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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).
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Antineoplastic and Immunomodulating Agents | Drug | Antineoplastic agents, endocrine therapy, immunostimulants and immunosuppressants drugs included in the ATC classification L |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Patients treated with Antineoplastic and immunomodulating agents
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AP-HP, Pitié-Salpêtrière Hospital,Department of Pharmacology, CIC-1421, Pharmacovigilance Unit, INSERM. | Paris | 75013 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34370839 | Derived | 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. | |
| 33092403 | Derived |
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| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D009369 | Neoplasms |
| D066126 | Cardiotoxicity |
| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D064420 | Drug-Related Side Effects and Adverse Reactions |
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| ID | Term |
|---|---|
| D000970 | Antineoplastic Agents |
| D000091369 | Immunomodulating Agents |
| ID | Term |
|---|---|
| D045506 | Therapeutic Uses |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D007155 | Immunologic Factors |
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| 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 |
| Description of the population of patients having a cardio-vascular adverse event | Case reported in the World Health Organization (WHO) of individual safety case reports to September 2018 |
| 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. |
| 32408984 | 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. |
| 32353110 | 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. |
| 31558250 | 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. |
| D064419 | Chemically-Induced Disorders |
| D011832 | Radiation Injuries |
| D014947 | Wounds and Injuries |
| D045505 |
| Physiological Effects of Drugs |