Journal of Neurogastroenterology and Motility : eISSN 2093-0887 / pISSN 2093-0879

Table. 3.

Overall Summaries of Teatment-emergent Averse Eents and Averse Drug Reactions in the Safety Set

TEAEs and ADRs Prior-to-meal group (n = 92) After-meal group (n = 92) P-value
Degree of drug exposure
Total duration of dose (day)a 18.10 ± 7.38 17.48 ± 7.60 0.3185
Total dosage (mg)a 705.22 ± 273.41 693.91 ± 297.00 0.9432
Subjects with TEAEs 9 (9.78) 8 (8.70) > 0.999
Total number of events,b [95% CI] 11, [4.57-17.76] 8, [3.83-16.42]
Abdominal pain/distension 1/0 0/1
Erosive gastritis 0 2
Constipation/diarrhea 0/1 1/0
Dry mouth/nausea 1/1 0/0
Creatine Phosphokinase increased 1 1
Liver enzyme increased 0 1
Headache 1 1
Insomnia 2 0
Acute myocardial infarction 1 0
COVID-19 1 0
Injury (ligament rupture) 0 1
Skin rash 1 0
Subjects with ADRs 4 (4.35) 5 (5.43) > 0.999
Total number of events,b [95% CI] 6, [1.20-10.76] 5, [1.79-12.23]
Abdominal pain/distension 1/0 0/1
Erosive gastritis 0 2
Diarrhea 1 0
Nausea 1 0
Liver enzyme increased 0 1
Headache 1 1
Insomnia 1 0
Skin rash 1 0
Subjects with serious TEAEs 1 (1.09) 1 (1.09) 1.000
Total number of events,b [95% CI] 1, [0.03-5.91] 1, [0.03-5.91]
Acute myocardial infarction 1 0
Injury (ligament rupture) 0 1
Subjects with serious ADRs 0 0

aContinuous variables were summarized as mean ± SD and analyzed by the 2-sample t test or Wilcoxon rank sum test. Categorical data were presented as n (%) or n, and analyzed by Fisher’s exact test.

bIn some cases, multiple adverse events were collected from a single subject.

TEAEs, treatment-emergent adverse events; ADRs, adverse drug reaction.

J Neurogastroenterol Motil 2025;31:86~94 https://doi.org/10.5056/jnm24032
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