[PDF] Top 20 Standardizing adverse drug event reporting data
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Standardizing adverse drug event reporting data
... tated drug names was ...for drug name normalization from the annotation ...the drug normalization in ...different drug name num- bers in gold standards, with discharge summaries (377), clinic ... See full document
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Signals of bleeding among direct-acting oral anticoagulant users compared to those among warfarin users: analyses of the post-marketing FDA Adverse Event Reporting System (FAERS) database, 2010–2015
... same drug. Reports indicating a drug of interest as the primary suspected drug were included in the ...ADR reporting databases to calculate ROR, which is obtained by the equation (ad*bc), ... See full document
7
Identification and reduction of adverse drug reactions
... (Figure 2) to collect pharmacogenomic data as part of the post-approval surveillance process. As new drugs are approved for use in the general population, patients who experience rare or severe ADRs should have ... See full document
6
Drug induced liver injury associated with Complementary and Alternative Medicine: a review of adverse event reports in an Asian community from 2009 to 2014
... ADR reporting and moni- toring the safety of CAM used by the population ...AE reporting system to facili- tate collection, monitoring and evaluation of adverse drug events are highly ... See full document
11
Dextromethorphan: a case study on addressing abuse of a safe and effective drug
... is adverse events reported to the FDA Adverse Event (AE) Reporting System database ...the drug was the causative ...serious adverse events associated with DXM over the first 3 ... See full document
7
Large-scale adverse effects related to treatment evidence standardization (LAERTES): an open scalable system for linking pharmacovigilance evidence sources with clinical data
... the drug at different levels of granularity: at the clinical drug product level, comprising the active ingredients, strength, formulation, and brand name for the product, but may also be more coarsely ... See full document
15
Concordance and predictive value of two adverse drug event data sets
... ADE data sets – Lexi-comp from 2010 and SIDER from ...two data sets were characterized in terms of drug categories, ADE categories and ADE ...two data sets were ...new drug-ADE ... See full document
8
A pipeline to extract drug-adverse event pairs from multiple data sources
... record data- bases to analyze drug safety such as EU-ADR [8,9], OMOP [10], Mini-Sentinel [11] as well as databases such as MEDLINE and Drugbank ...of data from multiple sources could help in better ... See full document
16
Drug-induced gingival hyperplasia: a retrospective study using spontaneous reporting system databases
... time-to-onset data has been pro- posed as a new method to detect signals for adverse events in ...Japanese Adverse Drug Event Report (JADER) database are ...rare adverse ... See full document
11
Analysis of Individual Case Safety Reports of Severe Cutaneous Adverse Reactions in Korea
... the drug labeling information provided by the Korea Pharmaceutical Information Center ...the drug labeling information (Table ...the drug labeling in- ...the drug label ...cutaneous ... See full document
8
A signal detection method for temporal variation of adverse effect with vaccine adverse event reporting system data
... VAERS uses MedDRA (Medical Dictionary for Regula- tory Activities) to categorize reported AEs. The MedDRA terminology is the international medical terminology developed under the auspices of the International Confer- ... See full document
8
Relevance of the Weber effect in contemporary pharmacovigilance of oncology drugs
... Numerous reporting biases have been known to affect spontaneous reporting ...in adverse event (AE) reporting of a drug at the end of second year after regulatory approval ... See full document
9
Safety Profile of Levonorgestrel: A Disproportionality Analysis of Food and Drug Administration Adverse Event Reporting System (FAERS) Database
... In our study, increased reports of menstruation- associated AEs were found. Delayed menstruation (>7 days) [4.5% of AEs] and heavier menstruation (menorrhagia) [30% of AEs] were reported in Plan B One-Step clinical ... See full document
5
Consumer reporting of adverse drug reactions: A current perspective
... However, greater participation in ADR reporting by consumers presents challenges. Among various challenges, it becomes important for a regulatory agency to be adequately resourced to respond to a larger number of ... See full document
7
REPORTING THE ADVERSE DRUG REACTIONS ASSOCIATED WITH PREGNANCY WOMENS
... The data observed were analyzed in order to study the characteristics of the ADRs and to determine the nature and pattern of ADRs related to hospital admission and difference in the severity of ADRs and management ... See full document
15
Evaluation of the quality and value of data sources for postmarket surveillance of the safety of cough and cold medications in children
... The data sources utilized in the Pediatric Cough and Cold Safety Surveillance System include the National Poison Data System (NPDS), the FDA Adverse Event Reporting System (FAERS), ... See full document
10
Self-management education for adults with poorly controlled epilepsy (SMILE (UK)): statistical, economic and qualitative analysis plan for a randomised controlled trial
... AE, Adverse event; AED, Antiepileptic drug; CACE, Complier average causal effect; CONSORT, Consolidated Standards of Reporting Trials; EQ-5D, European Quality of Life-5 Dimensions; ICC, ... See full document
19
Reevaluating the Safety Profile of Pediatrics: A Comparison of Computerized Adverse Drug Event Surveillance and Voluntary Reporting in the Pediatric Environment
... of drug and event ...serum drug levels, but there was no evidence of adverse patient ...streamline event evaluation processes across all detection ... See full document
9
Incidence and Severity of Adverse Drug Reactions and Spontaneous Adverse Drug Reporting in Hospital Settings of Lahore
... phenomenon. Reporting of ADR is done by various methods but the most commonly used method is spontaneous adverse drug ...Spontaneous adverse drug reaction reporting form is an ... See full document
7
Polyherbal dietary supplementation for prediabetic adults: study protocol for a randomized controlled trial
... and Drug Administration (FDA) Adverse Event Reporting System (AERS) and Natural MedWATCH, a tool developed and maintained by the Therapeutic Research Center’s Natural Medicines Com- prehensive ... See full document
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