{"@context":{"@vocab":"https://cir.nii.ac.jp/schema/1.0/","rdfs":"http://www.w3.org/2000/01/rdf-schema#","dc":"http://purl.org/dc/elements/1.1/","dcterms":"http://purl.org/dc/terms/","foaf":"http://xmlns.com/foaf/0.1/","prism":"http://prismstandard.org/namespaces/basic/2.0/","cinii":"http://ci.nii.ac.jp/ns/1.0/","datacite":"https://schema.datacite.org/meta/kernel-4/","ndl":"http://ndl.go.jp/dcndl/terms/","jpcoar":"https://github.com/JPCOAR/schema/blob/master/2.0/"},"@id":"https://cir.nii.ac.jp/crid/1360848662512756608.json","@type":"Article","productIdentifier":[{"identifier":{"@type":"DOI","@value":"10.1371/journal.pone.0144263"}},{"identifier":{"@type":"URI","@value":"http://dx.plos.org/10.1371/journal.pone.0144263"}},{"identifier":{"@type":"PMID","@value":"26641634"}}],"resourceType":"学術雑誌論文(journal article)","dc:title":[{"@value":"Factors Affecting the Timing of Signal Detection of Adverse Drug Reactions"}],"description":[{"notation":[{"@value":"We investigated factors affecting the timing of signal detection by comparing variations in reporting time of known and unknown ADRs after initial drug release in the USA. Data on adverse event reactions (AERs) submitted to U.S. FDA was used. Six ADRs associated with 6 drugs (rosuvastatin, aripiprazole, teriparatide, telithromycin, exenatide, varenicline) were investigated: Changes in the proportional reporting ratio, reporting odds ratio, and information component as indexes of signal detection were followed every 3 months after each drugs release, and the time for detection of signals was investigated. The time for the detection of signal to be detected after drug release in the USA was 2-10 months for known ADRs and 19-44 months for unknown ones. The median lag time for known and unknown ADRs was 99.0-122.5 days and 185.5-306.0 days, respectively. When the FDA released advisory information on rare but potentially serious health risks of an unknown ADR, the time lag to report from the onset of ADRs to the FDA was shorter. This study suggested that one factor affecting signal detection time is whether an ADR was known or unknown at release."}]}],"creator":[{"@id":"https://cir.nii.ac.jp/crid/1410001205228228614","@type":"Researcher","personIdentifier":[{"@type":"NRID","@value":"9000398138930"},{"@type":"NRID","@value":"9000010316691"},{"@type":"NRID","@value":"9000005134323"},{"@type":"NRID","@value":"9000258245273"},{"@type":"NRID","@value":"9000256106766"},{"@type":"NRID","@value":"9000021326589"},{"@type":"NRID","@value":"9000258207195"},{"@type":"NRID","@value":"9000258245324"},{"@type":"NRID","@value":"9000321410517"},{"@type":"NRID","@value":"9000022208009"},{"@type":"NRID","@value":"9000248214405"},{"@type":"NRID","@value":"9000021260509"},{"@type":"NRID","@value":"9000350545587"},{"@type":"NRID","@value":"9000261038682"},{"@type":"NRID","@value":"9000321414327"},{"@type":"NRID","@value":"9000021260536"},{"@type":"NRID","@value":"9000397862088"},{"@type":"NRID","@value":"9000258245703"},{"@type":"NRID","@value":"9000258207318"},{"@type":"NRID","@value":"9000020624713"},{"@type":"NRID","@value":"9000262360600"},{"@type":"RESEARCHMAP","@value":"https://researchmap.jp/7000025155"}],"foaf:name":[{"@value":"Masayuki Hashiguchi"}]},{"@id":"https://cir.nii.ac.jp/crid/1380848662512756485","@type":"Researcher","foaf:name":[{"@value":"Shungo