| Formoterol | Salbutamol | p‐value |
n | % | n | % |
Subjects | 8924 | | 8938 | | |
AEs | | | | | |
Total AEs | 3734 | 42.0 | 3775 | 42.0 | 0.59 |
Asthma-related AE | 1097 | 12.3 | 1205 | 13.5 | 0.018 |
Nonasthma-related AE | 2636 | 29.5 | 2569 | 28.7 | 0.24 |
Cardiovascular-related AE | 119 | 1.3 | 107 | 1.2 | 0.46 |
Serious AEs | | | | | |
Total serious AEs | 278 | 3.1 | 299 | 3.3 | 0.38 |
Deaths | 13 | 0.1 | 11 | 0.1 | 0.68 |
Asthma-related SAE | 108 | 1.2 | 121 | 1.4 | 0.39 |
Nonasthma-related SAE | 170 | 1.9 | 178 | 2.0 | 0.68 |
Cardiovascular-related SAE | 23 | 0.3 | 35 | 0.4 | 0.15 |
Discontinuations due to AEs | | | | | |
Total discontinuations | 213 | 2.4 | 119 | 1.3 | <0.001 |
Due to SAE | 40 | 0.4 | 37 | 0.4 | 0.73 |
Due to non-serious AE | 173 | 1.9 | 82 | 0.9 | <0.001 |
Due to asthma-related AE | 89 | 1.0 | 48 | 0.5 | <0.001 |
Due to nonasthma-related AE | 124 | 1.4 | 71 | 0.8 | <0.001 |