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

Caen University Hospital

Status: Enrolling

Conditions: Cancer

Treatments: Drug: Antineoplastic and Immunomodulating Agents

Study type: Observational

Funder types: Other

Identifiers

NCT04696250

Pharmaco112020

Details and patient eligibility

About

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).

Full 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.

Enrollment: 5,000,000 estimated patients

Sex: All

Ages: Under 100 years old

Volunteers: No Healthy Volunteers

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

Trial design

5,000,000 participants in 1 patient group

Adverse Events associated with Antineoplastic and Immunomodulating Agents

Description:

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

Treatment:

Drug: Antineoplastic and Immunomodulating Agents