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Updated: Nov 26, 2025

Establishing a Competing Risk Regression Nomogram Model for Survival Data
Published on: October 23, 2020
On selecting the critical boundary functions in group-sequential trials with two time-to-event outcomes
Toshimitsu Hamasaki1, H M James Hung2, Chin-Fu Hsiao3
1The Biostatistics Center and the Innovations in Design, Education, and Analysis Committee (IDEA), the George Washington University, USA; Department of Biostatistics and Bioinformatics, Milken Institute School of Public Health, the George Washington University, USA.
Abstract:
We investigate selection of critical boundary functions for testing the hypotheses of two time-to-event outcomes as both primary endpoints or a primary and a secondary endpoint in group-sequential clinical trials, where (1) the effect sizes of endpoints are unequal, or (2) one endpoint is for short-term evaluation and the other for long-term evaluation. Bonferroni-Holm and fixed-sequence procedures are considered. We assess the effects of the magnitudes of the hazard ratios and the correlation between the endpoints on statistical powers and provide guidance for consideration.
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