Modernizing the assessment and reporting of adverse events in oncology clinical trials using complementary statistical approaches: a case study of the MOTIVATE trial.
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| Title: | Modernizing the assessment and reporting of adverse events in oncology clinical trials using complementary statistical approaches: a case study of the MOTIVATE trial. |
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| Authors: | Morisseau M; Biostatistics & Health Data Science Unit, Oncopole Claudius Regaud- IUCT-O, 1 Avenue Irène Joliot-Curie, Toulouse, Cedex 9, 31059, France., Gomez-Roca C; Department of Medical Oncology, Oncopole Claudius Regaud- IUCT-O, Toulouse, France., Viala M; Department of Medical Oncology, Institut du Cancer de Montpellier (ICM), Montpellier, France., Rabeau A; Department of Pneumology, CHU Toulouse Larrey, Toulouse, France., Loirat D; Department of Medical Oncology, Institut Curie, Paris, Saint-Cloud, France.; Department of Drug Development and Innovation (D3i), Institut Curie, Paris, Saint-Cloud, France., Munsch N; Department of Medical Oncology, CH Albi, Albi, France., Thomas K; Department of Medical Oncology, Oncopole Claudius Regaud- IUCT-O, Toulouse, France., Pages C; Department of Dermatology Oncology, Oncopole Claudius Regaud- IUCT-O, Toulouse, France., Korakis I; Department of Medical Oncology, Oncopole Claudius Regaud- IUCT-O, Toulouse, France., Sibaud V; Department of Dermatology Oncology, Oncopole Claudius Regaud- IUCT-O, Toulouse, France., Delord JP; Department of Medical Oncology, Oncopole Claudius Regaud- IUCT-O, Toulouse, France., Filleron T; Biostatistics & Health Data Science Unit, Oncopole Claudius Regaud- IUCT-O, 1 Avenue Irène Joliot-Curie, Toulouse, Cedex 9, 31059, France. filleron.thomas@iuct-oncopole.fr.; Université Paris-Saclay, CESP, INSERM U1018 Oncostat, labeled Ligue Contre le Cancer, Villejuif, France. filleron.thomas@iuct-oncopole.fr., Cabarrou B; Biostatistics & Health Data Science Unit, Oncopole Claudius Regaud- IUCT-O, 1 Avenue Irène Joliot-Curie, Toulouse, Cedex 9, 31059, France. |
| Source: | Investigational new drugs [Invest New Drugs] 2024 Dec; Vol. 42 (6), pp. 664-674. Date of Electronic Publication: 2024 Nov 04. |
| Publication Type: | Journal Article; Research Support, Non-U.S. Gov't |
| Journal Info: | Publisher: Springer Country of Publication: United States NLM ID: 8309330 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1573-0646 (Electronic) Linking ISSN: 01676997 NLM ISO Abbreviation: Invest New Drugs Subsets: MEDLINE |
| Database: | MEDLINE Ultimate |
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| Header | DbId: mdl DbLabel: MEDLINE Ultimate An: 39495388 AccessLevel: 2 PubType: Academic Journal PubTypeId: academicJournal PreciseRelevancyScore: 0 |
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| Items | – Name: Title Label: Title Group: Ti Data: Modernizing the assessment and reporting of adverse events in oncology clinical trials using complementary statistical approaches: a case study of the MOTIVATE trial. – Name: Author Label: Authors Group: Au Data: <searchLink fieldCode="AU" term="%22Morisseau+M%22">Morisseau M</searchLink>; Biostatistics & Health Data Science Unit, Oncopole Claudius Regaud- IUCT-O, 1 Avenue Irène Joliot-Curie, Toulouse, Cedex 9, 31059, France.<br /><searchLink fieldCode="AU" term="%22Gomez-Roca+C%22">Gomez-Roca C</searchLink>; Department of Medical Oncology, Oncopole Claudius Regaud- IUCT-O, Toulouse, France.<br /><searchLink fieldCode="AU" term="%22Viala+M%22">Viala M</searchLink>; Department of Medical Oncology, Institut du Cancer de Montpellier (ICM), Montpellier, France.<br /><searchLink fieldCode="AU" term="%22Rabeau+A%22">Rabeau A</searchLink>; Department of Pneumology, CHU Toulouse Larrey, Toulouse, France.