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PURPOSE To describe instances of inadvertent intrathecal injection of ionic contrast media and to consider treatment approaches, and diagnostic and medicolegal issues. METHODS Ten cases of inadvertent injection, of which nine were reported to the manufacturers/authors and one appeared in the literature, are related with emphasis on similarity of(More)
PURPOSE Several data mining algorithms (DMAs) are being studied in hopes of enhancing screening of large post-marketing safety databases for signals of novel adverse events (AEs). The objective of this study was to apply two DMAs to the United States FDA Adverse Event Reporting System (AERS) database to see whether signals of potentially fatal AEs with(More)
The objective of this study was to apply 2 data-mining algorithms to a drug safety database to determine if these methods would have flagged potentially fatal/disabling adverse drug reactions that triggered black box warnings/drug withdrawals in advance of initial identification via "traditional" methods. Relevant drug-event combinations were identified(More)
Data mining is receiving considerable attention as a tool for pharmacovigilance and is generating many perspectives on its uses. This paper presents four concepts that have appeared in various professional venues and represent potential sources of misunderstanding and/or entail extended discussions: (i) data mining algorithms are unvalidated; (ii) data(More)
INTRODUCTION With increasing volumes of postmarketing safety surveillance data, data mining algorithms (DMAs) have been developed to search large spontaneous reporting system (SRS) databases for disproportional statistical dependencies between drugs and events. A crucial question is the proper deployment of such techniques within the universe of methods(More)
In the adjuvant setting, the third-generation aromatase inhibitors (AIs) anastrozole, letrozole and exemestane are recommended at some point during treatment, either in the upfront, switch after tamoxifen or extended treatment setting after tamoxifen in postmenopausal patients with hormone receptor-positive early breast cancer. AIs have demonstrated(More)
A new security testing method is proposed that combines the advantages of both traditional "black box" (monolithic functional) testing and "white box" (functional-synthesis-based) testing. The new method allows significant coverage both for security model-based tests and for individual kernel-call tests. It eliminates redundant kernel test cases 1) by using(More)