Imai"}]},{"@id":"https://cir.nii.ac.jp/crid/1380848662512756481","@type":"Researcher","foaf:name":[{"@value":"Keiko Uehara"}]},{"@id":"https://cir.nii.ac.jp/crid/1380848662512756490","@type":"Researcher","foaf:name":[{"@value":"Junya Maruyama"}]},{"@id":"https://cir.nii.ac.jp/crid/1420001326237128320","@type":"Researcher","personIdentifier":[{"@type":"KAKEN_RESEARCHERS","@value":"90396391"},{"@type":"NRID","@value":"1000090396391"},{"@type":"NRID","@value":"9000011098188"},{"@type":"NRID","@value":"9000398138925"},{"@type":"NRID","@value":"9000005290467"},{"@type":"NRID","@value":"9000005130132"},{"@type":"NRID","@value":"9000020343746"},{"@type":"NRID","@value":"9000412684360"},{"@type":"NRID","@value":"9000257889573"},{"@type":"NRID","@value":"9000005239244"},{"@type":"NRID","@value":"9000321410518"},{"@type":"NRID","@value":"9000006567960"},{"@type":"NRID","@value":"9000350545591"},{"@type":"NRID","@value":"9000261038683"},{"@type":"NRID","@value":"9000391991383"},{"@type":"NRID","@value":"9000262360602"},{"@type":"RESEARCHMAP","@value":"https://researchmap.jp/aodai-DMP"}],"foaf:name":[{"@value":"Mikiko Shimizu"}]},{"@id":"https://cir.nii.ac.jp/crid/1030003658537866498","@type":"Researcher","personIdentifier":[{"@type":"KAKEN_RESEARCHERS","@value":"60292679"},{"@type":"NRID","@value":"1000060292679"},{"@type":"NRID","@value":"9000003074352"},{"@type":"NRID","@value":"9000345348914"},{"@type":"NRID","@value":"9000345375340"},{"@type":"NRID","@value":"9000398138929"},{"@type":"NRID","@value":"9000283596125"},{"@type":"NRID","@value":"9000319050858"},{"@type":"NRID","@value":"9000347078068"},{"@type":"NRID","@value":"9000396135759"},{"@type":"NRID","@value":"9000408915351"},{"@type":"NRID","@value":"9000409314803"},{"@type":"NRID","@value":"9000258232510"},{"@type":"NRID","@value":"9000399834665"},{"@type":"NRID","@value":"9000005259935"},{"@type":"NRID","@value":"9000412154395"},{"@type":"NRID","@value":"9000397682657"},{"@type":"NRID","@value":"9000259839739"},{"@type":"NRID","@value":"9000285490851"},{"@type":"NRID","@value":"9000388998534"},{"@type":"NRID","@value":"9000010316689"},{"@type":"NRID","@value":"9000018501151"},{"@type":"NRID","@value":"9000248214410"},{"@type":"NRID","@value":"9000350545592"},{"@type":"NRID","@value":"9000261038691"},{"@type":"NRID","@value":"9000007564733"},{"@type":"NRID","@value":"9000353365991"},{"@type":"NRID","@value":"9000408634126"},{"@type":"NRID","@value":"9000397862093"},{"@type":"NRID","@value":"9000412661521"},{"@type":"NRID","@value":"9000018908612"},{"@type":"NRID","@value":"9000258207323"},{"@type":"NRID","@value":"9000283596166"},{"@type":"NRID","@value":"9000262360605"},{"@type":"RESEARCHMAP","@value":"https://researchmap.jp/7000025162"}],"foaf:name":[{"@value":"Mayumi Mochizuki"}]}],"contributor":[{"@id":"https://cir.nii.ac.jp/crid/1380848662512756610","@type":"Researcher","foaf:name":[{"@value":"Yoshihiro Yamanishi"}],"role":"editor"}],"publication":{"publicationIdentifier":[{"@type":"EISSN","@value":"19326203"}],"prism:publicationName":[{"@value":"PLOS ONE"}],"dc:publisher":[{"@value":"Public Library of Science (PLoS)"}],"prism:publicationDate":"2015-12-07","prism:volume":"10","prism:number":"12","prism:startingPage":"e0144263"},"reviewed":"false","dcterms:accessRights":"http://purl.org/coar/access_right/c_abf2","dc:rights":["http://creativecommons.org/licenses/by/4.0/"],"url":[{"@id":"http://dx.plos.org/10.1371/journal.pone.0144263"}],"createdAt":"2015-12-08","modifiedAt":"2024-06-12","foaf:topic":[{"@id":"https://cir.nii.ac.jp/all?q=Ketolides","dc:title":"Ketolides"},{"@id":"https://cir.nii.ac.jp/all?q=Time%20Factors","dc:title":"Time Factors"},{"@id":"https://cir.nii.ac.jp/all?q=Databases,%20Factual","dc:title":"Databases, Factual"},{"@id":"https://cir.nii.ac.jp/all?q=Drug-Related%20Side%20Effects%20and%20Adverse%20Reactions","dc:title":"Drug-Related Side Effects and Adverse Reactions"},{"@id":"https://cir.nii.ac.jp/all?q=Science","dc:title":"Science"},{"@id":"https://cir.nii.ac.jp/all?q=Aripiprazole","dc:title":"Aripiprazole"},{"@id":"https://cir.nii.ac.jp/all?q=Rhabdomyolysis","dc:title":"Rhabdomyolysis"},{"@id":"https://cir.nii.ac.jp/all?q=Teriparatide","dc:title":"Teriparatide"},{"@id":"https://cir.nii.ac.jp/all?q=Adverse%20Drug%20Reaction%20Reporting%20Systems","dc:title":"Adverse Drug Reaction Reporting Systems"},{"@id":"https://cir.nii.ac.jp/all?q=Data%20Mining","dc:title":"Data Mining"},{"@id":"https://cir.nii.ac.jp/all?q=Humans","dc:title":"Humans"},{"@id":"https://cir.nii.ac.jp/all?q=Rosuvastatin%20Calcium","dc:title":"Rosuvastatin Calcium"},{"@id":"https://cir.nii.ac.jp/all?q=Drug%20Labeling","dc:title":"Drug Labeling"},{"@id":"https://cir.nii.ac.jp/all?q=United%20States%20Food%20and%20Drug%20Administration","dc:title":"United States Food and Drug Administration"},{"@id":"https://cir.nii.ac.jp/all?q=Venoms","dc:title":"Venoms"},{"@id":"https://cir.nii.ac.jp/all?q=Q","dc:title":"Q"},{"@id":"https://cir.nii.ac.jp/all?q=R","dc:title":"R"},{"@id":"https://cir.nii.ac.jp/all?q=United%20States","dc:title":"United States"},{"@id":"https://cir.nii.ac.jp/all?q=Suicide","dc:title":"Suicide"},{"@id":"https://cir.nii.ac.jp/all?q=Pancreatitis","dc:title":"Pancreatitis"},{"@id":"https://cir.nii.ac.jp/all?q=Hypercalcemia","dc:title":"Hypercalcemia"},{"@id":"https://cir.nii.ac.jp/all?q=Medicine","dc:title":"Medicine"},{"@id":"https://cir.nii.ac.jp/all?q=Exenatide","dc:title":"Exenatide"},{"@id":"https://cir.nii.ac.jp/all?q=Chemical%20and%20Drug%20Induced%20Liver%20Injury","dc:title":"Chemical and Drug Induced Liver Injury"},{"@id":"https://cir.nii.ac.jp/all?q=Varenicline","dc:title":"Varenicline"},{"@id":"https://cir.nii.ac.jp/all?q=Peptides","dc:title":"Peptides"},{"@id":"https://cir.nii.ac.jp/all?q=Research%20Article","dc:title":"Research Article"}],"project":[{"@id":"https://cir.nii.ac.jp/crid/1040282256825421184","@type":"Project","projectIdentifier":[{"@type":"KAKEN","@value":"15K08045"},{"@type":"JGN","@value":"JP15K08045"},{"@type":"URI","@value":"https://kaken.nii.ac.jp/grant/KAKENHI-PROJECT-15K08045/"}],"notation":[{"@language":"ja","@value":"プロバイオティクスの薬物動態制御を介した炎症性疾患の予防・治療"},{"@language":"en","@value":"Prevention and treatment of inflammatory diseases: control of pharmacokinetics with probiotics"}]}],"relatedProduct":[{"@id":"https://cir.nii.ac.jp/crid/1360285711832085248","@type":"Article","resourceType":"学術雑誌論文(journal article)","relationType":["isReferencedBy"],"jpcoar:relatedTitle":[{"@value":"Drug-induced gingival hyperplasia: a retrospective study