<br /><searchLink fieldCode="AU" term="%22Loirat+D%22">Loirat D</searchLink>; Department of Medical Oncology, Institut Curie, Paris, Saint-Cloud, France.; Department of Drug Development and Innovation (D3i), Institut Curie, Paris, Saint-Cloud, France.<br /><searchLink fieldCode="AU" term="%22Munsch+N%22">Munsch N</searchLink>; Department of Medical Oncology, CH Albi, Albi, France.<br /><searchLink fieldCode="AU" term="%22Thomas+K%22">Thomas K</searchLink>; Department of Medical Oncology, Oncopole Claudius Regaud- IUCT-O, Toulouse, France.<br /><searchLink fieldCode="AU" term="%22Pages+C%22">Pages C</searchLink>; Department of Dermatology Oncology, Oncopole Claudius Regaud- IUCT-O, Toulouse, France.<br /><searchLink fieldCode="AU" term="%22Korakis+I%22">Korakis I</searchLink>; Department of Medical Oncology, Oncopole Claudius Regaud- IUCT-O, Toulouse, France.<br /><searchLink fieldCode="AU" term="%22Sibaud+V%22">Sibaud V</searchLink>; Department of Dermatology Oncology, Oncopole Claudius Regaud- IUCT-O, Toulouse, France.<br /><searchLink fieldCode="AU" term="%22Delord+JP%22">Delord JP</searchLink>; Department of Medical Oncology, Oncopole Claudius Regaud- IUCT-O, Toulouse, France.<br /><searchLink fieldCode="AU" term="%22Filleron+T%22">Filleron T</searchLink>; Biostatistics & Health Data Science Unit, Oncopole Claudius Regaud- IUCT-O, 1 Avenue Irène Joliot-Curie, Toulouse, Cedex 9, 31059, France. filleron.thomas@iuct-oncopole.fr.; Université Paris-Saclay, CESP, INSERM U1018 Oncostat, labeled Ligue Contre le Cancer, Villejuif, France. filleron.thomas@iuct-oncopole.fr.<br /><searchLink fieldCode="AU" term="%22Cabarrou+B%22">Cabarrou B</searchLink>; Biostatistics & Health Data Science Unit, Oncopole Claudius Regaud- IUCT-O, 1 Avenue Irène Joliot-Curie, Toulouse, Cedex 9, 31059, France. – Name: TitleSource Label: Source Group: Src Data: <searchLink fieldCode="JN" term="%228309330%22">Investigational new drugs</searchLink> [Invest New Drugs] 2024 Dec; Vol. 42 (6), pp. 664-674. <i>Date of Electronic Publication: </i>2024 Nov 04. – Name: TypePub Label: Publication Type Group: TypPub Data: Journal Article; Research Support, Non-U.S. Gov't – Name: TitleSource Label: Journal Info Group: Src Data: <i>Publisher: </i><searchLink fieldCode="PB" term="%22Springer%22">Springer </searchLink><i>Country of Publication: </i>United States <i>NLM ID: </i>8309330 <i>Publication Model: </i>Print-Electronic <i>Cited Medium: </i>Internet <i>ISSN: </i>1573-0646 (Electronic) <i>Linking ISSN: </i><searchLink fieldCode="IS" term="%2201676997%22">01676997 </searchLink><i>NLM ISO Abbreviation: </i>Invest New Drugs <i>Subsets: </i>MEDLINE |
| PLink | https://search.ebscohost.com/login.aspx?direct=true&site=eds-live&db=mdl&AN=39495388 |
| RecordInfo | BibRecord: BibEntity: Identifiers: – Type: doi Value: 10.1007/s10637-024-01481-9 Languages: – Code: eng Text: English PhysicalDescription: Pagination: StartPage: 664 Titles: – TitleFull: Modernizing the assessment and reporting of adverse events in oncology clinical trials using complementary statistical approaches: a case study of the MOTIVATE trial. Type: main BibRelationships: HasContributorRelationships: – PersonEntity: Name: NameFull: Morisseau M – PersonEntity: Name: NameFull: Gomez-Roca C – PersonEntity: Name: NameFull: Viala M – PersonEntity: Name: NameFull: Rabeau A – PersonEntity: Name: NameFull: Loirat D – PersonEntity: Name: NameFull: Munsch N – PersonEntity: Name: NameFull: Thomas K – PersonEntity: Name: NameFull: Pages C – PersonEntity: Name: NameFull: Korakis I – PersonEntity: Name: NameFull: Sibaud V – PersonEntity: Name: NameFull: Delord JP – PersonEntity: Name: NameFull: Filleron T – PersonEntity: Name: NameFull: Cabarrou B IsPartOfRelationships: – BibEntity: Dates: – D: 01 M: 12 Text: 2024 Dec Type: published Y: 2024 Identifiers: – Type: issn-electronic Value: 1573-0646 Numbering: – Type: volume Value: 42 – Type: issue Value: 6 Titles: – TitleFull: Investigational new drugs Type: main |
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