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Table 3 Adverse-event profile in ACCLAIM/COPD I and II

From: Efficacy and safety of once-daily aclidinium in chronic obstructive pulmonary disease

 

ACCLAIM/COPD I

ACCLAIM/COPD II

 

Aclidinium 200 μg

(n = 627)

n (%)

Placebo

(n = 216)

n (%)

Aclidinium 200 μg

(n = 600)

n (%)

Placebo

(n = 204)

n (%)

Total AEs

355 (56.6)

128 (59.3)

479 (79.8)

154 (75.5)

SAEs

50 (8.0)

22 (10.2)

62 (10.3)

23 (11.3)

Deaths

7 (1.1)

4 (1.9)

6 (1.0)

3 (1.5)

Cardiac disorders*

32 (5.1)

14 (6.5)

41 (6.8)

17 (8.3)

Vascular disorders*

22 (3.5)

14 (6.5)

34 (5.7)

12 (5.9)

  1. *System organ classes.
  2. COPD exacerbations were reported as part of the efficacy evaluations and, unless life-threatening, were not considered to be AEs.
  3. AEs: adverse events; COPD: chronic obstructive pulmonary disorder; SAEs: serious adverse events.