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| Name | Class |
|---|---|
| Institut National de la Santé Et de la Recherche Médicale, France | OTHER_GOV |
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Several drugs and chemotherapies seem to have an impact on the hematological system. This study investigates reports of hematological toxicities, including the International classification of disease ICD-10 for treatments in the World Health Organization (WHO) global Individual Case Safety Report (ICSR) database (VigiBase).
Several drugs and chemotherapies seem to have an impact on the hematological system and are responsible of a wide range of hematological side effects. Those are poorly described, due to the modification of the pharmacopeia, and the recent recognition of several of these adverse events. This study investigates the main characteristics of patients affected by rare hematological side effects imputed to drugs. A causality assessment according to the WHO-UMC (World Health Organization - Uppsala Monitoring Center) is systematically applied.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hematological toxicity induced by drugs and chemotherapies | Case reported in the World Health Organization (WHO) of hematological toxicities of patient treated by a drug, with a chronology compatible with the drug toxicity |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| drug inducing hematological toxicity | Drug | Drugs susceptible to induce hematological toxicities |
|
| Measure | Description | Time Frame |
|---|---|---|
| Hematological toxicities of drugs Identification and report of cases of hematological toxicities associated with drugs. | Case reported in the World Health Organization (WHO) database of individual safety case reports | to 01/02/2019 |
| Measure | Description | Time Frame |
|---|---|---|
| Causality assessment of reported hematological toxicities events according to the WHO system | Case reported in the World Health Organization (WHO) database of individual safety case reports | to 01/02/2019 |
| Description of the type of hematological toxicity depending on the category of drug |
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Inclusion Criteria:
Exclusion Criteria:
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Patients treated with a drug that could be reported in the WHO's pharmacovigilance database
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AP-HP, Pitié-Salpêtrière Hospital, Department of Pharmacology, CIC-1421, Pharmacovigilance Unit, INSERM | Paris | 75013 | France | |||
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Case reported in the World Health Organization (WHO) database of individual safety case reports |
| to 01/02/2019 |
| Description of the other immune related adverse events concomitant to the hematological toxicity induced by drugs | Case reported in the World Health Organization (WHO) database of individual safety case reports | to 01/02/2019 |
| Description of the duration of treatment when the toxicity happens (role of cumulative dose) | Case reported in the World Health Organization (WHO) database of individual safety case reports | to 01/02/2019 |
| Description of the drug-drug interactions associated with adverse events | Case reported in the World Health Organization (WHO) database of individual safety case reports | to 01/02/2019 |
| Description of the pathologies (cancer) for which the incriminated drugs have been prescribed | Case reported in the World Health Organization (WHO) database of individual safety case reports | to 01/02/2019 |
| Description of the population of patients having hematological toxicity adverse event | Case reported in the World Health Organization (WHO) database of individual safety case reports | to 01/02/2019 |
| Rhumatology department, CHU Strasbourg, Hautepierre hospital |
| Strasbourg |
| 67098 |
| France |