Table 4.

Summary of AEs and COPD exacerbations (ITT population)

n (%)	UMEC/VI (N=247)	TIO (N=247)
On-treatment AEs	75 (30)	77 (31)
On-treatment drug-related AEs	3 (1)	8 (3)
Any AEs leading to withdrawal/discontinuation of medication	5 (2)	4 (2)
On-treatment nonfatal SAE	6 (2)	6 (2)
On-treatment fatal SAE	1 (<1)	0
AEs reported in ≥3% patients in either treatment arm
Nasopharyngitis	18 (7)	17 (7)
Headache	16 (6)	18 (7)
Patients experiencing a COPD exacerbation	2 (<1)	8 (3)
Cardiovascular events of special interesta	4 (1.6)	3 (1.2)

Notes: AEs with onset during the follow-up period were considered on-treatment and were assigned to the treatment previously received.

^aStandardized MedDRA terms included cardiac arrhythmias, cardiac failure, ischemic heart disease, central nervous system hemorrhages, and cerebrovascular conditions.

Abbreviations: AEs, adverse events; ITT, intent-to-treat; MedDRA, Medical Dictionary for Regulatory Activities; SAE, serious adverse event; TIO, tiotropium; UMEC, umeclidinium; VI, vilanterol.