Postmarketing Colitis Cases Associated With Alpelisib Use Reported to the US Food and Drug Administration.

Autor: Sullivan KM; Division of Pharmacovigilance, Office of Surveillance and Epidemiology, Center for Drug Evaluation, US Food and Drug Administration, Silver Spring, Maryland., Dores GM; Division of Pharmacovigilance, Office of Surveillance and Epidemiology, Center for Drug Evaluation, US Food and Drug Administration, Silver Spring, Maryland., Nayernama A; Division of Pharmacovigilance, Office of Surveillance and Epidemiology, Center for Drug Evaluation, US Food and Drug Administration, Silver Spring, Maryland., Prowell TM; Office of Oncologic Diseases, Center for Drug Evaluation, US Food and Drug Administration, Silver Spring, Maryland.; Johns Hopkins Sidney Kimmel Comprehensive Cancer Center, Baltimore, Maryland., Pradhan SM; Office of Oncologic Diseases, Center for Drug Evaluation, US Food and Drug Administration, Silver Spring, Maryland., Osgood C; Office of Oncologic Diseases, Center for Drug Evaluation, US Food and Drug Administration, Silver Spring, Maryland., Jones SC; Division of Pharmacovigilance, Office of Surveillance and Epidemiology, Center for Drug Evaluation, US Food and Drug Administration, Silver Spring, Maryland.
Jazyk: angličtina
Zdroj: JAMA oncology [JAMA Oncol] 2022 Oct 01; Vol. 8 (10), pp. 1503-1505.
DOI: 10.1001/jamaoncol.2022.3249
Databáze: MEDLINE