All Drugs and Chemicals

Hematinics

Antineoplastic Agents

Amino Acids

Nilotinib

Liver Extracts

Dasatinib

Tyrosine Kinase Inhibitors

Lapatinib

Imatinib Mesylate

Erlotinib Hydrochloride

Gefitinib

Protein Kinase Inhibitors

Enzyme Inhibitors

Tyrosine

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

Lapatinib, erlotinib, gefitinib, dasatinib, imatinib, nilotinib (analyzed as a class of drugs, not by individual drug)

Tyrosine kinase inhibitors

GSK Clinical Trials

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).

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.

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

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

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).

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.

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).

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 whose maximum ALT elevation fell within the indicated ULN range among patients with at least one incident ALT elevation during follow-up

Median time (in months) between index date and the date of maximum ALT elevation.

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 (in months) between index date and date of maximum AST elevation

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

Median time (in months) between index date and date of maximum ALP elevation

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 (in months) between index date and date of maximum BIL elevation

GlaxoSmithKline

This is a retrospective study of pre-existing medical record and/or health insurance claims data; all data are de-identified, and thus no assessments of Serious or Non-serious Adverse Events are possible.

Adult (age \>=18 years) members of the LabRx database (A United States healthcare claims database containing the aggregated health claims experience of the covered lives managed by United Healthcare) with at least two International Classification of Disease (ICD)-9 codes for any cancer within a six-month timeframe and at least one code for an Epidermal Growth Factor Receptor (EGFR) targeted small molecule tyrosine kinase inhibitor (TKI) drug (erlotinib, gefitinib, dasatinib, imatinib, nilotinib, and lapatinib). TKI initiation must have occurred within 30 days prior to or any time after the first cancer diagnosis. The index date was the date of the first TKI prescription, and patients were followed from 30 days prior to the index date through the last visit in the database (which may be due to death or change in health plan), or the study cut-off date of June 1, 2009, whichever came first.

TKI Cohort

Age, Continuous

Female

Male

Unknown

Sex/Gender, Customized

GSK Response Center

Members of the TKI cohort who had liver function testing within 30 days prior to the initiation of TKI drug.

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

Members of the TKI cohort who had normal ALT (\<1x ULN) during baseline (within 30 days prior to the initiation of TKI drug)

Incidence of ALT >=3x ULN

Members of the TKI cohort who had liver function testing within 30 days prior to the initiation of TKI drug).

Number of Hy's Law Patients (ALT or AST >= 3x ULN and ALP <2x ULN and BIL >= 2x ULN)

Members of the TKI cohort who had normal ALT, AST, ALP, and BIL (\<1x ULN) during baseline (within 30 days prior to the initiation of TKI drug).

Incidence of Hy's Law (ALT or AST >=3x ULN and ALP <2x ULN and BIL >=2x ULN)

ALT: >=1x ULN to <3x ULN

ALT: >=3x ULN to <5x ULN

ALT: >=5x ULN to <10x ULN

ALT: >=10x ULN to <20x ULN

ALT: >=20x ULN

Members of the TKI cohort who had at least one incident ALT elevation during follow-up.

Maximum ALT Elevation Reached During Follow-up

ALT: >=10x ULN to <20x

Median Time to the Maximum ALT Elevation During Follow-up

AST: >=1x ULN to <3x ULN

AST: >=3x ULN to <5x ULN

AST: >=5x ULN to <10x ULN

AST: >=10x ULN to <20x ULN

AST: >=20x ULN

Members of the TKI cohort who had at least one incident AST elevation during follow-up.

Maximum AST Elevation Reached During Follow-up

Median Time to the Maximum AST Elevation During Follow-up

ALP: >=1x ULN to <2x ULN

ALP: >=2x ULN to <3x ULN

ALP: >=3x ULN to <5x ULN

ALP: >=5x ULN to <10x ULN

ALP: >=10x ULN

Members of the TKI cohort who had at least one incident ALP elevation during follow-up.

Maximum ALP Elevation Reached During Follow-up

Median Time to the Maximum ALP Elevation During Follow-up

BIL: >=1x ULN to <1.5x ULN

BIL: >=1.5x ULN to <2x ULN

BIL: >=2x ULN to <5x ULN

BIL: >=5x ULN to <10x ULN

BIL: >=10x ULN

Members of the TKI cohort who had at least one incident BIL elevation during follow-up.

Spots Global Cancer Trial Database for Liver Function Test (LFT) Elevations in Cancer Patients and Users of Tyrosine Kinase Inhibitor (TKI) Drugs

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