Establishment and Real-World Application of an Adverse Reaction Monitoring System for Targeted Therapy of Antitumor Drugs
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Keywords

Adverse reaction monitoring
Molecular targeted antitumor drugs
Real-world study

DOI

10.26689/otd.v3i3.12258

Submitted : 2025-09-17
Accepted : 2025-10-02
Published : 2025-10-17

Abstract

This multicenter prospective observational study aims to construct an adverse reaction monitoring system for molecular targeted antitumor drugs and explore its real-world application. By recruiting patients receiving molecular targeted therapy from outpatient, inpatient, and pharmacy settings, we collected comprehensive data including patient demographics, disease information, treatment regimens, and adverse reactions. The adverse reactions were graded according to CTCAE v5.0. With a planned enrollment of at least 100,000 patients over five years, this study will conduct descriptive analysis and build prediction models for adverse reactions. The results will contribute to establishing a national monitoring network and database, updating clinical guidelines, and enhancing the safety of molecular targeted therapy.

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