{"id":"https://openalex.org/W2130666159","doi":"https://doi.org/10.1093/eurheartj/ehs172","title":"The International Serious Adverse Events Consortium (iSAEC) phenotype standardization project for drug-induced torsades de pointes","display_name":"The International Serious Adverse Events Consortium (iSAEC) phenotype standardization project for drug-induced torsades de pointes","publication_year":2012,"publication_date":"2012-07-02","ids":{"openalex":"https://openalex.org/W2130666159","doi":"https://doi.org/10.1093/eurheartj/ehs172","mag":"2130666159","pmid":"https://pubmed.ncbi.nlm.nih.gov/22752616","pmcid":"https://www.ncbi.nlm.nih.gov/pmc/articles/3703308"},"language":"en","primary_location":{"id":"doi:10.1093/eurheartj/ehs172","doi":"https://doi.org/10.1093/eurheartj/ehs172","is_oa":false,"landing_page_url":"https://doi.org/10.1093/eurheartj/ehs172","pdf_url":null,"source":{"id":"https://openalex.org/S181568219","display_name":"European Heart Journal","issn_l":"0195-668X","issn":["0195-668X","1522-9645"],"is_oa":false,"is_in_doaj":false,"is_core":true,"listed_in":["anvur-scientific","cwts-core","dongbi-a","doyens","jufo-3","ki-jl-3","medline","norway-2","poland-200","russia-white-list-1","vabb-shw"],"host_organization":"https://openalex.org/P4310311648","host_organization_name":"Oxford University Press","host_organization_lineage":["https://openalex.org/P4310311648","https://openalex.org/P4310311647"],"host_organization_lineage_names":["Oxford University Press","University of Oxford"],"type":"journal"},"license":null,"license_id":null,"version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"European Heart Journal","raw_type":"journal-article"},"volume":null,"type":"article","indexed_in":["crossref","pubmed"],"open_access":{"is_oa":true,"oa_status":"green","oa_url":"https://www.ncbi.nlm.nih.gov/pmc/articles/3703308","any_repository_has_fulltext":true},"authorships":[{"author_position":"first","author":{"id":"https://openalex.org/A5011046385","display_name":"Elijah Raphael Behr","orcid":"https://orcid.org/0000-0002-8731-2853","observed_orcids":["https://orcid.org/0000-0002-8731-2853"]},"institutions":[{"id":"https://openalex.org/I165862685","display_name":"St George's, University of London","ror":"https://ror.org/040f08y74","country_code":"GB","type":"education","lineage":["https://openalex.org/I124357947","https://openalex.org/I165862685","https://openalex.org/I4401726869"]}],"countries":["GB"],"is_corresponding":true,"raw_author_name":"Elijah R. Behr","raw_affiliation_strings":["Cardiovascular Research Center, St George's University of London, London SW17 0RE, UK. ebehr@sgul.ac.uk","Cardiovascular Research Center, St George's University of London, London SW17 0RE, UK"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Cardiovascular Research Center, St George's University of London, London SW17 0RE, UK. ebehr@sgul.ac.uk","institution_ids":["https://openalex.org/I165862685"]},{"raw_affiliation_string":"Cardiovascular Research Center, St George's University of London, London SW17 0RE, UK","institution_ids":["https://openalex.org/I165862685"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5058388613","display_name":"Craig T. January","orcid":null,"observed_orcids":[]},"institutions":[{"id":"https://openalex.org/I135310074","display_name":"University of Wisconsin\u2013Madison","ror":"https://ror.org/01y2jtd41","country_code":"US","type":"education","lineage":["https://openalex.org/I135310074"]}],"countries":["US"],"is_corresponding":false,"raw_author_name":"Craig January","raw_affiliation_strings":["University of Wisconsin-Madison, Madison, WI, USA","University of Wisconsin, Madison"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"University of Wisconsin-Madison, Madison, WI, USA","institution_ids":["https://openalex.org/I135310074"]},{"raw_affiliation_string":"University of Wisconsin, Madison","institution_ids":["https://openalex.org/I135310074"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5066089743","display_name":"Eric Schulze\u2010Bahr","orcid":"https://orcid.org/0000-0001-6884-2501","observed_orcids":["https://orcid.org/0000-0001-6884-2501"]},"institutions":[{"id":"https://openalex.org/I4210103666","display_name":"University Hospital M\u00fcnster","ror":"https://ror.org/01856cw59","country_code":"DE","type":"healthcare","lineage":["https://openalex.org/I4210103666"]}],"countries":["DE"],"is_corresponding":false,"raw_author_name":"Eric Schulze-Bahr","raw_affiliation_strings":["Department of Cardiology and Angiology, Institute for Genetics of Heart Diseases, University Hospital, M\u00fcnster, Germany","Institute for Genetics of Heart Diseases, University Hospital,"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Department of Cardiology and Angiology, Institute for Genetics of Heart Diseases, University Hospital, M\u00fcnster, Germany","institution_ids":["https://openalex.org/I4210103666"]},{"raw_affiliation_string":"Institute for Genetics of Heart Diseases, University Hospital,","institution_ids":[]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5000336640","display_name":"Andrew A. Grace","orcid":"https://orcid.org/0000-0002-0686-215X","observed_orcids":["https://orcid.org/0000-0002-0686-215X"]},"institutions":[{"id":"https://openalex.org/I241749","display_name":"University of Cambridge","ror":"https://ror.org/013meh722","country_code":"GB","type":"education","lineage":["https://openalex.org/I241749"]}],"countries":["GB"],"is_corresponding":false,"raw_author_name":"Andrew A. Grace","raw_affiliation_strings":["University of Cambridge, Cambridge, UK","University of Cambridge,"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"University of Cambridge, Cambridge, UK","institution_ids":["https://openalex.org/I241749"]},{"raw_affiliation_string":"University of Cambridge,","institution_ids":["https://openalex.org/I241749"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5019224180","display_name":"Stefan K\u00e4\u00e4b","orcid":"https://orcid.org/0000-0001-8824-3581","observed_orcids":["https://orcid.org/0000-0001-8824-3581"]},"institutions":[{"id":"https://openalex.org/I8204097","display_name":"Ludwig-Maximilians-Universit\u00e4t M\u00fcnchen","ror":"https://ror.org/05591te55","country_code":"DE","type":"education","lineage":["https://openalex.org/I8204097"]}],"countries":["DE"],"is_corresponding":false,"raw_author_name":"Stefan K\u00e4\u00e4b","raw_affiliation_strings":["Department of Medicine I, Ludwig-Maximilians University Hospital Munich, Campus Grosshadern, Munich, Germany","Ludwig\u2010Maximilians\u2010University Hospital Munich"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Department of Medicine I, Ludwig-Maximilians University Hospital Munich, Campus Grosshadern, Munich, Germany","institution_ids":["https://openalex.org/I8204097"]},{"raw_affiliation_string":"Ludwig\u2010Maximilians\u2010University Hospital Munich","institution_ids":["https://openalex.org/I8204097"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5108512447","display_name":"M\u00f3nica L. Fiszman","orcid":null,"observed_orcids":[]},"institutions":[{"id":"https://openalex.org/I1320320070","display_name":"United States Food and Drug Administration","ror":"https://ror.org/034xvzb47","country_code":"US","type":"government","lineage":["https://openalex.org/I1299022934","https://openalex.org/I1320320070"]},{"id":"https://openalex.org/I1333606569","display_name":"Center for Drug Evaluation and Research","ror":"https://ror.org/00yf3tm42","country_code":"US","type":"facility","lineage":["https://openalex.org/I1299022934","https://openalex.org/I1320320070","https://openalex.org/I1333606569"]}],"countries":["US"],"is_corresponding":false,"raw_author_name":"Monica Fiszman","raw_affiliation_strings":["Division of Cardiovascular and Renal Products, CDER, FDA, Silver Spring, MD, USA","CDER/FDA;"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Division of Cardiovascular and Renal Products, CDER, FDA, Silver Spring, MD, USA","institution_ids":["https://openalex.org/I1320320070","https://openalex.org/I1333606569"]},{"raw_affiliation_string":"CDER/FDA;","institution_ids":["https://openalex.org/I1320320070","https://openalex.org/I1333606569"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5029120256","display_name":"Shaniece Gathers","orcid":null,"observed_orcids":[]},"institutions":[{"id":"https://openalex.org/I1320320070","display_name":"United States Food and Drug Administration","ror":"https://ror.org/034xvzb47","country_code":"US","type":"government","lineage":["https://openalex.org/I1299022934","https://openalex.org/I1320320070"]},{"id":"https://openalex.org/I1333606569","display_name":"Center for Drug Evaluation and Research","ror":"https://ror.org/00yf3tm42","country_code":"US","type":"facility","lineage":["https://openalex.org/I1299022934","https://openalex.org/I1320320070","https://openalex.org/I1333606569"]}],"countries":["US"],"is_corresponding":false,"raw_author_name":"Shaniece Gathers","raw_affiliation_strings":["Office of Translational Sciences, CDER, FDA, Silver Spring, MD, USA","CDER/FDA;"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Office of Translational Sciences, CDER, FDA, Silver Spring, MD, USA","institution_ids":["https://openalex.org/I1320320070","https://openalex.org/I1333606569"]},{"raw_affiliation_string":"CDER/FDA;","institution_ids":["https://openalex.org/I1320320070","https://openalex.org/I1333606569"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5107484671","display_name":"ShaAvhr\u00e9e Buckman","orcid":null,"observed_orcids":[]},"institutions":[{"id":"https://openalex.org/I1320320070","display_name":"United States Food and Drug Administration","ror":"https://ror.org/034xvzb47","country_code":"US","type":"government","lineage":["https://openalex.org/I1299022934","https://openalex.org/I1320320070"]}],"countries":["US"],"is_corresponding":false,"raw_author_name":"ShaAvhr\u00e9e Buckman","raw_affiliation_strings":["FDA, Silver Spring, MD, USA","FDA#TAB#"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"FDA, Silver Spring, MD, USA","institution_ids":["https://openalex.org/I1320320070"]},{"raw_affiliation_string":"FDA#TAB#","institution_ids":["https://openalex.org/I1320320070"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5103824738","display_name":"Ashraf F. Youssef","orcid":null,"observed_orcids":[]},"institutions":[{"id":"https://openalex.org/I4210140176","display_name":"Takeda (United States)","ror":"https://ror.org/03bygaq51","country_code":"US","type":"company","lineage":["https://openalex.org/I4210140176","https://openalex.org/I44892455"]},{"id":"https://openalex.org/I44892455","display_name":"Takeda (Japan)","ror":"https://ror.org/04hjbmv12","country_code":"JP","type":"company","lineage":["https://openalex.org/I44892455"]}],"countries":["JP","US"],"is_corresponding":false,"raw_author_name":"Ashraf Youssef","raw_affiliation_strings":["Takeda Global R & D Center, Deerfield, IL, USA","Takeda Global R & D Center"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Takeda Global R & D Center, Deerfield, IL, USA","institution_ids":["https://openalex.org/I4210140176"]},{"raw_affiliation_string":"Takeda Global R & D Center","institution_ids":["https://openalex.org/I44892455"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5006847944","display_name":"Munir Pirmohamed","orcid":"https://orcid.org/0000-0002-7534-7266","observed_orcids":["https://orcid.org/0000-0002-7534-7266"]},"institutions":[{"id":"https://openalex.org/I146655781","display_name":"University of Liverpool","ror":"https://ror.org/04xs57h96","country_code":"GB","type":"education","lineage":["https://openalex.org/I146655781"]}],"countries":["GB"],"is_corresponding":false,"raw_author_name":"Munir Pirmohamed","raw_affiliation_strings":["Institute of Translational Medicine, University of Liverpool, Liverpool, UK","Institute of Translational Medicine, University of Liverpool"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Institute of Translational Medicine, University of Liverpool, Liverpool, UK","institution_ids":["https://openalex.org/I146655781"]},{"raw_affiliation_string":"Institute of Translational Medicine, University of Liverpool","institution_ids":["https://openalex.org/I146655781"]}]},{"author_position":"last","author":{"id":"https://openalex.org/A5058141203","display_name":"Dan M. Roden","orcid":"https://orcid.org/0000-0002-6302-0389","observed_orcids":["https://orcid.org/0000-0002-6302-0389"]},"institutions":[{"id":"https://openalex.org/I200719446","display_name":"Vanderbilt University","ror":"https://ror.org/02vm5rt34","country_code":"US","type":"education","lineage":["https://openalex.org/I200719446"]},{"id":"https://openalex.org/I901861585","display_name":"Vanderbilt University Medical Center","ror":"https://ror.org/05dq2gs74","country_code":"US","type":"healthcare","lineage":["https://openalex.org/I4210162197","https://openalex.org/I901861585"]}],"countries":["US"],"is_corresponding":true,"raw_author_name":"Dan Roden","raw_affiliation_strings":["Vanderbilt University School of Medicine, Oates Institute for Experimental Therapeutics, Vanderbilt University Medical Center, MRB4 1285B, 2215B Garland Avenue, Nashville, TN 37232-0575, USA","Oates Institute for Experimental Therapeutics, Vanderbilt University Medical Center"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Vanderbilt University School of Medicine, Oates Institute for Experimental Therapeutics, Vanderbilt University Medical Center, MRB4 1285B, 2215B Garland Avenue, Nashville, TN 37232-0575, USA","institution_ids":["https://openalex.org/I200719446","https://openalex.org/I901861585"]},{"raw_affiliation_string":"Oates Institute for Experimental Therapeutics, Vanderbilt University Medical