Cardiovascular adverse events in oncology trials: understanding and appreciating the differences between clinical trial data and real-world reports

Abstract Reports of cardiac adverse events from oncology clinical trials often are at variance with reports derived from clinical observations or data-base reviews. These differences may lead to confusion, as different levels of risks abound in the literature, and the true cardiac risk of using some...
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Autor*in:	Ewer, Michael S. [verfasserIn] Herson, Jay

Format:	E-Artikel
Sprache:	Englisch

Erschienen:	2022

Schlagwörter:	Clinical trial adverse event rates Post-approval event rates Reconciliation of event rate discrepancies Disproportionality analysis Pharmacoepidemiology

Anmerkung:	© The Author(s) 2022

Übergeordnetes Werk:	Enthalten in: Cardio-Oncology - [London] : BioMed Central, 2015, 8(2022), 1 vom: 19. Juli
Übergeordnetes Werk:	volume:8 ; year:2022 ; number:1 ; day:19 ; month:07

Links:	Volltext

DOI / URN:	10.1186/s40959-022-00139-w

Katalog-ID:	SPR050866958

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520			\|a Abstract Reports of cardiac adverse events from oncology clinical trials often are at variance with reports derived from clinical observations or data-base reviews. These differences may lead to confusion, as different levels of risks abound in the literature, and the true cardiac risk of using some agents is uncertain. Additionally, such discrepancies may lead to the creation of over-cautious surveillance algorithms. Reasons for these reported differences are complex and often reflect subtleties in the criteria for individual patient evaluation. Both clinical trial data and real-world data have potential flaws that make reconciliation problematic. Importantly, however, both provide crucial information regarding the risk of adverse events. Major factors contribute to these differences including different tools used to diagnose events, and how those tools are interpreted. Additionally, differences in the populations of clinical trial participants and real-world populations play a crucial role. This paper looks at these differences and provides a perspective intended to help clinicians interpret reported variations in event rates derived from highly scrutinized clinical trials and broader real-world data.
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allfields	10.1186/s40959-022-00139-w doi (DE-627)SPR050866958 (SPR)s40959-022-00139-w-e DE-627 ger DE-627 rakwb eng Ewer, Michael S. verfasserin aut Cardiovascular adverse events in oncology trials: understanding and appreciating the differences between clinical trial data and real-world reports 2022 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © The Author(s) 2022 Abstract Reports of cardiac adverse events from oncology clinical trials often are at variance with reports derived from clinical observations or data-base reviews. These differences may lead to confusion, as different levels of risks abound in the literature, and the true cardiac risk of using some agents is uncertain. Additionally, such discrepancies may lead to the creation of over-cautious surveillance algorithms. Reasons for these reported differences are complex and often reflect subtleties in the criteria for individual patient evaluation. Both clinical trial data and real-world data have potential flaws that make reconciliation problematic. Importantly, however, both provide crucial information regarding the risk of adverse events. Major factors contribute to these differences including different tools used to diagnose events, and how those tools are interpreted. Additionally, differences in the populations of clinical trial participants and real-world populations play a crucial role. This paper looks at these differences and provides a perspective intended to help clinicians interpret reported variations in event rates derived from highly scrutinized clinical trials and broader real-world data. Clinical trial adverse event rates (dpeaa)DE-He213 Post-approval event rates (dpeaa)DE-He213 Reconciliation of event rate discrepancies (dpeaa)DE-He213 Disproportionality analysis (dpeaa)DE-He213 Pharmacoepidemiology (dpeaa)DE-He213 Herson, Jay aut Enthalten in Cardio-Oncology [London] : BioMed Central, 2015 8(2022), 1 vom: 19. Juli (DE-627)844073377 (DE-600)2842786-5 2057-3804 nnns volume:8 year:2022 number:1 day:19 month:07 https://dx.doi.org/10.1186/s40959-022-00139-w kostenfrei Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2014 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 8 2022 1 19 07
