.0042 | −1.0 (0.15) | −0.7 (0.2) | −1.08 to −0.31 | 0.0004 | |
| 12 | Placebo (n = 37) | −5.3 (0.58) | – | – | – | −0.8 (0.16) | – | – | – |
| Fezolinetant | |||||||||
| 15 mg BID (n = 38) | −7.2 (0.54) | −1.8 (0.75) | −3.30 to −0.35 | 0.0154 | −1.0 (0.15) | −0.3 (0.21) | −0.67 to 0.16 | 0.2324 | |
| 30 mg BID (n = 37) | −7.5 (0.56) | −2.1 (0.74) | −3.60 to −0.67 | 0.0043 | −1.1 (0.16) | −0.4 (0.21) | −0.80 to 0.04 | 0.0736 | |
| 60 mg BID (n = 31) | −7.6 (0.55) | −2.3 (0.75) | −3.76 to −0.83 | 0.0023 | −1.3 (0.16) | −0.6 (0.21) | −0.98 to −0.15 | 0.0080 | |
| 90 mg BID (n = 31) | −8.0 (0.58) | −2.6 (0.75) | −4.09 to −1.16 | 0.0005 | −1.4 (0.17) | −0.6 (0.21) | −1.07 to −0.22 | 0.0028 | |
| 30 mg QD (n = 33) | −7.4 (0.58) | −2.1 (0.75) | −3.52 to −0.58 | 0.0064 | −0.9 (0.16) | −0.2 (0.21) | −0.58 to 0.26 | 0.4647 | |
| 60 mg QD (n = 36) | −7.9 (0.54) | −2.6 (0.74) | −4.04 to −1.15 | 0.0005 | −1.3 (0.15) | −0.5 (0.21) | −0.92 to −0.10 | 0.0160 | |
| 120 mg QD (n = 36) | −7.4 (0.57) | −2.1 (0.75) | −3.52 to −0.59 | 0.0063 | −1.1 (0.16) | −0.4 (0.21) | −0.78 to 0.06 | 0.0901 | |
ANCOVA, analysis of covariance; LS, least squares; SE, standard error; VMS, vasomotor symptoms.
aFrom ANCOVA model with change from baseline as the dependent variable and treatment group, pooled centre, smoking status as factors and baseline measurement and baseline weight as covariates.
bBased on pairwise comparisons with placebo without adjustments for multiplicity.