TABLE 2.
Summary of pharmacodynamic categorical analysis of associations between concentrations and adverse events (n = 42)
| Adverse event | n | Associationa with:
|
||
|---|---|---|---|---|
| Cmax,ss | Cavg,ss | Cmin,ss | ||
| Nausea and/or vomiting | 12 | 0.21 | 0.05 | 0.15 |
| Headache | 11 | 0.01 | 0.07 | 0.34 |
| Diarrhea | 12 | 0.44 | 0.92 | 0.92 |
| Rash | 4 | 0.96 | 0.28 | 0.96 |
| Oral numbness | 5 | 0.02 | 0.02 | 0.18 |
Values are P values from the Mantel-Haenszel chi-square test with modified Ridits scores. Parameter values were categorized as greater or less than the median.