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

NCT03530215 | Completed FDA Drug

• 1 other identifier: CIC1421-18-12
• Study Type: observational
• Target: 500,000
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Cardiac Disease; Cancer

Keywords

Cardiotoxicity; Antineoplastic and immunomodulating agents

Outcome Measures

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)

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

Secondary Outcomes (6)

• Causality assessment of reported cardiovascular events according to the WHO system

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

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

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

• Description of the duration of treatment when the toxicity happens

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

• Description of the drug-drug interactions associated with adverse events

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

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

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

Study Arms (1)

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

Antineoplastic and Immunomodulating Agents DRUG

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

Adverse Events with Antineoplastic and immunomodulating agents

Eligibility Criteria

• Age: 0 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients treated with Antineoplastic and immunomodulating agents

You may qualify if:

• 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.

You may not qualify if:

• Chronology not compatible between the drug and the toxicity

Sponsors & Collaborators

• Groupe Hospitalier Pitie-Salpetriere: lead

Study Sites (1)

AP-HP, Pitié-Salpêtrière Hospital,Department of Pharmacology, CIC-1421, Pharmacovigilance Unit, INSERM.

Paris, 75013, France

Location

Related Publications (5)

• 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.

  PMID: 34370839 DERIVED

• 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.

  PMID: 33092403 DERIVED

• 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.

  PMID: 32408984 DERIVED

• 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.

  PMID: 32353110 DERIVED

• 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.

  PMID: 31558250 DERIVED

MeSH Terms

Conditions

Heart Diseases; Neoplasms; Cardiotoxicity

Interventions

Antineoplastic Agents; Immunomodulating Agents

Condition Hierarchy (Ancestors)

Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Drug-Related Side Effects and Adverse Reactions; Chemically-Induced Disorders; Radiation Injuries; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Immunologic Factors; Physiological Effects of Drugs

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant director, clinical investigation center Paris Est

Study Record Dates

• First Submitted: May 8, 2018
• First Posted: May 21, 2018
• Study Start: May 2, 2018
• Primary Completion: May 1, 2022
• Study Completion: April 8, 2023
• Last Updated: April 13, 2023

Record last verified: 2023-04

Locations

FR (1)