Table 4. Summary of AEs.

Event, n (%)	ITT Population (n = 1232)
Any AE	73 (6)
AEs that led to study discontinuation	5 (<1)
AEs reported in ≥3 patients
Headache	10 (<1)
Nasopharyngitis	8 (<1)
Back pain	6 (<1)
Sinusitis	5 (<1)
Cough	5 (<1)
COPD	4 (<1)
Arthralgia	4 (<1)
Pneumonia	3 (<1)
Upper respiratory tract infection	3 (<1)
Treatment-related AEs (placebo ELLIPTA DPI only)a
Cough	4 (<1)
Back pain	1 (<1)
Dyspnea	1 (<1)
Laceration	1 (<1)
Oral paresthesia	1 (<1)
Any SAE	5 (<1)
SAE related to study treatment	0 (0)
Fatal SAEs	0 (0)

^aOne patient had a cough from ELLIPTA powder inhalation; reason for cough was not specified in the other 3 patients. Patients experienced the following AEs secondary to the placebo ELLIPTA DPI: back pain (n = 1), increased dyspnea (n = 1), and oral paresthesia (n = 1). One patient experienced laceration (cuts on both thumbs) while opening the blister card packaging of placebo capsules.

AE, adverse event; COPD, chronic obstructive pulmonary disease; DPI, dry-powder inhaler; ITT, intent-to-treat; SAE, serious adverse event.