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Safety Profile of Ibrutinib: An Analysis of the WHO Pharmacovigilance Database
- Source :
- Frontiers in Pharmacology, Vol 12 (2021), Frontiers in Pharmacology
- Publication Year :
- 2021
-
Abstract
- As ibrutinib has become a standard of care in B-cell malignancies in monotherapy or in combination with other agents, definition of its safety profile appears essential. The aim of this study was to further characterize the safety profile of ibrutinib through the identification of potential safety signals in a large-scale pharmacovigilance database. All serious individual case safety reports (ICSRs) in patients aged ≥18 years involving ibrutinib suspected in the occurrence of serious adverse drug reactions or drug interacting from November 13th, 2013 to December 31st, 2020 were extracted from VigiBase, the World Health Organization global safety database. Disproportionality reporting was assessed using the information component (IC) and the proportional reporting ratio (PRR), with all other anticancer drugs used as the reference group. To mitigate the confounding of age, two subgroups were considered: patients aged
- Subjects :
- Drug
drug safety
media_common.quotation_subject
Population
adverse drug reaction
RM1-950
computer.software_genre
Bruton’s tyrosine kinase inhibitor
chemistry.chemical_compound
ibrutinib
Pharmacovigilance
medicine
Pharmacology (medical)
education
Original Research
media_common
Pharmacology
education.field_of_study
Database
business.industry
Confounding
medicine.disease
Clinical trial
Safety profile
chemistry
Ibrutinib
pharmacovigilance
Therapeutics. Pharmacology
business
computer
Adverse drug reaction
Subjects
Details
- Language :
- English
- Database :
- OpenAIRE
- Journal :
- Frontiers in Pharmacology, Vol 12 (2021), Frontiers in Pharmacology
- Accession number :
- edsair.doi.dedup.....dea952bbe7af42a184926e76c2c37861