Status:
UNKNOWN
Clozapine and Haematologic Malignancies: Observational and Retrospective Study Using the WHO Pharmacovigilance Database
Lead Sponsor:
University Hospital, Caen
Conditions:
Lymphoma
Leukemia
Eligibility:
All Genders
Brief 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 ...
Detailed 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 ha...
Eligibility Criteria
Inclusion
- 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
- Chronology not compatible between the drug and the toxicity
Key Trial Info
Start Date :
March 1 2019
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
August 1 2024
Estimated Enrollment :
1000000 Patients enrolled
Trial Details
Trial ID
NCT04074213
Start Date
March 1 2019
End Date
August 1 2024
Last Update
August 30 2019
Active Locations (1)
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1
Caen University Hospital, Department of Pharmacology
Caen, Normandy, France, 14033