Leukemia, Lymphoma
Conditions
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 (WHO) global database of individual safety case reports (VigiBase).
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 haematologic malignancies following treatment with clozapine.
Interventions
DRUGClozapine
Clozapine treatment
Sponsors
University Hospital, Caen
Study design
Observational model
CASE_ONLY
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Correlation between clozapine and haematologic malignancies using a disproportionality analysis in Individual Case Reports involving at least one liable antipsychotic drug in Vigibase®. | Case reported in the World Health Organization (WHO) of individual safety case reports to March 2019 ] | Study the correlation between clozapine and haematologic malignancies by comparing the proportion of Individual Case Reports (ICSRs) of hematologic malignancies with liable clozapine with the proportion of ICSRs of hematologic malignancies with at least one liable antipsychotic. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| investigate a potential dose-dependent effect | Case reported in the World Health Organization (WHO) of individual safety case reports to March 2019 ] | To investigate a potential dose-dependent effect, we will collect the clozapine daily dose from all clozapine ICSRs. In ICSRs with liable clozapine, the clozapine daily dose in mg will be divided into quartiles. A disproportionality analysis will be performed to evaluate the effect of the clozapine daily dose on the reporting of lymphomas and leukaemia. A significant difference of proportion of reports of haematologic malignancies between each quartile will be researched. |
| Description of the clinical features of clozapine-related haematologic malignancies | Case reported in the World Health Organization (WHO) of individual safety case reports to March 2019 ] | Description of the clinical features (mean age, sex ratio, time to onset, daily dose) of clozapine-related haematologic malignancies according to the main clinical subtypes |
Countries
France
Contacts
Primary ContactBasile Chrétien, PharmD, MSc
Outcome results
None listed