Table 4.
Summary of AEs
| Parameter | Fasted Group | Fed Group | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| T (N = 36) | R (N = 35) | T (N = 31) | R (N = 31) | |||||||||
| n | % | E | n | % | E | n | % | E | n | % | E | |
| Sum | 9 | 25.0 | 20 | 5 | 14.3 | 9 | 5 | 16.1 | 12 | 3 | 9.7 | 10 |
| AE severity | ||||||||||||
| Grade 1 | 9 | 25.0 | 20 | 5 | 14.3 | 9 | 5 | 16.1 | 12 | 3 | 9.7 | 10 |
| ≥Grade 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Drug correlation | ||||||||||||
| Highly Possible related | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Possible related | 1 | 2.8 | 5 | 1 | 2.9 | 2 | 3 | 9.7 | 7 | 2 | 6.5 | 7 |
| Possible unrelated | 9 | 25.0 | 15 | 5 | 14.3 | 7 | 5 | 16.1 | 5 | 2 | 6.5 | 2 |
| Name of AE | ||||||||||||
| Lymphocyte count decreased | 1 | 2.8 | 2 | 2 | 5.7 | 2 | 0 | 0.0 | 0 | 0 | 0.0 | 0 |
| TG elevated | 2 | 5.6 | 2 | 1 | 2.9 | 1 | 1 | 3.2 | 1 | 0 | 0.0 | 0 |
| Urine leukocyte positive | 1 | 2.8 | 2 | 1 | 2.9 | 2 | 0 | 0.0 | 0 | 0 | 0.0 | 0 |
| White blood cell count decreased | 1 | 2.85 | 1 | 1 | 2.9 | 1 | 1 | 3.2 | 1 | 0 | 0.0 | 0 |
| Direct bilirubin elevated | 2 | 5.6 | 2 | 0 | 0.0 | 0 | 0 | 0.0 | 0 | 0 | 0.0 | 0 |
| Blood bilirubin elevated | 2 | 5.6 | 2 | 0 | 0.0 | 0 | 0 | 0.0 | 0 | 0 | 0.0 | 0 |
| HGB decreased | 1 | 2.8 | 1 | 1 | 2.9 | 1 | 1 | 3.2 | 1 | 2 | 6.5 | 2 |
| CK-MB elevated | 2 | 5.6 | 2 | 0 | 0.0 | 0 | 0 | 0 | 0.0 | 0 | 0 | 0.0 |
| Red blood cell count decreased | 1 | 2.8 | 1 | 0 | 0.0 | 0 | 1 | 3.2 | 1 | 2 | 6.5 | 2 |
| Hematocrit decreased | 1 | 2.8 | 1 | 0 | 0.0 | 0 | 1 | 3.2 | 1 | 1 | 3.2 | 1 |
| Urine erythrocyte positive | 0 | 0.0 | 0 | 1 | 2.9 | 1 | 0 | 0.0 | 0 | 0 | 0.0 | 0 |
| Cells were detected in the urine | 0 | 0.0 | 0 | 1 | 2.9 | 1 | 0 | 0.0 | 0 | 0 | 0.0 | 0 |
| CK elevated | 1 | 2.8 | 1 | 0 | 0.0 | 0 | 0 | 0.0 | 0 | 0 | 0.0 | 0 |
| Blood magnesium decreased | 1 | 2.8 | 1 | 0 | 0.0 | 0 | 0 | 0.0 | 0 | 0 | 0.0 | 0 |
| Blood sodium decreased | 1 | 2.8 | 1 | 0 | 0.0 | 0 | 0 | 0.0 | 0 | 0 | 0.0 | 0 |
| Neutrophil count decreased | 1 | 2.8 | 1 | 0 | 0.0 | 0 | 1 | 3.2 | 1 | 0 | 0.0 | 0 |
| γ-glutamyltransferase elevated | 0 | 0.0 | 0 | 0 | 0.0 | 0 | 1 | 3.2 | 1 | 0 | 0.0 | 0 |
| Alanine aminotransferase elevated | 0 | 0.0 | 0 | 0 | 0.0 | 0 | 1 | 3.2 | 1 | 0 | 0.0 | 0 |
| Human chorionic gonadotropin elevated | 0 | 0.0 | 0 | 0 | 0.0 | 0 | 0 | 0.0 | 0 | 1 | 3.2 | 1 |
| Hyperuricemia | 0 | 0.0 | 0 | 0 | 0.0 | 0 | 0 | 0.0 | 0 | 1 | 3.2 | 1 |
| Blood fibrinogen decreased | 0 | 0.0 | 0 | 0 | 0.0 | 0 | 1 | 3.2 | 1 | 0 | 0.0 | 0 |
| Upper respiratory tract infection (URTI) | 0 | 0.0 | 0 | 0 | 0.0 | 0 | 1 | 3.2 | 1 | 0 | 0.0 | 0 |
| Tenosynovitis | 0 | 0.0 | 0 | 0 | 0.0 | 0 | 0 | 0.0 | 0 | 1 | 3.2 | 1 |
| Celialgia | 0 | 0.0 | 0 | 0 | 0.0 | 0 | 1 | 3.2 | 1 | 0 | 0.0 | 0 |
| Diarrhea | 0 | 0.0 | 0 | 0 | 0.0 | 0 | 1 | 3.2 | 1 | 0 | 0.0 | 0 |
Abbreviations: T, test formulation; R, reference formulation; E, cases of adverse events; AE, adverse event; TG, triglyceride; HGB, hemoglobin; CK-MB, creatine kinase isoenzyme; CK, creatine kinase; URTI, upper respiratory tract infection.