Randomization, sample size calculation, and statistical analysis
toxicity, death
SECONDARY, -11
Randomization was performed at the AMLSG Clinical Trials Office, two-arm in a ratio of 1:1 using the minimization approach of Pocock (Biometrics 1975) for the factors The sample size calculation was based on data from the British MRC 14 trialPairwise comparisons between patient subgroups were performed by the Mann–Whitney or Kruskal Wallis test for continuous variables and by Fisher’s exact test for categorical variables.The analysis was performed on an ITT basis according to initial randomization. The primary endpoint of the study was OS; secondary endpoints were event-free survival (EFS), response to therapy (CR/CRi), cumulative incidences of relapse (CIR) and death in CR/CRi (CID) and therapy-related toxicity. The median duration of follow-up was calculated by the reverse Kaplan–Meier estimateCIR and CID were assessed using the time from achievement of CR/CRi until relapse or death in CR/CRi. CIR and CID and their standard errors were estimated according to the method of Aalen and JohansenComparisons regarding safety endpoints were performed using Barnard’s test.All statistical analyses were performed with the statistical software environment R, version 4.3.1, using the R packages survival, version 3.2-13, and cmprsk, version 2.2-11