Table S2.

Moderate or severe COPD exacerbations 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	737 (44.0)	1,265	84.10	0.98 (0.88, 1.10)	0.83 (0.75, 0.91); P<0.001
SFC	844 (50.3)	1,452	98.20	1.19 (1.07, 1.32)
Asian cohort
IND/GLY	99 (39.6)	166	72.20	0.65 (0.51, 0.83)	0.75 (0.58, 0.97); P=0.027
SFC	124 (47.7)	238	97.44	0.87 (0.70, 1.08)

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.