Serious adverse events (SAEs)
| Budesonide/formoterol | Budesonide | Formoterol | Placebo | |
| Patients n | 208 | 198 | 201 | 205 |
| Deaths n | 6 | 5 | 6 | 9 |
| SAEs other than deaths n | 43 | 35 | 37 | 37 |
| SAEs per 1000 treatment days n | 0.8 | 0.7 | 0.7 | 0.9 |
| Patients with SAEs n (%) | 46 (22) | 35 (18) | 39 (19) | 42 (20) |