An observational study in Cancer, sponsored by GlaxoSmithKline. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-05-30.
Sponsored by GlaxoSmithKline · Observational
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.
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Retrospective cohort study using the LabRx medical claims EMR database. This database contains medical claims information including diagnoses, treatments, medications, and laboratory results for 23.3 million US residents. The study cohort included adult patients (age ≥18 years) with any cancer diagnosed between October 1, 2004-June 1, 2009 who were treated with 1 one or more of the TKI agents-erlotinib, gefitinib, dasatinib, imatinib, nilotinib, or lapatinib. The index date for this cohort was the date of first administration or prescription of the TKI agent on or following the date of the first cancer diagnosis.
Exclusion Criteria:
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
Drug: Tyrosine kinase inhibitors
Lapatinib, erlotinib, gefitinib, dasatinib, imatinib, nilotinib (analyzed as a class of drugs, not by individual drug)
Number of Patients With ALT (Alanine Transaminase) >=3x (Times) Upper Limit of Normal (ULN)
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).
Time frame: Study period was October 1, 2004-June 30, 2009. Patients had at least 91 days of follow-up post index date.
Incidence of ALT >=3x ULN
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.
Time frame: Study period was October 1, 2004-June 30, 2009. Patients had at least 91 days of follow-up post index date.
Number of Hy's Law Patients (ALT or AST >= 3x ULN and ALP <2x ULN and BIL >= 2x ULN)
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).
Time frame: Study period was October 1, 2004-June 30, 2009. Patients had at least 91 days of follow-up post index date.
Incidence of Hy's Law (ALT or AST >=3x ULN and ALP <2x ULN and BIL >=2x ULN)
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.
Time frame: Study period was October 1, 2004-June 30, 2009. Patients had at least 91 days of follow-up post index date.
Maximum ALT Elevation Reached During Follow-up
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
Time frame: Study period was October 1, 2004-June 30, 2009. Patients had at least 91 days of follow-up post index date.
Median Time to the Maximum ALT Elevation During Follow-up
Median time (in months) between index date and the date of maximum ALT elevation.
Time frame: Study period was October 1, 2004-June 30, 2009. Patients had at least 91 days of follow-up post index date.
Maximum AST Elevation Reached During Follow-up
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
Time frame: Study period was October 1, 2004-June 30, 2009. Patients had at least 91 days of follow-up post index date.
Median Time to the Maximum AST Elevation During Follow-up
Median time (in months) between index date and date of maximum AST elevation
Time frame: Study period was October 1, 2004-June 30, 2009. Patients had at least 91 days of follow-up post index date.
Maximum ALP Elevation Reached During Follow-up
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
Time frame: Study period was October 1, 2004-June 30, 2009. Patients had at least 91 days of follow-up post index date.
Median Time to the Maximum ALP Elevation During Follow-up
Median time (in months) between index date and date of maximum ALP elevation
Time frame: Study period was October 1, 2004-June 30, 2009. Patients had at least 91 days of follow-up post index date.
Maximum BIL Elevation Reached During Follow-up
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
Time frame: Study period was October 1, 2004-June 30, 2009. Patients had at least 91 days of follow-up post index date.
Median Time to the Maximum BIL Elevation During Follow-up
Median time (in months) between index date and date of maximum BIL elevation
Time frame: Study period was October 1, 2004-June 30, 2009. Patients had at least 91 days of follow-up post index date.
| Milestone | TKI Cohort |
|---|---|
| Started | 3800 |
| Completed | 3800 |
| Not completed | 0 |
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).
| participants | TKI Cohort |
|---|---|
| Number of Patients With ALT (Alanine Transaminase) >=3x (Times) Upper Limit of Normal (ULN) | 11 |
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.
| participants | TKI Cohort |
|---|---|
| Incidence of ALT >=3x ULN | 18 |
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).
| participants | TKI Cohort |
|---|---|
| Number of Hy's Law Patients (ALT or AST >= 3x ULN and ALP <2x ULN and BIL >= 2x ULN) | 2 |
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.
