Liver Function Test (LFT) Elevations in Cancer Patients and Users of Tyrosine Kinase Inhibitor (TKI) Drugs
- Registration Number
- NCT01098500
- Lead Sponsor
- GlaxoSmithKline
- Brief Summary
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).
- Detailed 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 3800
- 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.
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Cancer patients Tyrosine kinase inhibitors 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
- Primary Outcome Measures
Name Time Method Incidence of Hy's Law (ALT or AST >=3x ULN and ALP <2x ULN and BIL >=2x ULN) Study period was October 1, 2004-June 30, 2009. Patients had at least 91 days of follow-up post index date. Number of patients with Hy's Law (ALT or AST \>= 3x ULN and ALP \<2x ULN and BIL \>= 2x ULN) among patients with normal ALT, AST, ALP, and BIL measurements during the baseline period (30 days prior to initiation of TKI drug). Normal is defined as an ALT AST, ALP, and BIL \<1 times ULN at baseline.
Number of Patients With ALT (Alanine Transaminase) >=3x (Times) Upper Limit of Normal (ULN) Study period was October 1, 2004-June 30, 2009. Patients had at least 91 days of follow-up post index date. 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).
Incidence of ALT >=3x ULN Study period was October 1, 2004-June 30, 2009. Patients had at least 91 days of follow-up post index date. Number of patients with ALT \>=3 times ULN among patients with a normal ALT measurement during the baseline period (30 days prior to initiation of TKI drug). Normal is defined as an ALT \<1 times ULN at baseline.
Number of Hy's Law Patients (ALT or AST >= 3x ULN and ALP <2x ULN and BIL >= 2x ULN) Study period was October 1, 2004-June 30, 2009. Patients had at least 91 days of follow-up post index date. Prevalence of patients with Hy's Law (ALT or AST \>=3x ULN and ALP \<2x ULN and BIL \>=2x ULN, where AST = aspartate transaminase, ALP = alkaline phosphatase, BIL= bilirubin) among patients who had liver function testing during the baseline period (30 days prior to initiation of TKI drug).
- Secondary Outcome Measures
Name Time Method Maximum AST Elevation Reached During Follow-up Study period was October 1, 2004-June 30, 2009. Patients had at least 91 days of follow-up post index date. Number of patients whose maximum AST elevation fell within the indicated ULN range among patients with at least one incident AST elevation during follow-up
Median Time to the Maximum AST Elevation During Follow-up Study period was October 1, 2004-June 30, 2009. Patients had at least 91 days of follow-up post index date. Median time (in months) between index date and date of maximum AST elevation
Median Time to the Maximum ALP Elevation During Follow-up Study period was October 1, 2004-June 30, 2009. Patients had at least 91 days of follow-up post index date. Median time (in months) between index date and date of maximum ALP elevation
Maximum ALT Elevation Reached During Follow-up Study period was October 1, 2004-June 30, 2009. Patients had at least 91 days of follow-up post index date. Number of patients whose maximum ALT elevation fell within the indicated ULN range among patients with at least one incident ALT elevation during follow-up
Median Time to the Maximum ALT Elevation During Follow-up Study period was October 1, 2004-June 30, 2009. Patients had at least 91 days of follow-up post index date. Median time (in months) between index date and the date of maximum ALT elevation.
Maximum ALP Elevation Reached During Follow-up Study period was October 1, 2004-June 30, 2009. Patients had at least 91 days of follow-up post index date. Number of patients whose maximum ALP elevation fell within the indicated ULN range among patients with at least one incident ALP elevation during follow-up
Maximum BIL Elevation Reached During Follow-up Study period was October 1, 2004-June 30, 2009. Patients had at least 91 days of follow-up post index date. Number of patients whose maximum BIL elevations fell within the indicated ULN range among patients with at least one incident BIL elevation during follow-up
Median Time to the Maximum BIL Elevation During Follow-up Study period was October 1, 2004-June 30, 2009. Patients had at least 91 days of follow-up post index date. Median time (in months) between index date and date of maximum BIL elevation