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We used either acetone or DMSO as the solvent, and solvent concentrations were < 0.015% for all treatments except the high doses in the ANF-alone dose group, in which solvent concentrations were ≤0.1%.
Clinical chemistry data showed elevations of alanine aminotransferase (ALT), gamma glutamyltransferase (GGT) and total bilirubin in mid (ALT alone) and high dose groups, suggesting potential hepatobiliary effects with high dose exposure.
Through a permutation criterion, we have shown that the probability of observing such an extreme number of favourable trends in any dose group by chance alone is <1%.
Patients randomised to the escalated dose group (74 Gy) had a phase II boost to the prostate alone, with no margin added (PTV 2).
n = 9 15 per dose group.
n = 6 per dose group.
n = 10 15 per dose group.
n = 10 16 per dose group.
starting dose group (n=1)).
In this retrospective analysis, application of this method to the Pre-RELAX-AHF proof-of-concept study shows that the multiplicity adjusted P value for observing at least 6 of the 9 AHF endpoints examined with a one-sided P value < 0.10 favouring active treatment in one of 4 dose groups by chance alone was <1%.
Release efficiency varied between dose groups.
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CEO of Professional Science Editing for Scientists @ prosciediting.com