Table 4.
Adverse events occurring in at least 2% of patients (safety set).
|
Incidence, n (%)
|
|||
|---|---|---|---|
| FP/FORM (N = 106) | FP/SAL (N = 105) | FP/FORM EXT* (N = 208) | |
| Patients with ⩾1 AE | 31 (29.2) | 28 (26.7) | 91 (43.8) |
| Infections and infestations | 24 (22.6) | 22 (21.0) | 79 (38.0) |
| Nasopharyngitis | 3 (2.8) | 5 (4.8) | 17 (8.2) |
| Pharyngitis | 4 (3.8) | 4 (3.8) | 15 (7.2) |
| Bronchitis | 4 (3.8) | 3 (2.9) | 11 (5.3) |
| Respiratory, thoracic and mediastinal disorders | 5 (4.7) | 3 (2.9) | 9 (4.3) |
| Cough | 3 (2.8) | 1 (1.0) | 3 (1.4) |
AE, adverse event; EXT, extension treatment; N, number of patients in a treatment group; n, number of patients with specified AEs; SAE, serious adverse event; %, percentage calculated relative to n; FP/FORM, fluticasone propionate/formoterol fumarate; FP/SAL, fluticasone propionate/salmeterol xinafoate.
*
Comprises patients who received 12-weeks of randomized FP/FORM then 24-weeks of extension FP/FORM treatment, and those who received 12-weeks of randomized FP/SAL then 24-weeks of extension FP/FORM treatment.