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CompletedNCT03530215EROCAUpdated Apr 13, 2023

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

An observational study in Cardiac Disease and Cancer, sponsored by Groupe Hospitalier Pitie-Salpetriere. Completed at 1 site in France. Open to participants aged 0 Years to 100 Years. Per ClinicalTrials.gov, last updated 2023-04-13.

Sponsored by Groupe Hospitalier Pitie-Salpetriere · Observational

Study type
Observational
Model
Case-only
Time perspective
Cross-sectional
Enrollment
500,000
Ages
0 Years to 100 Years
Sex
All
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Study summary

Antineoplastic and immunomodulating agents may lead to various cardio-vascular adverse reactions. This study investigates reports of cardio-vascular toxicities for treatment including Anatomical Therapeutic Chemical (ATC) classification L (antineoplastic agents, endocrine therapy, immunostimulants, and immunosuppressants drugs) in the World Health Organization's (WHO) global database of individual safety case reports (VigiBase).

Read the detailed description

Antineoplastic therapies are responsible of a wide range of cardio-vascular side effects.The investigators use VigiBase, the World Health Organization (WHO) database of individual safety case reports, to identify cases of cardiovascular adverse drug reactions following treatment with antineoplastic and immunomodulating agents

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Conditions studied

  • Cardiac Disease
  • Cancer

Keywords

  • Cardiotoxicity
  • Antineoplastic and immunomodulating agents
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In context

Heart Diseases

3,674 studies on the registry are indexed under Heart Diseases; 458 are open to participants now.

This study's enrollment of 500,000 is above the median of 295 across 1,250 observational studies indexed under Heart Diseases.

Browse Heart Diseases studies →

Lead sponsor

Groupe Hospitalier Pitie-Salpetriere is the lead sponsor of 66 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
0 Years to 100 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients treated with Antineoplastic and immunomodulating agents

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Case reported in the World Health Organization (WHO) database of individual safety case reports to 30/04/2018
  • Adverse events reported were including the MedDRA terms: Cardiac and vascular investigations (excl enzyme tests) (HLGT), Vascular disorders (SOC), Skeletal and cardiac muscle analyses (HLT), Sudden death (PT), Sudden cardiac death (PT), Cardiac disorders (SOC), Cardiac arrhythmias (HLGT), Cardiac disorder signs and symptoms (HLGT), Cardiac neoplasms (HLGT), Cardiac valve disorders (HLGT), Congenital cardiac disorders (HLGT), Coronary artery disorders (HLGT), Endocardial disorders (HLGT), Heart failures (HLGT), Myocardial disorders (HLGT), Pericardial disorders (HLGT)
  • Patients treated with Antineoplastic and immunomodulating agents included in the ATC L.

Exclusion criteria

Exclusion Criteria:

  • Chronology not compatible between the drug and the toxicity
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Study design

Observational model
Case-only
Time perspective
Cross-sectional
Enrollment
500,000 participants (actual)
Patient registry
No

Groups and cohorts

  • Adverse Events with Antineoplastic and immunomodulating agents

    Cases reported in the World Health Organization (WHO) and the French pharmacovigilance database of patients treated by Antineoplastic and immunomodulating agents, with a chronology compatible with the drug toxicity

    Drug: Antineoplastic and Immunomodulating Agents

Interventions

  • DrugAntineoplastic and Immunomodulating Agents

    Antineoplastic agents, endocrine therapy, immunostimulants and immunosuppressants drugs included in the ATC classification L

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What researchers measure

Primary outcomes

  1. Cardio-vascular toxicity of antineoplastic and immunomodulating agents

    Identification and report of cardio-vascular toxicities of antineoplastic and immunomodulating agents. The research includes the report with MedDRA terms: SOC Cardiac Disorders, SOC Vascular Disorders, Sudden death (PT), Cardiac and vascular investigations (excl enzyme tests) (HLGT), Skeletal and cardiac muscle analyses (HLT)

    Time frame: Case reported in the World Health Organization (WHO) of individual safety case reports to September 2018

