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

Last updated: August 27, 2019
Sponsor: University Hospital, Caen
Overall Status: Active - Recruiting

Phase

N/A

Condition

Lymphoma

Neoplasms

Leukemia

Treatment

N/A

Clinical Study ID

NCT04074213
19-916
  • All Genders

Study Summary

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).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Case reported in the World Health Organization (WHO) database of individual safetycase 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

Exclusion Criteria:

  • Chronology not compatible between the drug and the toxicity

Study Design

Total Participants: 1000000
Study Start date:
March 01, 2019
Estimated Completion Date:
August 01, 2024

Study 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.

Connect with a study center

  • Caen University Hospital, Department of Pharmacology

    Caen, Normandie 14033
    France

    Active - Recruiting

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