TABLE 7.
Summary of AEs.
| Parameter | Fasting trial | Postprandial trial | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| T (N = 44) | R (N = 44) | T (N = 44) | R (N = 44) | |||||||||
| n | % | E | n | % | E | n | % | E | n | % | E | |
| sum | 19 | 43.18 | 22 | 21 | 47.73 | 38 | 8 | 18.18 | 11 | 14 | 31.82 | 24 |
| AE severity | ||||||||||||
| Grade 1 | 19 | 43.18 | 22 | 21 | 47.73 | 38 | 8 | 18.18 | 11 | 14 | 31.82 | 24 |
| ≥Grade 2 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Correlation with drugs | ||||||||||||
| Highly Possible related | 9 | 20.45 | 9 | 12 | 27.27 | 17 | 2 | 4.55 | 2 | 7 | 11.36 | 8 |
| Possible related | 6 | 13.64 | 8 | 6 | 13.64 | 9 | 1 | 2.27 | 1 | 2 | 4.55 | 3 |
| Possible unrelated | 4 | 9.09 | 5 | 9 | 20.45 | 12 | 5 | 11.36 | 8 | 10 | 22.73 | 14 |
| Lymphocyte % decreased | 0 | 0 | 0 | 1 | 2.27 | 1 | 0 | 0 | 0 | 0 | 0 | 0 |
| ALT elevated | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 2.27 | 1 |
| AST elevated | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 2.27 | 1 |
| GGT elevated | 1 | 2.27 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 2.27 | 1 |
| U-LEU positive | 1 | 2.27 | 2 | 1 | 2.27 | 2 | 1 | 2.27 | 2 | 0 | 0 | 0 |
| urine erythrocyte positive | 0 | 0 | 0 | 2 | 4.55 | 2 | 0 | 0 | 0 | 0 | 0 | 0 |
| UOB positive | 0 | 0 | 0 | 2 | 4.55 | 2 | 0 | 0 | 0 | 0 | 0 | 0 |
| urinary sediment detected | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 2.27 | 1 | 0 | 0 | 0 |
| urine nitrite detected | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 2.27 | 1 | 0 | 0 | 0 |
| Urinary bacteria positive | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 2.27 | 1 | 0 | 0 | 0 |
| MCHC decreased | 0 | 0 | 0 | 1 | 2.27 | 1 | 0 | 0 | 0 | 0 | 0 | 0 |
| Temperature elevated | 1 | 2.27 | 1 | 4 | 9.09 | 4 | 0 | 0 | 0 | 2 | 4.55 | 2 |
| ECG abnormality | 1 | 2.27 | 1 | 2 | 4.55 | 2 | 0 | 0 | 0 | 2 | 4.55 | 2 |
| Heart rate decreased | 0 | 0 | 0 | 1 | 2.27 | 2 | 0 | 0 | 0 | 0 | 0 | 0 |
| Serum calcium decreased | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 2.27 | 1 |
| Serum potassium decreased | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 2.27 | 1 |
| Serium phosphorus decreased | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 2.27 | 1 |
| TG elevated | 2 | 4.55 | 2 | 1 | 2.27 | 1 | 1 | 2.27 | 1 | 3 | 6.82 | 3 |
| HGB decreased | 2 | 4.55 | 2 | 2 | 4.55 | 2 | 0 | 0 | 0 | 1 | 2.27 | 1 |
| Mb elevated | 2 | 4.55 | 2 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Serum creatine phosphokinase elevated | 1 | 2.27 | 1 | 1 | 2.27 | 1 | 0 | 0 | 0 | 0 | 0 | 0 |
| Hyperuricacidemia | 0 | 0 | 0 | 0 | 0 | 0 | 2 | 4.55 | 2 | 2 | 4.55 | 2 |
| Scr elevated | 1 | 2.27 | 1 | 0 | 0 | 0 | 1 | 2.27 | 1 | 0 | 0 | 0 |
| Blood pressure decreased | 9 | 20.45 | 9 | 12 | 27.27 | 17 | 2 | 4.55 | 2 | 5 | 11.36 | 7 |
| Blood pressure increased | 0 | 0 | 0 | 1 | 2.27 | 1 | 0 | 0 | 0 | 0 | 0 | 0 |
| GLU decreased | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 2.27 | 1 |
| Headache | 1 | 2.27 | 1 | 0 | 0 | 0 | 1 | 2.27 | 1 | 0 | 0 | 0 |
| Dizziness | 1 | 2.27 | 1 | 1 | 2.27 | 1 | 0 | 0 | 0 | 1 | 2.27 | 1 |
| Hyperhidrosis | 2 | 4.55 | 2 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 2.27 | 1 |
| Acratia | 1 | 2.27 | 1 | 1 | 2.27 | 1 | 0 | 0 | 0 | 0 | 0 | 0 |
| Palpitation | 2 | 4.55 | 2 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Anemia | 0 | 0 | 0 | 2 | 4.55 | 2 | 0 | 0 | 0 | 1 | 2.27 | 1 |
| Nausea | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 2.27 | 1 | 0 | 0 | 0 |
| Diarrhea | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 2.27 | 1 | 0 | 0 | 0 |