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Table 2 Adverse events and serious adverse events (safety population)

From: Efficacy and safety of single-inhaler extrafine triple therapy versus inhaled corticosteroid plus long-acting beta2 agonist in eastern Asian patients with COPD: the TRIVERSYTI randomised controlled trial

Number (%) of patients

Overall population

China subgroup

BDP/FF/G (N = 352)

BUD/FF (N = 355)

BDP/FF/G (N = 287)

BUD/FF (N = 290)

Adverse events

215 (61.1)

238 (67.0)

173 (60.3)

195 (67.2)

   COPD exacerbation

66 (18.8)

110 (31.0)

49 (17.1)

93 (32.1)

   Upper respiratory tract infection

58 (16.5)

49 (13.8)

55 (19.2)

45 (15.5)

   Nasopharyngitis

22 (6.3)

23 (6.5)

16 (5.6)

17 (5.9)

   Hypertension

12 (3.4)

24 (6.8)

10 (3.5)

19 (6.6)

   Productive cough

9 (2.6)

9 (2.5)

8 (2.8)

8 (2.8)

   Pneumonia

8 (2.3)

13 (3.7)

4 (1.4)

7 (2.4)

   Cough

8 (2.3)

8 (2.3)

4 (1.4)

7 (2.4)

   Bronchitis

6 (1.7)

3 (0.8)

5 (1.7)

1 (0.3)

   Pharyngitis

5 (1.4)

3 (0.8)

5 (1.7)

3 (1.0)

   Dyspnoea

4 (1.1)

8 (2.3)

3 (1.0)

5 (1.7)

   Gamma-glutamyltransferase increased

2 (0.6)

6 (1.7)

2 (0.7)

4 (1.4)

   Hepatic function abnormal

2 (0.6)

6 (1.7)

2 (0.7)

6 (2.1)

   Alanine aminotransferase increased

2 (0.6)

6 (1.7)

1 (0.3)

3 (1.0)

   Back pain

0

8 (2.3)

0

8 (2.8)

   Hypokalaemia

0

7 (2.0)

0

5 (1.7)

   Neutrophil count increased

6 (1.7)

2 (0.6)

6 (2.1)

1 (0.3)

   Anaemia

4 (1.1)

5 (1.4)

4 (1.4)

5 (1.7)

   Lung infection

2 (0.6)

5 (1.4)

2 (0.7)

5 (1.7)

   Blood pressure increased

1 (0.3)

5 (1.4)

1 (0.3)

5 (1.7)

Serious adverse events

40 (11.4)

60 (16.9)

30 (10.5)

49 (16.9)

   COPD exacerbation

20 (5.7)

43 (12.1)

16 (5.6)

38 (13.1)

   Pneumonia

4 (1.1)

9 (2.5)

1 (0.3)

4 (1.4)

   Pneumothorax spontaneous

2 (0.6)

0

2 (0.7)

0

   Influenza

2 (0.6)

0

0

0

Treatment-related adverse events

9 (2.6)

16 (4.5)

8 (2.8)

14 (4.8)

   Muscle spasms

2 (0.6)

2 (0.6)

2 (0.7)

2 (0.7)

   Blood pressure increased

0

2 (0.6)

0

2 (0.7)

Treatment-related serious adverse events

1 (0.3)

0

1 (0.3)

0

Severe adverse events

31 (8.8)

56 (15.8)

23 (8.0)

48 (16.6)

   COPD exacerbation

22 (6.3)

46 (13.0)

18 (6.3)

41 (14.1)

   Pneumonia

3 (0.9)

8 (2.3)

2 (0.7)

4 (1.4)

   Influenza

2 (0.6)

0

0

0

   Lung infection

1 (0.3)

2 (0.6)

1 (0.3)

2 (0.7)

Adverse events leading to study drug discontinuation

8 (2.3)

13 (3.7)

8 (2.8)

10 (3.4)

   COPD exacerbation

1 (0.3)

7 (2.0)

1 (0.3)

5 (1.7)

Adverse events leading to death

1 (0.3)

3 (0.8)

1 (0.3)

3 (1.0)

  1. Data are n (%). ≥ 1.5% in either group of the overall population for adverse events and ≥ 0.5% in either group of the overall population for serious adverse events, treatment-related adverse events, and adverse events leading to study drug discontinuation. BDP beclometasone dipropionate, FF formoterol fumarate, G glycopyrronium, BUD budesonide, COPD chronic obstructive pulmonary disease