Table 6 Responsiveness: mean change from baseline in PSQ item scores and Guyatt's statistic by investigator-rated CGI-I at Week 12
Investigator-rated CGI-I | ||||||
|---|---|---|---|---|---|---|
PSQ domains | Very Much Improved n = 173 | Much Improved n = 126 | Minimally Improved n = 64 | No Change n = 73 | Worsen n = 7 | p-value |
Sleep quality | ||||||
Mean delta (SD) | -0.92 (0.74) | -0.67 (0.63) | -0.34 (0.60) | -0.14 (0.56) | 0.14 (0.38) | <0.0001 |
Guyatt's statistic | 1.64 | 1.19 | 0.61 | 0.24 | 0.25 | |
Daytime functioning | ||||||
Mean delta (SD) | -1.03 (0.91) | -0.62 (0.77) | -0.34 (0.76) | -0.15 (0.78) | 0.14 (0.38) | <0.0001 |
Guyatt's statistic | 1.33 | 0.80 | 0.44 | 0.19 | 0.18 | |
Nights with RLS symptoms | ||||||
Mean delta (SD) | -2.71 (1.03) | -1.75 (1.20) | -0.97 (1.10) | -0.26 (0.94) | 0.57 (0.53) | <0.0001 |
Guyatt's statistic | 2.87 | 1.86 | 1.03 | 0.28 | 0.61 | |
RLS-related sleep disturbance | ||||||
Mean delta (SD) | -1.72 (1.14) | -0.80 (0.96) | -0.58 (0.83) | -0.25 (0.95) | -1.14 (1.07) | <0.0001 |
Guyatt's statistic | 1.81 | 0.84 | 0.61 | 0.26 | 1.20 | |
RLS-related sleep latency | ||||||
Mean delta (SD) | -1.82 (1.47) | -0.80 (1.18) | -0.69 (1.40) | -0.19 (1.09) | -1.29 (0.95) | <0.0001 |
Guyatt's statistic | 1.67 | 0.74 | 0.63 | 0.18 | 1.18 | |