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perform a study in VigiBase® to assess if clozapine was associated with an over-reporting of infections and to characterize those infections. The investigators also decided to assess the dose dependency associated with those infections.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients presenting a possible drug-induced adverse effects |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| search for a clozapine intake | Drug | search for a clozapine intake |
|
| Measure | Description | Time Frame |
|---|---|---|
| Correlation between clozapine and hinfections using a disproportionality analysis in Individual Case Reports involving at least one liable antipsychotic drug in Vigibase® | from the 01/01/1963 to the 11/04/2023 |
| Measure | Description | Time Frame |
|---|---|---|
| investigate a potential dose-dependent effect | A logistical regression model will be applied to search for a dose-dependant effect of infection using clozapine quartile doses. | from the 01/01/1963 to the 11/04/2023 |
| Description of the clinical features of clozapine-related infections |
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Inclusion Criteria:
Exclusion Criteria:
Chronology not compatible between the drug and the toxicity
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Patients with a possible drug-induced adverse effect
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Caen University Hospital, Department of Pharmacology | Caen | Normandy | 14033 | France |
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| ID | Term |
|---|---|
| D007239 | Infections |
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Description of age, sex, time to onset, type of infections using MedDRA |
| from the 01/01/1963 to the 11/04/2023 |