Table 5.
IRs and RRs 180 days before and after the first exacerbation for cardiovascular NRSAEs by selected prespecified adverse event category according to presence or absence of cardiac disorders at baseline
| Prespecified adverse event categorya | Cardiac disorder present at baseline (N = 578) | Cardiac disorder absent at baseline (N = 1,711) | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Before exacerbation | After exacerbation | Incidence RR (95% CI) | Before exacerbation | After exacerbation | Incidence RR (95% CI) | |||||
| N | IRb | N | IRb | N | IRb | N | IRb | |||
| All | 60 | 22.3 | 112 | 46.9 | 2.11 (1.54–2.88) | 84 | 10.2 | 192 | 25.9 | 2.54 (1.97–3.28) |
| Ischemic heart disease | 8 | 2.82 | 16 | 6.05 | 2.14 (0.92–5.01) | 4 | 0.47 | 16 | 2.03 | 4.28 (1.43–12.8) |
| MI | 3 | 1.05 | 6 | 2.24 | 2.13 (0.53–8.51) | 2 | 0.24 | 9 | 1.14 | 4.80 (1.04–22.2) |
| Angina | 5 | 1.76 | 11 | 4.12 | 2.34 (0.81–6.73) | 2 | 0.24 | 9 | 1.14 | 4.80 (1.04–22.2) |
| Cardiac failure | 3 | 1.06 | 19 | 7.17 | 6.79 (2.01–22.9) | 1 | 0.12 | 21 | 2.67 | 22.5 (3.02–167) |
| Atrial fibrillation/flutter | 2 | 0.70 | 18 | 6.78 | 9.62 (2.23–41.5) | 2 | 0.24 | 7 | 0.88 | 3.73 (0.77–17.9) |
| Nonventricular tachycardia, including SVT | 1 | 0.35 | 2 | 0.74 | 2.12 (0.19–23.3) | 2 | 0.24 | 5 | 0.63 | 2.66 (0.52–13.7) |
| Stroke | 3 | 1.06 | 5 | 1.86 | 1.76 (0.42–7.38) | 3 | 0.36 | 8 | 1.01 | 2.84 (0.75–10.7) |
IR incidence rate, RR rate ratio (after/before), NRSAE nonlower respiratory serious adverse event, CI confidence interval, MI myocardial infarction, SVT supraventricular tachycardia, MedDRA Medical Dictionary for Regulatory Activities
aPreferred terms with a secondary relationship to MedDRA SOC
bIR per 100 patient-years