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 |