Table S3.

COPD exacerbations (mild, moderate, or severe) during double-blind treatment (full analysis set)

Treatment	Patients with exacerbation, n (%)	Total number of COPD exacerbation episodes	Occurrence rate in 100 patient years	Annualized rate; 95% CI	Rate ratio (IND/GLY versus SFC); 95% CI; P-value
Overall population
IND/GLY	1,295 (77.3)	4,943	328.62	3.59 (3.29, 3.92)	0.88 (0.82, 0.94); P<0.001
SFC	1,368 (81.5)	5,438	367.76	4.09 (3.75, 4.46)
Asian population
IND/GLY	169 (67.6)	513	223.12	2.41 (2.00, 2.92)	0.94 (0.76, 1.16); P=0.567
SFC	192 (73.8)	594	243.19	2.57 (2.15, 3.06)

Note: IND/GLY 110/50 µg q.d.; SFC 50/500 µg b.i.d.

Abbreviations: GLY, glycopyrronium; IND, indacaterol; SFC, salmeterol/fluticasone propionate combination.