Monitoring the HeMAtological TOXicity of Drugs (HeMATOX)

Completed

• Conditions: Hematotoxicity; Hematological Abnormality
• Interventions: Drug: drug inducing hematological toxicity

• Registration Number: NCT03828942
• Lead Sponsor: Groupe Hospitalier Pitie-Salpetriere

Brief 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.

Study Timeline

• Study Start: 2019-02-01
• Study First Submitted: 2019-02-01
• Study First Submitted QC: 2019-02-01
• Study First Posted: 2019-02-04
• Primary Completion: 2022-02-01
• Status Verified: 2023-04
• Study Completion: 2023-04-08
• Last Update Submitted: 2023-04-12
• Last Update Posted: 2023-04-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1000

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Hematological toxicity induced by drugs and chemotherapies	drug inducing hematological toxicity	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

Primary Outcome Measures

Name	Time	Method
Hematological toxicities of drugs Identification and report of cases of hematological toxicities associated with drugs.	to 01/02/2019	Case reported in the World Health Organization (WHO) database of individual safety case reports

Secondary Outcome Measures

Name	Time	Method
Description of the type of hematological toxicity depending on the category of drug	to 01/02/2019	Case reported in the World Health Organization (WHO) database of individual safety case reports
Description of the other immune related adverse events concomitant to the hematological toxicity induced by drugs	to 01/02/2019	Case reported in the World Health Organization (WHO) database of individual safety case reports
Description of the duration of treatment when the toxicity happens (role of cumulative dose)	to 01/02/2019	Case reported in the World Health Organization (WHO) database of individual safety case reports
Causality assessment of reported hematological toxicities events according to the WHO system	to 01/02/2019	Case reported in the World Health Organization (WHO) database of individual safety case reports
Description of the drug-drug interactions associated with adverse events	to 01/02/2019	Case reported in the World Health Organization (WHO) database of individual safety case reports
Description of the pathologies (cancer) for which the incriminated drugs have been prescribed	to 01/02/2019	Case reported in the World Health Organization (WHO) database of individual safety case reports
Description of the population of patients having hematological toxicity adverse event	to 01/02/2019	Case reported in the World Health Organization (WHO) database of individual safety case reports

Trial Locations

Locations (2)

Rhumatology department, CHU Strasbourg, Hautepierre hospital; 🇫🇷 Strasbourg, France

AP-HP, Pitié-Salpêtrière Hospital, Department of Pharmacology, CIC-1421, Pharmacovigilance Unit, INSERM; 🇫🇷 Paris, France