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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

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

Antineoplastic and Immunomodulating Agents

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

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

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)

Groupe Hospitalier Pitie-Salpetriere

Assistant director, clinical investigation center Paris Est

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

Joachim Alexandre, MD

Anticancer drugs can lead to various adverse events. This study analyses reports of adverse events 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).

The investigators use VigiBase, the World Health Organization (WHO) database of individual safety case reports, to identify cases of adverse events following treatment with antineoplastic agents, endocrine therapy, immunostimulants or immunosuppressants drugs.

Evaluation of Reporting of AdVerse Events Associated With AnTicAncer theRapy (AVATAR)

Evaluation of Reporting of AdVerse Events Associated With AnTicAncer theRapy : an Observational and Retrospective Study Using the WHO Pharmacovigilance Database(AVATAR)

Identification and report of adverse event of antineoplastic and immunomodulating agents. The research could include the report with SOC, HGLT, HLT, or PT MedDRA terms

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Evaluation of Reporting of Cardio-vascular Adverse Events With Antineoplastic and Immunomodulating Agents (EROCA)	NCT03530215	Cardiac Disease Cancer	Antineoplastic ...	0 Years - 100 Years	Groupe Hospitalier Pitie-Salpetriere
Evaluation of Reporting of Cardio-vascular Adverse Events With Antineoplastic and Immunomodulating Agents (EROCA)	NCT03530215	Cardiac Disease Cancer	Antineoplastic ...	0 Years - 100 Years	Groupe Hospitalier Pitie-Salpetriere
Evaluation of Reporting of AdVerse Events Associated With AnTicAncer theRapy (AVATAR)	NCT04696250	Cancer	Antineoplastic ...	- 100 Years	University Hospital, Caen

Spots Global Cancer Trial Database for antineoplastic and immunomodulating agents