{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,4,29]],"date-time":"2026-04-29T02:38:57Z","timestamp":1777430337493,"version":"3.51.4"},"reference-count":36,"publisher":"Public Library of Science (PLoS)","issue":"6","license":[{"start":{"date-parts":[[2015,6,19]],"date-time":"2015-06-19T00:00:00Z","timestamp":1434672000000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":["www.plosone.org"],"crossmark-restriction":false},"short-container-title":["PLoS ONE"],"DOI":"10.1371\/journal.pone.0130399","type":"journal-article","created":{"date-parts":[[2015,6,19]],"date-time":"2015-06-19T18:16:11Z","timestamp":1434737771000},"page":"e0130399","update-policy":"https:\/\/doi.org\/10.1371\/journal.pone.corrections_policy","source":"Crossref","is-referenced-by-count":29,"title":["Pediatric Drug Safety Surveillance in FDA-AERS: A Description of Adverse Events from GRiP Project"],"prefix":"10.1371","volume":"10","author":[{"given":"Sandra","family":"de Bie","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Carmen","family":"Ferrajolo","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Sabine M. J. M.","family":"Straus","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Katia M. C.","family":"Verhamme","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jan","family":"Bonhoeffer","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ian C. K.","family":"Wong","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Miriam C. J. M.","family":"Sturkenboom","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"name":"GRiP network","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"340","published-online":{"date-parts":[[2015,6,19]]},"reference":[{"issue":"1","key":"ref1","first-page":"133","article-title":"The Best Pharmaceuticals for Children Act of 2002: the rise of the voluntary incentive structure and congressional refusal to require pediatric testing","volume":"40","author":"LH Breslow","year":"2003","journal-title":"Harvard J Legis"},{"issue":"2","key":"ref2","doi-asserted-by":"crossref","first-page":"177","DOI":"10.1016\/j.prrv.2007.04.004","article-title":"The European Regulation on medicines for paediatric use","volume":"8","author":"J Dunne","year":"2007","journal-title":"Paediatr Respir Rev"},{"issue":"Suppl 1","key":"ref3","first-page":"S27","article-title":"Drug policy in Europe Research and funding in neonates: current challenges, future perspectives, new opportunities","volume":"87","author":"E Jacqz-Aigrain","year":"2011","journal-title":"Early Hum Dev"},{"key":"ref4","unstructured":"GRiP. Global Research in Paediatrics\u2013Network of Excellence (GRiP). 2011 [2012 Sep 27]; Available: http:\/\/grip-network.org\/<\/ext-link>."},{"issue":"2","key":"ref5","doi-asserted-by":"crossref","first-page":"71","DOI":"10.2165\/11589100-000000000-00000","article-title":"Detecting unexpected adverse drug reactions in children","volume":"13","author":"K Star","year":"2011","journal-title":"Paediatr Drugs"},{"issue":"6","key":"ref6","doi-asserted-by":"crossref","first-page":"475","DOI":"10.2165\/11534410-000000000-00000","article-title":"Validation of statistical signal detection procedures in eudravigilance post-authorization data: a retrospective evaluation of the potential for earlier signalling","volume":"33","author":"Y Alvarez","year":"2010","journal-title":"Drug safety"},{"key":"ref7","doi-asserted-by":"crossref","first-page":"409","DOI":"10.1177\/009286150804200501","article-title":"VigiBase, the WHO Global ICSR Database System: Basic Facts","volume":"42","author":"M Lindquist","year":"2008","journal-title":"Drug Information Journal"},{"issue":"22","key":"ref8","doi-asserted-by":"crossref","first-page":"2908","DOI":"10.1016\/S0264-410X(99)00132-2","article-title":"An overview of the vaccine adverse event reporting system (VAERS) as a surveillance system. VAERS Working Group","volume":"17","author":"JA Singleton","year":"1999","journal-title":"Vaccine"},{"issue":"6","key":"ref9","doi-asserted-by":"crossref","first-page":"713","DOI":"10.1517\/14740338.6.6.713","article-title":"Database size and power to detect safety signals in pharmacovigilance","volume":"6","author":"IW Hammond","year":"2007","journal-title":"Expert opinion on drug safety"},{"key":"ref10","unstructured":"Adverse Event Reporting System (AERS). [updated 27-9-20122012 Sep 27]; Available: http:\/\/www.fda.gov\/Drugs\/GuidanceComplianceRegulatoryInformation\/Surveillance\/AdverseDrugEffects\/default.htm<\/ext-link>."