Clinical trial · Observational
Clozapine and Haematologic Malignancies: Observational and Retrospective Study Using the WHO Pharmacovigilance Database
Clozapine and Haematologic Malignancies: an Observational and Retrospective Study Using the WHO Pharmacovigilance Database
NCT04074213CI-TRIAL-00040344CLOZARIXunknownClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Clozapine | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- 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
- interventionNames
- Drug: Clozapine
Primary outcomes (1)
- measure
- Correlation between clozapine and haematologic malignancies using a disproportionality analysis in Individual Case Reports involving at least one liable antipsychotic drug in Vigibase®.
- timeFrame
- Case reported in the World Health Organization (WHO) of individual safety case reports to March 2019 ]
- description
- 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 outcomes (2)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.