Center","institution_ids":["https://openalex.org/I901861585"]}]}],"institutions":[],"countries_distinct_count":4,"institutions_distinct_count":12,"corresponding_author_ids":["https://openalex.org/A5011046385","https://openalex.org/A5058141203"],"corresponding_institution_ids":["https://openalex.org/I165862685","https://openalex.org/I200719446","https://openalex.org/I901861585"],"apc_list":{"value":5240,"currency":"EUR","value_usd":5922},"apc_paid":null,"fwci":3.0823,"has_fulltext":false,"cited_by_count":28,"citation_normalized_percentile":{"value":0.92720467,"is_in_top_1_percent":false,"is_in_top_10_percent":true},"cited_by_percentile_year":{"min":88,"max":99},"biblio":{"volume":"34","issue":"26","first_page":"1958","last_page":"1963"},"is_retracted":false,"is_paratext":false,"is_xpac":false,"primary_topic":{"id":"https://openalex.org/T10217","display_name":"Cardiac electrophysiology and arrhythmias","score":0.9868000149726868,"subfield":{"id":"https://openalex.org/subfields/2705","display_name":"Cardiology and Cardiovascular Medicine"},"field":{"id":"https://openalex.org/fields/27","display_name":"Medicine"},"domain":{"id":"https://openalex.org/domains/4","display_name":"Health Sciences"}},"topics":[{"id":"https://openalex.org/T10217","display_name":"Cardiac electrophysiology and arrhythmias","score":0.9868000149726868,"subfield":{"id":"https://openalex.org/subfields/2705","display_name":"Cardiology and Cardiovascular Medicine"},"field":{"id":"https://openalex.org/fields/27","display_name":"Medicine"},"domain":{"id":"https://openalex.org/domains/4","display_name":"Health Sciences"}},{"id":"https://openalex.org/T11943","display_name":"Pharmacovigilance and Adverse Drug Reactions","score":0.006200000178068876,"subfield":{"id":"https://openalex.org/subfields/3005","display_name":"Toxicology"},"field":{"id":"https://openalex.org/fields/30","display_name":"Pharmacology, Toxicology and Pharmaceutics"},"domain":{"id":"https://openalex.org/domains/1","display_name":"Life Sciences"}},{"id":"https://openalex.org/T10375","display_name":"Pharmacogenetics and Drug Metabolism","score":0.0027000000700354576,"subfield":{"id":"https://openalex.org/subfields/3004","display_name":"Pharmacology"},"field":{"id":"https://openalex.org/fields/30","display_name":"Pharmacology, Toxicology and Pharmaceutics"},"domain":{"id":"https://openalex.org/domains/1","display_name":"Life Sciences"}}],"keywords":[{"id":"https://openalex.org/keywords/case-definition","display_name":"case definition","score":0.7210000157356262},{"id":"https://openalex.org/keywords/serious-adverse-drug-reactions","display_name":"serious adverse drug reactions","score":0.906000018119812},{"id":"https://openalex.org/keywords/qt-interval-prolongation","display_name":"QT prolongation","score":0.781000018119812},{"id":"https://openalex.org/keywords/polymorphic-ventricular-tachycardia","display_name":"polymorphic ventricular tachycardia","score":0.8769999742507935},{"id":"https://openalex.org/keywords/drug-induced-arrhythmia","display_name":"drug-induced arrhythmia","score":0.5429999828338623},{"id":"https://openalex.org/keywords/qt-prolonging-drugs","display_name":"QT-prolonging drugs","score":0.6039999723434448},{"id":"https://openalex.org/keywords/risk-factors","display_name":"risk factors","score":0.4519999921321869},{"id":"https://openalex.org/keywords/case-ascertainment","display_name":"case ascertainment","score":0.5720000267028809},{"id":"https://openalex.org/keywords/pharmacogenomics","display_name":"pharmacogenomics","score":0.4650000035762787},{"id":"https://openalex.org/keywords/pharmacovigilance","display_name":"pharmacovigilance","score":0.5059999823570251},{"id":"https://openalex.org/keywords/terfenadine","display_name":"terfenadine","score":0.6069999933242798},{"id":"https://openalex.org/keywords/astemizole","display_name":"astemizole","score":0.9049999713897705},{"id":"https://openalex.org/keywords/sotalol","display_name":"sotalol","score":0.6909999847412109}],"concepts":[{"id":"https://openalex.org/C71924100","wikidata":"https://www.wikidata.org/wiki/Q11190","display_name":"Medicine","level":0,"score":0.8875937461853027},{"id":"https://openalex.org/C2780486423","wikidata":"https://www.wikidata.org/wiki/Q1625433","display_name":"Torsades de pointes","level":3,"score":0.8522348999977112},{"id":"https://openalex.org/C118441451","wikidata":"https://www.wikidata.org/wiki/Q12074763","display_name":"QT interval","level":2,"score":0.5802626013755798},{"id":"https://openalex.org/C2776331378","wikidata":"https://www.wikidata.org/wiki/Q56002","display_name":"Ventricular tachycardia","level":2,"score":0.5761507749557495},{"id":"https://openalex.org/C177713679","wikidata":"https://www.wikidata.org/wiki/Q679690","display_name":"Intensive care medicine","level":1,"score":0.4899572432041168},{"id":"https://openalex.org/C2779303165","wikidata":"https://www.wikidata.org/wiki/Q417909","display_name":"Terfenadine","level":2,"score":0.4472028315067291},{"id":"https://openalex.org/C2781005686","wikidata":"https://www.wikidata.org/wiki/Q848662","display_name":"Ventricular fibrillation","level":2,"score":0.4441571831703186},{"id":"https://openalex.org/C164705383","wikidata":"https://www.wikidata.org/wiki/Q10379","display_name":"Cardiology","level":1,"score":0.3557952642440796},{"id":"https://openalex.org/C126322002","wikidata":"https://www.wikidata.org/wiki/Q11180","display_name":"Internal medicine","level":1,"score":0.3538631200790405},{"id":"https://openalex.org/C98274493","wikidata":"https://www.wikidata.org/wiki/Q128406","display_name":"Pharmacology","level":1,"score":0.297892689704895}],"mesh":[{"descriptor_ui":"D000889","descriptor_name":"Anti-Arrhythmia Agents","qualifier_ui":"Q000009","qualifier_name":"adverse effects","is_major_topic":false},{"descriptor_ui":"D000890","descriptor_name":"Anti-Infective Agents","qualifier_ui":"Q000009","qualifier_name":"adverse effects","is_major_topic":false},{"descriptor_ui":"D003245","descriptor_name":"Consensus Statements as Topic","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D005819","descriptor_name":"Genetic Markers","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D005820","descriptor_name":"Genetic Testing","qualifier_ui":"Q000379","qualifier_name":"methods","is_major_topic":false},{"descriptor_ui":"D006633","descriptor_name":"Histamine Antagonists","qualifier_ui":"Q000009","qualifier_name":"adverse effects","is_major_topic":false},{"descriptor_ui":"D006801","descriptor_name":"Humans","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D007400","descriptor_name":"Interprofessional Relations","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D010641","descriptor_name":"Phenotype","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D012307","descriptor_name":"Risk Factors","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D012737","descriptor_name":"Sex Factors","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D014150","descriptor_name":"Antipsychotic Agents","qualifier_ui":"Q000009","qualifier_name":"adverse effects","is_major_topic":false},{"descriptor_ui":"D016171","descriptor_name":"Torsades de