Completed

NCT Number: NCT03896139

Identification of PAthways of Kinase Inhibitors TOxicity

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.

Completed

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Key information

Conditions

Kinase Inhibitors Toxicity

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Paris, France

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Kinase inhibitor

Drug

Patients treated with kinase inhibitors for cancer or other conditions

Primary outcomes

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

Time frame: 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

Sponsors and collaborators

Lead sponsor

Groupe Hospitalier Pitie-Salpetriere

Other

Collaborators

Vanderbilt University Medical Center

Registry information

Official study title

Identification of PAthways of Kinase Inhibitors TOxicity Through Patient Databases

Acronym: PAKITO

Important dates

Study start: 2017
Primary completion: 2019
Study completion: 2019
First posted: Mar 29, 2019
Registry last updated: Mar 29, 2019

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.