misoprostol and Leukemia

To test the effect of a therapeutic or prognostic factor on the occurrence of a particular cause of failure in the presence of other causes, the interest has shifted in some studies from the modelling of the cause-specific hazard to that of the subdistribution hazard. We present approximate sample size formulas for the proportional hazards modelling of competing risk subdistribution, considering either independent or correlated covariates. The validity of these approximate formulas is investigated through numerical simulations. Two illustrations are provided, a randomized clinical trial, and a prospective prognostic study.

Topics: Administration, Intravaginal; Cohort Studies; Computer Simulation; Delivery, Obstetric; Dinoprostone; Double-Blind Method; Female; Graft vs Host Disease; Humans; Leukemia; Misoprostol; Oxytocics; Pregnancy; Proportional Hazards Models; Randomized Controlled Trials as Topic; Risk Factors; Sample Size; Stem Cell Transplantation