{"id":"https://openalex.org/W2980194271","doi":"https://doi.org/10.1182/blood.v110.11.962.962","title":"Evaluating Mortality with Erythropoietic Stimulating Agents (ESAs) in the Nephrology Setting: The Distinction between Evaluating Trials That Measure Survival as a Primary or Secondary Efficacy Endpoint Versus a Safety Endpoint.","display_name":"Evaluating Mortality with Erythropoietic Stimulating Agents (ESAs) in the Nephrology Setting: The Distinction between Evaluating Trials That Measure Survival as a Primary or Secondary Efficacy Endpoint Versus a Safety Endpoint.","publication_year":2007,"publication_date":"2007-11-16","ids":{"openalex":"https://openalex.org/W2980194271","doi":"https://doi.org/10.1182/blood.v110.11.962.962","mag":"2980194271"},"language":"en","primary_location":{"id":"doi:10.1182/blood.v110.11.962.962","doi":"https://doi.org/10.1182/blood.v110.11.962.962","is_oa":false,"landing_page_url":"https://doi.org/10.1182/blood.v110.11.962.962","pdf_url":null,"source":{"id":"https://openalex.org/S200071133","display_name":"Blood","issn_l":"0006-4971","issn":["0006-4971","1528-0020"],"is_oa":false,"is_in_doaj":false,"is_core":true,"listed_in":["cwts-core","doyens","jufo-3","ki-jl-3","medline","norway-2"],"host_organization":"https://openalex.org/P4310320990","host_organization_name":"Elsevier BV","host_organization_lineage":["https://openalex.org/P4310320990"],"host_organization_lineage_names":["Elsevier BV"],"type":"journal"},"license":null,"license_id":null,"version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"Blood","raw_type":"journal-article"},"volume":null,"type":"article","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/A5067764177","display_name":"Sara E. Barnato","orcid":null,"observed_orcids":[]},"institutions":[{"id":"https://openalex.org/I111979921","display_name":"Northwestern University","ror":"https://ror.org/000e0be47","country_code":"US","type":"education","lineage":["https://openalex.org/I111979921"]}],"countries":["US"],"is_corresponding":true,"raw_author_name":"Sara E. Barnato","raw_affiliation_strings":["Northwestern University, McGaw Medical Center, Chicago, IL, USA"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Northwestern University, McGaw Medical Center, Chicago, IL, USA","institution_ids":["https://openalex.org/I111979921"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5101653484","display_name":"Charles L. Bennett","orcid":"https://orcid.org/0000-0003-2475-3915","observed_orcids":["https://orcid.org/0000-0003-2475-3915"]},"institutions":[{"id":"https://openalex.org/I111979921","display_name":"Northwestern University","ror":"https://ror.org/000e0be47","country_code":"US","type":"education","lineage":["https://openalex.org/I111979921"]}],"countries":["US"],"is_corresponding":false,"raw_author_name":"Charles L. Bennett","raw_affiliation_strings":["Northwestern University, Feinberg School of Medicine, Chicago, IL, USA"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Northwestern University, Feinberg School of Medicine, Chicago, IL, USA","institution_ids":["https://openalex.org/I111979921"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5037627687","display_name":"Kathleen M Elverman","orcid":null,"observed_orcids":[]},"institutions":[{"id":"https://openalex.org/I111979921","display_name":"Northwestern University","ror":"https://ror.org/000e0be47","country_code":"US","type":"education","lineage":["https://openalex.org/I111979921"]}],"countries":["US"],"is_corresponding":true,"raw_author_name":"Kathleen Elverman","raw_affiliation_strings":["Northwestern University, Feinberg School of Medicine, Chicago, IL, USA"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Northwestern University, Feinberg School of Medicine, Chicago, IL, USA","institution_ids":["https://openalex.org/I111979921"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5022205095","display_name":"Dennis Paul West","orcid":"https://orcid.org/0000-0002-9107-6697","observed_orcids":["https://orcid.org/0000-0002-9107-6697"]},"institutions":[{"id":"https://openalex.org/I111979921","display_name":"Northwestern University","ror":"https://ror.org/000e0be47","country_code":"US","type":"education","lineage":["https://openalex.org/I111979921"]}],"countries":["US"],"is_corresponding":true,"raw_author_name":"Dennis