Results
A total of 3,960 patients had an exacerbation. The mean age was 65 years, forced expiratory volume in 1 s (FEV1) was 38% predicted, and 74% were men. For all NRSAEs, the IRs 30 days before and after an exacerbation were 20.2 and 65.2
with RR (95% CI) = 3.22 (2.40–4.33). The IRs for the 180-day periods were 13.2 and 31.0 with RR (95% CI) = 2.36 (1.93–2.87).
The most common NRSAEs by organ class for both time periods were cardiac, respiratory system (other), and gastrointestinal.
All NRSAEs as well as cardiac events were more common after the first exacerbation, irrespective of whether the patient had
cardiac disease at baseline.