Table 5 Results from the joint frailty model, including selected covariates, when applied to the pooled datasets
Exacerbations (moderate/severe) | Early treatment discontinuations | |||
|---|---|---|---|---|
Pooled A-C HR (95% CI) | Pooled D-E HR (95% CI) | Pooled A-C HR (95% CI) | Pooled D-E HR (95% CI) | |
Demographics | ||||
Age (+ 1 year) | 1.00 (0.99–1.00) | 1.00 (0.99–1.00) | 1.01 (1.00–1.02) | 1.01 (1.00–1.03) |
Sex (male vs female) | 1.29 (1.06–1.56) | 1.24 (1.00–1.55) | ||
Region | ||||
Western Europe vs US | 1.10 (0.91–1.34) | 1.56 (1.28–1.90) | 0.59 (0.43–0.82) | 1.27 (0.86–1.87) |
Eastern Europe vs US | 0.49 (0.42–0.57) | 0.61 (0.52–0.71) | 0.21 (0.16–0.28) | 0.45 (0.34–0.61) |
Rest of the World vs US | 0.83 (0.70–0.99) | 0.83 (0.73–0.95) | 0.30 (0.22–0.41) | 0.50 (0.39–0.64) |
Treatment | ||||
BUD/FM 320 vs FM | 0.71 (0.61–0.82) | 0.73 (0.56–0.94) | ||
BUD/FM 160 vs FM | 0.71 (0.61–0.83) | 0.75 (0.59–0.97) | ||
BUD 320 + FM vs FM | 0.57 (0.42–0.77) | 0.58 (0.36–0.94) | ||
BUD 320 vs FM | 0.77 (0.58–1.04) | 1.03 (0.65–1.64) | ||
PBO vs FM | 1.20 (1.00–1.44) | 1.12 (0.84–1.50) | ||
SOC + RFL vs SOC | 0.88 (0.80–0.97) | 1.61 (1.34–1.94) | ||
Disease related baseline factors | ||||
Exacerbation history (+ 1 previous year) | 1.16 (1.12–1.21) | 1.21 (1.14–1.28) | ||
Smoking history (+ 10 pack-years) | 1.02 (1.01–1.04) | |||
ICS history (yes vs no) | 1.19 (1.06–1.34) | |||
Bronchodilator history (yes vs no) | 1.30 (1.16–1.46) | |||
FEV1 (+ 100 mL) | 0.92 (0.90–0.93) | 0.52 (0.45–0.61) | 0.7 (0.53–0.93) | 0.551 (0.40–0.76) |
SGRQ total score (+ 10 points) | 1.04 (1.00–1.09) | 1.01 (1.00–1.02) | ||
Breathlessness (+ 1 point) | 1.11 (1.02–1.21) | |||
CAT total score (+ 5 points) | 1.09 (1.05–1.13) | 1.02 (1.00–1.03) | ||
Use of rescue medication (+ 1 puff) | 1.04 (1.03–1.06) | 1.03 (1.02–1.04) | 1.04 (1.01–1.06) | |
Seasonality | ||||
Spring vs Autumn | 0.76 (0.68–0.85) | 1.00 (0.90–1.11) | ||
Summer vs Autumn | 0.69 (0.61–0.77) | 0.78 (0.70–0.87) | ||
Winter vs Autumn | 1.07 (0.97–1.19) | 1.17 (1.06–1.29) | ||
Trial effect | ||||
A vs C | 0.76 (0.65–0.89) | 0.86 (0.67–1.10) | ||
B vs C | 0.85 (0.70–1.03) | 0.78 (0.57–1.07) | ||
E vs D | 1.08 (0.94–1.25) | 1.64 (1.20–2.24) | ||
Association parameters* | ||||
Pooled A-C | Pooled D-E | |||
Frailty variance | 1.14 (SE = 0.07) | 0.67 (SE = 0.05) | ||
Association (α) | 1.54 (SE = 0.15) | 0.95 (SE = 0.17) | ||