Study 1 Study 2 AE, n (%) OC/APAP ER (1 Tablet; 7.5/325 mg) (n=39) OC/APAP ER (2 Tablets; 15/650 mg) (n=41) IR OC/APAP (1 Tablet Twice; 15/650 mg) (n=39) IR OC/APAP (2 Tablets Twice; 30/1300 mg) (n=33) OC/APAP ER (2 Tablets; 15/650 mg) (n=39) IR Oxycodone (1 Tablet Twice; 30 mg OC) (n=43) IR tramadol/APAP (1 Tablet Twice; 75/650 mg) (n=36) IR OC/APAP (1 Tablet Twice; 15/650 mg) (n=40) Any AE 10 (25.6) 21 (51.2) 22 (56.4) 25 (75.8) 9 (23.1) 25 (58.1) 8 (22.2) 15 (37.5) Nausea 4 (10.3) 12 (29.3) 12 (30.8) 17 (51.5) 5 (12.8) 15 (34.9) 3 (8.3) 9 (22.5) Vomiting 2 (5.1) 7 (17.1) 4 (10.3) 6 (18.2) 1 (2.6) 10 (23.3) 1 (2.8) 1 (2.5) Somnolence 2 (5.1) 5 (12.2) 5 (12.8) 9 (27.3) 3 (7.7) 2 (4.7) 0 (0.0) 3 (7.5) Pruritus 0 3 (7.3) 5 (12.8) 12 (36.4) 1 (2.6) 5 (11.6) 0 (0.0) 1 (2.5) Headache 2 (5.1) 8 (19.5) 5 (12.8) 4 (12.1) 1 (2.6) 5 (11.6) 3 (8.3) 3 (7.5) Dizziness 1 (2.6) 4 (9.8) 4 (10.3) 7 (21.2) 3 (7.7) 10 (23.3) 2 (5.6) 4 (10.0) Feeling Hot 0 2 (4.9) 3 (7.7) 3 (9.1) 1 (2.6) 2 (4.7) 0 (0.0) 2 (5.0) AE, adverse event *AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA®; MedDRA MSSO, McLean, VA, USA)

Table 4: Summary of Most Frequently Occurring Adverse Events*.

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