
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) |
18.10 ± 7.38 | 17.48 ± 7.60 | 0.3185 |
Total dosage (mg) |
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, |
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, |
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, |
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.