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Table 7 On-treatment adverse events reported by ≥3% of patients within any treatment group (mITT population)

From: Dose response of umeclidinium administered once or twice daily in patients with COPD: a randomised cross-over study

  Number (%) of patients
Preferred term   UMEC QD
  Placebo 15.6 μg 31.25 μg 62.5 μg 125 μg
  N = 60 N = 60 N = 57 N = 59 N = 60
Headache 2 (3) 1 (2) 0 0 3 (5)
Nasopharyngitis 0 1 (2) 0 0 1 (2)
Dysgeusia 0 1 (2) 0 0 2 (3)
Sinusitis 0 0 0 0 2 (3)
Preferred term UMEC BID Tiotropium
  15.6 μg 31.25 μg QD 18 μg
  N= 56 N= 58 N= 56
Headache 4 (7) 1 (2) 0
Nasopharyngitis 0 0 2 (4)
Dysgeusia 0 0 0
Sinusitis 0 0 0
  1. Cut-off of ≥3% was based on percentage after rounding; on-treatment AEs were defined as AEs with onset within the period beginning with the first day of study drug administration through the day after the last day of study drug administration.
  2. BID, twice daily; mITT, modified intent-to-treat; QD, once daily; UMEC, umeclidinium bromide.