Pointes","qualifier_ui":"Q000139","qualifier_name":"chemically induced","is_major_topic":true},{"descriptor_ui":"D016171","descriptor_name":"Torsades de Pointes","qualifier_ui":"Q000175","qualifier_name":"diagnosis","is_major_topic":false},{"descriptor_ui":"D016171","descriptor_name":"Torsades de Pointes","qualifier_ui":"Q000235","qualifier_name":"genetics","is_major_topic":false},{"descriptor_ui":"D016907","descriptor_name":"Adverse Drug Reaction Reporting Systems","qualifier_ui":"Q000592","qualifier_name":"standards","is_major_topic":true},{"descriptor_ui":"D032921","descriptor_name":"Consensus","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D064420","descriptor_name":"Drug-Related Side Effects and Adverse Reactions","qualifier_ui":"Q000235","qualifier_name":"genetics","is_major_topic":false}],"locations_count":5,"locations":[{"id":"doi:10.1093/eurheartj/ehs172","doi":"https://doi.org/10.1093/eurheartj/ehs172","is_oa":false,"landing_page_url":"https://doi.org/10.1093/eurheartj/ehs172","pdf_url":null,"source":{"id":"https://openalex.org/S181568219","display_name":"European Heart Journal","issn_l":"0195-668X","issn":["0195-668X","1522-9645"],"is_oa":false,"is_in_doaj":false,"is_core":true,"listed_in":["anvur-scientific","cwts-core","dongbi-a","doyens","jufo-3","ki-jl-3","medline","norway-2","poland-200","russia-white-list-1","vabb-shw"],"host_organization":"https://openalex.org/P4310311648","host_organization_name":"Oxford University Press","host_organization_lineage":["https://openalex.org/P4310311648","https://openalex.org/P4310311647"],"host_organization_lineage_names":["Oxford University Press","University of Oxford"],"type":"journal"},"license":null,"license_id":null,"version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"European Heart Journal","raw_type":"journal-article"},{"id":"pmh:oai:europepmc.org:3057720","doi":null,"is_oa":true,"landing_page_url":"https://www.ncbi.nlm.nih.gov/pmc/articles/3703308","pdf_url":null,"source":{"id":"https://openalex.org/S4306400806","display_name":"Europe PMC (PubMed Central)","issn_l":null,"issn":null,"is_oa":false,"is_in_doaj":false,"is_core":false,"listed_in":[],"host_organization":"https://openalex.org/I1303153112","host_organization_name":"European Bioinformatics Institute","host_organization_lineage":["https://openalex.org/I1303153112"],"host_organization_lineage_names":[],"type":"repository"},"license":null,"license_id":null,"version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":null,"raw_type":"Text"},{"id":"pmh:oai:pubmedcentral.nih.gov:3703308","doi":null,"is_oa":true,"landing_page_url":"https://www.ncbi.nlm.nih.gov/pmc/articles/3703308","pdf_url":null,"source":{"id":"https://openalex.org/S2764455111","display_name":"PubMed Central","issn_l":null,"issn":null,"is_oa":true,"is_in_doaj":false,"is_core":false,"listed_in":[],"host_organization":"https://openalex.org/I1299303238","host_organization_name":"National Institutes of Health","host_organization_lineage":["https://openalex.org/I1299303238"],"host_organization_lineage_names":[],"type":"repository"},"license":null,"license_id":null,"version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"Eur Heart J","raw_type":"Text"},{"id":"pmid:22752616","doi":null,"is_oa":false,"landing_page_url":"https://pubmed.ncbi.nlm.nih.gov/22752616","pdf_url":null,"source":{"id":"https://openalex.org/S4306525036","display_name":"PubMed","issn_l":null,"issn":null,"is_oa":false,"is_in_doaj":false,"is_core":false,"listed_in":[],"host_organization":"https://openalex.org/I1299303238","host_organization_name":"National Institutes of Health","host_organization_lineage":["https://openalex.org/I1299303238"],"host_organization_lineage_names":[],"type":"repository"},"license":null,"license_id":null,"version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"European heart journal","raw_type":"Journal Article"},{"id":"pmh:oai:open-archive.highwire.org:ehj:34/26/1958","doi":null,"is_oa":false,"landing_page_url":"http://eurheartj.oxfordjournals.org/cgi/content/short/34/26/1958","pdf_url":null,"source":{"id":"https://openalex.org/S4406923041","display_name":"HighWire Press Open Archive","issn_l":null,"issn":null,"is_oa":false,"is_in_doaj":false,"is_core":false,"listed_in":[],"host_organization":null,"host_organization_name":null,"host_organization_lineage":[],"host_organization_lineage_names":[],"type":"repository"},"license":null,"license_id":null,"version":"submittedVersion","is_accepted":false,"is_published":false,"raw_source_name":"","raw_type":"TEXT"}],"best_oa_location":{"id":"pmh:oai:europepmc.org:3057720","doi":null,"is_oa":true,"landing_page_url":"https://www.ncbi.nlm.nih.gov/pmc/articles/3703308","pdf_url":null,"source":{"id":"https://openalex.org/S4306400806","display_name":"Europe PMC (PubMed Central)","issn_l":null,"issn":null,"is_oa":false,"is_in_doaj":false,"is_core":false,"listed_in":[],"host_organization":"https://openalex.org/I1303153112","host_organization_name":"European Bioinformatics Institute","host_organization_lineage":["https://openalex.org/I1303153112"],"host_organization_lineage_names":[],"type":"repository"},"license":null,"license_id":null,"version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":null,"raw_type":"Text"},"sustainable_development_goals":[{"display_name":"Good health and well-being","id":"https://metadata.un.org/sdg/3","score":1.0}],"study_designs":[],"awards":[{"id":"https://openalex.org/G1452116402","display_name":"Pharmacogenomics of Arrhythmia Therapy","funder_award_id":"U19HL065962","funder_id":"https://openalex.org/F4320337338","funder_display_name":"National Heart, Lung, and Blood Institute"}],"funders":[{"id":"https://openalex.org/F4320311904","display_name":"Wellcome Trust","ror":"https://ror.org/029chgv08"},{"id":"https://openalex.org/F4320337338","display_name":"National Heart, Lung, and Blood Institute","ror":"https://ror.org/012pb6c26"}],"has_content":{"pdf":false,"grobid_xml":false},"content_urls":null,"referenced_works_count":25,"referenced_works":["https://openalex.org/W1972199218","https://openalex.org/W2008125074","https://openalex.org/W2017380882","https://openalex.org/W2046508780","https://openalex.org/W2057406399","https://openalex.org/W2061967268","https://openalex.org/W2066538341","https://openalex.org/W2081517567","https://openalex.org/W2082626069","https://openalex.org/W2111819588","https://openalex.org/W2116581628","https://openalex.org/W2118617344","https://openalex.org/W2121948428","https://openalex.org/W2125955136","https://openalex.org/W2127815448","https://openalex.org/W2128940750","https://openalex.org/W2133605053","https://openalex.org/W2150745003","https://openalex.org/W2152072716","https://openalex.org/W2163175442","https://openalex.org/W2231835368","https://openalex.org/W2333201626","https://openalex.org/W2548813655","https://openalex.org/W4285719527","https://openalex.org/W6679031563"],"related_works":["https://openalex.org/W2002358890","https://openalex.org/W3006