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. 2021 Oct 4;29(1):7–15. doi: 10.1111/iju.14700

Table 2.

Estimates for the change from baseline in secondary end‐points, by population (FAS)

UUI population MUI population
Placebo (n = 204) Mirabegron 50 mg (n = 214) Placebo (n = 122) Mirabegron 50 mg (n = 139)
Urgency episodes/24 h
Median value at baseline (Q1–Q3) 4.33 (2.67–6.67) 4.33 (2.67–6.33) 3.67 (2.67–5.67) 4.33 (2.67–6.33)
Estimate of the median change (95% two‐sided CI) −1.83 (−2.17, −1.5) −2.50 (−2.83, −2.17) −1.67 (−2.17, −1.17) −2.17 (−2.50, −1.83)
Difference in median change versus placebo (95% two‐sided CI) −0.67 (−1.00, −0.33) −0.50 (−1.00, −0.00)
Two‐sided P‐value 0.002 0.266
Incontinence episodes/24 h
Median value at baseline (Q1–Q3) 1.33 (0.67–2.33) 1.67 (1.00–2.67) 1.67 (0.67–2.33) 1.33 (0.67–3.00)
Estimate of the median change (95% two‐sided CI) −0.67 (−0.83, −0.50) −1.00 (−1.17, −1.00) −0.67 (−0.83, −0.50) −1.17 (−1.33, −1.00)
Difference in median change versus placebo (95% two‐sided CI) −0.33 (−0.67, 0.00) −0.50 (−0.67, −0.33)
Two‐sided P‐value 0.002 <0.001
Mean voided volume/micturition
Median value at baseline (Q1–Q3) 143.261 (117.742–176.875) 141.584 (114.211–180.789) 140.769 (117.000–179.531) 148.267 (120.962–185.000)
Estimate of the median change (95% two‐sided CI) 6.303 (2.244–10.439) 25.619 (21.144–30.070) 14.578 (8.301–20.685) 24.839 (19.476–30.837)
Difference in median change versus placebo (95% two‐sided CI) 19.203 (13.121–25.285) 10.973 (3.363–18.583)
Two‐sided P‐value <0.001 0.005
Nocturia episodes/night
Median value at baseline (Q1–Q3) 1.50 (1.00–2.00) 1.50 (1.00–2.50) 1.50 (1.00–2.50) 1.50 (1.00–2.00)
Estimate of the median change (95% two‐sided CI) −0.25 (−0.50, −0.25) −0.50 (−0.50, −0.25) −0.25 (−0.50, 0.00) −0.50 (−0.50, −0.25)
Difference in median change versus placebo (95% two‐sided CI) 0.00 (0.00, 0.00) −0.25 (−0.50, 0.00)
Two‐sided P‐value 0.588 0.030

The Hodges–Lehmann method was used to obtain an estimate in the median (and 95% CI) change.

Ranked ancova (vs placebo).