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Table 3 Overview of safety findings (ITT population)

From: Single-inhaler fluticasone furoate/umeclidinium/vilanterol versus fluticasone furoate/vilanterol plus umeclidinium using two inhalers for chronic obstructive pulmonary disease: a randomized non-inferiority study

Category, n (%)

FF/UMEC/VI 100/62.5/25 μg

FF/VI 100/25 μg + UMEC 62.5 μg

(N = 527)

(N = 528)

On-treatment AEs

255 (48)

253 (48)

On-treatment drug-related AEs

27 (5)

19 (4)

On-treatment SAEs

52 (10)

57 (11)

On-treatment non-fatal SAEs

50 (9)

54 (10)

On-treatment fatal SAEs

4 (< 1)

4 (< 1)

On-treatment AESIsa

  

Adrenal suppression

1 (< 1)

0

Anticholinergic syndrome

12 (2)

5 (< 1)

Cardiovascular events

30 (6)

28 (5)

Cardiac arrhythmia

6 (1)

8 (2)

Cardiac failure

7 (1)

7 (1)

Ischemic heart disease

6 (1)

3 (< 1)

Hypertension

10 (2)

13 (2)

CNS hemorrhage/cerebrovascular conditions

3 (< 1)

1 (< 1)

Decreased bone mineral density and associated fractures

5 (< 1)

6 (1)

Hyperglycemia/new-onset diabetes mellitus

7 (1)

6 (1)

Hypersensitivity

7 (1)

9 (2)

LRTI excluding pneumonia

16 (3)

11 (2)

Local steroid effects

12 (2)

14 (3)

Ocular effects

4 (< 1)

5 (< 1)

Pneumonia

14 (3)

21 (4)

Tremor

1 (< 1)

0

  1. AE adverse event, AESI adverse event of special interest, CNS central nervous system, FF fluticasone furoate, ITT intent-to-treat, LRTI lower respiratory tract infection, SAE serious adverse event, SD standard deviation, UMEC umeclidinium, VI vilanterol
  2. aNo events were reported for the asthma/bronchospasm, effects on potassium, gastrointestinal obstruction, or urinary retention AESI groups