Table 4.
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] |
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.