Detection algorithms and attentive points of safety signal using spontaneous reporting systems as a clinical data source

Role and Applicability of Spontaneous Reporting Databases in Medical Big Data

(2021) Takamasa Sakai   YAKUGAKU ZASSHI-JOURNAL OF THE PHARMACEUTICAL SOCIETY OF JAPAN

Fatal adverse drug reactions: A worldwide perspective in the World Health Organization pharmacovigilance database

(2021) Jean‐Louis Montastruc et al.   BRITISH JOURNAL OF CLINICAL PHARMACOLOGY

Adverse drug reaction or innocent bystander? A systematic comparison of statistical discovery methods for spontaneous reporting systems

(2020) Louis Dijkstra et al.   PHARMACOEPIDEMIOLOGY AND DRUG SAFETY

The quality assessment of the Japanese Adverse Drug Event Report database using vigiGrade

(2020) Masami Tsuchiya et al.   International Journal of Clinical Pharmacy

Comparison of Signal Detection Algorithms Based on Frequency Statistical Model for Drug-Drug Interaction Using Spontaneous Reporting Systems

(2020) Yoshihiro Noguchi et al.   PHARMACEUTICAL RESEARCH

Antiepileptic combination therapy with Stevens‐Johnson syndrome and toxic epidermal necrolysis: Analysis of a Japanese pharmacovigilance database

(2020) Yoshihiro Noguchi et al.   EPILEPSIA

Borrowing external information to improve Bayesian confidence propagation neural network

(2020) Keisuke Tada et al.   EUROPEAN JOURNAL OF CLINICAL PHARMACOLOGY

Comparison of Data Mining Methods for the Signal Detection of Adverse Drug Events with a Hierarchical Structure in Postmarketing Surveillance

(2020) Goeun Park et al.   Life-Basel

Safety concerns reported by consumers, manufacturers and healthcare professionals: A detailed evaluation of opioid‐related adverse drug reactions in the FDA database over 15 years

(2020) Christian A. Andreaggi et al.   PHARMACOEPIDEMIOLOGY AND DRUG SAFETY

Analysis of immune‐related adverse events caused by immune checkpoint inhibitors using the Japanese Adverse Drug Event Report database

(2020) Shiori Hasegawa et al.   PHARMACOEPIDEMIOLOGY AND DRUG SAFETY

Extended multi‐item gamma Poisson shrinker methods based on the zero‐inflated Poisson model for postmarket drug safety surveillance

(2020) Seok‐Jae Heo et al.   STATISTICS IN MEDICINE

Improved Detection Criteria for Detecting Drug-Drug Interaction Signals Using the Proportional Reporting Ratio

(2020) Yoshihiro Noguchi et al.   Pharmaceuticals

A Comparison Study of Algorithms to Detect Drug–Adverse Event Associations: Frequentist, Bayesian, and Machine-Learning Approaches

(2019) Minh Pham et al.   DRUG SAFETY

Time to onset in statistical signal detection revisited: A follow‐up study in long‐term onset adverse drug reactions

(2019) Joep H.G. Scholl et al.   PHARMACOEPIDEMIOLOGY AND DRUG SAFETY

Breast cancer and spironolactone: an observational postmarketing study

(2019) Pierre Sabatier et al.   EUROPEAN JOURNAL OF CLINICAL PHARMACOLOGY

Review of Statistical Methodologies for Detecting Drug–Drug Interactions Using Spontaneous Reporting Systems

(2019) Yoshihiro Noguchi et al.   Frontiers in Pharmacology

Association between dipeptidyl peptidase-4 inhibitor and aspiration pneumonia: disproportionality analysis using the spontaneous reporting system in Japan

(2019) Yoshihiro Noguchi et al.   EUROPEAN JOURNAL OF CLINICAL PHARMACOLOGY

Quality evaluation of the Japanese Adverse Drug Event Report database (JADER)

(2019) Masami Tsuchiya et al.   PHARMACOEPIDEMIOLOGY AND DRUG SAFETY

A simple method for exploring adverse drug events in patients with different primary diseases using spontaneous reporting system

(2018) Yoshihiro Noguchi et al.   BMC BIOINFORMATICS

A New Search Method Using Association Rule Mining for Drug-Drug Interaction Based on Spontaneous Report System

(2018) Yoshihiro Noguchi et al.   Frontiers in Pharmacology

Large-scale mining disease comorbidity relationships from post-market drug adverse events surveillance data

