Clozapine and Haematologic Malignancies: Observational and Retrospective Study Using the WHO Pharmacovigilance Database (CLOZARIX)

Caen University Hospital

Status: Enrolling

Conditions: Lymphoma; Leukemia

Treatments: Drug: Clozapine

Study type: Observational

Funder types: Other

Identifiers

NCT04074213

19-916

Details and patient eligibility

About

Clozapine may lead to various adverse reactions, including neutropenia and agranulocytosis. This study investigates reports of lymphoma and leukaemias for clozapine in the World Health Organization's (WHO) global database of individual safety case reports (VigiBase).

Full description

Clozapine is responsible of a wide range of adverse side effects.The investigators use VigiBase, the World Health Organization (WHO) database of individual safety case reports, to identify cases of haematologic malignancies following treatment with clozapine.

Enrollment: 1,000,000 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Case reported in the World Health Organization (WHO) database of individual safety case reports to 03/05/2019
• Adverse events reported were including the MedDRA terms: Malignant Lymphoma (SMQ), Leukaemia (HLGT)
• Patients treated with at least one liable antipsychotic drug (ATC class N05A)

Exclusion criteria

• Chronology not compatible between the drug and the toxicity

Trial design

1,000,000 participants in 1 patient group

Haematologic malignancies with clozapine

Description:

Cases reported in the World Health Organization (WHO) database of patients treated by Clozapine, with a chronology compatible with the drug toxicity

Treatment:

Drug: Clozapine