Identification of PAthways of Kinase Inhibitors TOxicity
Completed
- Conditions
- Kinase Inhibitors Toxicity
- Interventions
- Drug: Kinase inhibitor
- Registration Number
- NCT03896139
- Lead Sponsor
- Groupe Hospitalier Pitie-Salpetriere
- Brief Summary
The investigators are identifying clinical diagnoses and toxicities associated with kinase inhibitors prescription. This identification will be applied will be applied in an electronic-health-record (EHR) cohort including North American and European.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 4000
Inclusion Criteria
- Patient treated with a kinase inhibitor
- Patient identified in the VUMC EHR cohort or having a toxicity reported in the VigiBase
Exclusion Criteria
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description VUMC EHR cohort Kinase inhibitor De-identified version of the electronic health record (EHR) at Vanderbilt University Medical Center (VUMC). Toxicity induced by kinase inhibitors in Vigibase database Kinase inhibitor Case reported in the World Health Organization (WHO) of toxicity or complication of patient treated by KIs, with a chronology compatible with the drug toxicity
- Primary Outcome Measures
Name Time Method Comparison of the incidence of kinase inhibitor (KIs) induced toxicities in health records and their associations with co-medications to identify new mechanisms of drug induced toxicity population included in VUMC database and/or WHO's database resource up to march 2019 Identification of a mechanism of a toxicity associated with a KI using comedications and comparing it to reported outcomes
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
AP-HP, Pitié-Salpêtrière Hospital, Department of Pharmacology, CIC-1421, Pharmacovigilance Unit, INSERM
🇫🇷Paris, France