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NCT05602103 Clinical Trial

Acute Cardiovascular Adverse Events Occuring in Children Treated by Anticancer Drugs for Malignancies

Cardiovascular Diseases Clinical Trial

Official title:
Description of Acute Cardiovascular Adverse Events Occuring in Children Treated by Anticancer Drugs for Malignancies Using the World Health Organization (WHO) Database VigiBase

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT05602103
Other study ID # Pharmaco_112022
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date November 1, 2022
Est. completion date January 1, 2027

Study information
Verified date October 2022
Source University Hospital, Caen
Contact Joachim Alexandre, MD, PhD
Phone +330231064770
Email alexandre-j@chu-caen.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Little is known about acute cardiovascular adverse events occuring in children treated by anticancer drugs for malignancies. Here the investigators use VigiBase (http://www.vigiaccess.org/), the World Health Organization (WHO) database of individual safety case reports, to identify and describe cases of acute cardiovascular adverse events associated with anticancer drugs.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 10000
Est. completion date January 1, 2027
Est. primary completion date January 1, 2026
Accepts healthy volunteers No
Gender All
Age group 0 Years to 18 Years
Eligibility Inclusion Criteria: - cases reported in the World Health Organization (WHO) database of individual safety case reports (vigibase) - related to children - and reported, or not, acute cardiovascular adverse events Exclusion Criteria: - cases reported in the World Health Organization (WHO) database of individual safety case reports (vigibase) related to adult patients - cases related to long-term and delayed cardiovascular adverse events

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• use of anticancer drugs in monotherapy or in combination therapy
Cases of acute cardiovascular events associated with anticancer drugs will be identify and describe

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
University Hospital, Caen

Outcome
Type Measure Description Time frame Safety issue
Primary Acute cardiovascular adverse events associated with anticancer drugs identification and description of cases of acute cardiovascular adverse events associated with anticancer drugs in the World Health Organization (WHO) database of individual safety case reports (vigibase) from inception to the octobre 31, 2022
Secondary Association between acute cardiovascular adverse events and anticancer drug exposure in the World Health Organization (WHO) database of individual safety case reports (vigibase) Disproportionnality analyses in Vigibase (IC025 and/or ROR) perfomed on cases reported in the World Health Organization (WHO) database of individual safety case reports (vigibase) from inception to the octobre 31, 2022
Secondary Description of the malignancies for which the incriminated drugs have been prescribed Cases reported in the World Health Organization (WHO) database of individual safety case reports (vigibase) from inception to the octobre 31, 2022
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