{"id":"https://openalex.org/W2965553368","doi":"https://doi.org/10.1200/jco.2013.31.15_suppl.6583","title":"Integration of patient-reported adverse events into a phase II chemotherapy treatment trial.","display_name":"Integration of patient-reported adverse events into a phase II chemotherapy treatment trial.","publication_year":2013,"publication_date":"2013-05-20","ids":{"openalex":"https://openalex.org/W2965553368","doi":"https://doi.org/10.1200/jco.2013.31.15_suppl.6583","mag":"2965553368"},"language":"en","primary_location":{"id":"doi:10.1200/jco.2013.31.15_suppl.6583","doi":"https://doi.org/10.1200/jco.2013.31.15_suppl.6583","is_oa":false,"landing_page_url":"https://doi.org/10.1200/jco.2013.31.15_suppl.6583","pdf_url":null,"source":{"id":"https://openalex.org/S15137598","display_name":"Journal of Clinical Oncology","issn_l":"0732-183X","issn":["0732-183X","1527-7755"],"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/P4310315671","host_organization_name":"Lippincott Williams & Wilkins","host_organization_lineage":["https://openalex.org/P4310315671","https://openalex.org/P4310318547"],"host_organization_lineage_names":["Lippincott Williams & Wilkins","Wolters Kluwer"],"type":"journal"},"license":null,"license_id":null,"version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"Journal of Clinical Oncology","raw_type":"journal-article"},"volume":null,"type":"conference-abstract","indexed_in":["crossref"],"open_access":{"is_oa":false,"oa_status":"closed","oa_url":null,"any_repository_has_fulltext":false},"authorships":[{"author_position":"first","author":{"id":"https://openalex.org/A5091400921","display_name":"Ethan Basch","orcid":"https://orcid.org/0000-0003-3813-9318","observed_orcids":["https://orcid.org/0000-0003-3813-9318"]},"institutions":[{"id":"https://openalex.org/I114027177","display_name":"University of North Carolina at Chapel Hill","ror":"https://ror.org/0130frc33","country_code":"US","type":"education","lineage":["https://openalex.org/I114027177"]}],"countries":["US"],"is_corresponding":false,"raw_author_name":"Ethan M. Basch","raw_affiliation_strings":["The University of North Carolina at Chapel Hill, Chapel Hill, NC"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"The University of North Carolina at Chapel Hill, Chapel Hill, NC","institution_ids":["https://openalex.org/I114027177"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5068743826","display_name":"Maria Catherine Pietanza","orcid":"https://orcid.org/0000-0002-5663-661X","observed_orcids":["https://orcid.org/0000-0002-5663-661X"]},"institutions":[{"id":"https://openalex.org/I1334819555","display_name":"Memorial Sloan Kettering Cancer Center","ror":"https://ror.org/02yrq0923","country_code":"US","type":"healthcare","lineage":["https://openalex.org/I1334819555"]}],"countries":["US"],"is_corresponding":false,"raw_author_name":"Maria Catherine Pietanza","raw_affiliation_strings":["Memorial Sloan-Kettering Cancer Center, New York, NY"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Memorial Sloan-Kettering Cancer Center, New York, NY","institution_ids":["https://openalex.org/I1334819555"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5039791495","display_name":"Mark G. Kris","orcid":"https://orcid.org/0000-0002-7317-5341","observed_orcids":["https://orcid.org/0000-0002-7317-5341"]},"institutions":[{"id":"https://openalex.org/I1334819555","display_name":"Memorial Sloan Kettering Cancer Center","ror":"https://ror.org/02yrq0923","country_code":"US","type":"healthcare","lineage":["https://openalex.org/I1334819555"]}],"countries":["US"],"is_corresponding":false,"raw_author_name":"Mark G. Kris","raw_affiliation_strings":["Memorial Sloan-Kettering Cancer Center, New York, NY"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Memorial Sloan-Kettering Cancer Center, New York, NY","institution_ids":["https://openalex.org/I1334819555"]}]},{"author_position":"middle","author":{"id":null,"display_name":"Mary Shaw","orcid":null,"observed_orcids":[]},"institutions":[{"id":"https://openalex.org/I1334819555","display_name":"Memorial Sloan Kettering Cancer