Liver Function Test (LFT) Elevations in Cancer Patients and Users of Tyrosine Kinase Inhibitor (TKI) Drugs

GlaxoSmithKline (GSK)

Status: Completed

Conditions: Cancer

Treatments: Drug: Tyrosine kinase inhibitors

Study type: Observational

Funder types: Industry

Identifiers

NCT01098500

WEUKSTV3635 (Other Identifier)

113153

EPI40661 (Other Identifier)

Details and patient eligibility

About

A retrospective cohort study using the LabRx medical claims database will be performed to address these objectives. The primary objective of this project is to examine the background rates of liver function test (LFT) abnormalities in cancer patients treated with tyrosine kinase inhibitors (TKIs).

Full description

Patients were not recruited for nor enrolled in this study. This study is a retrospective observational study. Data from medical records or insurance claims databases are anonymised and used to develop a patient cohort. All diagnoses and treatment are recorded in the course of routine medical practice.

Enrollment: 3,800 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult (age ≥18 years) with at least two ICD-9 codes for a particular cancer (ICD-9 code 140-208.9) within a 6 month timeframe and at least one code for a TKI drug that occurs on or after the first cancer diagnosis code
• At least one month (30 days) of enrolment prior to index date and three months (91 days) of follow-up post index date; and
• Continuous enrolment in the LabRx database during follow-up.

Exclusion criteria

• Less than 18 years old
• Less than one month (30 days) of enrolment prior to index date or three months (91 days) of follow-up post index date; and
• Not continuously enrolled in the LabRx database during follow-up.

Trial design

3,800 participants in 1 patient group

Cancer patients

Description:

Adults (age ≥18 years) with at least two ICD-9 codes for a particular cancer within a 6 month timeframe and at least one code for a TKI drug that occurs on or after the first cancer diagnosis code

Treatment:

Drug: Tyrosine kinase inhibitors