Table 5.

Serious adverse events, according to trial group

	Intravenous antibiotic therapy (n=126)		Oral antibiotic therapy (n=146)		Total (n=272)
	Events	Participants	Events	Participants	Events	Participants
Gastrointestinal disorders	2	2 (2%)	1	1 (1%)	3	3 (1%)
General disorders and administration site conditions	1	1 (1%)	2	2 (1%)	3	3 (1%)
Hepatobiliary disorders	1	1 (1%)	0	0	1	1 (<1%)
Infections and infestations*	1	1 (1%)	7	6 (4%)	8	7 (3%)
Nervous system disorders	1	1 (1%)	0	0	1	1 (<1%)
Psychiatric disorders	0	0	1	1 (1%)	1	1 (<1%)
Renal and urinary disorders	1	1 (1%)	0	0	1	1 (<1%)
Respiratory, thoracic, and mediastinal disorders	0	0	6	5 (3%)	6	5 (2%)
Skin and subcutaneous tissue disorders	1	1 (1%)	0	0	1	1 (<1%)
Surgical and medical procedures	1	1 (1%)	0	0	1	1 (<1%)
Vascular disorders	2	2 (2%)	0	0	2	2 (1%)
Total*	11	10 (8%)	17	12 (8%)	28	22 (8%)

Data are n or n (%).

^*Three additional serious adverse events were reported by three participants in the oral antibiotic therapy group but have not been included here as they were the event of interest for the primary outcome (P aeruginosa isolation) so should not have been reported as a serious adverse event. One additional adverse event was reported by one participant in the oral antibiotic therapy group but has not been included here as it contributed to the analysis of the outcome number of pulmonary exacerbations.