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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)
  1. Summary of incidence of on-treatment AEs, serious AEs, AEs of special interest, most frequent AEs and COPD exacerbation
  2. AE adverse event, COPD chronic obstructive pulmonary disease, ITT intent-to-treat, LRTI lower respiratory tract infection, FP/SAL salmeterol/fluticasone propionate, UMEC umeclidinium, VI, vilanterol
  3. aAll angina