Statistical Analysis
AML, bleeding, death
REGRESSION, BLEEDING, ADVERSE EVENTS, AML
Data are summarized as mean ± standard deviation (normally distributed variables), median and IQR (non-normally distributed variables), or as percent frequency (binary/categorical variables), and between-arms comparisons were performed by independent Efficacy and safety analyses were performed on the full analysis set, that is, randomized patients who had received at least one dose of eltrombopag, according to the modified intention-to-treat (ITT) principle.The primary end point (PLT-R) of the 24-week trial (first part) was analyzed with the use of a logistic regression model that included the trial group as an independent variable and was also presented graphically by reverse Kaplan-Meier curves and compared by log-rank test. PLT-R, defined according to International Working Group 2006 criteria,To account for differences in follow-up time between patients of the two study arms, we also performed a time-to-event analysis by a reverse Kaplan-Meier method.The duration of PLT-R (primary end point of second part) was calculated from the time of PLT-R to the date of loss of PLT-R, defined as bleeding or PLT count <30 × 10Safety outcomes (primary end point of both parts) were summarized descriptively. Between-treatment comparisons (adverse events [AEs], progression of MDS, AML evolution, and death) were conducted using a chi-square test. Additional information is provided in the Data Supplement.