Table 5 Summary of incidence of different classes of AEs and COPD exacerbation (ITT population)
From: Umeclidinium/vilanterol versus fluticasone propionate/salmeterol in COPD: a randomised trial
UMEC/VI 62.5/25 mcg (N = 358) | FP/SAL 500/50 mcg (N = 358) | |
|---|---|---|
AEs, n (%) | ||
Any | 99 (28) | 105 (29) |
Treatment-related | 7 (2) | 14 (4) |
Leading to permanent discontinuation or withdrawal | 6 (2) | 5 (1) |
Serious AEs, n (%) | ||
Any | 7 (2) | 2 (<1) |
Treatment-related | 0 | 0 |
Fatal | 1 (<1) | 0 |
AEs of special interest, n (%) | ||
Cardiac ischaemiaa | 3 (<1) | 0 |
Cardiac arrhythmias | 3 (<1) | 2 (<1) |
Pneumonia | 0 | 1 (<1) |
LRTI (excluding pneumonia) | 1 (<1) | 0 |
AEs occurring in ≥3 % patients in any treatment group, n (%) | ||
Headache | 33 (9) | 25 (7) |
Nasopharyngitis | 10 (3) | 11 (3) |
Back pain | 7 (2) | 9 (3) |
Dysphonia | 2 (<1) | 9 (3) |
COPD exacerbations, n (%) | 8 (2) | 3 (<1) |