Table 4. Adverse Events.

System organ class	Preferred term		p value
	Aceclofenac CR (n=50)	Aceclofenac (n=50)
	Adverse events	Adverse events
Gastrointestinal disorders, n (%)	10 (21.2)	7 (14.0)	0.595
Dyspepsia	10 (21.2)	4 (8.0)
Nausea	2 (4.2)	1 (2.0)
Constipation	2 (4.2)	0 (0.0)
Abdominal pain	2 (4.2)	0 (0.0)
Abdominal distension	0 (0.0)	2 (4.0)
Vomiting	1 (2.1)	0 (0.0)
Diarrhea	1 (2.1)	0 (0.0)
Skin and subcutaneous tissue disorders, n (%)	5 (10.6)	5 (10.0)	>0.999
Swelling face	3 (6.4)	3 (6.0)
Pruritus	1 (2.1)	1 (2.0)
Skin disorder	1 (2.1)	0 (0.0)
Acne	0 (0.0)	1 (2.0)
General disorders and administration site conditions, n (%)	9 (19.2)	1 (2.0)	0.016
Generalized edema	5 (10.6)	0 (0.0)
Swelling	1 (2.1)	1 (2.0)
Edema peripheral	1 (2.1)	0 (0.0)
Edema	1 (2.1)	0 (0.0)
Face edema	1 (2.1)	0 (0.0)
Nervous system disorders, n (%)	3 (6.4)	4 (8.0)	>0.999
Somnolence	2 (4.3)	1 (2.0)
Paresthesia	0 (0.0)	2 (4.0)
Dizziness	0 (0.0)	1 (2.0)
Headache	1 (2.1)	0 (0.0)
Investigations, n (%)	0 (0.0)	4 (8.0)	0.117
Aspartate aminotransferase increased	0 (0.0)	2 (4.0)
Gamma-glutamyltransferase increased	0 (0.0)	2 (4.0)
Alanine aminotransferase increased	0 (0.0)	1 (2.0)
Infections and infestations, n (%)	1 (2.1)	1 (2.0)	>0.999
Nasopharyngitis	0 (0.0)	1 (2.0)
Oral herpes	1 (2.1)	0 (0.0)
Musculoskeletal and connective tissue disorders, n (%)	2 (4.3)	0 (0.0)	0.495
Pain in extremity	1 (2.1)	0 (0.0)
Musculoskeletal pain	1 (2.1)	0 (0.0)
Vascular disorders, n (%)	1 (2.1)	0 (0.0)	>0.999
Flushing	1 (2.1)	0 (0.0)
Renal and urinary disorders, n (%)	1 (2.1)	0 (0.0)	>0.999
Pollakiuria	1 (2.1)	0 (0.0)
Eye disorders, n (%)	0 (0.0)	1 (2.0)	>0.999
Abnormal sensation in eye	0 (0.0)	1 (2.0)
Cardiac disorders, n (%)	1 (2.1)	0 (0.0)	>0.999
Palpitations	1 (2.1)	0 (0.0)

CR, controlled release.