scholarly journals Multinomial modeling and an evaluation of common data-mining algorithms for identifying signals of disproportionate reporting in pharmacovigilance databases

2012 ◽  
Vol 28 (23) ◽  
pp. 3123-3130 ◽  
Author(s):  
Kjell Johnson ◽  
Cen Guo ◽  
Mark Gosink ◽  
Vicky Wang ◽  
Manfred Hauben
2005 ◽  
Vol 26 (4) ◽  
pp. 391-394 ◽  
Author(s):  
Manfred Hauben ◽  
Lester Reich

AbstractObjective:To apply two data mining algorithms (DMAs) to Food and Drug Administration (FDA) Adverse Event Reporting System (AERS) reports that involved endotoxin-like reactions with intravenous gentamicin to determine whether a signal of disproportionate reporting of these events would have been generated concurrently with surveillance based on clinical observation.Design:Multi-item gamma-Poisson shrinker (MGPS) and proportional reporting ratios (PRRs) were used. Data used for data mining consisted of an extract of the FDA AERS database. Previously published details of clusters of endotoxin-like reactions to intravenous gentamicin were used to select adverse events for data mining.Results:The first signal of disproportionate reporting with any relevant event occurred in 1998, the year in which the outbreak was identified and evaluated by the Centers for Disease Control and Prevention and the FDA. In 1997, there were only 6 reports of rigors in the AERS; this jumped to 68 in 1998. In 1998, a signal was generated for endotoxic shock with PRRs but not with MGPS, based on one case.Conclusions:The two DMAs generated signals concurrently with the influx of reports. It would have been difficult for safety reviewers to ignore an increase in rigors by traditional methods of safety surveillance; therefore, DMAs might not have had a great deal to offer in this instance. If data mining were considered as a second-line defense to diligent clinical observations under similar circumstances, simple disproportionality methods such as PRRs might be more useful than DMAs such as MGPS when commonly cited thresholds are used.


2019 ◽  
Vol 14 (1) ◽  
pp. 21-26 ◽  
Author(s):  
Viswam Subeesh ◽  
Eswaran Maheswari ◽  
Hemendra Singh ◽  
Thomas Elsa Beulah ◽  
Ann Mary Swaroop

Background: The signal is defined as “reported information on a possible causal relationship between an adverse event and a drug, of which the relationship is unknown or incompletely documented previously”. Objective: To detect novel adverse events of iloperidone by disproportionality analysis in FDA database of Adverse Event Reporting System (FAERS) using Data Mining Algorithms (DMAs). Methodology: The US FAERS database consists of 1028 iloperidone associated Drug Event Combinations (DECs) which were reported from 2010 Q1 to 2016 Q3. We consider DECs for disproportionality analysis only if a minimum of ten reports are present in database for the given adverse event and which were not detected earlier (in clinical trials). Two data mining algorithms, namely, Reporting Odds Ratio (ROR) and Information Component (IC) were applied retrospectively in the aforementioned time period. A value of ROR-1.96SE>1 and IC- 2SD>0 were considered as the threshold for positive signal. Results: The mean age of the patients of iloperidone associated events was found to be 44years [95% CI: 36-51], nevertheless age was not mentioned in twenty-one reports. The data mining algorithms exhibited positive signal for akathisia (ROR-1.96SE=43.15, IC-2SD=2.99), dyskinesia (21.24, 3.06), peripheral oedema (6.67,1.08), priapism (425.7,9.09) and sexual dysfunction (26.6-1.5) upon analysis as those were well above the pre-set threshold. Conclusion: Iloperidone associated five potential signals were generated by data mining in the FDA AERS database. The result requires an integration of further clinical surveillance for the quantification and validation of possible risks for the adverse events reported of iloperidone.


Author(s):  
Ari Fadli ◽  
Azis Wisnu Widhi Nugraha ◽  
Muhammad Syaiful Aliim ◽  
Acep Taryana ◽  
Yogiek Indra Kurniawan ◽  
...  

BioResources ◽  
2021 ◽  
Vol 16 (3) ◽  
pp. 4891-4904
Author(s):  
Selahattin Bardak ◽  
Timucin Bardak ◽  
Hüseyin Peker ◽  
Eser Sözen ◽  
Yildiz Çabuk

Wood materials have been used in many products such as furniture, stairs, windows, and doors for centuries. There are differences in methods used to adapt wood to ambient conditions. Impregnation is a widely used method of wood preservation. In terms of efficiency, it is critical to optimize the parameters for impregnation. Data mining techniques reduce most of the cost and operational challenges with accurate prediction in the wood industry. In this study, three data-mining algorithms were applied to predict bending strength in impregnated wood materials (Pinus sylvestris L. and Millettia laurentii). Models were created from real experimental data to examine the relationship between bending strength, diffusion time, vacuum duration, and wood type, based on decision trees (DT), random forest (RF), and Gaussian process (GP) algorithms. The highest bending strength was achieved with wenge (Millettia laurentii) wood in 10 bar vacuum and the diffusion condition during 25 min. The results showed that all algorithms are suitable for predicting bending strength. The goodness of fit for the testing phase was determined as 0.994, 0.986, and 0.989 in the DT, RF, and GP algorithms, respectively. Moreover, the importance of attributes was determined in the algorithms.


Sign in / Sign up

Export Citation Format

Share Document