Table 2.
Mean % change from baseline in MRI parameters (full analysis set)
| Mean % change from baseline (95% confidence interval) |
P value* (300 mg vs. 100 mg) |
||
|---|---|---|---|
| Vandetanib 100 mg | Vandetanib 300 mg | ||
| Primary variables | |||
| iAUC60 | --3.4 (--13.6, 8.1) | --4.6 (--13.4, 5.0) | 0.429 (one-sided) |
| Ktrans | --4.6 (--22.4, 17.4) | --2.7 (--18.4, 16.2) | 0.558 (one-sided) |
| Exploratory variables | |||
| T2* | --2.2 (--7.1, 2.9) | 7.3 (3.1, 11.7) | 0.006 (two-sided) |
| LDDCE-MRI | 16.1 (9.7, 22.9) | 8.0 (2.9, 13.4) | 0.029 (one-sided) |
iAUC60 initial area under the DCE-MRI contrast agent concentration--time curve after 60 s
Ktrans volume transfer constant between blood plasma and extravascular extracellular space
T2* effective magnetic transverse relaxation time
LDDCE-MRI length of longest diameter of target lesion measured as part of the DCE-MRI acquisition protocol
*The effect of vandetanib on MRI parameters was assessed using repeated measures ANOVA, which was fitted to the log-transformed baseline as a covariate and dose as a factor. Point and interval estimates were exponentially back transformed to provide the estimates of the % differences. The preplanned statistical comparisons were between the dose levels and not within dose levels. Only the least squares mean (95% CI) changes are reported within dose. See 'Statistical analyses' section for full details