Evaluation of Reporting of Cardio-vascular Adverse Events With Antineoplastic and Immunomodulating Agents (EROCA) (EROCA)
April 12, 2023 updated by: Joe Elie Salem, Groupe Hospitalier Pitie-Salpetriere
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).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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
Study Type
Observational
Enrollment (Actual)
500000
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Paris, France, 75013
- AP-HP, Pitié-Salpêtrière Hospital,Department of Pharmacology, CIC-1421, Pharmacovigilance Unit, INSERM.
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
No older than 96 years (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
Patients treated with Antineoplastic and immunomodulating agents
Description
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:
- Chronology not compatible between the drug and the toxicity
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Cross-Sectional
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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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
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Antineoplastic agents, endocrine therapy, immunostimulants and immunosuppressants drugs included in the ATC classification L
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Cardio-vascular toxicity of antineoplastic and immunomodulating agents
Time Frame: Case reported in the World Health Organization (WHO) of individual safety case reports to September 2018
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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)
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Case reported in the World Health Organization (WHO) of individual safety case reports to September 2018
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
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
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Case reported in the World Health Organization (WHO) of individual safety case reports to September 2018
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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
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Case reported in the World Health Organization (WHO) of individual safety case reports to September 2018
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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
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Case reported in the World Health Organization (WHO) of individual safety case reports to September 2018
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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
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Case reported in the World Health Organization (WHO) of individual safety case reports to September 2018
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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
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Case reported in the World Health Organization (WHO) of individual safety case reports to September 2018
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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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Case reported in the World Health Organization (WHO) of individual safety case reports to September 2018
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 2, 2018
Primary Completion (Actual)
May 1, 2022
Study Completion (Actual)
April 8, 2023
Study Registration Dates
First Submitted
May 8, 2018
First Submitted That Met QC Criteria
May 8, 2018
First Posted (Actual)
May 21, 2018
Study Record Updates
Last Update Posted (Actual)
April 13, 2023
Last Update Submitted That Met QC Criteria
April 12, 2023
Last Verified
April 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CIC1421-18-12
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
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