Table 4.

Summary of adverse events (AEs) reported in each of the four treatment groups (intent-to-treat population)

	Placebo (n = 58)	FF/VI 100/25 μg (n = 56)	FF/VI 200/25 μg (n = 56)	Prednisolone (n = 15)
AEs, n (%)
On-treatment	16 (28)	23 (41)	21 (38)	5 (33)
Treatment-related AEs	1 (2)	1 (2)	2 (4)	0
AEs leading to permanent discontinuation of study drug or withdrawal from study	1 (2)	0	0	2 (13)
Most frequent on-treatment AEs, n (%)*
Headache	5 (9)	15 (27)	9 (16)	2 (13)
Back pain	0	1 (2)	2 (4)	1 (7)
Nasopharyngitis	1 (2)	2 (4)	1 (2)	0
Oropharyngeal pain	2 (3)	1 (2)	0	0
Sinus headache	0	1 (2)	2 (4)	0
Arthralgia	0	2 (4)	0	0
Cough	2 (3)	0	0	0
Nausea	1 (2)	0	0	1 (7)
Rhinitis allergic	0	2 (4)	0	0
Sinusitis	0	2 (4)	0	0
AEs of special interest (on- and post-treatment), n (%)
Any local steroid effect	0	2 (4)	2 (4)	0
Dysphonia	0	1 (2)	1 (2)	0
Oropharyngeal candidiasis	0	0	1 (2)	0
Throat irritation	0	1 (2)	0	0
Any cardiovascular effect	1 (2)	0	1 (2)	0
Increase in blood pressure	1 (2)	0	0	0
Palpitations	0	0	1 (2)	0

^*AEs occurring only in the prednisolone group are not shown. These were as follows: dizziness, exertional dyspnoea, facial palsy, fatigue, hypotension, insomnia, varicose vein [n = 1 (7%) patient for each].

FF, fluticasone furoate; VI, vilanterol.