What Is the Plural of a ‘Yellow’ Anecdote?

Evans, Stephen

doi:10.1007/s40264-015-0368-7

Cited by 7 publications

(6 citation statements)

References 13 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…However, further large population-based studies on cohorts of patients with colorectal, breast, and prostate cancer did not provide any evidence of an increased risk of cancer-specific mortality among patients using clopidogrel [ 28 ]. Other systematic review and meta-analysis studies have shown that thienopyridine exposure is not significantly associated with malignancy [ 29 ]. But, some studies suggest that clopidogrel even reduces cancer incidence [ 30 ].…”

Section: Discussionmentioning

confidence: 99%

Clopidogrel in a combined therapy with anticancer drugs—effect on tumor growth, metastasis, and treatment toxicity: Studies in animal models

et al. 2017

View full text Add to dashboard Cite

Clopidogrel, a thienopyridine derivative with antiplatelet activity, is widely prescribed for patients with cardiovascular diseases. In addition to antiplatelet activity, antiplatelet agents possess anticancer and antimetastatic properties. Contrary to this, results of some studies have suggested that the use of clopidogrel and other thienopyridines accelerates the progression of breast, colorectal, and prostate cancer. Therefore, in this study, we aimed to evaluate the efficacy of clopidogrel and various anticancer agents as a combined treatment using mouse models of breast, colorectal, and prostate cancer. Metastatic dissemination, selected parameters of platelet morphology and biochemistry, as well as angiogenesis were assessed. In addition, body weight, blood morphology, and biochemistry were evaluated to test toxicity of the studied compounds. According to the results, clopidogrel increased antitumor and/or antimetastatic activity of chemotherapeutics such as 5-fluorouracil, cyclophosphamide, and mitoxantrone, whereas it decreased the anticancer activity of doxorubicin, cisplatin, and tamoxifen. The mechanisms of such divergent activities may be based on the modulation of tumor vasculature via factors, such as transforming growth factor β1 released from platelets. Moreover, clopidogrel increased the toxicity of docetaxel and protected against mitoxantrone-induced toxicity, which may be due to the modulation of hepatic enzymes and protection of the vasculature, respectively. These results demonstrate that antiplatelet agents can be useful but also dangerous in anticancer treatment and therefore use of thienopyridines in patients undergoing chemotherapy should be carefully evaluated.

show abstract

Section: Discussionmentioning

confidence: 99%

Clopidogrel in a combined therapy with anticancer drugs—effect on tumor growth, metastasis, and treatment toxicity: Studies in animal models

et al. 2017

View full text Add to dashboard Cite

show abstract

“…By comparing OAE, MedDRA, and SNOMED-CT [ 42 ], the study by Sarntivijai et al showed many advantages of OAE in AE term classification [ 15 ]. By analyzing FAERS-reported drug AEs associated with tyrosine kinase inhibitors and monoclonal antibodies, a recent FDA-led research demonstrated that OAE can serve as a semantic framework to link MedDRA-coded clinical AE phenotypes to biological mechanisms [ 16 ]. Our current study provides new empirical evidence on the feasibility and advantages of using OAE in AE classification and clustering analysis after the MedDRA-OAE term mappings.…”

Section: Discussionmentioning

confidence: 99%

“…A biomedical ontology is a human- and computer-interpretable set of terms and relations that represent entities in a specific biomedical domain and how these entities relate to each other. After an AE term mapping between MedDRA and OAE, OAE can be used to classify VAERS reported AEs represented with MedDRA terms [ 15 , 16 ]. Empirical evidences have shown that OAE performs better than MedDRA in the area of AE classification [ 15 , 17 ].…”

Section: Introductionmentioning

confidence: 99%

Differential Adverse Event Profiles Associated with BCG as a Preventive Tuberculosis Vaccine or Therapeutic Bladder Cancer Vaccine Identified by Comparative Ontology-Based VAERS and Literature Meta-Analysis

