Hematological Abnormality, Hematotoxicity
Conditions
Keywords
advrese event, hematotoxicity, drugs, chemotherapies
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.
Interventions
DRUGdrug inducing hematological toxicity
Drugs susceptible to induce hematological toxicities
Sponsors
Institut National de la Santé Et de la Recherche Médicale, France
Groupe Hospitalier Pitie-Salpetriere
Study design
Observational model
CASE_ONLY
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 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 |
| 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 |
Countries
France
Outcome results
None listed