Clinical trial NCT03828942: Monitoring the HeMAtological TOXicity of Drugs (HeMATOX)
Official title: Monitoring the HeMAtological TOXicity of Drugs
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hematological Abnormality
Hematotoxicity
Keywords: advrese event
hematotoxicity
drugs
chemotherapies
Lead sponsor: Groupe Hospitalier Pitie-Salpetriere
Sponsor class: OTHER
Collaborators: name: Institut National de la Santé Et de la Recherche Médicale, France
First posted: 2019-02-04
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients treated with a drug that could be reported in the WHO's pharmacovigilance database

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.

Eligibility criteria: 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

Primary outcomes:
measure: Hematological toxicities of drugs Identification and report of cases of hematological toxicities associated with drugs.
timeFrame: to 01/02/2019
Secondary outcomes:
measure: Causality assessment of reported hematological toxicities events according to the WHO system
timeFrame: to 01/02/2019
measure: Description of the type of hematological toxicity depending on the category of drug
timeFrame: to 01/02/2019
measure: Description of the other immune related adverse events concomitant to the hematological toxicity induced by drugs
timeFrame: to 01/02/2019
measure: Description of the duration of treatment when the toxicity happens (role of cumulative dose)
timeFrame: to 01/02/2019
measure: Description of the drug-drug interactions associated with adverse events
timeFrame: to 01/02/2019
measure: Description of the pathologies (cancer) for which the incriminated drugs have been prescribed
timeFrame: to 01/02/2019
measure: Description of the population of patients having hematological toxicity adverse event
timeFrame: to 01/02/2019
Other outcomes:
Locations:
city: Paris
country: France
facility: AP-HP, Pitié-Salpêtrière Hospital, Department of Pharmacology, CIC-1421, Pharmacovigilance Unit, INSERM
city: Strasbourg
country: France
facility: Rhumatology department, CHU Strasbourg, Hautepierre hospital
Study officials:
References: