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A Food and Drug Administration analysis of survival outcomes comparing the Adjuvant Paclitaxel and Trastuzumab trial with an external control from historical clinical trials.
Amiri-Kordestani, L; Xie, D; Tolaney, S M; Bloomquist, E; Tang, S; Ibrahim, A; Goldberg, K B; Theoret, M R; Pazdur, R; Sridhara, R; Winer, E P; Beaver, J A.
Afiliação
  • Amiri-Kordestani L; Office of Oncologic Diseases, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring. Electronic address: Laleh.AmiriKordestani@fda.hhs.gov.
  • Xie D; Office of Biostatistics, Division of Biometrics V, Office of Translational Sciences, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, USA.
  • Tolaney SM; Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, USA.
  • Bloomquist E; Office of Biostatistics, Division of Biometrics V, Office of Translational Sciences, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, USA.
  • Tang S; Office of Biostatistics, Division of Biometrics V, Office of Translational Sciences, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, USA.
  • Ibrahim A; Office of Oncologic Diseases, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring.
  • Goldberg KB; Oncology Center of Excellence, U.S. Food and Drug Administration, Silver Spring, USA.
  • Theoret MR; Office of Oncologic Diseases, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring; Oncology Center of Excellence, U.S. Food and Drug Administration, Silver Spring, USA.
  • Pazdur R; Office of Oncologic Diseases, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring; Oncology Center of Excellence, U.S. Food and Drug Administration, Silver Spring, USA.
  • Sridhara R; Oncology Center of Excellence, U.S. Food and Drug Administration, Silver Spring, USA.
  • Winer EP; Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, USA.
  • Beaver JA; Office of Oncologic Diseases, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring.
Ann Oncol ; 31(12): 1704-1708, 2020 12.
Article em En | MEDLINE | ID: mdl-32866625
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Texto completo: 1 Base de dados: MEDLINE Assunto principal: Neoplasias da Mama / Paclitaxel Idioma: En Ano de publicação: 2020 Tipo de documento: Article
Texto completo
Imprimir
XML
PubMed Links
Buscar no Google

Texto completo: 1 Base de dados: MEDLINE Assunto principal: Neoplasias da Mama / Paclitaxel Idioma: En Ano de publicação: 2020 Tipo de documento: Article