Cumulative hazard ratio estimation for adverse events data from two-stage dynamic treatment regimes

Accurate analysis of adverse events in two-stage dynamic treatment regimes is complicated by the presence of competing risks, such as death, which can preclude the observation of an adverse event and introduce bias into standard survival estimates. To address these challenges, this study employs cumulative hazard functions to compare the safety profiles of different treatment policies, offering a more precise quantification of adverse event risk in the context of competing outcomes. The Nelson-Aalen estimator is utilized to decompose the overall hazard into cause-specific components, enabling a nuanced assessment of both mortality and adverse event risks. By appropriately censoring for competing events, the proposed approach ensures unbiased estimation of cumulative hazards, thereby facilitating robust and interpretable comparisons between treatment strategies. Our methodology is demonstrated through the estimation of the cumulative hazard ratio for adverse events in a real world data set for leukemia.

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Publication Details

Journal
Frontiers in Applied Mathematics and Statistics
Published
2025-06-25
DOI
https://doi.org/10.3389/fams.2025.1595650
Primary Topic
Statistical Methods in Clinical Trials
Type
article
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article

Cumulative hazard ratio estimation for adverse events data from two-stage dynamic treatment regimes

Sifiso Vilakati
Frontiers in Applied Mathematics and Statistics
Statistical Methods in Clinical Trials
article

Cumulative hazard ratio estimation for adverse events data from two-stage dynamic treatment regimes

Sifiso Vilakati
article en

Abstract

Accurate analysis of adverse events in two-stage dynamic treatment regimes is complicated by the presence of competing risks, such as death, which can preclude the observation of an adverse event and introduce bias into standard survival estimates. To address these challenges, this study employs cumulative hazard functions to compare the safety profiles of different treatment policies, offering a more precise quantification of adverse event risk in the context of competing outcomes. The Nelson-Aalen estimator is utilized to decompose the overall hazard into cause-specific components, enabling a nuanced assessment of both mortality and adverse event risks. By appropriately censoring for competing events, the proposed approach ensures unbiased estimation of cumulative hazards, thereby facilitating robust and interpretable comparisons between treatment strategies. Our methodology is demonstrated through the estimation of the cumulative hazard ratio for adverse events in a real world data set for leukemia.

Frontiers in Applied Mathematics and StatisticsVol. 11
University of the Free State (ZA)
Openalex Percentile: Top 85%
Statistical Methods in Clinical Trials
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Cumulative hazard ratio estimation for adverse events data from two-stage dynamic treatment regimes — Sifiso Vilakati · Frontiers in Applied Mathematics and Statistics (2025) | TGRS Research Map | TGRS