Table 2.
Treatment-emergent adverse events (affecting ≥ 10% of patients in either treatment group)
| MedDRA-Preferred Term, n (%) | 5 mg (n = 1) | 15 mg (n = 8) | 30 mg (n = 5) | All (n = 14) | ||||
|---|---|---|---|---|---|---|---|---|
| Any grade | Grades 3–4 | Any grade | Grades 3–4 | Any grade | Grades 3–4 | Any grade | Grades 3–4 | |
| Laboratory abnormalities | ||||||||
| Platelet count decreased | 0 | 0 | 1 (12.5) | 0 | 4 (80.0) | 2 (40.0) | 5 (35.7) | 2 (14.2) |
| Blood triglyceride increased | 0 | 0 | 3 (37.5) | 0 | 2 (40.0) | 0 | 5 (35.7) | 0 |
| ALT increased | 0 | 0 | 2 (25.0) | 0 | 2 (40.0) | 0 | 4 (28.6) | 0 |
| AST increased | 0 | 0 | 2 (25.0) | 0 | 2 (40.0) | 0 | 4 (28.6) | 0 |
| Blood LDH increased | 0 | 0 | 2 (25.0) | 0 | 1 (20.0) | 0 | 3 (21.4) | 0 |
| α-HBDH increased | 0 | 0 | 2 (25.0) | 0 | 0 | 0 | 2 (14.3) | 0 |
| Hyperlipidemia | 0 | 0 | 1 (12.5) | 0 | 2 (40.0) | 0 | 3 (21.4) | 0 |
| Hypokalemia | 0 | 0 | 3 (37.5) | 0 | 0 | 0 | 3 (21.4) | 0 |
| Cholesterol high | 0 | 0 | 2 (25.0) | 0 | 0 | 0 | 2 (14.3) | 0 |
| Neutrophil count decreased | 0 | 0 | 1 (12.5) | 0 | 1 (20.0) | 0 | 2 (14.3) | 0 |
| Lymphocyte count decreased | 0 | 0 | 1 (12.5) | 0 | 1 (20.0) | 0 | 2 (14.3) | 0 |
| White blood cell decreased | 0 | 0 | 1 (12.5) | 0 | 1 (20.0) | 0 | 2 (14.3) | 0 |
| Proteinuria | 0 | 0 | 0 | 0 | 2 (40.0) | 0 | 2 (14.3) | 0 |
| Clinical adverse events | ||||||||
| Hypertension | 0 | 0 | 2 (25.0) | 1 (12.5) | 4 (80.0) | 4 (80.0) | 6 (42.9) | 5 (35.7) |
| Sinus bradycardia | 0 | 0 | 2 (25.0) | 0 | 4 (80.0) | 0 | 6 (42.9) | 0 |
| Urinary tract infection | 1 (100.0) | 0 | 1 (12.5) | 0 | 2 (40.0) | 0 | 4 (28.6) | 0 |
| Mucositis oral | 0 | 0 | 0 | 0 | 2 (40.0) | 1 (20.0) | 2 (14.3) | 1 (7.1) |
| Diarrhea | 0 | 0 | 0 | 0 | 2 (40.0) | 0 | 2 (14.3) | 0 |
| Epilepsy | 0 | 0 | 0 | 0 | 2 (40.0) | 0 | 2 (14.3) | 0 |
| Hydrocephalus | 0 | 0 | 1 (12.5) | 0 | 1 (20.0) | 0 | 2 (14.3) | 0 |
| Headache | 0 | 0 | 0 | 0 | 2 (40.0) | 0 | 2 (14.3) | 0 |
Abbreviations: ALT, alanine aminotransferase; AST, aspartate aminotransferase; LDH, lactate dehydrogenase; α-HBDH, alpha-hydroxybutyrate-dehydrogenase.