spelling	10.1186/s40959-022-00139-w doi (DE-627)SPR050866958 (SPR)s40959-022-00139-w-e DE-627 ger DE-627 rakwb eng Ewer, Michael S. verfasserin aut Cardiovascular adverse events in oncology trials: understanding and appreciating the differences between clinical trial data and real-world reports 2022 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © The Author(s) 2022 Abstract Reports of cardiac adverse events from oncology clinical trials often are at variance with reports derived from clinical observations or data-base reviews. These differences may lead to confusion, as different levels of risks abound in the literature, and the true cardiac risk of using some agents is uncertain. Additionally, such discrepancies may lead to the creation of over-cautious surveillance algorithms. Reasons for these reported differences are complex and often reflect subtleties in the criteria for individual patient evaluation. Both clinical trial data and real-world data have potential flaws that make reconciliation problematic. Importantly, however, both provide crucial information regarding the risk of adverse events. Major factors contribute to these differences including different tools used to diagnose events, and how those tools are interpreted. Additionally, differences in the populations of clinical trial participants and real-world populations play a crucial role. This paper looks at these differences and provides a perspective intended to help clinicians interpret reported variations in event rates derived from highly scrutinized clinical trials and broader real-world data. Clinical trial adverse event rates (dpeaa)DE-He213 Post-approval event rates (dpeaa)DE-He213 Reconciliation of event rate discrepancies (dpeaa)DE-He213 Disproportionality analysis (dpeaa)DE-He213 Pharmacoepidemiology (dpeaa)DE-He213 Herson, Jay aut Enthalten in Cardio-Oncology [London] : BioMed Central, 2015 8(2022), 1 vom: 19. Juli (DE-627)844073377 (DE-600)2842786-5 2057-3804 nnns volume:8 year:2022 number:1 day:19 month:07 https://dx.doi.org/10.1186/s40959-022-00139-w kostenfrei Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2014 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 8 2022 1 19 07
allfields_unstemmed	10.1186/s40959-022-00139-w doi (DE-627)SPR050866958 (SPR)s40959-022-00139-w-e DE-627 ger DE-627 rakwb eng Ewer, Michael S. verfasserin aut Cardiovascular adverse events in oncology trials: understanding and appreciating the differences between clinical trial data and real-world reports 2022 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © The Author(s) 2022 Abstract Reports of cardiac adverse events from oncology clinical trials often are at variance with reports derived from clinical observations or data-base reviews. These differences may lead to confusion, as different levels of risks abound in the literature, and the true cardiac risk of using some agents is uncertain. Additionally, such discrepancies may lead to the creation of over-cautious surveillance algorithms. Reasons for these reported differences are complex and often reflect subtleties in the criteria for individual patient evaluation. Both clinical trial data and real-world data have potential flaws that make reconciliation problematic. Importantly, however, both provide crucial information regarding the risk of adverse events. Major factors contribute to these differences including different tools used to diagnose events, and how those tools are interpreted. Additionally, differences in the populations of clinical trial participants and real-world populations play a crucial role. This paper looks at these differences and provides a perspective intended to help clinicians interpret reported variations in event rates derived from highly scrutinized clinical trials and broader real-world data. Clinical trial adverse event rates (dpeaa)DE-He213 Post-approval event rates (dpeaa)DE-He213 Reconciliation of event rate discrepancies (dpeaa)DE-He213 Disproportionality analysis (dpeaa)DE-He213 Pharmacoepidemiology (dpeaa)DE-He213 Herson, Jay aut Enthalten in Cardio-Oncology [London] : BioMed Central, 2015 8(2022), 1 vom: 19. Juli (DE-627)844073377 (DE-600)2842786-5 2057-3804 nnns volume:8 year:2022 number:1 day:19 month:07 https://dx.doi.org/10.1186/s40959-022-00139-w kostenfrei Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2014 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 8 2022 1 19 07
allfieldsGer	10.1186/s40959-022-00139-w doi (DE-627)SPR050866958 (SPR)s40959-022-00139-w-e DE-627 ger DE-627 rakwb eng Ewer, Michael S. verfasserin aut Cardiovascular adverse events in oncology trials: understanding and appreciating the differences between clinical trial data and real-world reports 2022 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © The Author(s) 2022 Abstract Reports of cardiac adverse events from oncology clinical trials often are at variance with reports derived from clinical observations or data-base reviews. These differences may lead to confusion, as different levels of risks abound in the literature, and the true cardiac risk of using some agents is uncertain. Additionally, such discrepancies may lead to the creation of over-cautious surveillance