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Table 5 Overall safety outcomes (ITT population)

From: Once-daily single-inhaler versus twice-daily multiple-inhaler triple therapy in patients with COPD: lung function and health status results from two replicate randomized controlled trials

 Study 207608Study 207609
 FF/UMEC/VI
N = 363
BUD/FOR+TIO
N = 365
FF/UMEC/VI
N = 366
BUD/FOR+TIO
N = 366
 n (%)Rate [#]n (%)Rate [#]n (%)Rate [#]n (%)Rate [#]
AEs
 Any131 (36)2932.8 [244]121 (33)2651.8 [216]92 (25)2488.8 [205]109 (30)2321.2 [192]
 Drug-related23 (6)372.6 [31]16 (4)233.3 [19]9 (2)182.1 [15]10 (3)145.1 [12]
 Leading to permanent discontinuation or withdrawal7 (2)132.2 [11]7 (2)85.9 [7]2 (< 1)24.3 [2]5 (1)60.4 [5]
SAEs
 Any25 (7)444.7 [37]14 (4)221.0 [18]12 (3)279.2 [23]17 (5)266.0 [22]
 Drug-related4 (1)60.1 [5]0 1 (< 1)24.3 [2]1 (< 1)12.1 [1]
 Leading to permanent discontinuation or withdrawal5 (1)96.2 [8]5 (1)61.4 [5]1 (< 1)12.1 [1]4 (1)48.4 [4]
 Fatal0 0 0 1 (< 1)12.1 [1]
AESIs
 Cardiovascular effects10 (3)132.2 [11]8 (2)135.0 [11]11 (3)157.8 [13]8 (2)120.9 [10]
 Decreased BMD and associated fractures5 (1)72.1 [6]3 (< 1)36.8 [3]2 (< 1)36.4 [3]4 (1)48.4 [4]
 LRTI excluding pneumonia9 (2)108.2 [9]1 (< 1)12.3 [1]1 (< 1)12.1 [1]1 (< 1)12.1 [1]
 Pneumonia5 (1)60.1 [5]6 (2)73.7 [6]2 (< 1)24.3 [2]3 (< 1)60.4 [5]
  1. Rate is the number of events per 1000 patient-year, calculated as the number of events × 1000 divided by the total treatment exposure
  2. AE adverse event; AESI adverse event of special interest; BMD bone mineral density; BUD budesonide; FF fluticasone furoate; FOR formoterol; ITT intent-to-treat; LRTI lower respiratory tract infection; SAE serious adverse event; TIO tiotropium; UMEC umeclidinium; VI vilanterol