Table 2.
Number of Patients Experiencing Cardiovascular Events During and Following Exacerbation Events
| First CVAESI | First CVAESI resulting in hospitalization or death | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Total n | Patients experiencing cardiovascular event, n (%) | Total time at risk (patient‐years) | Event rate per 100 patient‐years | Primary analysis method* HR (95% CI) (time point vs baseline) | Secondary analysis method† HR (95% CI) (time point vs baseline) | Total n | Patients experiencing cardiovascular event, n (%) | Total time at‐risk (patient‐years) | Event rate per 100 patient‐years | Primary analysis method* HR (95% CI) (time point vs baseline) | Secondary analysis method† HR (95% CI) (time point vs baseline) | |
| Exacerbation‐free “baseline” “on study treatment” period | 10 340 | 681 (6.6) | 5916 | 11.5 | … | … | 10 340 | 174 (1.7) | 6139 | 2.8 | … | … |
| Moderate exacerbations | ||||||||||||
| Exacerbation event | 4207 | 80 (1.9) | 267 | 29.9 | 2.63 (2.08–3.32) | 2.01 (1.55–2.60) | 4361 | 19 (0.4) | 283 | 6.7 | 2.46 (1.53–3.97) | 1.55 (0.90–2.67) |
| 1–30 d post event | 3874 | 74 (1.9) | 466 | 15.9 | 1.63 (1.28–2.08) | 1.66 (1.32–2.10) | 4050 | 26 (0.6) | 495 | 5.3 | 2.00 (1.32–3.05) | 1.97 (1.33–2.92) |
| 31–90 d post event | 3410 | 49 (1.4) | 614 | 8.0 | 0.90 (0.67–1.21) | 0.91 (0.69–1.22) | 3599 | 22 (0.6) | 655 | 3.4 | 1.36 (0.86–2.13) | 1.22 (0.79–1.89) |
| 91–365 d post event | 2548 | 61 (2.4) | 785 | 7.8 | 0.95 (0.72–1.26) | 0.98 (0.75–1.28) | 2710 | 18 (0.7) | 836 | 2.2 | 0.90 (0.55–1.50) | 0.92 (0.57–1.47) |
| Severe exacerbations | ||||||||||||
| Exacerbation event | 1099 | 124 (11.3) | 52 | 238.9 | 21.84 (17.71–26.93) | 11.75 (9.11–15.16) | 1160 | 64 (5.5) | 58 | 111.1 | 41.29 (30.43–56.03) | 15.12 (10.11–22.63) |
| 1–30 d post event | 790 | 12 (1.5) | 68 | 17.8 | 1.75 (0.99–3.11) | 1.77 (1.02–3.07) | 873 | 9 (1.0) | 75 | 12.0 | 4.39 (2.24–8.60) | 4.09 (2.17–7.71) |
| 31–90 d post event | 600 | 13 (2.2) | 86 | 15.1 | 1.61 (0.93–2.81) | 1.95 (1.20–3.18) | 667 | 2 (0.3) | 97 | 2.1 | 0.81 (0.20–3.26) | 2.01 (0.89–4.56) |
| 91–365 d post event | 386 | 10 (2.6) | 106 | 9.5 | 1.12 (0.60–2.10) | 1.15 (0.63–2.11) | 435 | 6 (1.4) | 119 | 5.0 | 2.06 (0.90–4.73) | 1.74 (0.76–3.99) |
CVAESI indicates cardiovascular adverse events of special interest; and HR, hazard ratio.
*
The primary method of analysis assumed that if a cardiovascular event occurred on the same day as an exacerbation, the exacerbation occurred first.
†
The secondary method of analysis assumed that if a cardiovascular event occurred on the same day as an exacerbation, the cardiovascular event occurred first.