P. West","raw_affiliation_strings":["Northwestern University, Feinberg School of Medicine, Chicago, IL, USA"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Northwestern University, Feinberg School of Medicine, Chicago, IL, USA","institution_ids":["https://openalex.org/I111979921"]}]},{"author_position":"last","author":{"id":"https://openalex.org/A5113882158","display_name":"Mark J. Courtney","orcid":null,"observed_orcids":[]},"institutions":[{"id":"https://openalex.org/I111979921","display_name":"Northwestern University","ror":"https://ror.org/000e0be47","country_code":"US","type":"education","lineage":["https://openalex.org/I111979921"]}],"countries":["US"],"is_corresponding":true,"raw_author_name":"Mark Courtney","raw_affiliation_strings":["Northwestern University, Feinberg School of Medicine, Chicago, IL, USA"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Northwestern University, Feinberg School of Medicine, Chicago, IL, USA","institution_ids":["https://openalex.org/I111979921"]}]}],"institutions":[],"countries_distinct_count":1,"institutions_distinct_count":1,"corresponding_author_ids":["https://openalex.org/A5022205095","https://openalex.org/A5037627687","https://openalex.org/A5067764177","https://openalex.org/A5113882158"],"corresponding_institution_ids":["https://openalex.org/I111979921"],"apc_list":{"value":5500,"currency":"USD","value_usd":5500},"apc_paid":null,"fwci":0.0,"has_fulltext":false,"cited_by_count":0,"citation_normalized_percentile":{"value":0.41225322,"is_in_top_1_percent":false,"is_in_top_10_percent":false},"cited_by_percentile_year":null,"biblio":{"volume":"110","issue":"11","first_page":"962","last_page":"962"},"is_retracted":false,"is_paratext":false,"is_xpac":false,"primary_topic":{"id":"https://openalex.org/T11534","display_name":"Erythropoietin and Anemia Treatment","score":0.9994999766349792,"subfield":{"id":"https://openalex.org/subfields/2720","display_name":"Hematology"},"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/T11534","display_name":"Erythropoietin and Anemia Treatment","score":0.9994999766349792,"subfield":{"id":"https://openalex.org/subfields/2720","display_name":"Hematology"},"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":0.00019999999494757503,"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"}},{"id":"https://openalex.org/T12255","display_name":"Biosimilars and Bioanalytical Methods","score":0.0,"subfield":{"id":"https://openalex.org/subfields/2403","display_name":"Immunology"},"field":{"id":"https://openalex.org/fields/24","display_name":"Immunology and Microbiology"},"domain":{"id":"https://openalex.org/domains/1","display_name":"Life Sciences"}}],"keywords":[{"id":"https://openalex.org/keywords/erythropoiesis-stimulating-agents","display_name":"erythropoiesis-stimulating agents","score":0.9279999732971191},{"id":"https://openalex.org/keywords/mortality-risk","display_name":"mortality risk","score":0.597000002861023},{"id":"https://openalex.org/keywords/chronic-kidney-disease","display_name":"chronic kidney disease","score":0.7860000133514404},{"id":"https://openalex.org/keywords/anemia","display_name":"anemia","score":0.6819999814033508},{"id":"https://openalex.org/keywords/hemoglobin-target","display_name":"hemoglobin target","score":0.5289999842643738},{"id":"https://openalex.org/keywords/randomized-controlled-trials","display_name":"randomized controlled trials","score":0.6159999966621399},{"id":"https://openalex.org/keywords/safety-signals","display_name":"safety signals","score":0.5389999747276306},{"id":"https://openalex.org/keywords/bias-in-meta-analysis","display_name":"meta-analysis bias","score":0.4819999933242798},{"id":"https://openalex.org/keywords/survival-analysis","display_name":"survival analysis","score":0.30300000309944153},{"id":"https://openalex.org/keywords/adverse-drug-reactions","display_name":"adverse drug reactions","score":0.4880000054836273},{"id":"https://openalex.org/keywords/cancer-related-anemia","display_name":"cancer-related anemia","score":0.4909999966621399},{"id":"https://openalex.org/keywords/chemotherapy-induced-anemia","display_name":"chemotherapy-induced