Cargando…

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

BACKGROUND: The use of a statistical approach to analyze cumulative adverse event (AE) reports has been encouraged by regulatory authorities. However, data variations affect statistical analyses (eg, signal detection). Further, differences in regulations, social issues, and health care systems can c...

Descripción completa

Detalles Bibliográficos
Autores principales:	Nomura, Kaori, Takahashi, Kunihiko, Hinomura, Yasushi, Kawaguchi, Genta, Matsushita, Yasuyuki, Marui, Hiroko, Anzai, Tatsuhiko, Hashiguchi, Masayuki, Mochizuki, Mayumi
Formato:	Online Artículo Texto
Lenguaje:	English
Publicado:	Dove Medical Press 2015
Materias:	Original Research
Acceso en línea:	https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4472069/ https://www.ncbi.nlm.nih.gov/pubmed/26109846 http://dx.doi.org/10.2147/DDDT.S81998

Ejemplares similares

Adverse event reports in patients taking psychiatric medication during pregnancy from spontaneous reports in Japan and the United States: an approach using latent class analysis
por: Anzai, Tatsuhiko, et al.
Publicado: (2020)

Drug-Induced QT Prolongation and Torsade de Pointes in Spontaneous Adverse Event Reporting: A Retrospective Analysis Using the Japanese Adverse Drug Event Report Database (2004–2021)
por: Uchikawa, Mayu, et al.
Publicado: (2022)

Psychotherapeutic drug‐induced life‐threatening arrhythmias: A retrospective analysis using the Japanese adverse drug event report database
por: Yokohara, Saki, et al.
Publicado: (2023)

Do changes in working hours increase stress in Japanese white-collar workers?
por: Ozawa, Masaki, et al.
Publicado: (2023)

Factors Affecting the Timing of Signal Detection of Adverse Drug Reactions
por: Hashiguchi, Masayuki, et al.
Publicado: (2015)

Preliminary study for predicting better methotrexate efficacy in Japanese patients with rheumatoid arthritis
por: Hashiguchi, Masayuki, et al.
Publicado: (2016)

Effect of Common Comparators in Indirect Comparison Analysis of the Effectiveness of Different Inhaled Corticosteroids in the Treatment of Asthma
por: Kunitomi, Taro, et al.
Publicado: (2015)

Patients views and experiences in online reporting adverse drug reactions: findings of a national pilot study in Japan
por: Yamamoto, Michiko, et al.
Publicado: (2015)

In Silico Approach to Predict Severe Cutaneous Adverse Reactions Using the Japanese Adverse Drug Event Report Database
por: Ambe, Kaori, et al.
Publicado: (2021)

Expected value of the additional state in evaluating the method of quantification and uncertainty of additional states in an analytical model of grade I hypertension
por: Uchikura, Takeshi, et al.
Publicado: (2015)

Claims-Based Definition of Death in Japanese Claims Database: Validity and Implications
por: Ooba, Nobuhiro, et al.
Publicado: (2013)

Factors predicting the therapeutic response to infliximab during maintenance therapy in Japanese patients with Crohn’s disease
por: Matsuoka, Katsuyoshi, et al.
Publicado: (2018)

The Unusual Increase in Suicides Among Women in Japan During the COVID-19 Pandemic: A Time-series Analysis Until October 2021
por: Kikuchi, Kohtaro, et al.
Publicado: (2023)

Meta-analysis of the efficacy and safety of Ginkgo biloba extract for the treatment of dementia
por: Hashiguchi, Masayuki, et al.
Publicado: (2015)

Incidence of venous thromboembolism and bleeding events in patients with lower extremity orthopedic surgery: a retrospective analysis of a Japanese healthcare database
por: Fuji, Takeshi, et al.
Publicado: (2017)

Genetic polymorphisms of enzyme proteins and transporters related to methotrexate response and pharmacokinetics in a Japanese population
por: Hashiguchi, Masayuki, et al.
Publicado: (2016)

Meta-Analysis: Effects of Probiotic Supplementation on Lipid Profiles in Normal to Mildly Hypercholesterolemic Individuals
por: Shimizu, Mikiko, et al.
Publicado: (2015)

A Generalized Structural Equation Model Approach to Long Working Hours and Near-Misses among Healthcare Professionals in Japan
por: Anzai, Tatsuhiko, et al.
Publicado: (2021)