268853","https://openalex.org/W2120346674","https://openalex.org/W173153465","https://openalex.org/W206990137","https://openalex.org/W2483186581","https://openalex.org/W2338011979","https://openalex.org/W2187655698","https://openalex.org/W4206615254","https://openalex.org/W2094853505"],"abstract_inverted_index":{"Serious":[0,2557,2599],"adverse":[1],"drug":[2,14,386,644,903,920,946,1127,1177,1187,1197,1214,1256,1285,1303,1318,1382,1400,1778,1785,1885,2332],"reactions":[3],"(ADRs)":[4],"represent":[5],"an":[6,923,976,995,1090,1190,1234,1497,1639,1720,1808,1817,2346,2496],"important":[7,599,982,1235,1248,1948],"problem":[8],"for":[9,12,23,117,128,225,299,310,322,610,642,656,664,707,807,820,830,874,936,939,1019,1081,1119,1391,1584,1592,1833,1908,1932,2137,2142,2199,2247,2274,2280,2376,2475,2480,2499,2579,2630,2641,2708],"clinicians":[10,2350],"and":[11,88,112,153,170,189,210,255,281,285,314,326,333,339,344,507,566,595,618,626,681,687,723,729,758,765,770,793,832,848,867,876,889,983,1046,1055,1116,1152,1203,1268,1287,1319,1384,1395,1432,1460,1471,1591,1611,1622,1631,1697,1713,1750,1789,1838,1845,1856,1945,1949,1964,1969,2021,2061,2202,2222,2236,2250,2312,2517,2547,2562,2576,2582,2593,2604,2624,2627,2647,2657,2660,2675,2685,2705,2726,2745],"the":[13,24,42,51,106,110,124,129,142,179,265,340,360,405,423,436,447,461,471,478,559,621,633,649,665,685,698,717,720,775,802,808,827,843,862,864,882,893,896,926,940,954,966,973,1009,1022,1032,1041,1048,1057,1095,1107,1110,1132,1158,1163,1168,1213,1218,1225,1253,1279,1313,1317,1323,1336,1350,1409,1422,1429,1437,1505,1512,1540,1582,1587,1599,1602,1619,1623,1636,1648,1667,1673,1692,1704,1708,1717,1732,1758,1797,1805,1893,1896,1970,1977,2003,2019,2038,2080,2130,2168,2212,2282,2305,2325,2336,2353,2356,2362,2366,2374,2400,2404,2414,2427,2436,2456,2484,2532,2538,2555,2597,2654,2673,2681,2698,2702,2713],"development":[15,43,1169,2714],"process.":[16],"Since":[17],"these":[18,497,527,659,840,1520],"are":[19,28,271,276,301,356,372,516,529,933,1121,1360,1476,1757,1858,1929,2259,2265,2290,2494,2552,2649,2670,2676],"rare,":[20],"case":[21,66,103,564,1064,1182,1430,1524,1678,2138,2143,2210,2340,2363],"series":[22,1451],"analysis":[25,503],"of":[26,44,68,71,80,108,114,136,144,181,199,217,233,246,337,377,391,422,449,480,504,523,561,570,586,624,635,653,667,672,690,738,747,774,789,804,818,845,930,956,968,975,998,1050,1059,1134,1165,1170,1174,1183,1186,1192,1196,1200,1206,1210,1224,1229,1237,1255,1281,1292,1300,1316,1349,1352,1381,1408,1440,1452,1504,1519,1525,1530,1586,1601,1607,1638,1679,1707,1711,1725,1736,1780,1796,1807,1825,1895,1913,1937,1972,1984,2024,2041,2082,2113,2162,2178,2208,2321,2349,2355,2426,2448,2455,2469,2531,2584,2588,2611,2672,2680,2715,2724],"risk":[27,224,297,308,320,448,479,1715,2498],"generally":[29,1241],"accrued":[30],"across":[31,2193],"multiple":[32,1326],"institutions.":[33,731],"Thus,":[34],"a":[35,60,78,98,101,196,220,292,375,417,463,500,505,520,537,545,562,714,735,796,816,886,902,980,1015,1051,1063,1087,1126,1175,1181,1204,1330,1367,1379,1450,1507,1522,1662,1688,1698,1770,1777,1888,2111,2209,2244,2256,2329,2383,2424,2442,2445,2507,2515,2524,2609,2618,2631,2639],"key":[36],"step":[37,494],"in":[38,84,97,262,291,303,347,374,431,454,470,484,495,511,530,536,581,590,658,740,763,801,826,842,895,898,925,972,1031,1109,1162,1221,1366,1398,1405,1468,1511,1544,1574,1635,1804,1887,1917,1942,2223,2253,2287,2335,2397,2712],"this":[39,397,677,748,2173,2315,2523,2585,2716],"process":[40,694,829],"is":[41,174,227,363,394,499,598,1067,1128,1233,1240,1246,1446,1461,1481,1521,1542,1652,1661,1791,1801,1947,2052,2164,2473,2512,2608,2617,2638],"standard":[45,521,1337],"phenotype":[46,61,126,673,700,2367],"definitions.":[47,2368],"To":[48],"facilitate":[49],"this,":[50],"International":[52,2556,2598],"Severe":[53],"Adverse":[54,2558,2600],"Event":[55],"Consortium":[56],"(iSAEC)":[57],"has":[58,256,426,443,1263,2084,2105,2122,2464],"initiated":[59],"standardization":[62,2454],"project":[63],"to":[64,95,166,264,359,401,548,553,573,607,613,696,703,779,794,799,823,838,871,943,951,1045,1061,1125,1370,1421,1570,1722,1822,1874,1956,2026,2147,2154,2180,2211,2217,2307,2310,2327,2358,2365,2413,2435,2451,2488,2537,2554,2620,2633,2665,2691,2696],"improve":[65],"ascertainment":[67,828],"different":[69,2194],"types":[70],"serious":[72],"ADRs.1":[73],"For":[74,1329,2241],"each":[75,1495],"ADR":[76,135],"phenotype,":[77,2283],"group":[79,751,812,883,949,1003,2534],"investigators":[81,2309],"with":[82,105,150,195,219,236,248,381,429,446,467,477,592,662,761,791,958,1094,1212,1266,1302,1325,1344,1463,1496,1563,1598,1681,1769,1862,1884,1892,1986,2000,2048,2054,2116,2125,2324,2399,2411,2423,2483],"expertise":[83,762],"relevant":[85,985],"disciplines":[86],"(clinical":[87],"basic":[89],"science;":[90],"regulatory":[91,759,890,1933],"affairs)":[92],"was":[93,701,778,892,992,1071,1102,1852,1910,2032,2066,2097],"convened":[94],"develop,":[96],"pragmatic":[99],"fashion,":[100],"standardized":[102,2471,2518],"definition":[104,127,565,1008,1431],"goal":[107,2486],"enhancing":[109],"recruitment":[111,803,850,2479],"usability":[113],"data":[115,853,1039,1359,2205,2279,2285,2298],"sets":[116],"future":[118,643,2200],"genomic":[119,409],"analysis.":[120],"This":[121,362,978,1651,1729,1953,2317],"manuscript":[122],"describes":[123],"consensus":[125,693,2443,2470],"relatively":[130],"rare":[131,420,2419],"but":[132,191,396,1573,1879,2079,2110,2262,2293,2510],"potentially":[133,1226,2457],"life-threatening":[134],"drug-induced":[137,311,323,481,1826,2459,2635],"torsades":[138,315,327,1827],"de":[139,157,316,328,1444,1828],"pointes":[140,158,317,329,1445],"(DITdP),":[141],"syndrome":[143,350,1642,2431],"polymorphic":[145,1528,1608,1658,2042,2072],"ventricular":[146,167,482,1474,1609,1625,2103],"tachycardia":[147,1561,1610,1659],"(VT)":[148],"associated":[149,428,445,476,1478,1562,1938,2049,2239],"QT-interval":[151,468,1464,1633],"prolongation":[152,313,325,908,989,1283,1386,1566,1634,1799,1872,2051,2089,2128,2232],"T-wave":[154,1469],"abnormalities.":[155],"Torsades":[156,1443],"(TdP)":[159],"may":[160,603,638,854,1363,1532,1567,2184,2505],"be":[161,413,534,605,824,855,1029,1079,1180,1276,1310,1342,1364,1378,1536,1571,1814,1875,1951,1991,2007,2148,2155,2177,2185,2302,2319,2343,2380,2392,2408,2433],"self-limited":[162],"arrhythmia":[163,451,1091,1498,1541,1589,1751,1809,2104,2460],"or":[164,222,275,922,960,1077,1137,1150,1260,1415,1547,1551,1746,1899,1976,2055,2119,2188,2360],"progress":[165],"fibrillation":[168,2002],"(VF)":[169],"cardiac":[171,1974,2028,2062],"arrest.":[172,2063],"It":[173,1480],"most":[175,268],"often":[176,331,380,1129,1482,1930],"caused":[177],"by":[178,366,558,567,912,1007,1086,1106,1131,1278,1449,1594,1666,1816,2017,2167,2233,2304,2345,2352,2382,2403,2653],"use":[180,671,2179],"QT-prolonging":[182,237,1772],"anti-arrhythmic":[183,238],"drugs":[184,201,218,239,1216],"(e.g.":[185,1037,1412],"quinidine,":[186],"sotalol,":[187],"