anemia","score":0.6330000162124634}],"concepts":[{"id":"https://openalex.org/C71924100","wikidata":"https://www.wikidata.org/wiki/Q11190","display_name":"Medicine","level":0,"score":0.8918440341949463},{"id":"https://openalex.org/C203092338","wikidata":"https://www.wikidata.org/wiki/Q1340863","display_name":"Clinical endpoint","level":3,"score":0.6918878555297852},{"id":"https://openalex.org/C126322002","wikidata":"https://www.wikidata.org/wiki/Q11180","display_name":"Internal medicine","level":1,"score":0.6791394352912903},{"id":"https://openalex.org/C82789193","wikidata":"https://www.wikidata.org/wiki/Q2142611","display_name":"Relative risk","level":3,"score":0.6128193736076355},{"id":"https://openalex.org/C168563851","wikidata":"https://www.wikidata.org/wiki/Q1436668","display_name":"Randomized controlled trial","level":2,"score":0.5844893455505371},{"id":"https://openalex.org/C2778248108","wikidata":"https://www.wikidata.org/wiki/Q5445","display_name":"Anemia","level":2,"score":0.5483598709106445},{"id":"https://openalex.org/C197934379","wikidata":"https://www.wikidata.org/wiki/Q2047938","display_name":"Adverse effect","level":2,"score":0.5337686538696289},{"id":"https://openalex.org/C535046627","wikidata":"https://www.wikidata.org/wiki/Q30612","display_name":"Clinical trial","level":2,"score":0.48236674070358276},{"id":"https://openalex.org/C44249647","wikidata":"https://www.wikidata.org/wiki/Q208498","display_name":"Confidence interval","level":2,"score":0.4655165672302246},{"id":"https://openalex.org/C141071460","wikidata":"https://www.wikidata.org/wiki/Q40821","display_name":"Surgery","level":1,"score":0.33187276124954224}],"mesh":[],"locations_count":1,"locations":[{"id":"doi:10.1182/blood.v110.11.962.962","doi":"https://doi.org/10.1182/blood.v110.11.962.962","is_oa":false,"landing_page_url":"https://doi.org/10.1182/blood.v110.11.962.962","pdf_url":null,"source":{"id":"https://openalex.org/S200071133","display_name":"Blood","issn_l":"0006-4971","issn":["0006-4971","1528-0020"],"is_oa":false,"is_in_doaj":false,"is_core":true,"listed_in":["cwts-core","doyens","jufo-3","ki-jl-3","medline","norway-2"],"host_organization":"https://openalex.org/P4310320990","host_organization_name":"Elsevier BV","host_organization_lineage":["https://openalex.org/P4310320990"],"host_organization_lineage_names":["Elsevier BV"],"type":"journal"},"license":null,"license_id":null,"version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"Blood","raw_type":"journal-article"}],"best_oa_location":null,"sustainable_development_goals":[{"id":"https://metadata.un.org/sdg/3","score":1.0,"display_name":"Good health and well-being"}],"sustainable_development_goals_aurora":[{"id":"https://metadata.un.org/sdg/3","score":0.8999999761581421,"display_name":"Good health and well-being"}],"study_designs":[{"id":"https://openalex.org/study-designs/systematic-review","display_name":"Systematic Review"}],"awards":[],"funders":[],"has_content":{"grobid_xml":false,"pdf":false},"content_urls":null,"referenced_works_count":0,"referenced_works":[],"related_works":["https://openalex.org/W2017438361","https://openalex.org/W4220709714","https://openalex.org/W4361215268","https://openalex.org/W4378417534","https://openalex.org/W2330883931","https://openalex.org/W4248813706","https://openalex.org/W2922115310","https://openalex.org/W1967183025","https://openalex.org/W4384701829","https://openalex.org/W2976934717"],"abstract_inverted_index":{"Abstract":[0],"Background:":[1],"At":[2],"ASCO":[3],"2007,":[4,34],"we":[5,124],"reported":[6,248],"increased":[7],"mortality":[8,60,172,229],"risks":[9],"when":[10,22,72],"ESAs":[11,80,231],"are":[12,19,26],"administered":[13],"to":[14,82,134,233],"anemic":[15,73],"cancer":[16],"patients":[17,44,74],"who":[18],"receiving":[20],"chemotherapy":[21],"target":[23],"hemoglobin":[24,84,235],"levels":[25,236],"beyond":[27],"the":[28,47,92,126,160,209,225,245,250,267,283,293],"correction":[29],"of":[30,37,57,64,116,121,151,208,228,292,311],"anemia.":[31],"In":[32,215],"February":[33],"a":[35,53,114,119,143,181,241,275,296,309,316,328,346,406],"meta-analysis":[36,162],"nine":[38],"randomized":[39,130,154,322],"clinical":[40,131,156],"trials":[41,132,157,256,304,323],"with":[42,75,201,230],"5,143":[43],"published