TABLE 6.

Adverse events (preferred terms) reported for one or more patients in any treatment group (treated set)

	Placebo twice daily	BI 20 μg twice daily	BI 50 μg twice daily	BI 100 μg twice daily	BI 200 μg twice daily
Total number of patients	18 (100.0)	6 (100.0)	5 (100.0)	5 (100.0)	18 (100.0)
Patients with at least one adverse event	12 (66.7)	0	2 (40.0)	2 (40.0)	15 (83.3)
Gastrointestinal disorders
Diarrhoea	0	0	1 (20.0)	0	1 (5.6)
Nausea	0	0	0	0	2 (11.1)
General disorders and administration site conditions
Chest discomfort	0	0	0	0	2 (11.1)
Fatigue	1 (5.6)	0	0	0	1 (5.6)
Infections and infestations
Nasopharyngitis	4 (22.2)	0	0	0	2 (11.1)
Bronchitis	1 (5.6)	0	0	0	1 (5.6)
Infective pulmonary exacerbation of cystic fibrosis	1 (5.6)	0	0	0	1 (5.6)
Rhinitis	1 (5.6)	0	0	0	1 (5.6)
Metabolism and nutrition disorders
Hyperkalaemia	1 (5.6)	0	0	0	1 (5.6)
Musculoskeletal and connective tissue disorders
Myalgia	1 (5.6)	0	0	0	1 (5.6)
Nervous system disorders
Headache	0	0	2 (40.0)	1 (20.0)	2 (11.1)
Respiratory, thoracic and mediastinal disorders
Cough	1 (5.6)	0	0	1 (20.0)	3 (16.7)

Data are presented as n (%). Percentages were calculated using total number of patients per treatment group as the denominator. BI: BI 1265162.