dofetilide,":[188],"ibutilide),2,3":[190],"can":[192,533,542,1274,2520],"also":[193,814,1072,1275,1902,2176,2527],"occur":[194],"wide":[197],"variety":[198],"non-cardiovascular":[200],"including":[202,452,743,1040,1140,1322,1774,2540],"antibiotics/anti-infectives":[203],"(erythromycin,":[204],"clarithromycin,":[205],"pentamidine),":[206],"antipsychotics":[207],"(thioridazine,":[208],"haloperidol),":[209],"antihistamines":[211],"(terfenadine,":[212],"astemizole).2,3":[213],"A":[214,491,1271,1559,1614,1677,2031,2296],"comprehensive":[215,501,833],"list":[216],"known":[221,593,1771,2461],"potential":[223,941,999,1207],"TdP":[226,962,1120,1124,1171,1250,1301,1531,1680,1851,2251,2463],"maintained":[228],"at":[229,1288,1686,1792,1880,2010,2495],"www.QTdrugs.org.":[230],"Approximately":[231],"1\u20135%":[232],"patients":[234,355,487,609,790,1397,2492],"treated":[235],"will":[240,629,678,1376,2006,2175,2197,2215,2301,2318,2341,2371,2379,2391,2407,2432],"develop":[241,697,795],"TdP.2,3":[242],"The":[243,330,388,584,692,732,745,772,948,1099,1155,1243,1305,1424,1527,1753,1760,1905,1935,1982,2159,2339,2369,2467,2667,2693],"overall":[244,389,622],"incidence":[245,623],"DITdP":[247,300,338,343,378,430,453,514,625,654,776,792,1010,1066,1111,1211,1712,1726,1762,1835,2163],"\u2018non-cardiovascular\u2019":[249],"drugs,":[250],"however,":[251,412,1069,1309,1516,1534],"seems":[252],"much":[253],"smaller":[254],"not":[257,272,288,1103,1377,1403,1434,1653,2085,2106,2294,2677],"been":[258,289,427,444,475,556,1264,2077,2086,2093,2107,2123,2465],"accurately":[259],"determined":[260],"due":[261],"part":[263,2320],"fact":[266,1575],"that":[267,353,368,541,704,784,885,1006,1025,1074,1160,1499,1660,1800],"cases":[269,515,532,655,806,1027,1333,1724,1740,1824,1985,1999,2390],"reported":[270,513,2434],"well":[273,1296,2227],"characterized":[274],"mainly":[277],"derived":[278],"from":[279,399,755,858,1217,1742,1747,1967,2596,2701],"epidemiological":[280],"post-marketing":[282],"surveillance":[283],"studies4":[284],"therefore":[286,1568],"have":[287,474,555,1765,2076,2092,2661,2687],"ascertained":[290,1334],"consistent":[293,670,1891,2422],"fashion.":[294],"Common":[295,306,318],"clinical":[296,307,319,596,616,668,686,766,821,1709,1831,1918,2278],"factors":[298,309,321,588,1136,1959],"listed":[302,580,2286],"Table":[304,582,2269,2288],"1.":[305,583],"QT":[312,324,383,899,907,970,988,1042,1282,1293,1385,1565,1690,1782,1798,1871,1980,2004,2020,2050,2088,2127,2231,2248,2430],"sporadic":[332],"seemingly":[334],"unpredictable":[335],"nature":[336,1228],"parallels":[341],"between":[342,1618],"arrhythmias":[345,483,944,1787],"seen":[346],"congenital":[348,1978,2428],"long-QT":[349],"(LQTS)":[351],"suggests":[352],"some":[354],"genetically":[357,2489],"predisposed":[358],"ADR.":[361],"further":[364,614,1435],"supported":[365],"reports":[367,1209],"LQTS":[369],"disease-associated":[370],"mutations":[371,393],"identified":[373,517,1012,1665,2418],"minority":[376],"cases,":[379],"normal":[382],"intervals":[384,2023],"after":[385,901,1084,1172,1252],"withdrawal.5\u20139":[387],"prevalence":[390],"LQTS-associated":[392,424],"\u223c10%":[395],"varies":[398],"3":[400],"40%":[402],"depending":[403],"on":[404,519,953,965,1312,1428,1552,1647,1691,1703,2129],"cohort":[406,540],"studied.":[407],"Other":[408],"biomarkers":[410],"may,":[411],"involved.":[414],"KCNE1":[415],"D85N,":[416],"more":[418,981,2254],"common":[419,1477],"variant":[421],"gene,":[425],"white":[432,485],"Caucasians.10":[433],"In":[434,878,1848,1998],"addition":[435],"single":[437,2257],"nucleotide":[438],"polymorphism":[439],"(SNP),":[440],"SCN5A":[441],"S1103Y":[442],"acquired":[450],"black":[455],"Americans.11":[456],"More":[457],"recently":[458,705],"SNPs":[459],"around":[460],"NOS1AP,":[462],"gene":[464],"previously":[465],"linked":[466,1462],"variation":[469,2421],"general":[472],"population,":[473],"Caucasian":[486],"receiving":[488],"amiodarone":[489],"therapy.12":[490],"vital":[492],"first":[493],"identifying":[496],"markers":[498,935],"genetic":[502,550,587,611,688,1331,2160,2420],"large":[506],"diverse":[508],"patient":[509,2204,2478],"database":[510,1033,2214,2334],"which":[512,637,991,1232],"based":[518],"set":[522,817,2447],"phenotypic":[524,651,782,865,880,1734,2449],"characteristics.":[525],"Once":[526,2388],"definitions":[528,674],"place,":[531],"amassed":[535],"large,":[538],"well-defined":[539],"then":[543,1841,2342],"undergo":[544],"genome-based":[546],"study":[547],"identify":[549,1723,1823,2490],"markers.":[551],"Studies":[552],"date":[554],"hampered":[557],"lack":[560],"uniform":[563],"frequent":[568],"failure":[569],"individual":[571,2203],"sites":[572],"collect":[574],"possible":[575,1138,1761,2016],"covariates":[576],"such":[577,675,805,1166,1441,1924,1960],"as":[578,676,994,1065,1148,1295,1297,1860,1866,1925,1940,1961,2011,2015,2034,2068,2099,2102,2226,2228,2276,2373,2462],"those":[579,2491,2671,2679],"identification":[585,788],"(acting":[589],"combination":[591],"environmental":[594],"factors)":[597],"because":[600,1912],"(i)":[601],"it":[602,628,1070,2511],"ultimately":[604,639],"feasible":[606],"pre-screen":[608],"variability":[612,894],"guide":[615],"practice":[617],"eventually":[619],"reduce":[620],"(ii)":[627],"provide":[630,640,2314],"insights":[631],"into":[632,684,2394],"mechanisms":[634],"DITdP,":[636,1353],"lessons":[641],"development.":[645],"We":[646,2526],"present":[647,1705,1876],"here":[648,1340],"minimum":[650,781,1733,1754,2446],"characteristics":[652],"inclusion":[657,1082,1983],"studies,":[660,2482],"along":[661],"recommendations":[663,819],"collection":[666,2299],"cofactors;":[669],"enable":[679],"thorough":[680],"global":[682,2516],"investigations":[683],"predictors":[689],"DITdP.":[691,744,1184,1526,2501],"used":[695],"DiTdP":[699],"similar":[702,1368],"described":[706,1265,1941],"other":[708,1135,1201,1371,1921,1994,2181,2238,2529],"iSAEC":[709,712,2213,2306,2370],"phenotypes.1,13,14":[710],"Briefly,":[711],"represents":[713,1576],"collaboration":[715,2201],"among":[716],"Wellcome":[718,2577],"Trust,":[719],"US":[721,2655,2703],"Food":[722,2656,2704],"Drug":[724,2658,2706],"Administration":[725,2659,2707],"(FDA),":[726],"pharmaceutical":[727],"companies,":[728],"academic":[730,756,2385],"consortium":[733,2560],"organized":[734,2303],"face-to-face":[736],"meeting":[737],"experts":[739],"various":[741],"phenotypes":[742,1011,1372,1832],"members":[746,2530],"expert":[749,1595,2347,2405],"working":[750,811,1002,2186,2533],"(EWG)":[752],"comprised":[753],"individuals":[754,2700],"medicine":[757],"agencies":[760],"cardiology":[764],"electrophysiology,":[767],"pharmacoepidemiology,":[768],"pharmacogenomics,":[769],"pharmacovigilance.":[771],"task":[773],"EWG":[777,1023,1156,1425,1718,2357],"define":[780],"requirements":[783,1735,1756],"would":[785,1990],"allow":[786,2198,2308,2452],"accurate":[787,831,2477],"corresponding":[797],"algorithm":[798,868,1721,1730],"assist":[800