},{"key":"ref11","unstructured":"Vaccine Adverse Events Reporting System (VAERS) Data. [updated 27-9-20122012 Sep 27]; Available: http:\/\/vaers.hhs.gov\/data\/data<\/ext-link>."},{"key":"ref12","unstructured":"EudraVigilance access policy for medicines for human use [2012 Sep 27]; Available: http:\/\/www.ema.europa.eu\/docs\/en_GB\/document_library\/Other\/2011\/07\/WC500108538.pdf<\/ext-link>."},{"key":"ref13","unstructured":"UMC access policy for The WHO Global Individual Case Safety Report database, VigiBase. [2012 Sep 27]; Available: http:\/\/www.who-umc.org\/DynPage.aspx?id=105196&mn1=7347&mn2=7489&mn3=7248&newsid=10830<\/ext-link>."},{"issue":"5","key":"ref14","doi-asserted-by":"crossref","first-page":"415","DOI":"10.2165\/11587540-000000000-00000","article-title":"Suspected Adverse Drug Reactions Reported For Children Worldwide: An Exploratory Study Using VigiBase","volume":"34","author":"K Star","year":"2011","journal-title":"Drug safety"},{"issue":"1","key":"ref15","doi-asserted-by":"crossref","first-page":"24","DOI":"10.1002\/pds.1679","article-title":"Pediatric drug surveillance and the Food and Drug Administration's adverse event reporting system: an overview of reports, 2003\u20132007","volume":"18","author":"R Johann-Liang","year":"2009","journal-title":"Pharmacoepidemiology and drug safety"},{"issue":"5","key":"ref16","doi-asserted-by":"crossref","first-page":"e53","DOI":"10.1542\/peds.110.5.e53","article-title":"Reported adverse drug events in infants and children under 2 years of age","volume":"110","author":"TJ Moore","year":"2002","journal-title":"Pediatrics"},{"issue":"16","key":"ref17","doi-asserted-by":"crossref","first-page":"1752","DOI":"10.1001\/archinte.167.16.1752","article-title":"Serious adverse drug events reported to the Food and Drug Administration, 1998\u20132005","volume":"167","author":"TJ Moore","year":"2007","journal-title":"Arch Intern Med"},{"key":"ref18","unstructured":"Drug Information Online. [2012 Sep 27]; Available: http:\/\/www.drugs.com\/<\/ext-link>."},{"key":"ref19","unstructured":"Pharmacy Codes. [2012 Sep 27]; Available: http:\/\/pharmacycode.com<\/ext-link>."},{"key":"ref20"},{"key":"ref21","unstructured":"WHO Collaborating Centre for Drug Statistics Methodology. Guidelines for ATC classification and DDD assignment. [cited 27-9-2012]; Available: http:\/\/www.whocc.no\/<\/ext-link>."},{"key":"ref22","unstructured":"International Conference On Harmonisation Of Technical Requirements For Registration Of Pharmaceuticals For Human Use. Clinical Investigation Of Medicinal Products In The Pediatric Population E11. 2000 [27-9-2012]; Available: http:\/\/www.ich.org\/fileadmin\/Public_Web_Site\/ICH_Products\/Guidelines\/Efficacy\/E11\/Step4\/E11_Guideline.pdf<\/ext-link>."},{"issue":"7","key":"ref23","doi-asserted-by":"crossref","first-page":"796","DOI":"10.7150\/ijms.6048","article-title":"Data mining of the public version of the FDA Adverse Event Reporting System","volume":"10","author":"T Sakaeda","year":"2013","journal-title":"International journal of medical sciences"},{"key":"ref24","unstructured":"WHO. International Conference On Harmonisation Of Technical Requirements For Registration Of Pharmaceuticals For Human Use. The Extend of Population Exposure to Assess Clinical Safety for Drugs Intended for Long-term Treatment of Non-life Threatening Conditions: E1. 1994."