Table 8.
Analysis of treatment-emergent adverse event subsystems
| SOC | Fasting | High-fat meal | Total | |||
|---|---|---|---|---|---|---|
| PT | n (%) | Frequency | n (%) | Frequency | n (%) | Frequency |
| N | 24 | 24 | 24 | |||
| Total | 6 (25.0) | 7 | 4 (16.7) | 4 | 9 (37.5) | 11 |
| Various inspections | 5 (20.8) | 6 | 3 (12.5) | 3 | 7 (29.2) | 9 |
| Elevated alanine aminotransferase | 2 (8.3) | 2 | 0 (0) | 0 | 2 (8.3) | 2 |
| Elevated amylase | 1 (4.2) | 1 | 1 (4.2) | 1 | 2 (8.3) | 2 |
| Positive urinary leukocyte | 1 (4.2) | 1 | 1 (4.2) | 1 | 2 (8.3) | 2 |
| Decreased leukocyte count | 1 (4.2) | 1 | 0 (0) | 0 | 1 (4.2) | 1 |
| Detected urinary sediment | 1 (4.2) | 1 | 0 (0) | 0 | 1 (4.2) | 1 |
| Elevated serum uric acid | 0 (0) | 0 | 1 (4.2) | 1 | 1 (4.2) | 1 |
| Various nervous system diseases | 0 (0) | 0 | 1 (4.2) | 1 | 1 (4.2) | 1 |
| Myoclonus | 0 (0) | 0 | 1 (4.2) | 1 | 1 (4.2) | 1 |
| Heart organ diseases | 1 (4.2) | 1 | 0 (0) | 0 | 1 (4.2) | 1 |
| Sinus bradycardia | 1 (4.2) | 1 | 0 (0) | 0 | 1 (4.2) | 1 |
SOC System Organ Class, PT Preferred Term