Safety analysis of new medications in clinical trials: a simulation study to assess the differences between cause-specific and subdistribution frameworks in the presence of competing events.

Genet, Astrid; Bogner, Kathrin; Goertz, Ralf; Böhme, Sarah; Leverkus, Friedhelm

Genet, Astrid; Bogner, Kathrin; Goertz, Ralf; Böhme, Sarah; Leverkus, Friedhelm.

Afiliação

Genet A; Pfizer Pharma GmbH, Linkstraße 10, Berlin, 10785, Germany. astrid.genet@Pfizer.com.
Bogner K; AMS Advanced Medical Services GmbH, Am Exerzierplatz 2, Mannheim, 68167, Germany.
Goertz R; AMS Advanced Medical Services GmbH, Am Exerzierplatz 2, Mannheim, 68167, Germany.
Böhme S; Pfizer Pharma GmbH, Linkstraße 10, Berlin, 10785, Germany.
Leverkus F; Pfizer Pharma GmbH, Linkstraße 10, Berlin, 10785, Germany.

BMC Med Res Methodol ; 23(1): 168, 2023 07 13.

Article em En | MEDLINE | ID: mdl-37442979

Assuntos

Simulação por Computador; Humanos; Modelos de Riscos Proporcionais; Ensaios Clínicos como Assunto

Palavras-chave

Cause-specific versus subdistribution hazard ratio; Competing risks; Drug development; Safety analysis; Simulation study

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Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Simulação por Computador Tipo de estudo: Prognostic_studies Limite: Humans Idioma: En Ano de publicação: 2023 Tipo de documento: Article

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