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

Recruiting

• Conditions: Cancer
• Interventions: Drug: Antineoplastic and Immunomodulating Agents

• Registration Number: NCT04696250
• Lead Sponsor: University Hospital, Caen

Brief Summary

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).

Detailed Description

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.

Study Timeline

• Status Verified: 2020-11
• Study Start: 2021-01-01
• Primary Completion: 2021-01-01
• Study First Submitted: 2021-01-04
• Study First Submitted QC: 2021-01-04
• Last Update Submitted: 2021-01-04
• Study First Posted: 2021-01-06
• Last Update Posted: 2021-01-06
• Study Completion: 2025-01-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 5000000

Inclusion Criteria

• Case reported in the World Health Organization (WHO) database of individual safety case reports at the time of the extraction
• Adverse events reported were including in the MedDRA terms. The research could include the report with SOC, HGLT, HLT, or PT MedDRA terms
• Patients treated with Antineoplastic and immunomodulating agents included in the ATC L.

Exclusion Criteria

• Chronology not compatible between the drug and the toxicity

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Adverse Events associated with Antineoplastic and Immunomodulating Agents	Antineoplastic and Immunomodulating Agents	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

Primary Outcome Measures

Name	Time	Method
Adverse events of antineoplastic and immunomodulating agents	Case reported in the World Health Organization (WHO) of individual safety case reports to January 1st 2025	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

Secondary Outcome Measures

Name	Time	Method
Causality assessment of reported adverse events according to the WHO system	Case reported in the World Health Organization (WHO) of individual safety case reports to January 1st 2025
Description of the cancer for which the incriminated drugs have been prescribed	Case reported in the World Health Organization (WHO) of individual safety case reports to January 1st 2025
Description of the time from anticancer drug initiation and the occurrence of the adverse event	Case reported in the World Health Organization (WHO) of individual safety case reports to January 1st 2025
Description of the type of adverse event depending on the category of antineoplastic and immunomodulating agents	Case reported in the World Health Organization (WHO) of individual safety case reports to January 1st 2025
Description of the drug-drug interactions associated with adverse events	Case reported in the World Health Organization (WHO) of individual safety case reports to January 1st 2025
Description of the population of patients having adverse event	Case reported in the World Health Organization (WHO) of individual safety case reports to January 1st 2025

Trial Locations

Locations (1)

Alexandre Joachim; 🇫🇷 Caen, Basse Normandie, France