Table 5.
Discomfort and mini-RQLQ at baseline and changes from baseline to end of study according to Patient Benefit Index
| Q1 | Q2 | Q3 | Q4 | Q5 | p | |
|---|---|---|---|---|---|---|
| N = 615 | N = 602 | N = 619 | N = 613 | N = 614 | ||
| Global PBI | 1.4 ± 0.5 | 2.3 ± 0.2 | 2.8 ± 0.1 | 3.1 ± 0.1 | 3.7 ± 0.2 | - |
| [0.00-2.01] | [2.01-2.57] | [2.57-2.983] | [2.983-3.384] | [3.384-4.00] | ||
| Discomfort at baseline | 6.7 ± 1.6 | 7.0 ± 1.4 | 7.2 ± 1.4 | 7.4 ± 1.3 | 7.5 ± 1.4 | <0.0001 |
| Mini RQLQ at baseline | 40.3 ± 14.4 | 43.0 ± 13.3 | 46.8 ± 13.4 | 50.1 ± 14.1 | 51.5 ± 14.2 | <0.0001 |
| Change in discomfort at baseline compared to end of study | −2.9 ± 1.9 | −3.7 ± 1.7 | −4.2 ± 1.6 | −4.5 ± 1.8 | −5.0 ± 1.9 | <0.0001 |
| Change in miniRQLQ at baseline compared to end of study | −20.9 ± 15.5 | −26.6 ± 13.0 | −32.4 ± 13.6 | −36.1 ± 15.2 | −42.0 ± 15.4 | <0.0001 |
| Worsening in somnolence having a negative impact on daily life | 55 (9.1%) | 24 (4.0%) | 14 (2.3%) | 13 (2.1%) | 7 (1.2%) | <0.0001 |
The population was divided in quintiles (Q1 to Q5) according to PBI. PBI extent and mean value is described in each quintile. Changes in discomfort and quality of life are calculated as change in 14-day value minus baseline so that improvements are expressed as negative values. Results are expressed as mean ± SD or number (%). Comparisons used ANOVA for continuous variables or chi2 for categorical variables.