Table 3– Summary of serious adverse events (SAEs) and discontinuations due to adverse events (DAEs) in the primary dataset
SubjectsAsthma-relatedCardiac-relatedAll-cause
SAEsDAEsSAEsDAEsSAEsDAEs
Formoterol-randomised patients#67 380463 (0.7)534 (0.8)129 (0.2)197 (0.3)1865 (2.8)1543(2.3)
Salmeterol-randomised patients417038 (0.9)32 (0.8)12 (0.3)4 (0.1)151 (3.6)83 (2.0)
CBP-randomised patients439425 (0.6)7 (0.2)3 (0.1)7 (0.2)97 (2.2)34 (0.8)
Non-LABA-randomised patients18 740204 (1.1)291 (1.6)45 (0.2)37 (0.2)565 (3.0)523 (2.8)
Total#94 683730 (0.8)864 (0.9)189 (0.2)245 (0.3)2678 (2.8)2183 (2.3)
  • Data are presented as n or n (%). CBP: current best practice; LABA: long-acting β-agonist. #: DAEs were not collected in three trials, reducing n for formoterol to 65 774 and n for total to 93 077 with respect to DAEs.