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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Haematologic malignancies with clozapine | Cases reported in the World Health Organization (WHO) database of patients treated by Clozapine, with a chronology compatible with the drug toxicity |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Clozapine | Drug | Clozapine treatment |
|
| Measure | Description | Time Frame |
|---|---|---|
| Correlation between clozapine and haematologic malignancies using a disproportionality analysis in Individual Case Reports involving at least one liable antipsychotic drug in Vigibase®. | 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. | Case reported in the World Health Organization (WHO) of individual safety case reports to March 2019 ] |
| Measure | Description | Time Frame |
|---|---|---|
| investigate a potential dose-dependent effect | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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Patients treated with at least one liable antipsychotic drug (ATC class N05A)
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Basile Chrétien, PharmD, MSc | Contact | +33231064672 | chretien-b@chu-caen.fr |
| Name | Affiliation | Role |
|---|---|---|
| Basile Chrétien, PharmD, MSc | University Hospital, Caen | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Caen University Hospital, Department of Pharmacology | Recruiting | Caen | Normandy | 14033 | France |
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| ID | Term |
|---|---|
| D008223 | Lymphoma |
| D007938 | Leukemia |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
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| ID | Term |
|---|---|
| D003024 | Clozapine |
| ID | Term |
|---|---|
| D003984 | Dibenzazepines |
| D006575 | Heterocyclic Compounds, 3-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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| Case reported in the World Health Organization (WHO) of individual safety case reports to March 2019 ] |
| Description of the clinical features of clozapine-related haematologic malignancies | 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 | Case reported in the World Health Organization (WHO) of individual safety case reports to March 2019 ] |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D006402 | Hematologic Diseases |