TABLE 2.

Results of the sensitivity analysis, excluding spirometry data, collected at visits without corresponding health status

	ITT population 24 weeks		EXT population 52 weeks
	FF/UMEC/VI 100/62.5/25 µg	BUD/FOR 400/12 µg	FF/UMEC/VI 100/62.5/25 µg	BUD/FOR 400/12 µg
Subjects	911	899	210	220
SGRQ-containing CID definition
Patients with a CID event	416 (46)	594 (66)	122 (58)	168 (76)
FF/UMEC/VI versus BUD/FOR
HR (95% CI)	0.53 (0.47–0.61)		0.59 (0.46–0.74)
p-value	<0.001		<0.001
CAT-containing CID definition
Patients with a CID event	419 (46)	593 (66)	127 (60)	164 (75)
FF/UMEC/VI versus BUD/FOR
HR (95% CI)	0.55 (0.48–0.62)		0.58 (0.45–0.73)
p-value	<0.001		<0.001

Data are presented as n or n (%), unless otherwise stated. ITT: intent-to-treat; EXT: extension; FF: fluticasone furoate; UMEC: umeclidinium; VI: vilanterol; BUD: budesonide; FOR: formoterol; SGRQ: St George's Respiratory Questionnaire; CID: clinically important deterioration; CAT: chronic obstructive pulmonary disease assessment test.