Table 9.

Major Treatment Emergent Adverse Events Related to the Study Drug of Subjects in Either Treatment Group by System Organ Class and Preferred Term

	Misoprostol (n=236)	Rebamipide (n=242)	Total (n=478)	p-value*
Total no. of TEAEs	69 (29.2) [126]	53 (21.9) [95]	122 (25.5) [221]	0.0746
Gastrointestinal disorders
Upper abdominal pain	42 (17.8) [56]	38 (15.7) [45]	80 (16.7) [101]	0.5432
Abdominal distension	12 (5.1) [12]	8 (3.3) [9]	20 (4.2) [21]	0.3680
Nausea	15 (6.4) [19]	4 (1.7) [4]	19 (4.0) [23]	0.0095
Diarrhea	10 (4.2) [11]	5 (2.1) [10]	15 (3.1) [21]	0.1980

Data are presented as subjects (%) [events].

TEAE, treatment emergent adverse event.

^*Fisher exact test.