Postmarketing Analysis of Sipuleucel-T-The Importance of Real-World Data.

08:00 EDT 2nd August 2019 | BioPortfolio

Summary of "Postmarketing Analysis of Sipuleucel-T-The Importance of Real-World Data."

No Summary Available


Journal Details

This article was published in the following journal.

Name: JAMA network open
ISSN: 2574-3805
Pages: e199233


DeepDyve research library

PubMed Articles [34175 Associated PubMed Articles listed on BioPortfolio]

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 asympto...

Postmarketing surveillance on clinical use of edoxaban in patients with nonvalvular atrial fibrillation (ETNA-AF-Japan): Three-month interim analysis results.

Direct oral anticoagulants are the first-line drugs for anticoagulation therapy in nonvalvular atrial fibrillation (NVAF). However, a real-world, large-scale, clinical study on edoxaban has not been p...

Adding value to real-world data: the role of biomarkers.

Adding biomarker information to real world datasets (e.g. biomarker data collected into disease/drug registries) can enhance mechanistic understanding of intra-patient differences in disease trajector...

Early Access to Medicines Scheme: real-world data collection.

Real-world data (RWD) generated during the preapproval phase could be supplementary to primary clinical trial outcomes; however, as we discuss here, a data collection framework is needed to ensure the...

Real-world safety and efficacy of sofosbuvir and ledipasvir for elderly patients.

In September 2015, sofosbuvir and ledipasvir were approved for clinical use in Japan for patients infected with genotype 1 hepatitis C virus. We conducted a postmarketing prospective cohort study to e...

Clinical Trials [9100 Associated Clinical Trials listed on BioPortfolio]

Korea Osimertinib Real World Evidence Study to Assess Safety and Efficacy - PLUS

This is a local, prospective, non-interventional, regulatory postmarketing surveillance study. The objectives of this study are to assess the safety and efficacy of single agent Tagrisso (...

Real-world Retrospective Data Analysis of Adjuvant Therapy for Patients With Stage II-III Colon Cancer After Radical Surgery

Background: 1. . The incidence and mortality of colon cancer are high in China and in the world. 2. . The treatment of many patients in the real world is not standardized, and there ...

Clinical Study of Atezolizumab (Anti-PD-L1) and Sipuleucel-T in Patients Who Have Asymptomatic or Minimally Symptomatic Metastatic Castrate Resistant Prostate Cancer

The purpose of the study is to compare the safety and tolerability of sequential atezolizumab followed by sipuleucel-T (Arm 1) vs. sipuleucel-T followed by atezolizumab (Arm 2) in patients...

Nivolumab in the Real World: Analysis of the Expanded Use in Spanish Patient

We will retrospectively review the case note of patients registered in the EAP of Nivolumab. A standard anonymous data collection form will be used to collect data and to analyze it. Pat...

A Study of Sipuleucel-T With Administration of Enzalutamide in Men With Metastatic Castrate-Resistant Prostate Cancer

This is a randomized, open-label study designed to assess the effects of sipuleucel-T when administered concurrently or sequentially with enzalutamide.

Medical and Biotech [MESH] Definitions

Analysis based on the mathematical function first formulated by Jean-Baptiste-Joseph Fourier in 1807. The function, known as the Fourier transform, describes the sinusoidal pattern of any fluctuating pattern in the physical world in terms of its amplitude and its phase. It has broad applications in biomedicine, e.g., analysis of the x-ray crystallography data pivotal in identifying the double helical nature of DNA and in analysis of other molecules, including viruses, and the modified back-projection algorithm universally used in computerized tomography imaging, etc. (From Segen, The Dictionary of Modern Medicine, 1992)

Systematic gathering of data for a particular purpose from various sources, including questionnaires, interviews, observation, existing records, and electronic devices. The process is usually preliminary to statistical analysis of the data.

The ongoing, systematic collection, analysis, and interpretation of health-related data with the purpose of preventing or controlling disease or injury, or of identifying unusual events of public health importance, followed by the dissemination and use of information for public health action. (From Am J Prev Med 2011;41(6):636)

The science concerned with the benefit and risk of drugs used in populations and the analysis of the outcomes of drug therapies. Pharmacoepidemiologic data come from both clinical trials and epidemiological studies with emphasis on methods for the detection and evaluation of drug-related adverse effects, assessment of risk vs benefit ratios in drug therapy, patterns of drug utilization, the cost-effectiveness of specific drugs, methodology of postmarketing surveillance, and the relation between pharmacoepidemiology and the formulation and interpretation of regulatory guidelines. (Pharmacoepidemiol Drug Saf 1992;1(1); J Pharmacoepidemiol 1990;1(1))

Works consisting of an announcement or statement of recent or current events of new data and matters of interest in the field of medicine or science. In some publications, such as "Nature" or "Science," the news reports are substantively written and herald medical and scientific data of vital or controversial importance.

Quick Search

DeepDyve research library

Searches Linking to this Article