Table 2 Escalation to triple therapy (fixed-dose or any concurrent ICS/LAMA/LABA) during each study period
Variable | Prespecified study period (1 April 2015 to 31 March 2019) | Post hoc extension study period (1 April 2015 to 31 March 2020) | ||
|---|---|---|---|---|
Tio | Tio/Olo | Tio | Tio/Olo | |
hdPS-matched cohort (primary analysis) | ||||
Number of patients | 1302 | 1302 | 1723 | 1723 |
Number of events | 8 | 7 | 20 | 14 |
Number of patient-years | 919 | 899 | 1211 | 1203 |
Events per 1000 patient-years (95% CI) | 8.71 (4.11–16.43) | 7.79 (3.47–15.29) | 16.52 (9.28–23.75) | 11.64 (5.54–17.73) |
Median (IQR) time-to-escalation to triple therapy, days | 28.0 (15.0–139.2) | 193 (94.5–302.0) | 108 (60.5–256.8) | 225 (82.2–312.0) |
HR for time-to-escalation (95% CI) | 0.89 (0.32–2.46) | 0.71 (0.36–1.40) | ||
Unmatched cohort | ||||
Number of patients | 5352 | 1436 | 6505 | 1860 |
Number of escalation events | 30 | 8 | 49 | 20 |
Number of patient-years | 4180 | 981 | 5065 | 1291 |
Events per 1000 patient-years (95% CI) | 7.18 (4.61–9.75) | 8.16 (3.52–16.07) | 9.67 (6.97–12.38) | 15.49 (8.70–22.28) |
Median (IQR) time-to-escalation to triple therapy, days | 100.5 (28.0–196.8) | 191 (117.2–292.0) | 112 (56.0–245.0) | 255.5 (176.8–311.5) |
HR for time-to-escalation (95% CI) | 1.11 (0.51–2.43) | 1.60 (0.95–2.69) | ||