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Adverse Events Associated With the Use of Sipuleucel-T Reported to the US Food and Drug Administration's Adverse Event Reporting System, 2010-2017.

08:00 EDT 2nd August 2019 | BioPortfolio

Summary of "Adverse Events Associated With the Use of Sipuleucel-T Reported to the US Food and Drug Administration's Adverse Event Reporting System, 2010-2017."

Sipuleucel-T was the first therapeutic cancer vaccine approved by the US Food and Drug Administration (FDA) in 2010. Although almost a decade has passed since its approval for the treatment of asymptomatic or minimally symptomatic castration-resistant prostate cancer (CRPC), there remains a paucity of literature describing safety data in the postmarketing period.

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This article was published in the following journal.

Name: JAMA network open
ISSN: 2574-3805
Pages: e199249

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Medical and Biotech [MESH] Definitions

Liver disease lasting six months or more, caused by an adverse drug effect. The adverse effect may result from a direct toxic effect of a drug or metabolite, or an idiosyncratic response to a drug or metabolite.

Persons who experienced traumatic events during childhood.

Systems developed for collecting reports from government agencies, manufacturers, hospitals, physicians, and other sources on adverse drug reactions.

Liver disease lasting six months or more, caused by an adverse effect of a drug or chemical. The adverse effect may be caused by drugs, drug metabolites, chemicals from the environment, or an idiosyncratic response.

Disorders that result from the intended use of PHARMACEUTICAL PREPARATIONS. Included in this heading are a broad variety of chemically-induced adverse conditions due to toxicity, DRUG INTERACTIONS, and metabolic effects of pharmaceuticals.

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