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 set
Buprenorphine transdermal system
Oral tramadol/acetaminophen
Total
Subjects ()
Events
Subjects ()
Events
Subjects ()
Events
Gastrointestinal disorders
12 (17.4)
14
9 (13.9)
9
21 (15.7)
23
General disorders and administration site conditions
4 (5.8)
5
1 (1.5)
1
5 (3.7)
6
Nervous system disorders
4 (5.8)
4
—
—
4 (3.0)
4
Musculoskeletal and connective tissue disorders
3 (4.4)
4
1 (1.5)
1
4 (3.0)
5
Investigations
1 (1.5)
1
3 (4.6)
6
4 (3.0)
7
Skin and subcutaneous tissue disorders
—
—
3 (4.6)
3
3 (2.2)
3
Infections and infestations
2 (2.9)
2
1 (1.5)
1
3 (2.2)
3
Cardiac disorders
—
—
1 (1.5)
1
1 (0.8)
1
Injury, poisoning and procedural complications
1 (1.5)
1
—
—
1 (0.8)
1
18 (26.1)
27
13 (20.0)
22
31 (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).
