Table 2.

Selected adverse events

		Rifaximin-α group (n=68)	Placebo group (n=68)
Any adverse events		48 (71%)	53 (78%)
Adverse events from gastrointestinal disorders system organ class		26 (38%)	32 (47%)
Adverse events from any system organ class, according to preferred term*
	Diarrhoea	6 (9%)	12 (18%)
	Abdominal pain	6 (9%)	5 (7%)
	Abdominal distension	10 (15%)	6 (9%)
	Vomiting	1 (1%)	4 (6%)
	Infection	9 (13%)	8 (12%)
	Trauma	7 (10%)	8 (12%)
	Neck and back pain	1 (1%)	6 (9%)
Adverse events that resulted in premature discontinuation of treatment
	All adverse events	0	1 (1%)
	Abdominal pain	0	1 (1%)
Serious adverse events
	All serious adverse events	14 (21%)	12 (18%)
	Gastrointestinal disorders	4 (6%)	0
	Cardiovascular disorders	0	2 (3%)
	Respiratory, thoracic, and mediastinal disorders	0	1 (1%)
	Musculoskeletal and connective tissue disorders	2 (3%)	2 (3%)
	Infections	4 (6%)	0
	Renal and urinary disorders	0	1 (1%)
	Psychiatric disorders	0	1 (1%)
	Alcohol-related hospital admissions	2 (3%)	1 (1%)
	Liver-related event	2 (3%)	2 (3%)
	General disorders	0	2 (3%)
Neoplasms		1 (1%)	2 (3%)
	Malignant neoplasms	1 (1%)	1 (1%)
	Polyp in large intestine	0	1 (1%)
Fatal events		3 (4%)	0
	Small-cell lung carcinoma	1 (1%)	0
	Suicide	1 (1%)	0
	Sudden death (suspected cardiovascular disease)	1 (1%)	0

Data are number of patients with events (%).

^*The most common adverse events with an incidence above 5% are reported here. Additional information on adverse events is in the appendix (p 9).