(2018) Chunlei Zheng et al.   BMC BIOINFORMATICS

Utilization of chi-square statistics for screening adverse drug-drug interactions in spontaneous reporting systems

(2017) Masahiko Gosho et al.   EUROPEAN JOURNAL OF CLINICAL PHARMACOLOGY

SGLT-2 inhibitors and ketoacidosis: a disproportionality analysis in the World Health Organization's adverse drug reactions database

(2017) Abdel Nasser Ado Moumouni et al.   FUNDAMENTAL & CLINICAL PHARMACOLOGY

VigiBase, the WHO Global ICSR Database System: Basic Facts

(2017) Marie Lindquist   DRUG INFORMATION JOURNAL

Dipeptidyl peptidase-4 inhibitors and heart failure: Analysis of spontaneous reports submitted to the FDA Adverse Event Reporting System

(2016) E. Raschi et al.   NUTRITION METABOLISM AND CARDIOVASCULAR DISEASES

The value of time-to-onset in statistical signal detection of adverse drug reactions: a comparison with disproportionality analysis in spontaneous reports from the Netherlands

(2016) Joep H. G. Scholl et al.   PHARMACOEPIDEMIOLOGY AND DRUG SAFETY

Effect of database profile variation on drug safety assessment: an analysis of spontaneous adverse event reports of Japanese cases

(2015) Kaori Nomura et al.   Drug Design Development and Therapy

The Precision-Recall Plot Is More Informative than the ROC Plot When Evaluating Binary Classifiers on Imbalanced Datasets

(2015) Takaya Saito et al.   PLoS One

Commonality of Drug-associated Adverse Events Detected by 4 Commonly Used Data Mining Algorithms

(2014) Toshiyuki Sakaeda et al.   International Journal of Medical Sciences

Effect of reporting bias in the analysis of spontaneous reporting data

(2014) Palash Ghosh et al.   PHARMACEUTICAL STATISTICS

Acute kidney injury during concomitant use of valacyclovir and loxoprofen: detecting drug-drug interactions in a spontaneous reporting system

(2014) Zhihua Yue et al.   PHARMACOEPIDEMIOLOGY AND DRUG SAFETY

Performance of Pharmacovigilance Signal-Detection Algorithms for the FDA Adverse Event Reporting System

(2013) R Harpaz et al.   CLINICAL PHARMACOLOGY & THERAPEUTICS

Data Mining of the Public Version of the FDA Adverse Event Reporting System

(2013) Toshiyuki Sakaeda et al.   International Journal of Medical Sciences

Alleged isotretinoin-associated inflammatory bowel disease: Disproportionate reporting by attorneys to the Food and Drug Administration Adverse Event Reporting System

(2013) Derrick J. Stobaugh et al.   JOURNAL OF THE AMERICAN ACADEMY OF DERMATOLOGY

A Review of Statistical Methods for Safety Surveillance

(2013) Lan Huang et al.   Therapeutic Innovation & Regulatory Science

Using time-to-onset for detecting safety signals in spontaneous reports of adverse events following immunization: a proof of concept study

(2012) Lionel Van Holle et al.   PHARMACOEPIDEMIOLOGY AND DRUG SAFETY

Epidemiology and characteristics of adverse drug reactions caused by drug–drug interactions

(2011) Lara Magro et al.   Expert Opinion On Drug Safety

A Likelihood Ratio Test Based Method for Signal Detection With Application to FDA’s Drug Safety Data

(2011) Lan Huang et al.   JOURNAL OF THE AMERICAN STATISTICAL ASSOCIATION

Mining multi-item drug adverse effect associations in spontaneous reporting systems

(2010) Rave Harpaz et al.   BMC BIOINFORMATICS

An Experimental Investigation of Masking in the US FDA Adverse Event Reporting System Database

(2010) Hsin-wei Wang et al.   DRUG SAFETY

Influence of the MedDRA® hierarchy on pharmacovigilance data mining results

(2009) Ronald K. Pearson et al.   INTERNATIONAL JOURNAL OF MEDICAL INFORMATICS

Quantitative signal detection using spontaneous ADR reporting

(2009) A. Bate et al.   PHARMACOEPIDEMIOLOGY AND DRUG SAFETY

A statistical methodology for drug–drug interaction surveillance

(2008) G. Niklas Norén et al.   STATISTICS IN MEDICINE