Evidence map›Paper›PMID 34370839›Full record

ArticleEuropean heart journal2021

Anticancer drug-induced life-threatening ventricular arrhythmias: a World Health Organization pharmacovigilance study.

Joe-Elie Salem, Lee S Nguyen, Javid J Moslehi, Stéphane Ederhy, Bénédicte Lebrun-Vignes, Dan M Roden, Christian Funck-Brentano, Paul Gougis

Registry-linked trialOpen access · bronzeAbstract read
In one paragraph

Article in European heart journal, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03530215 (Evaluation of Reporting of Cardio-vascular Adverse Events With Antineoplastic and Immunomodulating Agents), which is not on this map. Cited by 34 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
34citing papers in PubMed, 1 pooled it
5.4field-weighted citation impact, top 3% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03530215 completednot on this map

Evaluation of Reporting of Cardio-vascular Adverse Events With Antineoplastic and Immunomodulating Agents (EROCA)

TypeobservationalSponsorGroupe Hospitalier Pitie-SalpetriereRan2018 to 2023Enrolled500,000ConditionsCardiac Disease, CancerArmsAntineoplastic and Immunomodulating Agents
3 · Its place in the literature

Who cites it

34 citing papers in PubMed, 1 synthesis or guideline pooled it, 75 citations in OpenAlex.

  1. Pooled it
  2. Review
  3. The intersection of colorectal cancer and cardiovascular disease: shared mechanisms and clinical implications.Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2026
    Review
  4. Article
  5. Article
  6. Review
  7. Epigenetic Mechanisms in Heart Diseases.Reviews in cardiovascular medicine · 2025
    Review
  8. Article
  9. Revolutionising Cardio-Oncology Care with Precision Genomics.International journal of molecular sciences · 2025
    Review
  10. Article
  11. Review
  12. Article
  13. Article
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  15. Article
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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

8 authors at 2 institutions in 2 countries.

Joe-Elie SalemINSERM, CIC-1901, Sorbonne Université, AP-HP, Pitié-Salpêtrière Hospital, Department of Pharmacology, CLIP² Galilée, Regional Pharmacovigilance Center, UNICO-GRECO Cardio-Oncology Program, Paris 75013, France.ORCID 0000-0002-0331-3307
Lee S NguyenINSERM, CIC-1901, Sorbonne Université, AP-HP, Pitié-Salpêtrière Hospital, Department of Pharmacology, CLIP² Galilée, Regional Pharmacovigilance Center, UNICO-GRECO Cardio-Oncology Program, Paris 75013, France.ORCID 0000-0002-6014-6269
Javid J MoslehiCardio-Oncology Program, Department of Medicine and Pharmacology, Vanderbilt University Medical Center, Nashville, TN, USA.
Stéphane EderhyINSERM, Sorbonne Université, Department of Cardiology, AP-HP, Saint Antoine Hospital, UNICO-GRECO Cardio-oncology program, Paris, France.
Bénédicte Lebrun-VignesINSERM, CIC-1901, Sorbonne Université, AP-HP, Pitié-Salpêtrière Hospital, Department of Pharmacology, CLIP² Galilée, Regional Pharmacovigilance Center, UNICO-GRECO Cardio-Oncology Program, Paris 75013, France.ORCID 0000-0001-6676-5063
Dan M RodenCardio-Oncology Program, Department of Medicine and Pharmacology, Vanderbilt University Medical Center, Nashville, TN, USA.ORCID 0000-0002-6302-0389
Christian Funck-BrentanoINSERM, CIC-1901, Sorbonne Université, AP-HP, Pitié-Salpêtrière Hospital, Department of Pharmacology, CLIP² Galilée, Regional Pharmacovigilance Center, UNICO-GRECO Cardio-Oncology Program, Paris 75013, France.ORCID 0000-0003-0406-5189
Paul GougisINSERM, CIC-1901, Sorbonne Université, AP-HP, Pitié-Salpêtrière Hospital, Department of Pharmacology, CLIP² Galilée, Regional Pharmacovigilance Center, UNICO-GRECO Cardio-Oncology Program, Paris 75013, France.
Inserm · FRVanderbilt University Medical Center · US

Funding

Immunologic and Antigenic Drivers of Immune Checkpoint Inhibitor-Associated MyocarditisR01HL156021 · NHLBI · VANDERBILT UNIVERSITY MEDICAL CENTER · PI Justin M Balko, Javid J Moslehi · 2021 to 2026
$4.9M
Novel mechanisms and predictors of VEGF receptor inhibitor-associated hypertensionR01HL141466 · NHLBI · VANDERBILT UNIVERSITY MEDICAL CENTER · PI MOSLEHI, JAVID J · 2019 to 2023
$3.3M
Long-Term Cardiovascular Sequelae of Cancer ImmunotherapiesR01HL155990 · NHLBI · VANDERBILT UNIVERSITY MEDICAL CENTER · PI JOHNSON, DOUGLAS B, MOSLEHI, JAVID J · 2021 to 2025
$3.3M
NHLBI NIH HHS R01 HL141466NHLBI NIH HHS R01 HL155990NHLBI NIH HHS R01 HL156021
6 · The paper itself

Abstract

aimsWith the explosion of anticancer drugs, an emerging concern is the risk for drug-induced sudden death (SD) via ventricular arrhythmias (VA). METHODS AND

resultsWe used the international pharmacovigilance database VigiBase (n = 18 441 659 reports) to compare drug-induced long QT (diLQT, n = 18 123) and VA (n = 29 193) including torsade de pointes (TdP, n = 8163) reporting for 663 anticancer drugs vs. all other drugs until 01/01/2019. The analysis used the 95% lower-end credibility interval of the information component (IC025), an indicator for disproportionate Bayesian reporting; significant when IC025 >0. There were 2301 reports (13.8% fatal) for 40 anticancer drugs significantly associated with diLQT (with 27 also associated with VA or SD) and 9 drugs associated with VA without diLQT. Half of these (46.9%, 23/49) were associated with SD. Most (41%, 20/49) were kinase inhibitors, 8% (4/49) were hormonal therapies, 6% (3/49) were immunotherapies, 24% (12/49) were cytotoxics, and 20% (10/49) were miscellaneous. In VigiBase, reports of diLQT, TdP, or VA increased from 580 in the period 1967-83 to 15 070 in 2014-18 with the proportion related to anticancer drugs increasing from 0.9% (5/580) to 14.0% (2115/15 070) (P < 0.0001). Concordance between these VigiBase signals and data concerning diLQT and VA/TdP identified in CredibleMeds or US Food and Drug Administration (FDA) labels was moderate (κ = 0.47 and 0.40, P < 0.0001). Twenty-three drugs represent new signals, while 24 flagged by CredibleMeds or FDA had no signal in VigiBase. A three-level SD risk stratification relying on isolated long QT (low risk), associated with VA without SD (moderate risk), and VA with SD (high risk) is proposed.

conclusionThis list of liable anticancer drugs may prove useful for physicians and regulatory authorities to re-evaluate cardiac monitoring requirements. CLINICAL

trial registrationNCT03530215.

Indexed as

Antineoplastic AgentsLong QT SyndromeTorsades de PointesAdverse Drug Reaction Reporting SystemsBayes TheoremHumansPharmacovigilanceWorld Health OrganizationAntineoplastic AgentsAnticancer drugsDisproportionality analysisLong QTPharmacovigilanceTorsade de pointesVentricular arrhythmias

Identifiers

PMID34370839
PMCPMC8677441
OpenAlexW3190510233

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.