Xie

Codd

et al. 2016

PLoS ONE

View full text Add to dashboard Cite

M. bovis strain Bacillus Calmette–Guérin (BCG) has been the only licensed live attenuated vaccine against tuberculosis (TB) for nearly one century and has also been approved as a therapeutic vaccine for bladder cancer treatment since 1990. During its long time usage, different adverse events (AEs) have been reported. However, the AEs associated with the BCG preventive TB vaccine and therapeutic cancer vaccine have not been systematically compared. In this study, we systematically collected various BCG AE data mined from the US VAERS database and PubMed literature reports, identified statistically significant BCG-associated AEs, and ontologically classified and compared these AEs related to these two types of BCG vaccine. From 397 VAERS BCG AE case reports, we identified 64 AEs statistically significantly associated with the BCG TB vaccine and 14 AEs with the BCG cancer vaccine. Our meta-analysis of 41 peer-reviewed journal reports identified 48 AEs associated with the BCG TB vaccine and 43 AEs associated with the BCG cancer vaccine. Among all identified AEs from VAERS and literature reports, 25 AEs belong to serious AEs. The Ontology of Adverse Events (OAE)-based ontological hierarchical analysis indicated that the AEs associated with the BCG TB vaccine were enriched in immune system (e.g., lymphadenopathy and lymphadenitis), skin (e.g., skin ulceration and cyanosis), and respiratory system (e.g., cough and pneumonia); in contrast, the AEs associated with the BCG cancer vaccine mainly occurred in the urinary system (e.g., dysuria, pollakiuria, and hematuria). With these distinct AE profiles detected, this study also discovered three AEs (i.e., chills, pneumonia, and C-reactive protein increased) shared by the BCG TB vaccine and bladder cancer vaccine. Furthermore, our deep investigation of 24 BCG-associated death cases from VAERS identified the important effects of age, vaccine co-administration, and immunosuppressive status on the final BCG-associated death outcome.

show abstract

“…More concerning is interpreting RRs as estimated relative risks (which shares ‘RR’ as an acronym). While another recent study from IMI-PROTECT [Macia-Martinez et al 2016] (with substantial limitations) [Evans, 2016] reported a positive association between PRR values calculated using SRS data and subsequently estimated relative risk in confirmed safety issues, correlation is not synonymous with agreement, and DA metrics should not be misinterpreted or misrepresented as estimated relative risks, which are duly estimated from more robust datasets.…”

Section: Discussionmentioning

confidence: 99%

Revisiting the reported signal of acute pancreatitis with rasburicase: an object lesson in pharmacovigilance

Hauben

Hung

2016

Therapeutic Advances in Drug Safety

View full text Add to dashboard Cite

Introduction:There is an interest in methodologies to expeditiously detect credible signals of drug-induced pancreatitis. An example is the reported signal of pancreatitis with rasburicase emerging from a study [the 'index publication' (IP)] combining quantitative signal detection findings from a spontaneous reporting system (SRS) and electronic health records (EHRs). The signal was reportedly supported by a clinical review with a case series manuscript in progress. The reported signal is noteworthy, being initially classified as a false-positive finding for the chosen reference standard, but reclassified as a 'clinically supported' signal. Objective: This paper has dual objectives: to revisit the signal of rasburicase and acute pancreatitis and extend the original analysis via reexamination of its findings, in light of more contemporary data; and to motivate discussions on key issues in signal detection and evaluation, including recent findings from a major international pharmacovigilance research initiative. Methodology: We used the same methodology as the IP, including the same disproportionality analysis software/dataset for calculating observed to expected reporting frequencies (O/ Es), Medical Dictionary for Regulatory Activities Preferred Term, and O/E metric/threshold combination defining a signal of disproportionate reporting. Baseline analysis results prompted supplementary analyses using alternative analytical choices. We performed a comprehensive literature search to identify additional published case reports of rasburicase and pancreatitis. Results: We could not replicate positive findings (e.g. a signal or statistic of disproportionate reporting) from the SRS data using the same algorithm, software, dataset and vendor specified in the IP. The reporting association was statistically highlighted in default and supplemental analysis when more sensitive forms of disproportionality analysis were used. Two of three reports in the FAERS database were assessed as likely duplicate reports. We did not identify any additional reports in the FAERS corresponding to the three cases identified in the IP using EHRs. We did not identify additional published reports of pancreatitis associated with rasburicase. Discussion: Our exercise stimulated interesting discussions of key points in signal detection and evaluation, including causality assessment, signal detection algorithm performance, pharmacovigilance terminology, duplicate reporting, mechanisms for communicating signals, the structure of the FAERs database, and recent results from a major international pharmacovigilance research initiative.

show abstract

What Is the Plural of a ‘Yellow’ Anecdote?

Cited by 7 publications

References 13 publications

Clopidogrel in a combined therapy with anticancer drugs—effect on tumor growth, metastasis, and treatment toxicity: Studies in animal models

Clopidogrel in a combined therapy with anticancer drugs—effect on tumor growth, metastasis, and treatment toxicity: Studies in animal models

Differential Adverse Event Profiles Associated with BCG as a Preventive Tuberculosis Vaccine or Therapeutic Bladder Cancer Vaccine Identified by Comparative Ontology-Based VAERS and Literature Meta-Analysis

Revisiting the reported signal of acute pancreatitis with rasburicase: an object lesson in pharmacovigilance

Contact Info

Product

Resources

About