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Table 2 Treatment-emergent adverse events a (≥2% in any treatment group)

From: Efficacy and safety of fixed-dose combinations of aclidinium bromide/formoterol fumarate: the 24-week, randomized, placebo-controlled AUGMENT COPD study

 

PBO (n = 332)

ACL400/FOR12 FDC (n = 335)

ACL400/FOR6 FDC (n = 333)

ACL400 (n = 337)

FOR 12 (n = 332)

Patients with ≥1 TEAE, n (%)

181 (54.5)

215 (64.2)

203 (61.0)

210 (62.3)

189 (56.9)

TEAEs by preferred term, n (%)

     

Coughb

12 (3.6)

17 (5.1)

13 (3.9)

7 (2.1)

10 (3.0)

Headacheb

11 (3.3)

16 (4.8)

14 (4.2)

13 (3.9)

12 (3.6)

Nasopharyngitis

12 (3.6)

16 (4.8)

17 (5.1)

12 (3.9)

22 (6.6)

Urinary tract infectionb,c

10 (3.0)

15 (4.5)

7 (2.1)

11 (3.3)

9 (2.7)

Back pain

9 (2.7)

10 (3.0)

5 (1.5)

4 (1.2)

6 (1.8)

Upper respiratory tract infection

5 (1.5)

10 (3.0)

13 (3.9)

11 (3.3)

9 (2.7)

Diarrhea

8 (2.4)

9 (2.7)

10 (3.0)

9 (2.7)

6 (1.8)

Muscle spasmsb

3 (0.9)

9 (2.7)

4 (1.2)

2 (0.6)

6 (1.8)

Sinusitis

7 (2.1)

9 (2.7)

8 (2.4)

12 (3.6)

6 (1.8)

Dry mouthc

1 (0.3)

8 (2.4)

5 (1.5)

2 (0.6)

3 (0.9)

Tooth abscess

2 (0.6)

8 (2.4)

2 (0.6)

2 (0.6)

0

Musculoskeletal pain

2 (0.6)

7 (2.1)

0

2 (0.6)

3 (0.9)

Oropharyngeal pain

10 (3.0)

7 (2.1)

6 (1.8)

4 (1.2)

6 (1.8)

Dizziness

7 (2.1)

6 (1.8)

4 (1.2)

5 (1.5)

8 (2.4)

Insomniab

2 (0.6)

6 (1.8)

3 (0.9)

3 (0.9)

9 (2.7)

Dyspnea

6 (1.8)

5 (1.5)

11 (3.3)

6 (1.8)

3 (0.9)

Nausea

4 (1.2)

5 (1.5)

15 (4.5)

12 (3.6)

14 (4.2)

Hypertensionb

6 (1.8)

4 (1.2)

9 (2.7)

10 (3.0)

9 (2.7)

Constipationb,c

6 (1.8)

3 (0.9)

4 (1.2)

7 (2.1)

4 (1.2)

Pain in extremity

0

3 (0.9)

3 (0.9)

7 (2.1)

2 (0.6)

Vomiting

2 (0.6)

3 (0.9)

7 (2.1)

5 (1.5)

3 (0.9)

Fatigue

8 (2.4)

2 (0.6)

6 (1.8)

4 (1.2)

7 (2.1)

ÎĽgastroenteritis viral

8 (2.4)

2 (0.6)

5 (1.5)

3 (0.9)

2 (0.6)

  1. aPer protocol exacerbations of COPD were not considered an a priori safety outcome and are therefore not included within the safety results; bPotential β2-agonist TEAE; cPotential anticholiergic TEAE.
  2. ACL 400, aclidinium 400ÎĽg; ACL400/FOR12 FDC, fixed-dose combination of aclidinium 400ÎĽg and formoterol 12ÎĽg; ACL400/FOR6 FDC, fixed-dose combination of aclidinium 400ÎĽg and formoterol 6ÎĽg; FOR 12, formoterol 12ÎĽg; PBO, placebo; TEAE, treatment-emergent adverse event.