Randomized controlled trial to evaluate the efficacy and safety of fexuprazan compared with esomeprazole in erosive esophagitis

Table 4 Overall Summary of treatment-emergent adverse events (safety set)

	Fexuprazan 40 mg (n = 131)	Esomeprazole 40 mg (n = 131)	Total (n = 262)
	n (%) [number of event]
Subjects with TEAEs	22 (16.8) [34]	25 (19.1) [34]	47 (17.9) [68]
95%CI	[10.4, 23.2]	[12.4, 25.8]	[13.3, 22.6]
P value1			0.629c
Subjects with ADRs	9 (6.9) [13]	7 (5.3) [11]	16 (6.1) [24]
95%CI	[2.5, 11.2]	[1.5, 9.2]	[3.2, 9.0]
P value1			0.606c
Subjects with serious TEAEs	0	0	0
Subjects with serious ADRs	0	0	0
Most frequently occurring (≥ 2%) TEAEs by system organ class and preferred term
System organ class preferred term
Gastrointestinal disorders
Diarrhoea	4 (3.1) [4]	2 (1.5) [2]	6 (2.3) [6]
Nervous system disorders
Dizziness	1 (0.8) [1]	3 (2.3) [3]	4 (1.5) [4]

¹Testing for difference among treatment groups [Chi-square test (c)].

Note: Denominator of percentage is the number of subjects in each treatment group. TEAEs: Treatment-emergent adverse events; ADRs: Adverse drug reactions.