Center","ror":"https://ror.org/02yrq0923","country_code":"US","type":"healthcare","lineage":["https://openalex.org/I1334819555"]}],"countries":["US"],"is_corresponding":false,"raw_author_name":"Mary Shaw","raw_affiliation_strings":["Memorial Sloan-Kettering Cancer Center, New York, NY"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Memorial Sloan-Kettering Cancer Center, New York, NY","institution_ids":["https://openalex.org/I1334819555"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5008675566","display_name":"Camelia S. Sima","orcid":null,"observed_orcids":[]},"institutions":[{"id":"https://openalex.org/I1334819555","display_name":"Memorial Sloan Kettering Cancer Center","ror":"https://ror.org/02yrq0923","country_code":"US","type":"healthcare","lineage":["https://openalex.org/I1334819555"]}],"countries":["US"],"is_corresponding":false,"raw_author_name":"Camelia S. Sima","raw_affiliation_strings":["Department of Epidemiology and Biostatistics, Memorial Sloan-Kettering Cancer Center, New York, NY"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Department of Epidemiology and Biostatistics, Memorial Sloan-Kettering Cancer Center, New York, NY","institution_ids":["https://openalex.org/I1334819555"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5069643040","display_name":"Lauren J. Rogak","orcid":"https://orcid.org/0009-0009-9430-2256","observed_orcids":["https://orcid.org/0009-0009-9430-2256","https://orcid.org/0000-0002-6415-1575"]},"institutions":[{"id":"https://openalex.org/I1334819555","display_name":"Memorial Sloan Kettering Cancer Center","ror":"https://ror.org/02yrq0923","country_code":"US","type":"healthcare","lineage":["https://openalex.org/I1334819555"]}],"countries":["US"],"is_corresponding":false,"raw_author_name":"Lauren J. Rogak","raw_affiliation_strings":["Memorial Sloan-Kettering Cancer Center, New York, NY"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Memorial Sloan-Kettering Cancer Center, New York, NY","institution_ids":["https://openalex.org/I1334819555"]}]},{"author_position":"last","author":{"id":"https://openalex.org/A5088893766","display_name":"Deborah Schrag","orcid":"https://orcid.org/0000-0002-4334-5717","observed_orcids":["https://orcid.org/0000-0002-4334-5717"]},"institutions":[{"id":"https://openalex.org/I4210117453","display_name":"Dana-Farber Cancer Institute","ror":"https://ror.org/02jzgtq86","country_code":"US","type":"facility","lineage":["https://openalex.org/I4210117453"]}],"countries":["US"],"is_corresponding":false,"raw_author_name":"Deborah Schrag","raw_affiliation_strings":["Dana-Farber Cancer Institute, Boston, MA"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Dana-Farber Cancer Institute, Boston, MA","institution_ids":["https://openalex.org/I4210117453"]}]}],"institutions":[],"countries_distinct_count":1,"institutions_distinct_count":3,"corresponding_author_ids":[],"corresponding_institution_ids":[],"apc_list":null,"apc_paid":null,"fwci":null,"has_fulltext":false,"cited_by_count":0,"citation_normalized_percentile":null,"cited_by_percentile_year":null,"biblio":{"volume":"31","issue":"15_suppl","first_page":"6583","last_page":"6583"},"is_retracted":false,"is_paratext":false,"is_xpac":false,"primary_topic":{"id":"https://openalex.org/T11943","display_name":"Pharmacovigilance and Adverse Drug Reactions","score":0.5669000148773193,"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"}},"topics":[{"id":"https://openalex.org/T11943","display_name":"Pharmacovigilance and Adverse Drug Reactions","score":0.5669000148773193,"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/T10178","display_name":"Cancer survivorship and care","score":0.31029999256134033,"subfield":{"id":"https://openalex.org/subfields/2730","display_name":"Oncology"},"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/T11235","display_name":"Statistical Methods in Clinical Trials","score":0.04340000078082085,"subfield":{"id":"https://openalex.org/subfields/2613","display_name":"Statistics and Probability"},"field":{"id":"https://openalex.org/fields/26","display_name":"Mathematics"},"domain":{"id":"https://openalex.org/domains/3","display_name":"Physical