Monitoring the HeMAtological TOXicity of Drugs (HeMATOX)

Groupe Hospitalier Pitie-Salpetriere1,000 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

1,000

Conditions

Hematological Abnormality Hematotoxicity

Interventions

drug inducing hematological toxicityDRUG

Drugs susceptible to induce hematological toxicities

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Case reported in the WHO's pharmacovigilance database till 01/02/2019 Exclusion Criteria: * Chronology not compatible between the drug and the toxicity

Locations (2)

AP-HP, Pitié-Salpêtrière Hospital, Department of Pharmacology, CIC-1421, Pharmacovigilance Unit, INSERM

Paris, France

Rhumatology department, CHU Strasbourg, Hautepierre hospital

Strasbourg, France

Outcomes

Primary Outcomes

Hematological toxicities of drugs Identification and report of cases of hematological toxicities associated with drugs.