],"database.1":[809],"Expert":[810,1001],"participants":[813,873,1004,1108],"generated":[815],"cofactors":[822],"included":[825,1030],"phenotyping.":[834],"Participants":[835],"were":[836,869,1840,1996],"asked":[837],"consider":[839,1436],"criteria":[841,866,1096,1338,1995,2219,2450,2472],"context":[844],"both":[846,1114],"prospective":[847],"retrospective":[849],"strategies":[851],"where":[852,1356,2037,2071],"largely":[856,1426],"extracted":[857],"medical":[859,1744],"notes.":[860],"Following":[861],"meeting,":[863],"circulated":[870],"all":[872,1075,1869],"revision":[875],"approval.":[877],"determining":[879],"requirements,":[881],"recognized":[884],"competing":[887],"research":[888,2195,2592],"question":[891],"change":[897],"interval":[900,928,1043,1411,1455,1617,2005],"challenge;":[904],"indeed,":[905],"exaggerated":[906],"[e.g.":[909],"QTc":[910,927,1410],"corrected":[911],"Bazett's":[913],"formula":[914,1907,1927],"(QTcB)":[915],">":[916],"500":[917],"ms]":[918],"during":[919,945,1284,1767],"exposure":[921,1383,1401,1955],"increase":[924],"(\u0394QT)":[929],">60":[931],"ms":[932,1414,1419],"considered":[934,1005,1105,2260,2291],"increased":[937,2497],"scrutiny":[938],"susceptibility":[942],"development.13":[947],"elected":[950],"focus":[952],"accrual":[955],"subjects":[957],"documented":[959,2053,2078,2108],"suspected":[961,1052,1779,1834],"rather":[963],"than":[964,987,1486,2255],"issue":[967],"variable":[969],"responses":[971],"absence":[974],"arrhythmia.":[977,2636],"represented":[979],"clinically":[984,1802],"endpoint":[986],"alone,":[990],"viewed":[993],"imperfect":[996],"marker":[997],"risk.":[1000],"do":[1013],"introduce":[1014],"bias,":[1016],"i.e.":[1017],"selection,":[1018],"survivors.":[1020],"Therefore,":[1021],"agreed":[1024],"post-mortem":[1026],"should":[1028,1901,1950],"if":[1034,1249,2267,2439],"enough":[1035],"information":[1036,2146,2153,2272],"ECG":[1038,1493,1549,1603,2131,2242,2246],"prior":[1044],"upon":[1047],"initiation":[1049,1254],"culprit":[1053],"drug,":[1054,1773,2234],"supporting":[1056],"presence":[1058,1133,1164,1280,1936,1971],"TdP)":[1060],"establish":[1062],"available;":[1068],"noted":[1073],"cases\u2014prospective":[1076],"retrospective\u2014should":[1078],"submitted":[1080],"only":[1083,1517,1545,2513],"review":[1085],"physician":[1088],"(generally":[1089],"specialist/electrophysiologist)":[1092],"familiar":[1093,1597],"outlined":[1097,1339,2220],"here.":[1098],"causality":[1100,1188,1238],"assessment":[1101,1191,1239],"formally":[1104],"group.":[1112],"Clearly,":[1113],"drug-":[1115],"non-drug-induced":[1117],"aetiologies":[1118],"important.":[1122],"Attributing":[1123],"complicated":[1130],"causes,":[1139,1202],"underlying":[1141],"heart":[1142,2013],"disease,":[1143],"comedications,":[1144],"comorbid":[1145],"conditions":[1146],"(such":[1147],"hypokalaemia":[1149],"bradycardia),":[1151],"sudden":[1153],"death.":[1154],"took":[1157],"position":[1159],"even":[1161,1373],"conditions,":[1167],"administration":[1173],"suspect":[1176],"could":[1178,1341],"still":[1179],"Confirmation":[1185],"requires":[1189],"temporal":[1193,1244],"relationships,":[1194],"withdrawal":[1195],"exposure,":[1198,1286],"exclusion":[1199],"determination":[1205],"previous":[1208],"(or":[1215],"same":[1219],"class)":[1220],"question.":[1222],"Because":[1223,1348],"fatal":[1227,1988,2458],"TdP,":[1230,2235],"\u2018rechallenge\u2019":[1231],"aspect":[1236],"impractical.15":[1242],"relationship":[1245],"particularly":[1247,1538],"occurs":[1251],"therapy":[1257],"although":[1258,1920],"delayed":[1259],"\u2018late":[1261],"proarrhythmia\u2019":[1262],"quinidine":[1267],"non-cardiac":[1269],"drugs.16,17":[1270],"causal":[1272],"association":[1273],"strengthened":[1277],"least":[1289,1793,1881,2045],"partial":[1290,1794],"resolution":[1291,1795],"prolongation,":[1294],"THE":[1298],"cessation":[1299],"withdrawal.":[1304],"time":[1306,1889,2652],"course":[1307,1890],"will,":[1308],"dependent":[1311],"pharmacokinetic":[1314],"behaviour":[1315],"its":[1320,1714,1914,2563],"pharmacology":[1321,1894],"interactions":[1324],"ion":[1327],"channels.18":[1328],"analysis,":[1332],"using":[1335],"compared":[1343],"several":[1345],"control":[1346],"groups:":[1347],"rarity":[1351],"population-based":[1354],"controls":[1355,1389],"genome-wide":[1357,2395],"SNP":[1358],"freely":[1361],"available":[1362],"utilized":[1365],"fashion":[1369],"though":[1374],"there":[1375,1790],"history":[1380,2112],"available.17":[1387],"population":[1388],"matched":[1390],"age,":[1392],"gender,":[1393],"BMI,":[1394],"comorbidities;":[1396],"whom":[1399],"does":[1402],"result":[1404],"marked":[1406],"lengthening":[1407],"<500":[1413],"\u0394QTc":[1416],"<":[1417],"60":[1418],"relative":[1420],"baseline).":[1423],"focused":[1427],"did":[1433],"statistical":[1438],"design":[1439],"studies.":[1442],"characteristically":[1447],"preceded":[1448],"\u2018short-long-short\u2019":[1453,1682],"R\u2013R":[1454],"cycles":[1456],"(\u2018pause":[1457],"dependent\u2019":[1458],"phenomenon)":[1459],"prolongation.19,20":[1465],"Pause-dependent":[1466],"changes":[1467,1685],"morphology":[1470,1529],"late":[1472],"coupled":[1473],"ectopy":[1475],"features.21,22":[1479],"slower":[1483],"(160\u2013240":[1484],"b.p.m.)":[1485],"coarse":[1487],"VF.19,20Figure":[1488],"1":[1489,2270],"shows":[1490],"three":[1491],"surface":[1492],"recordings":[1494],"displays":[1500],"TdP-like":[1501],"characteristic":[1502],"\u2018twisting":[1503],"points\u2019,":[1506],"beat-to-beat":[1508],"slow":[1509],"shift":[1510],"QRS":[1513],"electrical":[1514],"axis;":[1515],"one":[1518,1546],"true":[1523],"not,":[1533],"always":[1535],"evident,":[1537],"when":[1539],"recorded":[1543],"two":[1548],"leads":[1550],"implantable":[1553],"cardiovertor":[1554],"defibrillator":[1555],"(ICD)":[1556],"stored":[1557],"electrograms.":[1558],"pause-dependent":[1560,2039],"severe":[1564,2126],"appear":[1569],"\u2018monomorphic\u2019":[1572],"TdP.23":[1577],"These":[1578],"diagnostic":[1579,2453],"difficulties":[1580],"reinforce":[1581],"need":[1583,2216],"documentation":[1585,1812,1865],"index":[1588],"event":[1590,1763],"adjudication":[1593],"physicians":[1596,1749],"nuances":[1600],"diagnosis.":[1604],"Surface":[1605],"ECGs":[1606,2229],"TdP.":[1612,1654],"(A)":[1613],"very":[1615],"short":[1616],"sinus":[1620,1694],"beat":[1621,1695],"subsequent":[1624,1987,2059],"ectopic":[1626],"(short":[1627],"coupling":[1628,1700],"interval;":[1629],"arrows)":[1630],"no":[1632,2117,2662,2688],"setting":[1637],"acute":[1640],"coronary":[1641],"(note":[1643],"elevated":[1644],"ST":[1645],"segment":[1646],"top":[1649],"lead).":[1650],"(B)":[1655],"An":[1656],"apparent":[1657],"recording":[1663,1674],"artefact,":[1664],"continued":[1668],"regular":[1669],"rhythm":[1670],"\u2018marching":[1671],"through\u2019":[1672],"(arrows).":[1675],"(C)":[1676],"cycle":[1683],"length":[1684],"initiation,":[1687],"long":[1689,1699,1979,2429],"last":