| participants | TKI Cohort |
|---|---|
| Incidence of Hy's Law (ALT or AST >=3x ULN and ALP <2x ULN and BIL >=2x ULN) | 1 |
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
| participants | TKI Cohort |
|---|---|
| ALT: >=1x ULN to <3x ULN | 82 |
| ALT: >=3x ULN to <5x ULN | 8 |
| ALT: >=5x ULN to <10x ULN | 10 |
| ALT: >=10x ULN to <20x ULN | 0 |
| ALT: >=20x ULN | 1 |
Median time (in months) between index date and the date of maximum ALT elevation.
| months | TKI Cohort |
|---|---|
| ALT: >=1x ULN to <3x ULN | 4 (1 to 42) |
| ALT: >=3x ULN to <5x ULN | 8 (0 to 17) |
| ALT: >=5x ULN to <10x ULN | 3 (1 to 18) |
| ALT: >=10x ULN to <20x | 0 (0 to 0) |
| ALT: >=20x ULN | 7 (7 to 7) |
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
| participants | TKI Cohort |
|---|---|
| AST: >=1x ULN to <3x ULN | 87 |
| AST: >=3x ULN to <5x ULN | 8 |
| AST: >=5x ULN to <10x ULN | 3 |
| AST: >=10x ULN to <20x ULN | 2 |
| AST: >=20x ULN | 1 |
Median time (in months) between index date and date of maximum AST elevation
| months | TKI Cohort |
|---|---|
| AST: >=1x ULN to <3x ULN | 4 (0 to 50) |
| AST: >=3x ULN to <5x ULN | 5 (1 to 18) |
| AST: >=5x ULN to <10x ULN | 3 (1 to 17) |
| AST: >=10x ULN to <20x ULN | 7 (3 to 11) |
| AST: >=20x ULN | 7 (7 to 7) |
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
| participants | TKI Cohort |
|---|---|
| ALP: >=1x ULN to <2x ULN | 61 |
| ALP: >=2x ULN to <3x ULN | 7 |
| ALP: >=3x ULN to <5x ULN | 4 |
| ALP: >=5x ULN to <10x ULN | 3 |
| ALP: >=10x ULN | 0 |
Median time (in months) between index date and date of maximum ALP elevation
| months | TKI Cohort |
|---|---|
| ALP: >=1x ULN to <2x ULN | 5 (0 to 34) |
| ALP: >=2x ULN to <3x ULN | 3 (0 to 5) |
| ALP: >=3x ULN to <5x ULN | 11 (3 to 17) |
| ALP: >=5x ULN to <10x ULN | 8 (3 to 11) |
| ALP: >=10x ULN | 0 (0 to 0) |
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
| participants | TKI Cohort |
|---|---|
| BIL: >=1x ULN to <1.5x ULN | 46 |
| BIL: >=1.5x ULN to <2x ULN | 9 |
| BIL: >=2x ULN to <5x ULN | 8 |
| BIL: >=5x ULN to <10x ULN | 4 |
| BIL: >=10x ULN | 3 |
Median time (in months) between index date and date of maximum BIL elevation
| months | TKI Cohort |
|---|---|
| BIL: >=1x ULN to <1.5x ULN | 3 (0 to 26) |
| BIL: >=1.5x ULN to <2x ULN | 3 (0 to 33) |
| BIL: >=2x ULN to <5x ULN | 4 (2 to 17) |
| BIL: >=5x ULN to <10x ULN | 8 (5 to 11) |
| BIL: >=10x ULN | 6 (2 to 18) |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| TKI Cohort | — | — | — |
| Age, Continuous(Years) | TKI Cohort |
|---|---|
| Mean | 57 ± 12 |
| Sex/Gender, Customized(participants) | TKI Cohort |
|---|---|
| Female | 2061 |
| Male | 1737 |
| Unknown | 2 |
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