Secondary outcomes

  1. Causality assessment of reported cardiovascular events according to the WHO system

    Time frame: Case reported in the World Health Organization (WHO) of individual safety case reports to September 2018

  2. Description of the type of cardiotoxicity depending on the category of antineoplastic and immunomodulating agents

    Time frame: Case reported in the World Health Organization (WHO) of individual safety case reports to September 2018

  3. Description of the duration of treatment when the toxicity happens

    Time frame: Case reported in the World Health Organization (WHO) of individual safety case reports to September 2018

  4. Description of the drug-drug interactions associated with adverse events

    Time frame: Case reported in the World Health Organization (WHO) of individual safety case reports to September 2018

  5. Description of the pathologies (cancer) for which the incriminated drugs have been prescribed

    Time frame: Case reported in the World Health Organization (WHO) of individual safety case reports to September 2018

  6. Description of the population of patients having a cardio-vascular adverse event

    Time frame: Case reported in the World Health Organization (WHO) of individual safety case reports to September 2018

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Study locations

1 site
  • AP-HP, Pitié-Salpêtrière Hospital,Department of Pharmacology, CIC-1421, Pharmacovigilance Unit, INSERM.
    Paris, 75013, France
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References and documents

Publications

  • Salem JE, Nguyen LS, Moslehi JJ, Ederhy S, Lebrun-Vignes B, Roden DM, Funck-Brentano C, Gougis P. Anticancer drug-induced life-threatening ventricular arrhythmias: a World Health Organization pharmacovigilance study. Eur Heart J. 2021 Oct 7;42(38):3915-3928. doi: 10.1093/eurheartj/ehab362. PubMed 34370839 ↗
  • Xiao L, Salem JE, Clauss S, Hanley A, Bapat A, Hulsmans M, Iwamoto Y, Wojtkiewicz G, Cetinbas M, Schloss MJ, Tedeschi J, Lebrun-Vignes B, Lundby A, Sadreyev RI, Moslehi J, Nahrendorf M, Ellinor PT, Milan DJ. Ibrutinib-Mediated Atrial Fibrillation Attributable to Inhibition of C-Terminal Src Kinase. Circulation. 2020 Dec 22;142(25):2443-2455. doi: 10.1161/CIRCULATIONAHA.120.049210. Epub 2020 Oct 23. PubMed 33092403 ↗
  • Salem JE, Ederhy S, Lebrun-Vignes B, Moslehi JJ. Cardiac Events Associated With Chimeric Antigen Receptor T-Cells (CAR-T): A VigiBase Perspective. J Am Coll Cardiol. 2020 May 19;75(19):2521-2523. doi: 10.1016/j.jacc.2020.02.070. No abstract available. PubMed 32408984 ↗
  • Alexandre J, Salem JE, Moslehi J, Sassier M, Ropert C, Cautela J, Thuny F, Ederhy S, Cohen A, Damaj G, Vilque JP, Plane AF, Legallois D, Champ-Rigot L, Milliez P, Funck-Brentano C, Dolladille C. Identification of anticancer drugs associated with atrial fibrillation: analysis of the WHO pharmacovigilance database. Eur Heart J Cardiovasc Pharmacother. 2021 Jul 23;7(4):312-320. doi: 10.1093/ehjcvp/pvaa037. PubMed 32353110 ↗
  • Salem JE, Manouchehri A, Bretagne M, Lebrun-Vignes B, Groarke JD, Johnson DB, Yang T, Reddy NM, Funck-Brentano C, Brown JR, Roden DM, Moslehi JJ. Cardiovascular Toxicities Associated With Ibrutinib. J Am Coll Cardiol. 2019 Oct 1;74(13):1667-1678. doi: 10.1016/j.jacc.2019.07.056. PubMed 31558250 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 13, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03530215
Lead sponsor
Groupe Hospitalier Pitie-Salpetriere
Responsible party
Joe Elie Salem (Assistant director, clinical investigation center Paris Est, Groupe Hospitalier Pitie-Salpetriere) — Principal investigator
First posted
May 21, 2018
Start date
May 2, 2018
Primary completion
May 1, 2022
Completion
Apr 8, 2023
Last update
Apr 13, 2023

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.

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