TABLE 2

Pneumonia incidence determined by clinical end-point committee

Study and treatment groupPatients, nPneumonia events submitted to clinical end-point committee, n (%)Pneumonia events confirmed by clinical end-point committee, n (%)
ETHOS [14]
 BUD/GLY/FOR (160/18/9.6 µg)2124100 (4.7)75 (3.5)
 BUD/GLY/FOR (320/18/9.6 µg)2144115 (5.4)90 (4.2)
 BUD/FOR (320/9.6 µg)2136118 (5.5)96 (4.5)
 GLY/FOR (18/9.6 µg)212566 (3.1)48 (2.3)
KRONOS [26]
 BUD/GLY/FOR (320/18/9.6 µg; via MDI)63916 (2.5)12 (1.9)
 BUD/FOR (320/9.6 µg; via MDI)3147 (2.2)6 (1.9)
 BUD/FOR (400/12 µg; via DPI)3186 (1.9)4 (1.3)
 GLY/FOR (18/9.6 µg; via MDI)62511 (1.8)10 (1.6)

BUD: budesonide; GLY: glycopyrronium; FOR: formoterol; MDI: metered dose inhaler; DPI: dry powder inhaler.