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Table 3 Adverse events

From: Efficacy of umeclidinium/vilanterol versus umeclidinium and salmeterol monotherapies in symptomatic patients with COPD not receiving inhaled corticosteroids: the EMAX randomised trial

  UMEC/VI (N = 812) UMEC (N = 804) SAL (N = 809)
AE, n (%)
 AE 315 (39) 316 (39) 314 (39)
 Drug-related AE 29 (4) 37 (5) 27 (3)
 AE leading to study withdrawal 32 (4) 36 (4) 26 (3)
SAE, n (%)
 Non-fatal SAE 46 (6) 31 (4) 38 (5)
 Drug-related non-fatal SAE 0 0 0
 Fatal SAEa 4 (< 1) 4 (< 1) 0
 Drug-related fatal SAE 0 0 0
Most frequent AEsa, n (%)
 Nasopharyngitis 68 (8) 87 (11) 84 (10)
 Upper respiratory tract infection 19 (2) 12 (1) 20 (2)
 Influenza 20 (2) 9 (1) 18 (2)
 Back pain 10 (1) 13 (2) 15 (2)
 Cough 14 (2) 11 (1) 10 (1)
 Headache 10 (1) 17 (2) 6 (< 1)
  1. aThe incidence of fatal cardiovascular SAEs was < 1% in all treatment groups, with three cardiac disorders observed in the UMEC/VI arm and one in the UMEC arm (one acute myocardial infarction in each treatment group). bincludes all on-treatment AEs occurring in ≥2% of any treatment group
  2. AE Adverse event, SAE Serious adverse event, SAL Salmeterol, UMEC Umeclidinium, VI Vilanterol