Pain Research and Management / 2017 / Article / Tab 6

Clinical Study

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

Table 6

Adverse events by system organ class.

Safety setBuprenorphine transdermal systemOral tramadol/acetaminophenTotal
Subjects ()EventsSubjects ()EventsSubjects ()Events

Gastrointestinal disorders12 (17.4)149 (13.9)921 (15.7)23
General disorders and administration site conditions4 (5.8)51 (1.5)15 (3.7)6
Nervous system disorders4 (5.8)44 (3.0)4
Musculoskeletal and connective tissue disorders3 (4.4)41 (1.5)14 (3.0)5
Investigations1 (1.5)13 (4.6)64 (3.0)7
Skin and subcutaneous tissue disorders3 (4.6)33 (2.2)3
Infections and infestations2 (2.9)21 (1.5)13 (2.2)3
Cardiac disorders1 (1.5)11 (0.8)1
Injury, poisoning and procedural complications1 (1.5)11 (0.8)1

18 (26.1)2713 (20.0)2231 (23.1)53

adverse events were of severity grades 1 (mild) or 2 (moderate). There were no adverse events of severity greater than grade 3 (severe).

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