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On estimands and the analysis of adverse events in the presence of varying follow-up times within the benefit assessment of therapies.
Unkel, Steffen; Amiri, Marjan; Benda, Norbert; Beyersmann, Jan; Knoerzer, Dietrich; Kupas, Katrin; Langer, Frank; Leverkus, Friedhelm; Loos, Anja; Ose, Claudia; Proctor, Tanja; Schmoor, Claudia; Schwenke, Carsten; Skipka, Guido; Unnebrink, Kristina; Voss, Florian; Friede, Tim.
Afiliación
  • Unkel S; Department of Medical Statistics, University Medical Center Goettingen, Goettingen, Germany.
  • Amiri M; Center for Clinical Trials, University Hospital Essen, Essen, Germany.
  • Benda N; Biostatistics and Special Pharmacokinetics Unit, Federal Institute for Drugs and Medical Devices, Bonn, Germany.
  • Beyersmann J; Institute of Statistics, Ulm University, Germany.
  • Knoerzer D; Roche Pharma AG, Grenzach, Germany.
  • Kupas K; Bristol-Myers Squibb GmbH & Co. KGaA, München, Germany.
  • Langer F; Lilly Deutschland GmbH, Bad Homburg, Germany.
  • Leverkus F; Pfizer Deutschland GmbH, Berlin, Germany.
  • Loos A; Merck KGaA, Darmstadt, Germany.
  • Ose C; Center for Clinical Trials, University Hospital Essen, Essen, Germany.
  • Proctor T; Institute of Medical Biometry and Informatics, University of Heidelberg, Heidelberg, Germany.
  • Schmoor C; Clinical Trials Unit, Faculty of Medicine and Medical Center, University of Freiburg, Freiburg im Breisgau, Germany.
  • Schwenke C; Schwenke Consulting: Strategies and Solutions in Statistics (SCO:SSIS), Berlin, Germany.
  • Skipka G; Institute for Quality and Efficiency in Health Care, Cologne, Germany.
  • Unnebrink K; AbbVie Deutschland GmbH & Co. KG, Ludwigshafen, Germany.
  • Voss F; Boehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim, Germany.
  • Friede T; Department of Medical Statistics, University Medical Center Goettingen, Goettingen, Germany.
Pharm Stat ; 18(2): 166-183, 2019 03.
Article en En | MEDLINE | ID: mdl-30458579
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Texto completo: 1 Banco de datos: MEDLINE Asunto principal: Ensayos Clínicos como Asunto / Interpretación Estadística de Datos / Efectos Colaterales y Reacciones Adversas Relacionados con Medicamentos Tipo de estudio: Guideline / Health_technology_assessment / Observational_studies / Prognostic_studies / Risk_factors_studies Límite: Humans Idioma: En Revista: Pharm Stat Asunto de la revista: FARMACOLOGIA Año: 2019 Tipo del documento: Article País de afiliación: Alemania
Texto completo
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XML
PubMed Links
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Texto completo: 1 Banco de datos: MEDLINE Asunto principal: Ensayos Clínicos como Asunto / Interpretación Estadística de Datos / Efectos Colaterales y Reacciones Adversas Relacionados con Medicamentos Tipo de estudio: Guideline / Health_technology_assessment / Observational_studies / Prognostic_studies / Risk_factors_studies Límite: Humans Idioma: En Revista: Pharm Stat Asunto de la revista: FARMACOLOGIA Año: 2019 Tipo del documento: Article País de afiliación: Alemania