Table 2. Coprimary Effectiveness End Point Responses at Month 4 and Months 12 and 15.
End point | No./total No. (%) | Standardized mean difference, Treatment-control (95% CI) | ||
---|---|---|---|---|
Treatment | Control | Treatment-control, RR (95% CI) | ||
M4 AHI RR | 46/88 (52.3) | 9/46 (19.6) | 32.7 (15.2 to 49.0) | 0.725 (0.360 to 1.163) |
M4 ODI RR | 55/85 (62.5) | 19/46 (41.3) | 21.2 (3.3 to 38.1) | 0.434 (0.070 to 0.843) |
End point | Pooled 11-mo active therapy: treatment and control | Pooled therapy–performance goal of 50% (95% CI) | Standardized mean difference, pooled therapy–performance goal of 50% (95% CI) | |
M12/15 AHI RR | 59/138 (42.5) | −7.5 (−16.0 to 1.4) | −0.151 (−0.330 to 0.015) | |
M12/15 ODI RR | 83/138 (60.4) | 10.4 (1.6 to 18.8) | 0.214 (0.045 to 0.402) |
Abbreviations: AHI, apnea-hypopnea index; M4, month 4; M12/15, month 12/15; ODI, oxygen desaturation index; RR, response rate.