Table 3.
Summary of AEs (ITT population)
| UMEC/VI 62.5/25 μg (n=248) |
PBO (n=248) |
|
|---|---|---|
| On-treatment AEs, n (%) | 80 (32) | 75 (30) |
| Any AEs leading to withdrawal/discontinuation of medication,a n (%) | 8 (3) | 6 (2) |
| On-treatment nonfatal SAE, n (%) | 17 (7) | 13 (5) |
| On-treatment fatal SAE, n (%) | 2 (<1) | 0 |
| AEs reported in ≥3% patients, n (%) | ||
| Headache | 16 (6) | 16 (6) |
| Nasopharyngitis | 13 (5) | 16 (6) |
| COPDb | 8 (3) | 7 (3) |
| Patients experiencing a COPD exacerbation,c n (%) | 18 (7) | 28 (11) |
| Total no of exacerbations | 21 | 32 |
| Withdrawn due to an exacerbationd | 4 (19) | 7 (22) |
| Requiring oral/systemic corticosteroidd | 12 (57) | 16 (50) |
| Requiring antibioticsd | 16 (76) | 27 (84) |
| Requiring emergency room visitd | 3 (14) | 2 (6) |
| Requiring hospitalizationd | 12 (57) | 11 (34) |
Notes:
a
Includes both on- and posttreatment AEs.
b
COPD was listed as an AE by the participating investigator and was likely due to a worsening of the underlying condition, although no further information is available in the AE reporting.
c
COPD exacerbations were not to be recorded as AEs unless they met the definition of an SAE.
d
Proportion of the number of exacerbations per treatment group.
Abbreviations: AE, adverse event; COPD, chronic obstructive pulmonary disease; ITT, intent-to-treat; PBO, placebo; SAE, serious adverse event; UMEC, umeclidinium; VI, vilanterol.