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Table 3 Summary of TEAEs (safety population)

From: Efficacy of budesonide/glycopyrronium/formoterol metered dose inhaler in patients with COPD: post-hoc analysis from the KRONOS study excluding patients with airway reversibility and high eosinophil counts

  BGF
320/14.4/10 µg
GFF
14.4/10 µg
BFF
320/10 µg
BUD/FORM
400/12 µg
Non-reversible and EOS < 300b
(n = 319)
Overall population
(n = 639)
Non-reversible and EOS < 300b
(n = 315)
Overall population
(n = 625)
Non-reversible and EOS < 300b
(n = 161)
Overall population
(n = 314)
Non-reversible and EOS < 300b
(n = 153)
Overall population
(n = 318)
TEAEs, n (%)
 ≥ 1 TEAE 189 (59.2) 388 (60.7) 192 (61.0) 384 (61.4) 85 (52.8) 175 (55.7) 85 (55.6) 183 (57.5)
 Treatment-related TEAEsa 51 (16.0) 112 (17.5) 51 (16.2) 91 (14.6) 20 (12.4) 48 (15.3) 17 (11.1) 40 (12.6)
 TEAEs that led to early discontinuation 20 (6.3) 30 (4.7) 16 (5.1) 30 (4.8) 7 (4.3) 11 (3.5) 2 (1.3) 11 (3.5)
 Serious TEAEs 27 (8.5) 55 (8.6) 36 (11.4) 68 (10.9) 10 (6.2) 21 (6.7) 9 (5.9) 29 (9.1)
Serious TEAEs relateda to study treatment 4 (1.3) 7 (1.1) 10 (3.2) 12 (1.9) 2 (1.2) 3 (1.0) 1 (0.7) 6 (1.9)
 Serious TEAEs that led to early discontinuation 7 (2.2) 14 (2.2) 11 (3.5) 22 (3.5) 3 (1.9) 6 (1.9) 1 (0.7) 10 (3.1)
 Deaths (all causes) 2 (0.6) 6 (0.9) 1 (0.3) 3 (0.5) 1 (0.6) 2 (0.6) 0 1 (0.3)
TEAEs occurring in ≥ 2% of patients with non-reversible airways and EOS < 300b in any treatment arm, preferred term, n (%)
 Nasopharyngitis 28 (8.8) 49 (7.7) 17 (5.4) 41 (6.6) 11 (6.8) 26 (8.3) 16 (10.5) 30 (9.4)
 Upper respiratory tract infection 28 (8.8) 65 (10.2) 24 (7.6) 38 (6.1) 8 (5.0) 18 (5.7) 7 (4.6) 22 (6.9)
 COPD 11 (3.4) 17 (2.7) 20 (6.3) 32 (5.1) 6 (3.7) 8 (2.5) 4 (2.6) 13 (4.1)
 Bronchitis 9 (2.8) 20 (3.1) 8 (2.5) 15 (2.4) 7 (4.3) 12 (3.8) 8 (5.2) 9 (2.8)
 Dysphonia 8 (2.5) 20 (3.1) 3 (1.0) 5 (0.8) 6 (3.7) 15 (4.8) 4 (2.6) 6 (1.9)
 Hypertension 8 (2.5) 13 (2.0) 5 (1.6) 10 (1.6) 4 (2.5) 8 (2.5) 3 (2.0) 4 (1.3)
 Muscle spasms 11 (3.4) 21 (3.3) 1 (0.3) 8 (1.3) 4 (2.5) 17 (5.4) 4 (2.6) 6 (1.9)
 Pneumonia 9 (2.8) 12 (1.9) 3 (1.0) 10 (1.6) 3 (1.9) 6 (1.9) 2 (1.3) 4 (1.3)
 Back pain 1 (0.3) 8 (1.3) 9 (2.9) 12 (1.9) 2 (1.2) 4 (1.3) 4 (2.6) 8 (2.5)
 Urinary tract infection 7 (2.2) 12 (1.9) 5 (1.6) 10 (1.6) 1 (0.6) 4 (1.3) 3 (2.0) 4 (1.3)
 Dyspnea 7 (2.2) 9 (1.4) 4 (1.3) 9 (1.4) 1 (0.6) 8 (2.5) 1 (0.7) 8 (2.5)
 Oral candidiasis 4 (1.3) 10 (1.6) 4 (1.3) 5 (0.8) 4 (2.5) 5 (1.6) 2 (1.3) 5 (1.6)
 Pharyngitis 4 (1.3) 8 (1.3) 2 (0.6) 5 (0.8) 5 (3.1) 5 (1.6) 2 (1.3) 3 (0.9)
 Herpes zoster 0 1 (0.2) 1 (0.3) 3 (0.5) 1 (0.6) 2 (0.6) 3 (2.0) 3 (0.9)
  1. Overall population data from [4]
  2. BFF, budesonide/formoterol fumarate dihydrate; BGF, budesonide/glycopyrronium/formoterol fumarate dihydrate; BUD/FORM DPI, budesonide/formoterol fumarate dihydrate dry powder inhaler; COPD, chronic obstructive pulmonary disease; EOS, blood eosinophil count; GFF, glycopyrronium/formoterol fumarate dihydrate; MDI, metered dose inhaler; TEAE, treatment-emergent adverse event
  3. aRelated = possibly, probably, definitely
  4. bPatients with airways not reversible to albuterol and EOS < 300 cells/mm3