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

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

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).

Study Overview

• Status: Recruiting
• Conditions: Cancer
• Intervention / Treatment: Drug: Antineoplastic and Immunomodulating Agents

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 Type: Observational
• Enrollment (Anticipated): 5000000

Contacts and Locations

Study Locations

• France
  • Basse Normandie
    • Caen, Basse Normandie, France, 14000
      • Recruiting
      • Alexandre Joachim

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 100 years (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients treated with Antineoplastic and immunomodulating agents

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Adverse Events associated with 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	Drug: Antineoplastic and Immunomodulating Agents; Antineoplastic agents, endocrine therapy, immunostimulants and immunosuppressants drugs included in the ATC classification L

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Time Frame
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 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 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 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 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 population of patients having adverse event	Case reported in the World Health Organization (WHO) of individual safety case reports to January 1st 2025

Collaborators and Investigators

• Sponsor: University Hospital, Caen

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): January 1, 2021
• Primary Completion (ANTICIPATED): January 1, 2021
• Study Completion (ANTICIPATED): January 1, 2025

Study Registration Dates

• First Submitted: January 4, 2021
• First Submitted That Met QC Criteria: January 4, 2021
• First Posted (ACTUAL): January 6, 2021

Study Record Updates

• Last Update Posted (ACTUAL): January 6, 2021
• Last Update Submitted That Met QC Criteria: January 4, 2021
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Antineoplastic Agents
• Other Study ID Numbers: Pharmaco112020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No