Clinical Study
A Phase I Trial to Evaluate the Multiple-Dose Safety and Antitumor Activity of Ursolic Acid Liposomes in Subjects with Advanced Solid Tumors
Table 2
Incidence of treatment-related adverse events.
| AE, | Number of subjects | 56 mg/m2 () | 74 mg/m2 () | 98 mg/m2 () | Total () | G1 | G2 | ≥G3 | G1 | G2 | ≥G3 | G1 | G2 | ≥G3 | G1 | G2 | ≥G3 |
| Hepatotoxicity | | | | | | | | | | | | | AST | — | — | — | 1 | — | — | — | — | — | 1 (5%) | — | — | ALT | — | 1 | — | — | — | — | — | — | — | — | 1 (5%) | — | GGT | — | 1 | — | — | 1 | — | — | 1 | — | — | 3 (14%) | — | TG | — | — | — | 1 | — | — | — | — | — | 1 (5%) | — | — | Abdominal distention | 1 | — | — | 1 | — | — | — | — | — | 2 (10%) | — | — | Pruritus | — | — | — | 1 | — | — | — | — | — | 1 (5%) | — | — | Arthralgia | — | — | — | 1 | — | — | — | — | — | 1 (5%) | — | — | Low-grade fever | 3 | — | — | — | — | — | — | — | — | 3 (14%) | — | — | Hypokalemia | — | — | — | 1 | — | — | — | — | — | 1 (5%) | — | — |
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G1, G2, and G3 represent grade 1, grade 2, and grade 3, respectively, according to NCI-CTC grades. AE: adverse event; —: no occurrence.
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