TABLE 3.

Incidence of most common adverse events^*

	BTDS	Mean maximum severity	Placebo	Mean maximum severity	P
Nausea	28 (38.4)	2.0	11 (16.9)	1.0	0.0330
Somnolence	22 (30.1)	2.3	4 (6.2)	1.9	0.0010
Pruritus	22 (30.1)	1.3	18 (27.7)	1.7	0.8084
Asthenia	21 (28.8)	2.0	10 (15.4)	2.3	0.1336
Constipation	20 (27.4)	1.6	14 (21.5)	1.6	0.2207
Insomnia	18 (24.7)	2.3	17 (26.2)	1.9	1.000
Dizziness	16 (21.9)	2.5	5 (7.7)	1.4	0.1797
Sweating	15 (20.6)	2.3	10 (15.4)	1.7	0.2253
Pain	14 (19.2)	2.4	18 (27.7)	2.3	0.2253
Anorexia	14 (19.2)	2.0	12 (18.5)	1.5	0.5930
Vomiting	11 (15.1)	2.0	3 (4.6)	2.7	0.0956
Yawn	11 (15.1)	1.3	12 (18.5)	1.4	1.000
Nervousness	10 (13.7)	1.8	14 (21.5)	1.8	0.2850
Rash	9 (12.3)	1.6	7 (10.8)	1.4	0.7389
Headache	8 (11.0)	2.3	6 (9.2)	1.8	1.000
Diarrhea	8 (11.0)	2.1	13 (20.0)	1.4	0.2482
Overall	72 (98.6)	2.3	58 (89.2)	2.2	0.0143

Data presented as n (%) unless otherwise indicated.

*Based on 73 patients who received buprenorphine transdermal system (BTDS) and 65 patients who received placebo