Monitoring the HeMAtological TOXicity of Drugs (HeMATOX) (HeMATOX)

Monitoring the HeMAtological TOXicity of Drugs

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).

Study Overview

• Status: Completed
• Conditions: Hematological Abnormality; Hematotoxicity
• Intervention / Treatment: Drug: drug inducing hematological toxicity

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.

• Study Type: Observational
• Enrollment (Actual): 1000

Contacts and Locations

Study Locations

• France
  • Paris, France, 75013
    • AP-HP, Pitié-Salpêtrière Hospital, Department of Pharmacology, CIC-1421, Pharmacovigilance Unit, INSERM
  • Strasbourg, France, 67098
    • Rhumatology department, CHU Strasbourg, Hautepierre hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients treated with a drug that could be reported in the WHO's pharmacovigilance database

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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	Drug: drug inducing hematological toxicity; Drugs susceptible to induce hematological toxicities

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Groupe Hospitalier Pitie-Salpetriere
• Collaborators: Institut National de la Santé Et de la Recherche Médicale, France

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2019
• Primary Completion (Actual): February 1, 2022
• Study Completion (Actual): April 8, 2023

Study Registration Dates

• First Submitted: February 1, 2019
• First Submitted That Met QC Criteria: February 1, 2019
• First Posted (Actual): February 4, 2019

Study Record Updates

• Last Update Posted (Actual): April 13, 2023
• Last Update Submitted That Met QC Criteria: April 12, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: drugs; chemotherapies; advrese event; hematotoxicity
• Additional Relevant MeSH Terms: Congenital Abnormalities
• Other Study ID Numbers: CIC1421-19-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes