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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Cancer

Intervention / Treatment
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* Drug: Antineoplastic and Immunomodulating Agents


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Adverse Events associated with Antineoplastic and Immunomodulating Agents<br>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<br>* Antineoplastic agents, endocrine therapy, immunostimulants and immunosuppressants drugs included in the ATC classification L<br>|

What is the study measuring?
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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 | Measure Description | 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 |