MGeND: an integrated database for Japanese clinical and genomic information
por: Kamada, Mayumi, et al.
Publicado: (2019)

Characteristics of Medical Adverse Events/Near Misses Associated With Laparoscopic/Thoracoscopic Surgery: A Retrospective Study Based on the Japanese National Database of Medical Adverse Events
por: Abe, Takashige, et al.
Publicado: (2019)

Characteristics of pediatric adverse drug reaction reports in the Japanese Adverse Drug Event Report Database
por: Noda, Aoi, et al.
Publicado: (2020)

Adverse event profiles of microscopic colitis in the Japanese Adverse Drug Event Report (JADER) database
por: Yamashiro, Kaito, et al.
Publicado: (2022)

Comparison of Adverse Event Profiles of Tumor Necrosis Factor-Alfa Inhibitors: Analysis of a Spontaneous Reporting Database
por: Wakabayashi, Tomohito, et al.
Publicado: (2020)

Involvement of Serotonin Transporter Gene Polymorphisms (5-HTT) in Impulsive Behavior in the Japanese Population
por: Nomura, Michio, et al.
Publicado: (2015)

Antipsychotics-Associated Serious Adverse Events in Children: An Analysis of the FAERS Database
por: Kimura, Goji, et al.
Publicado: (2015)

Ceritinib‐associated hyperglycemia in the Japanese Adverse Drug Event Report Database
por: Fujita, Haruka, et al.
Publicado: (2019)

Current Status of Adverse Event Profile of Cyclosporine in Kidney, Stem Cell, and Heart Transplantations Using the Japanese Pharmacovigilance Database
por: Niinomi, Iku, et al.
Publicado: (2022)

Analysis of anticholinergic adverse effects using two large databases: The US Food and Drug Administration Adverse Event Reporting System database and the Japanese Adverse Drug Event Report database
por: Nagai, Junko, et al.
Publicado: (2021)

Possible associations of personality traits representing harm avoidance and self-directedness with medication adherence in Japanese patients with type 2 diabetes
por: Tominaga, Yoshiko, et al.
Publicado: (2018)

Excess Mortality From Suicide During the Early COVID-19 Pandemic Period in Japan: A Time-Series Modeling Before the Pandemic
por: Anzai, Tatsuhiko, et al.
Publicado: (2021)

Have restrictions on human mobility impacted suicide rates during the COVID-19 pandemic in Japan?
por: Anzai, Tatsuhiko, et al.
Publicado: (2022)

Analysis of spontaneous inquiries about suspected adverse drug reactions posted by the general public on the electronic Japanese bulletin board “Yahoo! Japan Chiebukuro”
por: Dobashi, Akira, et al.
Publicado: (2016)

Evaluation of lung adverse events with nivolumab using the spontaneous reporting system in Japan
por: Kanbayashi, Yuko, et al.
Publicado: (2023)

Characteristics of Adverse Events Following Immunization Reporting in Children: The Japanese Adverse Drug Event Report Database
por: Noda, Aoi, et al.
Publicado: (2020)

Visualization of Kinase Inhibition-Related Adverse Events Using the Japanese Adverse Drug Event Report Database
por: Mizuno, Takahito, et al.
Publicado: (2021)

Estimating time-to-onset of adverse drug reactions from spontaneous reporting databases
por: Leroy, Fanny, et al.
Publicado: (2014)

Spontaneous nephroblastoma with oncocytic differentiation in a Japanese White rabbit
por: Katsuta, Osamu, et al.
Publicado: (2017)

Efficacy of treatment with corticosteroids for fibrotic hypersensitivity pneumonitis: a propensity score-matched cohort analysis
por: Ejima, Masaru, et al.
Publicado: (2021)

An anthropometric evidence against the use of age-based estimation of bodyweight in pediatric patients admitted to intensive care units
por: Nosaka, Nobuyuki, et al.
Publicado: (2023)

Analysis of factors associated with hiccups based on the Japanese Adverse Drug Event Report database
por: Hosoya, Ryuichiro, et al.
Publicado: (2017)

Cannot write session to /tmp/vufind_sessions/sess_6he1uvmsc1i09f5m6ervvbe37b