Daily dose of formoterol | Patients n | Mean duration days | Patients reporting SAEs¶ n (%) |
9 μg+ | 5306 | 218 | 57 (1.07) |
18 μg | 15923 | 131 | 92 (0.58) |
36 μg | 909 | 239 | 4 (0.44) |
As-needed use/adjustable dosing | 27768 | 185 | 221 (0.80) |
Total§ | 49906 | 173 | 374 (0.75) |
#: defined using International Conference on Harmonisation recommendations; ¶: at least one asthma-related nonfatal SAE per patient; +: includes children who received 80/4.5 μg budesonide/formoterol once daily plus terbutaline as needed in trial SD-039-0673; §: all trials combined.