Parameters | Base case analysis | ITT scenario analysis |
---|---|---|
Female, % | 19.2 [34] | 39.8 |
Age (years), mean (SE) | 68.2 (0.4) [34] | 64.4 (0.6) |
Smoking status (current smokers), % | 23.1 [35] | 53.0 |
Any cardiovascular comorbidity, % | 26.3a | 26.3b |
Any other comorbidity, % | 78.4a | 78.4 |
History of exacerbation, ≥1 moderate or severe in the previous 12 months, % | 18.2a | 18.2 |
BMI (kg/m2), % | ||
< 21 | 7.1 [35] | 10 |
21–30 | 60.8 [35] | 50 |
> 30 | 32.1 [35] | 40 |
mMRC score ≥ 2, % | 100a | 100 |
Number of moderate and severe exacerbations in previous year, mean (SE) | 0.2 (0.03)a | 0.2 (0.03) |
Number of severe exacerbations in previous year as a % of total previous year exacerbations, mean | 13.7a | 13.7 |
Baseline FEV1% predicted, mean (SD) | 59.6 (5.6)a | 59.6 (5.6) |
Baseline FEV1 mL, mean (SE) | 1563 (28.6)a | 1563 (28.6) |
Height (cm), mean (SE) | 167.6 (0.3) [36] | 169.9 (0.6) |
Fibrinogen (mcg/dL), mean | 456.7c | 453.2c |
SGRQ score, mean (SE) | 42.7 (0.3) [56] | 43.1 (1.0)d |
6MWT distance (m), mean | 346.1c | 349.9c |
Exacerbation event costs (€) | ||
Moderate exacerbation | 72.76 | |
Severe exacerbation | 4466.09 | |
Annual disease management costs (€/year) | ||
Without dyspnea symptoms | 524.87 | |
With dyspnea symptoms several days per week | 699.98 | |
With dyspnea symptoms most days per week | 925.85 |