Table 3.

Subjects with treatment-emergent adverse events with at least two subjects or two instances overall in the randomized safety population

AE, MedDRA-preferred term	ORF-F 10 mg (n = 29) n (%)			ORF-C 10 mg (n = 29) n (%)			OC-F 10 mg (n = 30) n (%)			Overall n = 30
	Mild	Moderate	Severe	Mild	Moderate	Severe	Mild	Moderate	Severe
Dizziness	0	1 (3.4)	0	1 (3.4)	0	0	1 (3.3)	0	0	3 (10.0)
Dry throat	0	0	0	0	2 (6.9)	0	0	0	0	2 (6.7)
Headache	3 (10.3)	2 (6.9)	0	1 (3.4)	5 (17.2)	0	2 (6.7)	3 (10.0)	1 (3.3)	10 (33.3)
Nausea	5 (17.2)	3 (10.3)	1 (3.4)	6 (20.7)	1 (3.4)	0	2 (6.7)	3 (10.0)	2 (6.7)	10 (33.3)
Pharyngolaryngeal pain	0	0	0	0	0	0	1 (3.3)	1 (3.3)	0	2 (6.7)
Presyncope	0	0	0	0	0	0	0	2 (6.7)	0	2 (6.7)
Vomiting	2 (6.9)	0	1 (3.4)	3 (10.3)	1 (3.4)	0	2 (6.7)	4 (13.3)	2 (6.7)	6 (20.0)

AE adverse event, MedDRA Medical Dictionary for Regulatory Activities, version 9.1, OC-F finely crushed original formulation of oxycodone HCl controlled release, ORF-C coarsely crushed reformulated oxycodone HCl controlled release, ORF-F finely crushed reformulated oxycodone HCl controlled release