Detecting deviations from the efficacy and safety results of single-arm trials using real-world data: The case of a CAR-T cell therapy in B-cell lymphoma.

Jakobsen, Lasse Hjort; Callréus, Torbjörn; Sessa, Maurizio; Jerkeman, Mats; Andersen, Morten; El-Galaly, Tarec Christoffer

Jakobsen, Lasse Hjort; Callréus, Torbjörn; Sessa, Maurizio; Jerkeman, Mats; Andersen, Morten; El-Galaly, Tarec Christoffer.

Afiliação

Jakobsen LH; Department of Hematology, Clinical Cancer Research Center, Aalborg University Hospital, Denmark.
Callréus T; Department of Clinical Medicine, Aalborg University, Aalborg, Denmark.
Sessa M; Pharmacovigilance Research Center, Department of Drug Design and Pharmacology, University of Copenhagen, Copenhagen, Denmark.
Jerkeman M; Pharmacovigilance Research Center, Department of Drug Design and Pharmacology, University of Copenhagen, Copenhagen, Denmark.
Andersen M; Department of Oncology, Lund University, Lund, Sweden.
El-Galaly TC; Pharmacovigilance Research Center, Department of Drug Design and Pharmacology, University of Copenhagen, Copenhagen, Denmark.

Pharmacoepidemiol Drug Saf ; 30(4): 514-519, 2021 04.

Article em En | MEDLINE | ID: mdl-33432654

Assuntos

Imunoterapia Adotiva; Linfoma Difuso de Grandes Células B; Receptores de Antígenos Quiméricos; Terapia Baseada em Transplante de Células e Tecidos; Humanos; Ensaios Clínicos Controlados Aleatórios como Assunto

Palavras-chave

CAR-T cell therapy; monitoring; single-arm trial

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Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Imunoterapia Adotiva / Linfoma Difuso de Grandes Células B / Receptores de Antígenos Quiméricos Tipo de estudo: Clinical_trials Limite: Humans Idioma: En Revista: Pharmacoepidemiol Drug Saf Assunto da revista: EPIDEMIOLOGIA / TERAPIA POR MEDICAMENTOS Ano de publicação: 2021 Tipo de documento: Article País de afiliação: Dinamarca

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