Study 1 Study 2
AE, n (%) OC/APAP ER
1 tablet q12h
(n=40) 		OC/APAP ER
2 tablets q12h (n=41) 		IR OC/APAP
1 tablet q6h
(n=41) 		OC/APAP ER
2 tablets q12h
(n=33)		 IR Oxycodone
1 tablet q6h
(n=34)		 IR tramadol/APAP
1 tablet q6h
(n=28)		 IR OC/APAP
1 tablet q6h
(n=31)
Subjects with at least 1 TEAE 19 (47.5) 29 (70.7) 30 (73.2) 15 (45.5) 28 (82.4) 12 (42.9) 20 (64.5)
Nausea 5 (12.5) 12 (29.3) 13 (31.7) 8 (24.2) 13 (38.2) 2 (7.1) 9 (29.0)
Vomiting 1 (2.5) 5 (12.2) 4 (9.8) 7 (21.2) 8 (23.5) 2 (7.1) 5 (16.1)
Dizziness 5 (12.5) 6 (14.6) 7 (17.1) 4 (12.1) 13 (38.2) 2 (7.1) 4 (12.9)
Pruritus 5 (12.5) 10 (24.4) 10 (24.4) 7 (21.2) 13 (38.2) 5 (17.9) 2 (6.5)
Headache 9 (22.5) 4 (9.8) 7 (17.1) 5 (15.2) 5 (14.7) 3 (10.7) 3 (9.7)
Feeling hot 0 1 (2.4) 3 (7.3) 2 (6.1) 4 (11.8) 1 (3.6) 2 (6.5)
Infrequent bowel movements 4 (10.0) 5 (12.2) 3 (7.3) 0 (0.0) 6 (17.6) 1 (3.6) 2 (6.5)
Abdominal pain 1 (2.5) 3 (7.3) 1 (2.4) 2 (6.1) 0 (0.0) 1 (3.6) 3 (9.7)
Somnolence 5 (12.5) 5 (12.2) 1 (2.4) 1 (3.0) 1 (2.9) 2 (7.1) 1 (3.2)
aAEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA®; MedDRA MSSO, McLean, Virginia, USA) APAP, acetaminophen; ER, extended release; IR, immediate release; OC, oxycodone; q6h, every 6 hours; q12h, every 12 hours; TEAE, treatment-emergent adverse event
Table 4: Summary of treatment-emergent adverse eventsa.
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