Monitoring the HeMAtological TOXicity of Drugs (HeMATOX)

Groupe Hospitalier Pitie-Salpetriere

Status: Completed

Conditions: Hematological Abnormality; Hematotoxicity

Treatments: Drug: drug inducing hematological toxicity

Study type: Observational

Funder types: Other

Identifiers

NCT03828942

CIC1421-19-01

Details and patient eligibility

About

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).

Full description

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.

Enrollment: 1,000 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

1,000 participants in 1 patient group

Hematological toxicity induced by drugs and chemotherapies

Description:

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

Treatment:

Drug: drug inducing hematological toxicity