Table 4.

All reported adverse events

	Treatment group
	XaraColl® (n = 14) n (%)	ON-Q (n = 13) n (%)	Combined (n = 27) n (%)
All adverse events	7 (50.0)	9 (69.2)	16 (59.3)
Blood and lymphatic system disorder	1 (7.1)	0 (0.0)	1 (3.7)
Anemia	1 (7.1)	0 (0.0)	1 (3.7)
Gastrointestinal	4 (28.6)	5 (38.5)	9 (33.3)
Constipation	2 (14.3)	0 (0.0)	2 (7.4)
Flatulence	2 (14.3)	0 (0.0)	2 (7.4)
Nausea	1 (7.1)	2 (15.4)	3 (11.1)
Abdominal distension	0 (0.0)	1 (7.7)	1 (3.7)
Glossodynia	0 (0.0)	1 (7.7)	1 (3.7)
Rectal bleeding	1 (7.1)	0 (0.0)	1 (3.7)
Vomiting	1 (7.1)	1 (7.7)	2 (7.4)
General disorders and administration site conditions	1 (7.1)	3 (23.1)	4 (14.8)
Pyrexia	1 (7.1)	2 (15.4)	3 (11.1)
Peripheral edema	0 (0.0)	1 (7.7)	1 (3.7)
Chills	0 (0.0)	1 (7.7)	1 (3.7)
Injury, poisoning, and procedural complications	1 (7.1)	0 (0.0)	1 (3.7)
Postoperative wound complication (reported as numbness at surgical site)	1 (7.1)	0 (0.0)	1 (3.7)
Metabolism and nutrition disorders	1 (7.1)	0 (0.0)	1 (3.7)
Dehydration	1 (7.1)	0 (0.0)	1 (3.7)
Musculoskeletal and connective tissue disorders	1 (7.1)	1 (7.1)	2 (7.4)
Back pain	0 (0.0)	1 (7.7)	1 (3.7)
Joint swelling	1 (7.1)	0 (0.0)	1 (3.7)
Nervous system disorders	2 (14.3)	2 (15.4)	4 (14.8)
Headache	2 (14.3)	1 (7.7)	3 (11.1)
Hypoesthesia	0 (0.0)	1 (7.7)	1 (3.7)
Renal and urinary disorders	0 (0.0)	1 (7.7)	1 (3.7)
Urinary retention	0 (0.0)	1 (7.7)	1 (3.7)
Skin and subcutaneous tissue disorders	2 (14.3)	0 (0.0)	2 (7.4)
Rash	2 (14.3)	0 (0.0)	2 (7.4)

Notes: Counts indicate the numbers of patients reporting one or more events that map to the MedDRA system organ class. At each level of summarization (system organ class or preferred term) patients were only counted once. Percentages of patients are given in parentheses. Each patient at each system organ class and preferred term level is counted only once.

Abbreviations: MedDRA, Medical Dictionary for Regulatory Activities; ON-Q, ON-Q PainBuster^® Post-op Pain Relief System.