The most frequently reported adverse events (AEs)
| B/F | B | F | Placebo | |
| Subjects n | 254 | 257 | 255 | 256 |
| COPD# | 48 (19) | 62 (24) | 73 (29) | 79 (31) |
| Respiratory infection | 36 (14) | 34 (13) | 33 (13) | 24 (9) |
| Fever | 5 (2) | 9 (4) | 11 (4) | 2 (1) |
| Dyspnoea | 5 (2) | 5 (2) | 12 (5) | 5 (2) |
| Back pain | 8 (3) | 4 (2) | 6 (2) | 7 (3) |
| Pharyngitis | 7 (3) | 5 (2) | 8 (3) | 5 (2) |
| Chest pain | 8 (3) | 4 (2) | 6 (2) | 5 (2) |
| Hypertension | 6 (2) | 9 (4) | 3 (1) | 5 (2) |
| Pneumonia | 8 (3) | 5 (2) | 7 (3) | 2 (1) |
| Rhinitis | 11 (4) | 3 (1) | 6 (2) | 1 (<0.5) |
| Dysphonia | 5 (2) | 5 (2) | 1 (<0.5) | 1 (<0.5) |
| Moniliasis | 4 (2) | 4 (2) | 2 (1) | 0 (0) |
Data are presented as n (%) of patients reporting at least one AE after the first dose of investigational product unless otherwise stated
B: budesonide
F: formoterol
COPD: chronic obstructive pulmonary disease
#: COPD was reported as an AE only if the COPD symptom (bronchitis, phlegm, cough, increased sputum production, breathlessness, wheeze, dyspnoea) was serious (resulted in death, was life-threatening, required hospitalisation or prolonged existing hospitalisation, or resulted in persistent or significant disability/incapacity), or resulted in the patient's withdrawal from the study