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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| ISSN: | 1573-0646 |
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| DOI: | 10.1007/s10637-024-01481-9 |
