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To Adjudicate or Not Adjudicate: That Is the Question.

作者信息

Hicks Karen A, Fashoyin-Aje Lola A, Amiri-Kordestani Laleh

机构信息

Office of Medical Policy, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA.

Division of Oncology III, Office of Oncologic Drugs, Office of New Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA.

出版信息

JACC CardioOncol. 2022 Dec 20;4(5):657-659. doi: 10.1016/j.jaccao.2022.11.003. eCollection 2022 Dec.

DOI:10.1016/j.jaccao.2022.11.003
PMID:36636434
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC9830205/
Abstract
摘要

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1
To Adjudicate or Not Adjudicate: That Is the Question.裁决还是不裁决：这就是问题所在。
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2
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Do we need to adjudicate major clinical events?我们需要对重大临床事件进行判定吗？
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本文引用的文献

1
Burden of Cardiovascular Disease in Immune Checkpoint Inhibitor-Treated Patients: Reconciling Adjudicated and Coded Outcomes.免疫检查点抑制剂治疗患者的心血管疾病负担：协调判定结果和编码结果
JACC CardioOncol. 2022 Dec 20;4(5):649-656. doi: 10.1016/j.jaccao.2022.09.003. eCollection 2022 Dec.
2
Myocarditis occurrence with cancer immunotherapy across indications in clinical trial and post-marketing data.在临床试验和上市后数据中，不同适应证的癌症免疫疗法均有心肌炎发生。
Sci Rep. 2021 Aug 30;11(1):17324. doi: 10.1038/s41598-021-96467-5.
3
Myocarditis following the use of different immune checkpoint inhibitor regimens: A real-world analysis of post-marketing surveillance data.
使用不同免疫检查点抑制剂方案后的心肌炎：上市后监测数据的真实世界分析。
Int Immunopharmacol. 2019 Nov;76:105866. doi: 10.1016/j.intimp.2019.105866. Epub 2019 Sep 3.
4
Toxicities with Immune Checkpoint Inhibitors: Emerging Priorities From Disproportionality Analysis of the FDA Adverse Event Reporting System.免疫检查点抑制剂的毒性：来自 FDA 不良事件报告系统的比例失调分析的新兴重点。
Target Oncol. 2019 Apr;14(2):205-221. doi: 10.1007/s11523-019-00632-w.
5
Cardiovascular toxicities associated with immune checkpoint inhibitors: an observational, retrospective, pharmacovigilance study.免疫检查点抑制剂相关的心血管毒性：一项观察性、回顾性、药物警戒研究。
Lancet Oncol. 2018 Dec;19(12):1579-1589. doi: 10.1016/S1470-2045(18)30608-9. Epub 2018 Nov 12.
6
Disagreements between central clinical events committee and site investigator assessments of myocardial infarction endpoints in an international clinical trial: review of the PURSUIT study.国际临床试验中中央临床事件委员会与现场研究者对心肌梗死终点评估的分歧：PURSUIT研究综述
Curr Control Trials Cardiovasc Med. 2001 Jul 17;2(4):187-194. doi: 10.1186/cvm-2-4-187.
7
How good is that agreement?那份协议有多好？
Epidemiology. 1996 Sep;7(5):561. doi: 10.1097/00001648-199609000-00030.