Table 8 Observed adverse events in overdose safety study
Group | Number of cases | Adverse event | Time of onset | Severity | Procedures | Causal relationship with test extract |
|---|---|---|---|---|---|---|
Control | 1 | Elevated white blood cell count | Observation period | Mild | None | None |
Low-dose | 1 | Cold | Intake period | Mild | None | None |
1 | Protein in urine | Intake period | Mild | None | None | |
1 | AST and ALT elevation | Observation period | Mild | None | None | |
1 | Protein in urine | Observation period | Mild | None | None | |
High-dose | 1 | CK elevation | Intake period | Mild | None | None |
1 | Slight cold | Intake period | Mild | None | None | |
1 | Ketone bodies in urine | Observation period | Mild | None | None |