Know Cancer

or
forgot password

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


N/A
18 Years
N/A
Not Enrolling
Both
Cancer

Thank you

Trial Information

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


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.


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.

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Retrospective

Outcome Measure:

Number of Patients With ALT (Alanine Transaminase) >=3x (Times) Upper Limit of Normal (ULN)

Outcome Description:

Prevalence of patients with an ALT elevation >=3x ULN among patients who had liver function testing during the baseline period (30 days prior to initiation of TKI drug).

Outcome Time Frame:

Study period was October 1, 2004-June 30, 2009. Patients had at least 91 days of follow-up post index date.

Safety Issue:

Yes

Principal Investigator

GSK Clinical Trials

Investigator Role:

Study Director

Investigator Affiliation:

GlaxoSmithKline

Authority:

United Kingdom: No Health Authority

Study ID:

113153

NCT ID:

NCT01098500

Start Date:

February 2009

Completion Date:

October 2010

Related Keywords:

  • Cancer
  • Liver function
  • Tyrosine Kinase Inhibitor

Name

Location