TABLE 6.

Overall treatment-emergent AE profile of mesalamine (safety population; N = 82)

	Mesalamine dose groups
Category	Low dose (n = 41)	High dose (n = 41)
AEs
No. people with AE, n (%)	23 (56.1)	21 (51.2)
No. AEs	50	41
Serious AEs
No. people with AE, n (%)	5 (12.2)	2 (4.9)
No. AEs	8	3
Withdrawn because of AEs
No. people with AE, n (%)	5 (12.2)	2 (4.9)
No. AEs	6	3
AE severity, n (%)	n = 50	n = 41
Mild	34 (68.0)	25 (61.0)
Moderate	14 (28.0)	9 (22.0)
Severe	2 (4.0)	7 (17.1)
AE causality, n (%)	n = 50	n = 41
Doubtful	38 (76.0)	29 (70.7)
Possible	11 (22.0)	10 (24.4)
Probable	1 (2.0)	2 (4.9)

AE = adverse event.