Adverse events of alpelisib: A postmarketing study of the World Health Organization pharmacovigilance database.
Br J Clin Pharmacol
; 88(5): 2180-2189, 2022 05.
Article
in English
| MEDLINE | ID: covidwho-1895952
ABSTRACT
AIMS:
To explore and describe the adverse reaction signals in the safety reporting for alpelisib.METHODS:
We performed a disproportionality analysis of the World Health Organization's VigiBase pharmacovigilance database from 1 January 2019 to 30 June 2021. Disproportionality analysis by information components (ICs) were used to evaluate the potential association between adverse events (AEs) and alpelisib.RESULTS:
A total of 33 327 reports were extracted, 5695 of them were chosen with alpelisib as the suspected drug. After combining the same ID, 687 cases remained. The 45-64-years group had the most cases (n = 203, 29.55%). There were 129 Preferred Terms with significant signals. Hyperglycaemia (IC025 = 6.74), breast cancer metastatic (IC025 = 5.85) and metastases to liver (IC025 = 4.70) were the AEs with the strongest signal. AEs with the most cases were hyperglycaemia (n = 595), rash (n = 535) and diarrhoea (n = 475).CONCLUSION:
We established a comprehensive list of AEs potentially associated with alpelisib. AEs with the most significant signals were hyperglycaemia, breast cancer metastatic, metastases to liver. The AEs with the most cases were hyperglycaemia, rash, diarrhoea, blood glucose increase and nausea.Keywords
Full text:
Available
Collection:
International databases
Database:
MEDLINE
Main subject:
Breast Neoplasms
/
Drug-Related Side Effects and Adverse Reactions
/
Exanthema
/
Hyperglycemia
Type of study:
Experimental Studies
/
Observational study
Limits:
Female
/
Humans
Language:
English
Journal:
Br J Clin Pharmacol
Year:
2022
Document Type:
Article
Similar
MEDLINE
...
LILACS
LIS