Skip to main content
OpenTrials
Completed

NCT Number: NCT03828942

Monitoring the HeMAtological TOXicity of Drugs (HeMATOX)

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).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Hematological Abnormality Hematotoxicity

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

drug inducing hematological toxicity

Drug

Drugs susceptible to induce hematological toxicities

Primary outcomes

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

    Time frame: to 01/02/2019

    Case reported in the World Health Organization (WHO) database of individual safety case reports

Secondary outcomes

  1. Causality assessment of reported hematological toxicities events according to the WHO system

    Time frame: to 01/02/2019

    Case reported in the World Health Organization (WHO) database of individual safety case reports

  2. Description of the type of hematological toxicity depending on the category of drug

    Time frame: to 01/02/2019

    Case reported in the World Health Organization (WHO) database of individual safety case reports

  3. Description of the other immune related adverse events concomitant to the hematological toxicity induced by drugs

    Time frame: to 01/02/2019

    Case reported in the World Health Organization (WHO) database of individual safety case reports

  4. Description of the duration of treatment when the toxicity happens (role of cumulative dose)

    Time frame: to 01/02/2019

    Case reported in the World Health Organization (WHO) database of individual safety case reports

  5. Description of the drug-drug interactions associated with adverse events

    Time frame: to 01/02/2019

    Case reported in the World Health Organization (WHO) database of individual safety case reports

  6. Description of the pathologies (cancer) for which the incriminated drugs have been prescribed

    Time frame: to 01/02/2019

    Case reported in the World Health Organization (WHO) database of individual safety case reports

  7. Description of the population of patients having hematological toxicity adverse event

    Time frame: to 01/02/2019

    Case reported in the World Health Organization (WHO) database of individual safety case reports

Sponsors and collaborators

Lead sponsor

Groupe Hospitalier Pitie-Salpetriere

Other

Collaborators

  • Institut National de la Santé Et de la Recherche Médicale, France

Registry information

Official study title

Monitoring the HeMAtological TOXicity of Drugs

Acronym: HeMATOX

Important dates

Study start
2019
Primary completion
2022
Study completion
2023
First posted
Feb 4, 2019
Registry last updated
Apr 13, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.