Efficacy and Safety of Transdermal Buprenorphine versus Oral Tramadol/Acetaminophen in Patients with Persistent Postoperative Pain after Spinal Surgery

Table 5

Adverse events.

Safety set	Group	Subjects,	Number of events,	Incidence, (%)	95% CI (lower, upper)	value
Adverse events (AE)	BTDS	69	31	18 (26.1)	(15.7, 36.5)	0.4037
	TA	65	22	13 (20.0)	(10.3, 29.7)
	Total	134	53	31 (23.1)	(16.0, 30.3)
Serious adverse event (SAE)	BTDS	69	3	3 (4.4)	(0.0, 9.2)	0.2450
	TA	65	0	0 (0)	—
	Total	134	3	3 (2.2)	(0.0, 4,7)
Adverse drug reaction (ADR)	BTDS	69	19	14 (20.3)	(10.8, 29.8)	0.6171
	TA	65	13	11 (16.9)	(7.8, 26.0)
	Total	134	32	25 (18.7)	(12.1, 25.3)
Withdrawals due to AE	BTDS	69	5	4 (5.8)	(0.3, 11.3)	0.1201
	TA	65	0	0 (0)	—
	Total	134	5	4 (3.0)	(0.1, 5.9)

-square test; test; BTDS: buprenorphine transdermal system; TA: tramadol/acetaminophen.