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Table 3 Summary of on-treatment serious and fatal serious CVAESIa 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 [#]
Serious CVAESIb151 (4)54.1 [201]119 (3)38.2 [132]74 (4)51.2 [87]
 Cardiac arrhythmia47 (1)15.1 [56]40 (< 1)11.9 [41]27 (1)17.1 [29]
  Arrhythmia-related investigations, signs and symptoms (SMQ)22 (< 1)5.9 [22]17 (< 1)5.2 [18]14 (< 1)8.2 [14]
  Bradyarrhythmia terms, nonspecific (SMQ)0 (0)0 [0]0 (0)0 [0]0 (0)0 [0]
  Cardiac arrhythmia terms, nonspecific (SMQ)0 (0)0 [0]0 (0)0 [0]0 (0)0 [0]
  Conduction defects (SMQ)1 (< 1)0.3 [1]1 (< 1)0.3 [1]3 (< 1)1.8 [3]
  Disorders of sinus node function (SMQ)1 (< 1)0.3 [1]1 (< 1)0.3 [1]0 (0)0 [0]
  Supraventricular tachyarrhythmias (SMQ)26 (< 1)7.8 [29]16 (< 1)4.6 [16]9 (< 1)5.3 [9]
  Tachyarrhythmia terms, nonspecific (SMQ)1 (< 1)0.3 [1]0 (0)0 [0]1 (< 1)0.6 [1]
  Ventricular tachyarrhythmias (SMQ)2 (< 1)0.5 [2]5 (< 1)1.4 [5]2 (< 1)1.2 [2]
 Cardiac failure (SMQ)45 (1)14.8 [55]33 (< 1)9.8 [34]15 (< 1)10.6 [18]
 CNS hemorrhages and cerebrovascular conditions (SMQ)32 (< 1)9.4 [35]20 (< 1)6.1 [21]7 (< 1)4.1 [7]
 Hypertension (SMQ)6 (< 1)1.6 [6]4 (< 1)1.2 [4]2 (< 1)1.2 [2]
 Ischemic heart disease (SMQ)44 (1)13.2 [49]32 (< 1)9.3 [32]29 (1)18.3 [31]
Fatal serious CVAESIb21 (< 1)7.0 [26]24 (< 1)6.9 [24]19 (< 1)11.2 [19]
 Cardiac arrhythmia12 (< 1)3.8 [4]9 (< 1)2.6 [9]11 (< 1)6.5 [11]
  Arrhythmia-related investigations, signs and symptoms (SMQ)11 (< 1)3.0 [11]8 (< 1)2.3 [8]10 (< 1)5.9 [10]
  Bradyarrhythmia terms, nonspecific (SMQ)0 (0)0 [0]0 (0)0 [0]0 (0)0 [0]
  Cardiac arrhythmia terms, nonspecific (SMQ)0 (0)0 [0]0 (0)0 [0]0 (0)0 [0]
  Conduction defects (SMQ)0 (0)0 [0]0 (0)0 [0]0 (0)0 [0]
  Disorders of sinus node function (SMQ)0 (0)0 [0]0 (0)0 [0]0 (0)0 [0]
  Supraventricular tachyarrhythmias (SMQ)2 (< 1)0.5 [2]0 (0)0 [0]1 (< 1)0.6 [1]
  Tachyarrhythmia terms, nonspecific (SMQ)0 (0)0 [0]0 (0)0 [0]0 (0)0 [0]
  Ventricular tachyarrhythmias (SMQ)2 (< 1)0.5 [2]0 (0)0 [0]1 (< 1)0.6 [1]
 Cardiac failure (SMQ)4 (< 1)1.1 [4]6 (< 1)1.7 [6]3 (< 1)1.8 [3]
 CNS hemorrhages and cerebrovascular conditions (SMQ)3 (< 1)1.3 [5]7 (< 1)2.0 [7]1 (< 1)0.6 [1]
 Hypertension (SMQ)0 (0)0 [0]0 (0)0 [0]0 (0)0 [0]
 Ischemic heart disease (SMQ)3 (< 1)0.8 [3]2 (< 1)0.6 [2]4 (< 1)2.4 [4]
  1. aSerious as specified in the study protocol [23]; bNote, a patient may have experienced more than one CVAESI (including those that led to a fatal outcome). #, 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
  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