Table 8.

Treatment Emergent Adverse Events and Adverse Events in the Rebamipide and Misoprostol Groups

	TEAEs			AEs*
	Misoprostol (n=236)	Rebamipide (n=242)	Total (n=478)	Misoprostol (n=236)	Rebamipide (n=242)	Total (n=478)
Total no., subjects (%) [events]	161 (68.2) [373]	158 (65.3) [347]	319 (66.7) [720]	166 (70.3) [400]	165 (68.2) [405]	331 (69.3) [805]
Exact 95% CI	61.9–74.1	58.9–71.3	62.3–70.9	64.1–76.1	61.9–74.0	64.9–73.4
p-value†			0.4988			0.6215
No. of AEs
Mild	284 (76.1)	295 (85.0)	579 (80.4)	307 (76.8)	347 (85.7)	654 (81.2)
Moderate	74 (19.8)	45 (13.0)	119 (16.5)	78 (19.5)	48 (11.9)	126 (15.7)
Severe	15 (4.0)	7 (2.0)	22 (3.1)	15 (3.8)	10 (2.5)	25 (3.1)
Serious AEs, subjects (%) [events]	3 (1.3) [3]	7 (2.9) [9]	10 (2.1) [12]	3 (1.3) [3]	10 (4.1) [13]	13 (2.7) [16]
Exact 95% CI	0.3–3.7	1.2–5.9	1.0–3.8	0.3–3.7	2.0–7.5	1.5–4.6
p-value†			0.3389			0.0882

Data are presented as number (%).

TEAE, treatment emergent adverse event; AE, adverse event; CI, confidence interval.

^*All of the AEs (including the TEAEs) during the study;

^†Fisher exact test.