Cross-study safety analysis of risk factors in CAR T cell clinical trials: An FDA database pilot project.

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Title: Cross-study safety analysis of risk factors in CAR T cell clinical trials: An FDA database pilot project.
Authors: Foster M; Science Applications International Corporation (SAIC), Reston, VA 20190, USA., Negash Y; Science Applications International Corporation (SAIC), Reston, VA 20190, USA., Eberhardt L; Science Applications International Corporation (SAIC), Reston, VA 20190, USA., Bryan WW; Office of Tissues and Advanced Therapies (OTAT), Center for Biologics Evaluation and Research (CBER), U.S. Food and Drug Administration (FDA), Silver Spring, MD 20993, USA., Schultz K; Office of Tissues and Advanced Therapies (OTAT), Center for Biologics Evaluation and Research (CBER), U.S. Food and Drug Administration (FDA), Silver Spring, MD 20993, USA., Wang X; Office of Tissues and Advanced Therapies (OTAT), Center for Biologics Evaluation and Research (CBER), U.S. Food and Drug Administration (FDA), Silver Spring, MD 20993, USA., Xu Y; Office of Translational Sciences (OTS), Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration (FDA), Silver Spring, MD 20993, USA., George B; Office of Tissues and Advanced Therapies (OTAT), Center for Biologics Evaluation and Research (CBER), U.S. Food and Drug Administration (FDA), Silver Spring, MD 20993, USA.
Source: Molecular therapy oncolytics [Mol Ther Oncolytics] 2022 Oct 20; Vol. 27, pp. 182-194. Date of Electronic Publication: 2022 Oct 20 (Print Publication: 2022).
Publication Type: Journal Article
Journal Info: Publisher: Cell Press Country of Publication: United States NLM ID: 101666776 Publication Model: eCollection Cited Medium: Print ISSN: 2372-7705 (Print) Linking ISSN: 23727705 NLM ISO Abbreviation: Mol Ther Oncolytics Subsets: PubMed not MEDLINE
Database: MEDLINE Ultimate
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  Data: <searchLink fieldCode="AU" term="%22Foster+M%22">Foster M</searchLink>; Science Applications International Corporation (SAIC), Reston, VA 20190, USA.<br /><searchLink fieldCode="AU" term="%22Negash+Y%22">Negash Y</searchLink>; Science Applications International Corporation (SAIC), Reston, VA 20190, USA.<br /><searchLink fieldCode="AU" term="%22Eberhardt+L%22">Eberhardt L</searchLink>; Science Applications International Corporation (SAIC), Reston, VA 20190, USA.<br /><searchLink fieldCode="AU" term="%22Bryan+WW%22">Bryan WW</searchLink>; Office of Tissues and Advanced Therapies (OTAT), Center for Biologics Evaluation and Research (CBER), U.S. Food and Drug Administration (FDA), Silver Spring, MD 20993, USA.<br /><searchLink fieldCode="AU" term="%22Schultz+K%22">Schultz K</searchLink>; Office of Tissues and Advanced Therapies (OTAT), Center for Biologics Evaluation and Research (CBER), U.S. Food and Drug Administration (FDA), Silver Spring, MD 20993, USA.<br /><searchLink fieldCode="AU" term="%22Wang+X%22">Wang X</searchLink>; Office of Tissues and Advanced Therapies (OTAT), Center for Biologics Evaluation and Research (CBER), U.S. Food and Drug Administration (FDA), Silver Spring, MD 20993, USA.<br /><searchLink fieldCode="AU" term="%22Xu+Y%22">Xu Y</searchLink>; Office of Translational Sciences (OTS), Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration (FDA), Silver Spring, MD 20993, USA.<br /><searchLink fieldCode="AU" term="%22George+B%22">George B</searchLink>; Office of Tissues and Advanced Therapies (OTAT), Center for Biologics Evaluation and Research (CBER), U.S. Food and Drug Administration (FDA), Silver Spring, MD 20993, USA.
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  Data: <i>Publisher: </i><searchLink fieldCode="PB" term="%22Cell+Press%22">Cell Press </searchLink><i>Country of Publication: </i>United States <i>NLM ID: </i>101666776 <i>Publication Model: </i>eCollection <i>Cited Medium: </i>Print <i>ISSN: </i>2372-7705 (Print) <i>Linking ISSN: </i><searchLink fieldCode="IS" term="%2223727705%22">23727705 </searchLink><i>NLM ISO Abbreviation: </i>Mol Ther Oncolytics <i>Subsets: </i>PubMed not MEDLINE
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        Value: 10.1016/j.omto.2022.10.006
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        Text: English
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        StartPage: 182
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      – TitleFull: Cross-study safety analysis of risk factors in CAR T cell clinical trials: An FDA database pilot project.
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              Text: 2022 Oct 20
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              Y: 2022
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