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Table 2 Summary of on-treatment CVAESI by SMQs and sub-SMQs (ITT population)

From: Single-inhaler triple therapy fluticasone furoate/umeclidinium/vilanterol versus fluticasone furoate/vilanterol and umeclidinium/vilanterol in patients with COPD: results on cardiovascular safety from the IMPACT trial

Special interest group/subgroup

FF/UMEC/VI

(N = 4151)

FF/VI

(N = 4134)

UMEC/VI

(N = 2070)

Total duration at risk (patient-years)

3714.9

3457.9

1698.3

 

n (%)

Rate [#]

n (%)

Rate [#]

n (%)

Rate [#]

CVAESIa

450 (11)

167.2 [621]

430 (10)

157.0 [543]

224 (11)

166.6 [283]

 Cardiac arrhythmia

153 (4)

50.9 [189]

161 (4)

51.5 [178]

81 (4)

51.2 [87]

  Arrhythmia-related investigations, signs and symptoms (SMQ)

63 (2)

19.7 [73]

71 (2)

22.8 [79]

33 (2)

20.6 [35]

  Bradyarrhythmia terms, nonspecific (SMQ)

0 (0)

0 [0]

0 (0)

0 [0]

0 (0)

0 [0]

  Cardiac arrhythmia terms, nonspecific (SMQ)

7 (< 1)

1.9 [7]

10 (< 1)

2.9 [10]

6 (< 1)

3.5 [6]

  Conduction defects (SMQ)

20 (< 1)

5.7 [21]

16 (< 1)

4.6 [16]

10 (< 1)

5.9 [10]

  Disorders of sinus node function (SMQ)

3 (< 1)

0.8 [3]

2 (< 1)

0.6 [2]

0 (0)

0 [0]

  Supraventricular tachyarrhythmias (SMQ)

65 (2)

18.8 [70]

51 (1)

15.9 [55]

27 (1)

16.5 [28]

  Tachyarrhythmia terms, nonspecific (SMQ)

3 (< 1)

0.8 [3]

4 (< 1)

1.2 [4]

1 (< 1)

0.6 [1]

  Ventricular tachyarrhythmias (SMQ)

13 (< 1)

3.5 [13]

13 (< 1)

3.8 [13]

7 (< 1)

4.1 [7]

 Cardiac failure (SMQ)

138 (3)

42.5 [158]

126 (3)

42.8 [148]

68 (3)

44.8 [76]

 CNS hemorrhages and cerebrovascular conditions (SMQ)

41 (< 1)

12.1 [45]

28 (< 1)

9.3 [32]

11 (< 1)

6.5 [11]

 Hypertension (SMQ)

113 (3)

35.5 [132]

115 (3)

35.0 [121]

54 (3)

34.2 [58]

 Ischemic heart disease (SMQ)

80 (2)

26.1 [97]

57 (1)

18.5 [64]

47 (2)

30.6 [52]

  1. #, number of events. Rates are reported as number of events per 1000 patient-years, calculated as the number of events × 1000, divided by the total duration at risk. aNote, a patient may have experienced more than one CVAESI
  2. CNS Central nervous system; CVAESI, Cardiovascular adverse event of special interest; FF Fluticasone furoate; ITT Intent-to-treat; MedDRA Medical Dictionary for Regulatory Activities; n Number of patients; SMQ Standardized MedDRA Query; UMEC Umeclidinium; VI Vilanterol