":[45],"in":[46,153,159,249,260,282],"Lancet":[48,161,251],"[vol":[49],"369;":[50],"381\u201388]":[51],"identified":[52],"statistically":[54,297,317],"significant":[55,298,318],"risk":[56,62,227,247],"all":[58],"cause":[59],"(relative":[61],"(RR)":[63],"1.17,":[65],"95%":[66,189],"confidence":[67],"interval":[68],"(CI)":[69],"1.01,":[70],"1.35)":[71],"chronic":[76],"kidney":[77],"disease":[78],"received":[79],"targeted":[81,232],"higher":[83,234],"concentrations":[85],"(120\u2013150":[86],"g/L).":[87],"A":[88],"recent":[89],"report":[90],"from":[91,193],"RADAR":[93],"(Research":[94],"against":[95],"Adverse":[96],"Drug":[97],"Reactions)":[98],"group":[99],"raises":[100],"concern":[101],"that":[102,262,305,324],"survival":[103,110,138,218,287],"analyses":[104],"might":[105],"differ":[106],"depending":[107],"on":[108,170],"whether":[109,135],"was":[111,139,219,237,288,301],"evaluated":[112],"as":[113,142,175,180,221,274,290,308,327,345,405],"measure":[115,120,270,281,310,330],"efficacy":[117,147,177,223,279,294,350],"versus":[118],"safety.":[122],"Herein,":[123],"re-analyze":[125],"data":[127],"by":[128,206],"evaluating":[129],"according":[133],"or":[136,145,179,277,348],"not":[137,314,438],"prospectively":[140,272],"included":[141,158,259,273,289,306,344,403],"primary":[144,276,347],"secondary":[146,278,349],"outcome.":[148,183],"Methods:":[149],"Risks":[150],"death":[152],"controlled":[155,255],"were":[163,191],"evaluated.":[164],"We":[165],"classified":[166],"those":[167],"studies":[168,216],"based":[169],"their":[171],"outcomes,":[173],"either":[174],"an":[176,222],"outcome":[178,280,351],"safety":[182,269,299,312,319,329,336,407],"Effect":[184],"estimates":[185],"for":[186],"RR":[187,340],"and":[188,204,211,333],"CI":[190],"derived":[192],"Stata":[194],"(version":[195],"9.1,":[196],"College":[197],"Station,":[198],"TX),":[199],"calculated":[200],"random-effects":[202],"models":[203],"pooled":[205],"use":[207],"Dersimonian":[210],"Laird":[212],"method.":[213],"Results:":[214],"where":[217],"measured":[220],"endpoint,":[224],"relative":[226,246],"1.27":[238,399],"(1.08,":[239,400],"1.49),":[240],"number":[242],"greater":[243],"than":[244],"meta-analysis.":[252],"Conclusions:":[253],"Randomized":[254,303],"should":[257],"be":[258],"meta-analyses":[261],"evaluate":[263],"harms":[264,307,326],"only":[265,404],"if":[266],"relevant":[268],"is":[271],"study":[284],"protocol.":[285],"When":[286],"part":[291],"analysis,":[295],"signal":[300],"present.":[302],"did":[313],"present":[315],"signal.":[320],"Including":[321],"include":[325],"introduce":[331],"noise":[332],"can":[334],"mask":[335],"signals.":[337],"Studies:":[338],"Events:":[339],"(95%":[341],"CI)":[342],"Survival":[343,402],"measure:":[352,408],"High":[353,409],"vs":[354,362,371,380,389,397,410,418,427,436,444,453,462,470],"Low":[355,411],"Hb":[356,412],"Target:":[357,413],"Besarab":[358],"1998":[359],"(n=1233)":[360],"183/618":[361],"150/615":[363],"1.21":[364],"(1.01,":[365],"1.46)":[366],"Gouva":[367],"2004":[368],"(n=88)":[369],"4/43":[370],"3/45":[372],"1.40":[373],"(0.33,":[374],"5.87)":[375],"Drueke":[376],"2006":[377,386,459],"(n=602)":[378],"31/300":[379],"21/302":[381],"1.49":[382],"(0.87,":[383],"2.53)":[384],"Singh":[385],"(n=1432)":[387],"52/715":[388],"36/717":[390],"1.45":[391],"(0.96,":[392],"2.19)":[393],"Subtotal":[394,467],"(n=3355)":[395],"270/1676":[396],"210/1679":[398],"1.49)":[401],"Foley":[414],"2000":[415],"(n=146)":[416],"4/73":[417],"3/73":[419],"1.33":[420],"(0.31,":[421],"5.75)":[422],"Furuland":[423],"2003":[424],"(n=416)":[425],"29/216":[426],"27/200":[428],"0.99":[429],"(0.61,":[430],"1.62)":[431],"Roger":[432],"2005":[433,441,450],"(n=154)":[434],"0/75":[435],"0/79":[437],"estimable":[439],"Levin":[440],"(n=152)":[442],"1/74":[443],"3/78":[445],"0.35":[446],"(0.04,":[447],"3.30)":[448],"Parfrey":[449],"(n=696)":[451],"12/396":[452],"20/300":[454],"0.45":[455],"(0.23,":[456],"0.92)":[457],"Rossert":[458],"(n=390)":[460],"1/195":[461],"6/195":[463],"0.17":[464],"(0.02,":[465],"1.37)":[466],"(n=1954)":[468],"47/1029":[469],"59/925":[471],"0.67":[472],"(0.37,":[473],"1.19)":[474]},"counts_by_year":[],"updated_date":"2026-09-27T08:07:27.782135","created_date":"2025-10-10T00:00:00"}