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

University Hospital, Caen5,000,000 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

5,000,000

Conditions

Cancer

Interventions

Antineoplastic and Immunomodulating AgentsDRUG

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

Eligibility

Sex: ALLMax age: 100 Years

Medical Language ↔ Plain English

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

Locations (1)

Alexandre Joachim

Caen, Basse Normandie, France

RECRUITING

Outcomes

Primary Outcomes

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