using spontaneous reporting system databases"}]},{"@id":"https://cir.nii.ac.jp/crid/1360567186689555712","@type":"Article","resourceType":"学術雑誌論文(journal article)","relationType":["isReferencedBy"],"jpcoar:relatedTitle":[{"@value":"Analysis of adverse events of renal impairment related to platinum-based compounds using the Japanese Adverse Drug Event Report database"}]},{"@id":"https://cir.nii.ac.jp/crid/1360574095770064128","@type":"Article","relationType":["references"],"jpcoar:relatedTitle":[{"@value":"A comparison of measures of disproportionality for signal detection in spontaneous reporting systems for adverse drug reactions"}]},{"@id":"https://cir.nii.ac.jp/crid/1360855568659568896","@type":"Article","relationType":["references"],"jpcoar:relatedTitle":[{"@value":"Evaluation of patient reporting of adverse drug reactions to the UK ‘Yellow Card Scheme’: literature review, descriptive and qualitative analyses, and questionnaire surveys"}]},{"@id":"https://cir.nii.ac.jp/crid/1360855571469926144","@type":"Article","relationType":["references"],"jpcoar:relatedTitle":[{"@value":"A Data Mining Approach for Signal Detection and Analysis"}]},{"@id":"https://cir.nii.ac.jp/crid/1361137045330756608","@type":"Article","relationType":["references"],"jpcoar:relatedTitle":[{"@value":"Use of proportional reporting ratios (PRRs) for signal generation from spontaneous adverse drug reaction reports"}]},{"@id":"https://cir.nii.ac.jp/crid/1361137045574652672","@type":"Article","relationType":["references"],"jpcoar:relatedTitle":[{"@value":"Reports of hyperkalemia after publication of RALES—a pharmacovigilance study"}]},{"@id":"https://cir.nii.ac.jp/crid/1361699993410202112","@type":"Article","relationType":["references"],"jpcoar:relatedTitle":[{"@value":"Perspectives on the Use of Data Mining in Pharmacovigilance"}]},{"@id":"https://cir.nii.ac.jp/crid/1361699996234813184","@type":"Article","relationType":["references"],"jpcoar:relatedTitle":[{"@value":"Quantitative signal detection using spontaneous ADR reporting"}]},{"@id":"https://cir.nii.ac.jp/crid/1361981468536693888","@type":"Article","relationType":["references"],"jpcoar:relatedTitle":[{"@value":"Data Mining of the Public Version of the FDA Adverse Event Reporting System"}]},{"@id":"https://cir.nii.ac.jp/crid/1361981470288451456","@type":"Article","relationType":["references"],"jpcoar:relatedTitle":[{"@value":"Novel Statistical Tools for Monitoring the Safety of Marketed Drugs"}]},{"@id":"https://cir.nii.ac.jp/crid/1362262943659173632","@type":"Article","relationType":["references"],"jpcoar:relatedTitle":[{"@value":"Drug target prediction using adverse event report systems: a pharmacogenomic approach"}]},{"@id":"https://cir.nii.ac.jp/crid/1362262943731396480","@type":"Article","relationType":["references"],"jpcoar:relatedTitle":[{"@value":"Bayesian Data Mining in Large Frequency Tables, with an Application to the FDA Spontaneous Reporting System"}]},{"@id":"https://cir.nii.ac.jp/crid/1362262946125566976","@type":"Article","relationType":["references"],"jpcoar:relatedTitle":[{"@value":"Stimulated Reporting: The Impact of US Food and Drug Administration-Issued Alerts on the Adverse Event Reporting System (FAERS)"}]},{"@id":"https://cir.nii.ac.jp/crid/1362825894372428672","@type":"Article","relationType":["references"],"jpcoar:relatedTitle":[{"@value":"Empirical