algorithms. Reasons for these reported differences are complex and often reflect subtleties in the criteria for individual patient evaluation. Both clinical trial data and real-world data have potential flaws that make reconciliation problematic. Importantly, however, both provide crucial information regarding the risk of adverse events. Major factors contribute to these differences including different tools used to diagnose events, and how those tools are interpreted. Additionally, differences in the populations of clinical trial participants and real-world populations play a crucial role. This paper looks at these differences and provides a perspective intended to help clinicians interpret reported variations in event rates derived from highly scrutinized clinical trials and broader real-world data. Clinical trial adverse event rates (dpeaa)DE-He213 Post-approval event rates (dpeaa)DE-He213 Reconciliation of event rate discrepancies (dpeaa)DE-He213 Disproportionality analysis (dpeaa)DE-He213 Pharmacoepidemiology (dpeaa)DE-He213 Herson, Jay aut Enthalten in Cardio-Oncology [London] : BioMed Central, 2015 8(2022), 1 vom: 19. Juli (DE-627)844073377 (DE-600)2842786-5 2057-3804 nnns volume:8 year:2022 number:1 day:19 month:07 https://dx.doi.org/10.1186/s40959-022-00139-w kostenfrei Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2014 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 8 2022 1 19 07
allfieldsSound	10.1186/s40959-022-00139-w doi (DE-627)SPR050866958 (SPR)s40959-022-00139-w-e DE-627 ger DE-627 rakwb eng Ewer, Michael S. verfasserin aut Cardiovascular adverse events in oncology trials: understanding and appreciating the differences between clinical trial data and real-world reports 2022 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © The Author(s) 2022 Abstract Reports of cardiac adverse events from oncology clinical trials often are at variance with reports derived from clinical observations or data-base reviews. These differences may lead to confusion, as different levels of risks abound in the literature, and the true cardiac risk of using some agents is uncertain. Additionally, such discrepancies may lead to the creation of over-cautious surveillance algorithms. Reasons for these reported differences are complex and often reflect subtleties in the criteria for individual patient evaluation. Both clinical trial data and real-world data have potential flaws that make reconciliation problematic. Importantly, however, both provide crucial information regarding the risk of adverse events. Major factors contribute to these differences including different tools used to diagnose events, and how those tools are interpreted. Additionally, differences in the populations of clinical trial participants and real-world populations play a crucial role. This paper looks at these differences and provides a perspective intended to help clinicians interpret reported variations in event rates derived from highly scrutinized clinical trials and broader real-world data. Clinical trial adverse event rates (dpeaa)DE-He213 Post-approval event rates (dpeaa)DE-He213 Reconciliation of event rate discrepancies (dpeaa)DE-He213 Disproportionality analysis (dpeaa)DE-He213 Pharmacoepidemiology (dpeaa)DE-He213 Herson, Jay aut Enthalten in Cardio-Oncology [London] : BioMed Central, 2015 8(2022), 1 vom: 19. Juli (DE-627)844073377 (DE-600)2842786-5 2057-3804 nnns volume:8 year:2022 number:1 day:19 month:07 https://dx.doi.org/10.1186/s40959-022-00139-w kostenfrei Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2014 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 8 2022 1 19 07
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source	Enthalten in Cardio-Oncology 8(2022), 1 vom: 19. Juli volume:8 year:2022 number:1 day:19 month:07
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topic_facet	Clinical trial adverse event rates Post-approval event rates Reconciliation of event rate discrepancies Disproportionality analysis Pharmacoepidemiology
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spellingShingle	Ewer, Michael S. misc Clinical trial adverse event rates misc Post-approval event rates misc Reconciliation of event rate discrepancies misc Disproportionality analysis misc Pharmacoepidemiology Cardiovascular adverse events in oncology trials: understanding and appreciating the differences between clinical trial data and real-world reports
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topic_title	Cardiovascular adverse events in oncology trials: understanding and appreciating the differences between clinical trial data and real-world reports Clinical trial adverse event rates (dpeaa)DE-He213 Post-approval event rates (dpeaa)DE-He213 Reconciliation of event rate discrepancies (dpeaa)DE-He213 Disproportionality analysis (dpeaa)DE-He213 Pharmacoepidemiology (dpeaa)DE-He213