[1693],"(star),":[1696],"interval.":[1701],"Based":[1702],"understanding":[1706],"features":[1710,2121],"factors,":[1716],"developed":[1719],"(Figure":[1727],"2).":[1728,1847],"identifies":[1731],"candidate":[1737],"patients,":[1738],"whether":[1739],"originate":[1741],"electronic":[1743],"records":[1745],"practising":[1748],"specialists.":[1752],"proposed":[1755,1859],"following:":[1759],"must":[1764,1813,2090],"occurred":[1766],"treatment":[1768],"amiodarone,":[1775],"and/or":[1776,2058,2074],"causing":[1781],"prolongation.":[1783],"Upon":[1784],"withdrawal,":[1786,1886],"abate":[1788],"significant":[1803],"opinion":[1806],"specialist.":[1810],"Arrhythmia":[1811,1898],"reviewed":[1815,2344],"appropriately":[1818],"experienced":[1819],"physician/electrophysiologist.":[1820],"Algorithm":[1821],"pointes.":[1829],"Three":[1830],"(A,":[1836],"B,":[1837],"C)":[1839],"defined":[1842,2033,2067,2098],"(see":[1843],"below":[1844],"Figure":[1846,2224],"A,":[1849],"typical":[1850],"documented,":[1853],"while":[1854],"B":[1855,2065],"C":[1857,2096],"categories":[1861],"increasingly":[1863],"incomplete":[1864],"illustrated.":[1867],"At":[1868],"times,":[1870],"had":[1873],"(as":[1877],"above)":[1878],"partially":[1882],"resolve":[1883],"drug.":[1897],"syncope":[1900,2115],"similarly":[1903],"resolve.":[1904],"Bazett":[1906],"QTcB":[1909],"retained":[1911],"established":[1915],"role":[1916],"practice,":[1919],"correction":[1922],"methods,":[1923],"Fridericia's":[1926],"(QTcF)":[1928],"required":[1931,2136,2141,2273],"needs.":[1934],"features,":[1939],"Tables":[1943],"2":[1944,2289],"3,":[1946],"documented.":[1952,2094],"includes":[1954],"transient":[1957],"exacerbating":[1958],"hypokalaemia,":[1962],"bradycardia,":[1963],"recent":[1965],"conversion":[1966],"AF,":[1968],"structural":[1973],"disease":[1975],"syndrome.":[1981],"outcomes":[1989],"acceptable":[1992,2266],"provided":[1993],"met.":[1997],"atrial":[2001],"measured":[2008],"manually":[2009],"stable":[2012],"rates":[2014],"averaging":[2018],"RR":[2022],"up":[2025],"10":[2027],"cycles.":[2029],"Phenotype":[2030,2064,2095],"\u2018classical":[2035],"DITdP\u2019":[2036,2070,2101],"onset":[2040,2081],"VT":[2043,2073],"(at":[2044],"five":[2046],"beats)":[2047],"without":[2056],"resuscitation":[2057],"VF":[2060,2075],"\u2018probable":[2069],"TDP":[2083],"seen.":[2087],"nonetheless":[2091],"\u2018possible":[2100],"sufficiently":[2109],"unexplained":[2114],"vagal":[2118],"neurological":[2120],"elicited":[2124],"(QTc":[2132],">550":[2133],"ms).":[2134],"Data":[2135,2140],"submission":[2139,2144,2275],"Further":[2145,2152],"requested":[2149,2156],"aWith":[2150,2157],"dates/times.":[2151,2158],"basis":[2161],"under":[2165],"investigation":[2166],"iSAEC.":[2169,2401],"However,":[2170],"we":[2171,2521,2551],"hope":[2172],"guidance":[2174],"researchers":[2182],"who":[2183,2493,2535],"individually":[2187],"within":[2189],"their":[2190,2580,2709],"own":[2191],"consortia\u2014standardization":[2192],"consortia":[2196],"meta-analysis.":[2206],"Submission":[2207],"meet":[2218],"above":[2221],"2,":[2225],"documenting":[2230],"any":[2237],"features.":[2240],"documentation,":[2243],"12-lead":[2245],"measurements":[2249],"registration":[2252],"lead":[2258],"ideal,":[2261],"single-lead":[2263],"tracings":[2264],"unambiguous.":[2268],"lists":[2271],"essential":[2277],"confirming":[2281],"whereas":[2284],"desirable":[2292],"essential.":[2295],"web-enabled":[2297],"tool":[2300],"rapidly":[2311],"efficiently":[2313],"information.":[2316],"2012\u201314":[2322],"work":[2323],"NIH/NCBI/EBI/PharmGKB":[2326],"create":[2328],"comprehensive,":[2330],"integrated":[2331],"safety-related":[2333],"near":[2337],"future.":[2338],"panel":[2348,2406],"led":[2351],"cochairs":[2354],"include":[2359],"exclude":[2361],"according":[2364],"act":[2372],"repository":[2375],"data.":[2377],"DNA":[2378],"aggregated":[2381],"central":[2384],"coordinating":[2386],"centre.":[2387],"accepted,":[2389],"entered":[2393],"characterization":[2396],"conjunction":[2398],"Rejection":[2402],"fed":[2409],"back":[2410],"reasons":[2412],"reporting":[2415],"physician.":[2416],"Any":[2417],"diagnosis":[2425],"enrolling":[2437],"clinician":[2438],"requested.":[2440],"Using":[2441],"approach,":[2444],"identified.":[2466],"creation":[2468],"necessary":[2474],"facilitating":[2476],"pharmacogenetic":[2481],"ultimate":[2485],"being":[2487],"developing":[2500],"Such":[2502],"\u2018personalized":[2503],"medicine\u2019":[2504],"seem":[2506],"distant":[2508],"goal,":[2509],"through":[2514],"effort":[2519],"make":[2522],"reality.":[2525],"thank":[2528,2697],"contributed":[2536],"manuscript,":[2539],"Sarah":[2541],"Mee,":[2542],"Aidan":[2543],"Power,":[2544],"Peter":[2545],"Shaw,":[2546],"Miriam":[2548],"Sturkenboom.":[2549],"Finally,":[2550],"indebted":[2553],"Events":[2559,2601],"(Isaec)":[2561],"member":[2564],"companies":[2565],"(Abbott,":[2566],"Amgen,":[2567],"Astra-Zeneca,":[2568],"Daiichi-":[2569],"Sankyo,":[2570],"GSK,":[2571],"Merck,":[2572,2621],"Novartis,":[2573],"Pfizer,":[2574],"Takeda,":[2575],"Trust)":[2578],"funding":[2581],"support":[2583],"work.":[2586],"Conflict":[2587],"interest:":[2589],"E.R.B.":[2590],"receives":[2591,2628],"fellowship":[2594],"funds":[2595],"Consortium,":[2602],"Biotronik":[2603],"Boston":[2605],"Scientific.":[2606],"C.J.":[2607],"cofounder":[2610],"Cellular":[2612],"Dynamics":[2613],"International,":[2614],"Inc.":[2615],"D.R.":[2616],"consultant":[2619,2640],"Sanofi,":[2622],"Dai-ichi-Sankyo,":[2623],"Vitae":[2625],"Pharmaceutical,":[2626],"royalities":[2629],"patent":[2632],"predict":[2634],"A.A.G.":[2637],"Xention":[2642],"Pharma":[2643],"Ltd.":[2644],"M.F.,":[2645],"S.B.,":[2646],"S.G.":[2648],"employed":[2650],"full":[2651],"financial":[2663,2689],"interests":[2664],"disclose.":[2666,2692],"views":[2668],"expressed":[2669],"authors":[2674,2694],"necessarily":[2678],"FDA.":[2682],"M.P.,":[2683],"S.K.,":[2684],"A.Y.":[2686],"conflicts":[2690],"wish":[2695],"following":[2699],"valuable":[2710],"input":[2711],"manuscript:":[2717],"Norman":[2718],"Stockbridge,":[2719],"MD,":[2720,2731],"PhD,":[2721],"Director,":[2722],"Division":[2723],"Cardiovascular":[2725],"Renal":[2727],"Products;":[2728],"Suchitra":[2729],"Balakrishnan,":[2730],"PhD;":[2732,2735],"John":[2733],"Koerner,":[2734],"Karen":[2736],"Hicks,":[2737],"MD;":[2738,2741,2744],"Shari":[2739],"Targum,":[2740],"Randall":[2742],"Brockman,":[2743],"Brian":[2746],"Lewis,":[2747],"MD.":[2748]},"counts_by_year":[{"year":2025,"cited_by_count":1},{"year":2024,"cited_by_count":2},{"year":2023,"cited_by_count":2},{"year":2022,"cited_by_count":1},{"year":2021,"cited_by_count":1},{"year":2020,"cited_by_count":2},{"year":2017,"cited_by_count":3},{"year":2016,"cited_by_count":1},{"year":2015,"cited_by_count":4},{"year":2014,"cited_by_count":7},{"year":2013,"cited_by_count":3},{"year":2012,"cited_by_count":1}],"updated_date":"2026-10-31T12:09:11.096373","created_date":"2016-06-24T00:00:00"}