Chimeric antigen receptor T-cells safety: A pharmacovigilance and meta-analysis study.
Antigens, CD19
/ adverse effects
Bayes Theorem
Biological Products
Cytokine Release Syndrome
/ etiology
Drug-Related Side Effects and Adverse Reactions
/ etiology
Hematologic Diseases
/ etiology
Humans
Immunotherapy, Adoptive
/ adverse effects
Incidence
Nervous System Diseases
/ etiology
Pharmacovigilance
Receptors, Antigen, T-Cell
/ therapeutic use
Receptors, Chimeric Antigen
/ therapeutic use
Journal
American journal of hematology
ISSN: 1096-8652
Titre abrégé: Am J Hematol
Pays: United States
ID NLM: 7610369
Informations de publication
Date de publication:
01 09 2021
01 09 2021
Historique:
revised:
07
05
2021
received:
13
04
2021
accepted:
24
05
2021
pubmed:
1
6
2021
medline:
30
9
2021
entrez:
31
5
2021
Statut:
ppublish
Résumé
Chimeric-antigen-receptor T cells directed against CD19 (CAR-T) are emerging hematological therapeutics with scarce data on its overall safety profile spectrum. To determine the clinical features and incidence of adverse-drug reactions (ADR) associated with CAR-T. This observational, cross-sectional, pharmacovigilance cohort study examined individual case safety reports from the World Health Organization database VigiBase and meta-analysis of data from CAR-T trials and cohorts in the literature was also performed through March, 2020. The primary objective was to identify ADR associated with approved CAR-T (axicabtagene-ciloleucel; tisagenlecleucel). We conducted a Bayesian disproportionate analysis with the 95% lower credibility-interval of information component (IC
Substances chimiques
Antigens, CD19
0
Biological Products
0
Receptors, Antigen, T-Cell
0
Receptors, Chimeric Antigen
0
tisagenlecleucel
Q6C9WHR03O
axicabtagene ciloleucel
U2I8T43Y7R
Banques de données
ClinicalTrials.gov
['NCT04279470']
Types de publication
Journal Article
Meta-Analysis
Systematic Review
Langues
eng
Sous-ensembles de citation
IM
Pagination
1101-1111Informations de copyright
© 2021 Wiley Periodicals LLC.
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