topic	misc Clinical trial adverse event rates misc Post-approval event rates misc Reconciliation of event rate discrepancies misc Disproportionality analysis misc Pharmacoepidemiology
topic_unstemmed	misc Clinical trial adverse event rates misc Post-approval event rates misc Reconciliation of event rate discrepancies misc Disproportionality analysis misc Pharmacoepidemiology
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title	Cardiovascular adverse events in oncology trials: understanding and appreciating the differences between clinical trial data and real-world reports
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title_sort	cardiovascular adverse events in oncology trials: understanding and appreciating the differences between clinical trial data and real-world reports
title_auth	Cardiovascular adverse events in oncology trials: understanding and appreciating the differences between clinical trial data and real-world reports
abstract	Abstract Reports of cardiac adverse events from oncology clinical trials often are at variance with reports derived from clinical observations or data-base reviews. These differences may lead to confusion, as different levels of risks abound in the literature, and the true cardiac risk of using some agents is uncertain. Additionally, such discrepancies may lead to the creation of over-cautious surveillance algorithms. Reasons for these reported differences are complex and often reflect subtleties in the criteria for individual patient evaluation. Both clinical trial data and real-world data have potential flaws that make reconciliation problematic. Importantly, however, both provide crucial information regarding the risk of adverse events. Major factors contribute to these differences including different tools used to diagnose events, and how those tools are interpreted. Additionally, differences in the populations of clinical trial participants and real-world populations play a crucial role. This paper looks at these differences and provides a perspective intended to help clinicians interpret reported variations in event rates derived from highly scrutinized clinical trials and broader real-world data. © The Author(s) 2022
abstractGer	Abstract Reports of cardiac adverse events from oncology clinical trials often are at variance with reports derived from clinical observations or data-base reviews. These differences may lead to confusion, as different levels of risks abound in the literature, and the true cardiac risk of using some agents is uncertain. Additionally, such discrepancies may lead to the creation of over-cautious surveillance algorithms. Reasons for these reported differences are complex and often reflect subtleties in the criteria for individual patient evaluation. Both clinical trial data and real-world data have potential flaws that make reconciliation problematic. Importantly, however, both provide crucial information regarding the risk of adverse events. Major factors contribute to these differences including different tools used to diagnose events, and how those tools are interpreted. Additionally, differences in the populations of clinical trial participants and real-world populations play a crucial role. This paper looks at these differences and provides a perspective intended to help clinicians interpret reported variations in event rates derived from highly scrutinized clinical trials and broader real-world data. © The Author(s) 2022
abstract_unstemmed	Abstract Reports of cardiac adverse events from oncology clinical trials often are at variance with reports derived from clinical observations or data-base reviews. These differences may lead to confusion, as different levels of risks abound in the literature, and the true cardiac risk of using some agents is uncertain. Additionally, such discrepancies may lead to the creation of over-cautious surveillance algorithms. Reasons for these reported differences are complex and often reflect subtleties in the criteria for individual patient evaluation. Both clinical trial data and real-world data have potential flaws that make reconciliation problematic. Importantly, however, both provide crucial information regarding the risk of adverse events. Major factors contribute to these differences including different tools used to diagnose events, and how those tools are interpreted. Additionally, differences in the populations of clinical trial participants and real-world populations play a crucial role. This paper looks at these differences and provides a perspective intended to help clinicians interpret reported variations in event rates derived from highly scrutinized clinical trials and broader real-world data. © The Author(s) 2022
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title_short	Cardiovascular adverse events in oncology trials: understanding and appreciating the differences between clinical trial data and real-world reports
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