},{"issue":"Suppl 1","key":"ref25","doi-asserted-by":"crossref","first-page":"S9","DOI":"10.1517\/14740338.2014.939581","article-title":"Pediatric drug safety surveillance in Italian pharmacovigilance network: an overview of adverse drug reactions in the years 2001\u20132012","volume":"13","author":"C Ferrajolo","year":"2014","journal-title":"Expert opinion on drug safety"},{"key":"ref26","doi-asserted-by":"crossref","unstructured":"Subbarao P, Mandhane PJ, Sears MR. Asthma: epidemiology, etiology and risk factors. CMAJ: Canadian Medical Association journal = journal de l'Association medicale canadienne. 2009;181(9):E181-90. Epub 2009\/09\/16.","DOI":"10.1503\/cmaj.080612"},{"issue":"3","key":"ref27","doi-asserted-by":"crossref","first-page":"534","DOI":"10.1016\/j.eururo.2012.05.059","article-title":"EAU guidelines on vesicoureteral reflux in children","volume":"62","author":"S Tekgul","year":"2012","journal-title":"European urology"},{"issue":"6","key":"ref28","doi-asserted-by":"crossref","first-page":"942","DOI":"10.1176\/ajp.2007.164.6.942","article-title":"The worldwide prevalence of ADHD: a systematic review and metaregression analysis","volume":"164","author":"G Polanczyk","year":"2007","journal-title":"The American journal of psychiatry"},{"key":"ref29","doi-asserted-by":"crossref","first-page":"a2245","DOI":"10.1136\/bmj.a2245","article-title":"Drug use in children: cohort study in three European countries","volume":"337","author":"MC Sturkenboom","year":"2008","journal-title":"Bmj"},{"issue":"1","key":"ref30","doi-asserted-by":"crossref","first-page":"23","DOI":"10.1542\/peds.2011-2879","article-title":"Trends of outpatient prescription drug utilization in US children, 2002\u20132010","volume":"130","author":"G Chai","year":"2012","journal-title":"Pediatrics"},{"issue":"1","key":"ref31","doi-asserted-by":"crossref","first-page":"45","DOI":"10.2165\/11594320-000000000-00000","article-title":"Experiences with adverse drug reaction reporting by patients: an 11-country survey","volume":"35","author":"F van Hunsel","year":"2012","journal-title":"Drug safety"},{"issue":"1","key":"ref32","doi-asserted-by":"crossref","first-page":"17","DOI":"10.1001\/archpedi.157.1.17","article-title":"Psychotropic practice patterns for youth: a 10-year perspective","volume":"157","author":"JM Zito","year":"2003","journal-title":"Arch Pediatr Adolesc Med"},{"issue":"4","key":"ref33","doi-asserted-by":"crossref","first-page":"335","DOI":"10.2165\/11598120-000000000-00000","article-title":"Vaccine-based subgroup analysis in VigiBase: effect on sensitivity in paediatric signal detection","volume":"35","author":"S de Bie","year":"2012","journal-title":"Drug safety"},{"key":"ref34","article-title":"Report of CIOMS Working Group VIII","author":"CWG VIII","year":"2010"},{"issue":"3","key":"ref35","doi-asserted-by":"crossref","first-page":"305","DOI":"10.1007\/s10618-006-0052-8","article-title":"Duplicate detection in adverse drug reaction surveillance","volume":"14","author":"GN Noren","year":"2007","journal-title":"Data Mining and Knowledge Discovery"},{"issue":"6","key":"ref36","first-page":"551","article-title":"'Extreme duplication' in the US FDA Adverse Events Reporting System database","volume":"30","author":"M Hauben","year":"2007","journal-title":"Drug safety"}],"container-title":["PLOS ONE"],"original-title":[],"language":"en","link":[{"URL":"http:\/\/dx.plos.org\/10.1371\/journal.pone.0130399","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2019,8,27]],"date-time":"2019-08-27T11:17:20Z","timestamp":1566904640000},"score":1,"resource":{"primary":{"URL":"https:\/\/dx.plos.org\/10.1371\/journal.pone.0130399"}},"subtitle":[],"editor":[{"given":"Silvio","family":"Garattini","sequence":"first","affiliation":[],"role":[{"role":"editor","vocabulary":"crossref"}]}],"short-title":[],"issued":{"date-parts":[[2015,6,19]]},"references-count":36,"journal-issue":{"issue":"6","published-online":{"date-parts":[[2015,6,19]]}},"URL":"https:\/\/doi.org\/10.1371\/journal.pone.0130399","relation":{},"ISSN":["1932-6203"],"issn-type":[{"value":"1932-6203","type":"electronic"}],"subject":[],"published":{"date-parts":[[2015,6,19]]}}}