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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/subgroupFF/UMEC/VI
(N = 4151)
FF/VI
(N = 4134)
UMEC/VI
(N = 2070)
Total duration at risk (patient-years)3714.93457.91698.3
 n (%)Rate [#]n (%)Rate [#]n (%)Rate [#]
CVAESIa450 (11)167.2 [621]430 (10)157.0 [543]224 (11)166.6 [283]
 Cardiac arrhythmia153 (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