Sciences"}}],"keywords":[{"id":"https://openalex.org/keywords/patient-reported-side-effects","display_name":"patient-reported adverse events","score":0.9990000128746033},{"id":"https://openalex.org/keywords/chemotherapy-toxicity","display_name":"chemotherapy toxicity","score":0.7480000257492065},{"id":"https://openalex.org/keywords/non-small-cell-lung-cancer","display_name":"non-small cell lung cancer","score":0.7940000295639038},{"id":"https://openalex.org/keywords/paclitaxel","display_name":"paclitaxel","score":0.8809999823570251},{"id":"https://openalex.org/keywords/pemetrexed","display_name":"pemetrexed","score":1.0},{"id":"https://openalex.org/keywords/bevacizumab","display_name":"bevacizumab","score":1.0},{"id":"https://openalex.org/keywords/toxicity-grading","display_name":"toxicity grading","score":0.5170000195503235}],"concepts":[{"id":"https://openalex.org/C71924100","wikidata":"https://www.wikidata.org/wiki/Q11190","display_name":"Medicine","level":0,"score":0.9429198503494263},{"id":"https://openalex.org/C2777793932","wikidata":"https://www.wikidata.org/wiki/Q1116229","display_name":"Common Terminology Criteria for Adverse Events","level":3,"score":0.7403703927993774},{"id":"https://openalex.org/C197934379","wikidata":"https://www.wikidata.org/wiki/Q2047938","display_name":"Adverse effect","level":2,"score":0.6909551024436951},{"id":"https://openalex.org/C2777802072","wikidata":"https://www.wikidata.org/wiki/Q413299","display_name":"Bevacizumab","level":3,"score":0.5288166999816895},{"id":"https://openalex.org/C535046627","wikidata":"https://www.wikidata.org/wiki/Q30612","display_name":"Clinical trial","level":2,"score":0.4891858398914337},{"id":"https://openalex.org/C2776135927","wikidata":"https://www.wikidata.org/wiki/Q5242559","display_name":"Referral","level":2,"score":0.46300533413887024},{"id":"https://openalex.org/C2778336483","wikidata":"https://www.wikidata.org/wiki/Q5090632","display_name":"Chemotherapy regimen","level":3,"score":0.41132238507270813},{"id":"https://openalex.org/C2776256026","wikidata":"https://www.wikidata.org/wiki/Q47912","display_name":"Lung cancer","level":2,"score":0.4101518988609314},{"id":"https://openalex.org/C121608353","wikidata":"https://www.wikidata.org/wiki/Q12078","display_name":"Cancer","level":2,"score":0.3794165849685669},{"id":"https://openalex.org/C2776694085","wikidata":"https://www.wikidata.org/wiki/Q974135","display_name":"Chemotherapy","level":2,"score":0.3584918975830078},{"id":"https://openalex.org/C187212893","wikidata":"https://www.wikidata.org/wiki/Q123028","display_name":"Pediatrics","level":1,"score":0.35064762830734253},{"id":"https://openalex.org/C126322002","wikidata":"https://www.wikidata.org/wiki/Q11180","display_name":"Internal medicine","level":1,"score":0.3366723656654358},{"id":"https://openalex.org/C512399662","wikidata":"https://www.wikidata.org/wiki/Q3505712","display_name":"Family medicine","level":1,"score":0.2321723997592926}],"mesh":[],"locations_count":1,"locations":[{"id":"doi:10.1200/jco.2013.31.15_suppl.6583","doi":"https://doi.org/10.1200/jco.2013.31.15_suppl.6583","is_oa":false,"landing_page_url":"https://doi.org/10.1200/jco.2013.31.15_suppl.6583","pdf_url":null,"source":{"id":"https://openalex.org/S15137598","display_name":"Journal of Clinical Oncology","issn_l":"0732-183X","issn":["0732-183X","1527-7755"],"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/P4310315671","host_organization_name":"Lippincott Williams & Wilkins","host_organization_lineage":["https://openalex.org/P4310315671","https://openalex.org/P4310318547"],"host_organization_lineage_names":["Lippincott Williams & Wilkins","Wolters Kluwer"],"type":"journal"},"license":null,"license_id":null,"version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"Journal of Clinical Oncology","raw_type":"journal-article"}],"best_oa_location":null,"sustainable_development_goals":[{"display_name":"Good health and