TABLE 2.
Days lost and of underproductivity at work/school based on the Sheehan Disability Scale, full analysis set
| FUNCTIONAL DISABILITY | STUDY 1 | STUDY 2 | ||
|---|---|---|---|---|
| PBO | LDX | PBO | LDX | |
| Days lost from work/school | ||||
| Baseline, mean±SD | 0.4±1.08 (n=182) | 0.3±0.87 (n=188) | 0.5±1.38 (n=173) | 0.4±1.03 (n=172) |
| Week 12, mean±SD | 0.2±0.69 (n=158) | 0.2±0.79 (n=166) | 0.2±0.83 (n=145) | 0.1±0.43 (n=153) |
| Week 12 change from baseline, mean±SD | -0.3±1.09 (n=157) | -0.1±1.08 (n=164) | -0.3±1.10 (n=142) | -0.4±1.13 (n=151) |
| Week 12 LS mean (95% CI) treatment difference; p-value* | 0.0 (-0.2, 0.2); 0.962 | -0.2 (-0.3, -0.0); 0.023 | ||
| Effect size† | 0.01 | 0.26 | ||
| Days of underproductvity at work/school | ||||
| Baseline, mean±SD | 1.5±1.72 (n=181) | 1.6±2.00 (n=188) | 1.4±1.87 (n=173) | 1.6±1.83 (n=172) |
| Week 12, mean±SD | 0.6±1.20 (n=156) | 0.3±0.90 (n=166) | 0.6±1.25 (n=146) | 0.3±1.12 (n=153) |
| Week 12 change from baseline, mean±SD | -0.9±1.79 (n=155) | -1.3±1.88 (n=164) | -0.7±1.78 (n=143) | -1.2±2.04 (n=151) |
| Week 12 LS mean (95% CI) treatment difference; p-value* | -0.4 (-0.6, -0.1); 0.001 | -0.3 (-0.6, -0.1); 0.012 | ||
| Effect size† | 0.36 | 0.29 | ||
| Combined days lost and days of underproductivity at work/school | ||||
| Baseline, mean±SD | 2.0±2.36 (n=181) | 1.9±2.41 (n=188) | 1.9±2.72 (n=173) | 2.0±2.38 (n=172) |
| Week 12, mean±SD | 0.8±1.61 (n=156) | 0.4±1.31 (n=166) | 0.9±1.85 (n=145) | 0.4±1.31 (n=153) |
| Week 12 change from baseline, mean±SD | -1.2±2.44 (n=155) | -1.4±2.34 (n=164) | -1.0±2.26 (n=142) | -1.6±2.66 (n=151) |
| Week 12 LS mean (95% CI) treatment difference; p-value* | -0.4 (-0.7, -0.1); 0.022 | -0.5 (-0.8, -0.2); 0.003 | ||
| Effect size† | 0.25 | 0.34 | ||
*
Reported p-values are nominal (unadjusted for multiplicity and descriptive) and based on post-hoc analyses that were not part of the hierarchical testing strategy for controlling multiplicity.
†
Effect size is based on the estimated standard deviation from the unstructured covariance matrix.
CI: confidence interval; LDX: lisdexamfetamine dimesylate; LS: least squares; PBO: placebo; SD: standard deviation