Daily dose of formoterol | Patients | Patients reporting at least one asthma-related SAE |
9 μg# | 6348 | 88 (1.39) |
18 μg | 16 643 | 95 (0.57) |
36 μg | 909 | 4 (0.44) |
As-needed use, adjustable dosing or uncertain dose | 43 480 | 276 (0.63) |
Total | 67 380 | 463 (0.79) |
Data are presented as n or n (%). #: includes the 114 children who received 80/4.5 μg budesonide/formoterol + terbutaline as needed in trial SD-039-0673.