well-being","id":"https://metadata.un.org/sdg/3","score":1.0}],"study_designs":[],"awards":[],"funders":[],"has_content":{"pdf":false,"grobid_xml":false},"content_urls":null,"referenced_works_count":0,"referenced_works":[],"related_works":["https://openalex.org/W2118638289","https://openalex.org/W3036687020","https://openalex.org/W2588457571","https://openalex.org/W2586059174","https://openalex.org/W2339024595","https://openalex.org/W2160182926","https://openalex.org/W2906588083","https://openalex.org/W4293222009","https://openalex.org/W1600079158","https://openalex.org/W2597543786"],"abstract_inverted_index":{"6583":[0],"Background:":[1],"It":[2,28],"has":[3],"been":[4],"shown":[5],"that":[6,20,24],"patient":[7,185,252,305],"reporting":[8,156,306],"of":[9,77,130,152,176,181,191,240,246,269,281,296,302,313],"symptomatic":[10],"adverse":[11],"events":[12],"(AEs)":[13],"is":[14,29,35,321],"feasible":[15,36,322],"during":[16],"routine":[17],"chemotherapy,":[18],"and":[19,80,154,243,254,284,334],"patients":[21,153,213,267],"report":[22],"AEs":[23,146,157,200,236,315],"clinicians":[25,42,53,124,155,244,264,303],"otherwise":[26],"miss.":[27],"not":[30],"known":[31],"if":[32,52],"this":[33,337],"approach":[34],"in":[37,71,107,194,292,323],"a":[38,72,165,324],"treatment":[39],"trial;":[40],"whether":[41],"will":[43,54],"agree":[44,126,328],"or":[45,51,127],"disagree":[46],"with":[47,64,163,184,266,329],"patent-reported":[48],"AE":[49,60,332],"grades;":[50],"take":[55],"actions":[56,193,289],"based":[57],"on":[58,336],"patients'":[59],"reports.":[61],"Methods:":[62],"Patients":[63,234],"advanced":[65],"non-small":[66],"cell":[67],"lung":[68],"cancer":[69],"enrolling":[70],"single-arm":[73],"phase":[74],"2":[75],"trial":[76],"paclitaxel,":[78],"pemetrexed,":[79],"bevacizumab":[81],"at":[82,158,171,237,316],"Memorial":[83],"Sloan-Kettering":[84],"Cancer":[85],"Center":[86],"(NCT00807573)":[87],"reported":[88,145,235],"13":[89],"validated":[90],"plain":[91],"language":[92],"questions":[93],"adapted":[94],"from":[95],"the":[96,131,139,143,148,177,241,247,270,278,282],"NCI's":[97],"Common":[98],"Terminology":[99],"Criteria":[100],"for":[101,147],"Adverse":[102],"Events":[103],"(CTCAE),":[104],"via":[105,122,319],"iPads":[106],"waiting":[108],"areas":[109],"before":[110],"each":[111,129,159],"visit.":[112],"Patients\u2019":[113],"grades":[114,186,333],"were":[115,135,214,290],"transmitted":[116,137],"to":[117,138,173,196,275,294],"an":[118,164],"investigator":[119],"web":[120],"page":[121],"which":[123,134],"could":[125],"reassign":[128],"CTCAE":[132],"grades,":[133],"then":[136],"institutional":[140],"database":[141],"as":[142],"official":[144],"trial.":[149,326],"The":[150,179,189],"proportion":[151],"visit":[160],"was":[161,187,201,257],"tabulated":[162],"priori":[166],"average":[167],"compliance":[168],"threshold":[169],"set":[170],"75%":[172],"conclude":[174],"feasibility":[175],"approach.":[178],"rate":[180],"clinician":[182,255],"agreement":[183],"computed.":[188],"frequency":[190],"clinical":[192],"response":[195,293],"patient-reported":[197,297,314],"grade":[198,279,298],"3/4":[199,299],"calculated":[202],"(ie,":[203],"chemotherapy":[204,325],"dose":[205],"modification,":[206],"ER":[207],"referral,":[208],"supportive":[209],"medication).":[210],"Results:":[211],"44":[212],"enrolled":[215],"between":[216,251],"1/09-9/11":[217],"(mean":[218],"age":[219],"59;":[220],"50%":[221],"female;":[222],"93%":[223,268],"white),":[224],"encompassing":[225],"721":[226],"total":[227],"clinic":[228,317],"visits":[229,238,318],"(median":[230],"10;":[231],"range":[232],"1-65).":[233],"99.6%":[239],"time":[242,250,271,283],"98.7%":[245],"time.":[248],"Median":[249],"self-reports":[253],"reviews":[256],"1":[258],"hour":[259],"(range":[260],"0.2-18).":[261],"Across":[262],"symptoms,":[263],"agreed":[265],"(weighted":[272],"kappas":[273],".83":[274],".92),":[276],"increasing":[277],"5%":[280],"decreasing":[285],"it":[286],"2%.":[287],"Clinical":[288],"taken":[291],"67%":[295],"AEs.":[300],"71%":[301],"stated":[304],"informed":[307],"their":[308],"toxicity":[309],"grading.":[310],"Conclusions:":[311],"Collection":[312],"computer":[320],"Clinicians":[327],"patients\u2019":[330],"self-reported":[331],"act":[335],"information.":[338]},"counts_by_year":[],"updated_date":"2026-09-29T14:09:16.559479","created_date":"2019-08-13T00:00:00"}
