NCT03828942

Monitoring the HeMAtological TOXicity of Drugs (HeMATOX)

Monitoring the HeMAtological TOXicity of Drugs

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 1,000 (actual)
• Sponsor: Groupe Hospitalier Pitie-Salpetriere · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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).

Detailed 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.

Conditions

• Hematological Abnormality
• Hematotoxicity

Interventions

Type	Name	Description
DRUG	drug inducing hematological toxicity	Drugs susceptible to induce hematological toxicities

Timeline

• Start date: 2019-02-01
• Primary completion: 2022-02-01
• Completion: 2023-04-08
• First posted: 2019-02-04
• Last updated: 2023-04-13

Locations

2 sites across 1 country: France

Regulatory

• FDA-regulated drug study