Pain Research and Management / 2017 / Article / Tab 5

Clinical Study

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

Table 5

Adverse events.

Safety setGroupSubjects, Number of events, Incidence, (%)95% CI (lower, upper) value

Adverse events (AE)BTDS693118 (26.1)(15.7, 36.5)0.4037
TA652213 (20.0)(10.3, 29.7)
Total1345331 (23.1)(16.0, 30.3)

Serious adverse event (SAE)BTDS6933 (4.4)(0.0, 9.2)0.2450
TA6500 (0)
Total13433 (2.2)(0.0, 4,7)

Adverse drug reaction (ADR)BTDS691914 (20.3)(10.8, 29.8)0.6171
TA651311 (16.9)(7.8, 26.0)
Total1343225 (18.7)(12.1, 25.3)

Withdrawals due to AEBTDS6954 (5.8)(0.3, 11.3)0.1201
TA6500 (0)
Total13454 (3.0)(0.1, 5.9)

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

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