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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.