{"denomUnitsSelected":"Participants","description":"Changes in parameters will be both graphically and quantitatively summarized and explored. Standard paired comparisons methodologies (paired t-tests, Wilcoxon signed rank tests and Fisher's exact tests for interval, ordinal and nominal level data, respectively) will be used to assess changes in these variables before and after therapy. In addition, these changes in pharmacologic markers and biological results will be explored in relation to clinical outcome to explore any differences between responders and non-responders.","reportingStatus":"NOT_POSTED","timeFrame":"Day 5 and 19 of the first course and then day 1 of each subsequent courses (courses 2-4) prior to the daily dose and 1 and 2 hours after each dose","title":"Change in Pharmacologic (Pharmacokinetic/Pharmacodynamic) Parameters","type":"OTHER_PRE_SPECIFIED"}