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. 2022 Nov 28;28(44):6294–6309. doi: 10.3748/wjg.v28.i44.6294

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]
1

Testing 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.