Table 2.

Adverse events, overall and most common (occurring in ≥ 2 patients with any treatment; safety set)

	BDP/FF/G (N = 99)	BDP/FF (N = 99)	Placebo (N = 105)
Adverse events	27 (27.3)	25 (25.3)	20 (19.0)
Arthralgia	2 (2.0)	2 (2.0)	2 (1.9)
Chronic obstructive pulmonary disease exacerbation or worsening of symptoms	0	0	4 (3.8)
COVID-19	0	3 (3.0)	4 (3.8)
Cystitis	2 (2.0)	0	0
Diarrhoea	1 (1.0)	2 (2.0)	2 (1.9)
Dysphonia	1 (1.0)	3 (3.0)	0
Dyspnoea	0	0	2 (1.9)
Headache	2 (2.0)	0	1 (1.0)
Nasopharyngitis	4 (4.0)	3 (3.0)	3 (2.9)
Nausea	0	2 (2.0)	1 (1.0)
Oropharyngeal pain	1 (1.0)	2 (2.0)	0
Treatment-related adverse events	1 (1.0)	3 (3.0)	2 (1.9)
Dysphonia	0	2 (2.0)	0
Severe adverse events	0	0	0
Serious adverse events	0	0	0
Adverse event leading to study discontinuation	0	3 (3.0)	7 (6.7)
Chronic obstructive pulmonary disease exacerbation or worsening of symptoms	0	0	3 (2.9)
COVID-19	0	2 (2.0)	3 (2.9)

Data are patients (%). COVID-19, coronavirus disease 2019