TABLE 4.

Incidence of most common adverse events^*

Adverse event	CR oxycodone/CR naloxone n (%)	Placebo n (%)	P*
Nausea	9 (12.2)	9 (11.7)	0.7630
Constipation	6 (8.1)	2 (2.6)	0.1025
Diarrhea	4 (5.4)	7 (9.1)	0.3173
Fatigue	4 (5.4)	2 (2.6)	0.4142
Somnolence	4 (5.4)	0 (0)	0.0455
Vomiting	4 (5.4)	3 (3.9)	0.6547
Dizziness	3 (4.1)	2 (2.6)	1.0000
Dry mouth	3 (4.1)	4 (5.2)	0.4142
Upper respiratory tract infection	3 (4.1)	0 (0)	0.0833
Abdominal pain	2 (2.7)	5 (6.5)	0.4142
Overall	48 (64.9)	40 (51.9)	0.0679

^*Based on 74 patients who received controlled release (CR) oxycodone/CR naloxone and 77 patients who received placebo. During CR oxycodone/CR naloxone treatment, 99 events were reported with a mean maximum severity of 1.5 compared with 107 events with a mean maximum severity of 1.6 in the placebo group. 7.2% and 6.0% of patients withdrew from the study due to adverse events in the CR oxycodone/CR naloxone and placebo groups, respectively (Figure 1)