Table 5—

Nonfatal asthma-related serious adverse events (SAEs) by age, sex and ethnicity (overall data set)

Formoterol-containing productsNon-LABA-containing productsTotal
Age group
4–11 yrs39/3264 (1.2)25/2165 (1.2)64/5429 (1.2)
12–17 yrs24/4556 (0.5)17/1889 (0.9)41/6445 (0.6)
18–64 yrs270/37882 (0.7)136/12596 (1.1)404/50478 (0.8)
≥65 yrs43/4162 (1.0)21/1448 (1.5)64/5610 (1.1)
Unknown0/42 (0)0/0 (0)0/42 (0)
Sex
Male146/22057 (0.7)72/8068 (0.9)218/30125 (0.7)
Female228/27800 (0.8)127/10030 (1.3)355/37830 (0.9)
Unknown0/49 (0)0/0 (0)0/49 (0)
Ethnicity
Caucasian268/39868 (0.7)123/14818 (0.8)391/54686 (0.7)
Black8/861 (0.9)3/328 (0.9)11/1189 (0.9)
Oriental70/4065 (1.7)53/1916 (2.8)123/5981 (2.1)
Other25/2170 (1.2)20/1036 (1.9)45/3206 (1.4)
Unknown3/2942 (0.1)0/0 (0)3/2942 (0.1)
Total374/49906 (0.7)199/18098 (1.1)573/68004 (0.8)
  • Data are presented as n/N (%) of patients reporting at least one asthma-related nonfatal SAE (defined using International Conference on Harmonisation recommendations). LABA: long-acting β2-agonist.