Skip to main content

Table 3 Number (%) of patients with TEAEs, TESAEs and discontinuations (safety population)

From: Efficacy and safety of aclidinium bromide/formoterol fumarate fixed-dose combinations compared with individual components and placebo in patients with COPD (ACLIFORM-COPD): a multicentre, randomised study

  

FDC

FDC

Aclidinium

Formoterol

 

Placebo

400/12 μg

400/6 μg

400 μg

12 μg

n (%)

(n = 194)

(n = 385)

(n = 381)

(n = 385)

(n = 384)

Any TEAE

103 (53.1)

194 (50.4)

193 (50.7)

190 (49.4)

217 (56.5)

TEAEs in ≥2% of any treatment group (by preferred term)

    

 COPD exacerbation

27 (13.9)

36 (9.4)

38 (10.0)

46 (11.9)

60 (15.6)

 Headache

16 (8.2)

29 (7.5)

27 (7.1)

35 (9.1)

43 (11.2)

 Nasopharyngitis

14 (7.2)

30 (7.8)

30 (7.9)

22 (5.7)

26 (6.8)

 Back pain

9 (4.6)

18 (4.7)

13 (3.4)

20 (5.2)

19 (4.9)

 Diarrhoea

5 (2.6)

6 (1.6)

5 (1.3)

2 (0.5)

6 (1.6)

 Nausea

5 (2.6)

3 (0.8)

4 (1.0)

4 (1.0)

1 (0.3)

 Abdominal pain, upper

4 (2.1)

2 (0.5)

3 (0.8)

4 (1.0)

6 (1.6)

 Arthralgia

3 (1.5)

6 (1.6)

3 (0.8)

3 (0.8)

12 (3.1)

 URTI

3 (1.5)

8 (2.1)

4 (1.0)

7 (1.8)

10 (2.6)

 Hypertension

2 (1.0)

3 (0.8)

4 (1.0)

2 (0.5)

9 (2.3)

 Sinusitis

1 (0.5)

3 (0.8)

10 (2.6)

3 (0.8)

3 (0.8)

 Rhinitis

1 (0.5)

2 (0.5)

6 (1.6)

2 (0.5)

10 (2.6)

 Oropharyngeal pain

1 (0.5)

10 (2.6)

2 (0.5)

5 (1.3)

2 (0.5)

TEAEs leading to discontinuation

8 (4.1)

16 (4.2)

12 (3.1)

17 (4.4)

14 (3.6)

TESAEs

12 (6.2)

23 (6.0)

18 (4.7)

16 (4.2)

14 (3.6)

TESAEs occurring in >2 patients in any treatment group (by preferred term)

     

 COPD exacerbation

5 (2.6)

4 (1.0)

4 (1.0)

7 (1.8)

1 (0.3)

 Pneumonia

1 (0.5)

3 (0.8)

4 (1.0)

0 (0.0)

0 (0.0)

  1. COPD, chronic obstructive pulmonary disease; FDC, aclidinium/formoterol fixed-dose combination; TEAE, treatment-emergent adverse event; TESAE, treatment-emergent serious adverse event; URTI, upper respiratory tract infection.