bayes screening for multi-item associations"}]},{"@id":"https://cir.nii.ac.jp/crid/1363670320045175040","@type":"Article","relationType":["references"],"jpcoar:relatedTitle":[{"@value":"A Bayesian neural network method for adverse drug reaction signal generation"}]},{"@id":"https://cir.nii.ac.jp/crid/1364233269567072000","@type":"Article","relationType":["references"],"jpcoar:relatedTitle":[{"@value":"Practical pharmacovigilance analysis strategies"}]},{"@id":"https://cir.nii.ac.jp/crid/1364233269769980160","@type":"Article","relationType":["references"],"jpcoar:relatedTitle":[{"@value":"A novel signal detection algorithm for identifying hidden drug-drug interactions in adverse event reports"}]},{"@id":"https://cir.nii.ac.jp/crid/1364233270244310016","@type":"Article","relationType":["references"],"jpcoar:relatedTitle":[{"@value":"Extending the methods used to screen the WHO drug safety database towards analysis of complex associations and improved accuracy for rare events"}]},{"@id":"https://cir.nii.ac.jp/crid/1370848662512756485","@type":"Product","relationType":["references"],"jpcoar:relatedTitle":[{"@value":"Public Health Advisory: Ketek (telithromycin) Tables"}]},{"@id":"https://cir.nii.ac.jp/crid/1370848662512756615","@type":"Product","relationType":["references"],"jpcoar:relatedTitle":[{"@value":"Utilization of the spontaneous report data to the signal detection"}]},{"@id":"https://cir.nii.ac.jp/crid/1370848662512756618","@type":"Product","relationType":["references"],"jpcoar:relatedTitle":[{"@value":"Early Communication About an Ongoing Safety Review of Varenicline (marketed as Chantix)"}]},{"@id":"https://cir.nii.ac.jp/crid/1390001204484675584","@type":"Article","relationType":["references"],"jpcoar:relatedTitle":[{"@language":"ja","@value":"アジアのデータベースとレコード・リンケージ"},{"@language":"en","@value":"Databases in Asia and Record-Linkage"},{"@value":"Database and record linkage in Asia"}]},{"@id":"https://cir.nii.ac.jp/crid/1390025197283251712","@type":"Article","relationType":["isReferencedBy"],"jpcoar:relatedTitle":[{"@language":"en","@value":"Impact of Multiregional Clinical Trials on the Frequency of Revision of Package Inserts for New Efficacy Drugs in Japan and the United States"}]},{"@id":"https://cir.nii.ac.jp/crid/1390846609821301120","@type":"Article","resourceType":"学術雑誌論文(journal article)","relationType":["isReferencedBy"],"jpcoar:relatedTitle":[{"@language":"en","@value":"Exploration of Education and Research on Drug Informatics"},{"@language":"ja","@value":"医薬品情報学の教育と研究の探究"},{"@language":"ja-Kana","@value":"イヤクヒン ジョウホウガク ノ キョウイク ト ケンキュウ ノ タンキュウ"}]}],"dataSourceIdentifier":[{"@type":"CROSSREF","@value":"10.1371/journal.pone.0144263"},{"@type":"KAKEN","@value":"PRODUCT-20192704"},{"@type":"OPENAIRE","@value":"doi_dedup___::2a87dbc5f17a8504319f876b67639179"},{"@type":"CROSSREF","@value":"10.1248/bpbreports.8.6_246_references_DOI_WwkTtTXgmb2V8fW2bTz9cu4IGGQ"},{"@type":"CROSSREF","@value":"10.1186/s40780-017-0088-5_references_DOI_WwkTtTXgmb2V8fW2bTz9cu4IGGQ"},{"@type":"CROSSREF","@value":"10.1177/2050312118772475_references_DOI_WwkTtTXgmb2V8fW2bTz9cu4IGGQ"},{"@type":"CROSSREF","@value":"10.1248/yakushi.19-00250_references_DOI_WwkTtTXgmb2V8fW2bTz9cu4IGGQ"}]}