N/A
N=3,800
Liver Function Test (LFT) Elevations in Cancer Patients and Users of Tyrosine Kinase Inhibitor (TKI) Drugs
Cancer
Bottom Line
View on ClinicalTrials.gov: NCT01098500 ↗Enrolled (actual)
3,800
Serious AEs
—
Results posted
Jul 2011
Primary outcome: Primary: Number of Patients With ALT (Alanine Transaminase) >=3x (Times) Upper Limit of Normal (ULN) — 11 participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Tyrosine kinase inhibitors (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- GlaxoSmithKline
- Primary completion
- Oct 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Patients With ALT (Alanine Transaminase) >=3x (Times) Upper Limit of Normal (ULN) |
11 | — |
| PRIMARY Incidence of ALT >=3x ULN |
18 | — |
| PRIMARY Number of Hy's Law Patients (ALT or AST >= 3x ULN and ALP <2x ULN and BIL >= 2x ULN) |
2 | — |
| PRIMARY Incidence of Hy's Law (ALT or AST >=3x ULN and ALP <2x ULN and BIL >=2x ULN) |
1 | — |
| SECONDARY Maximum ALT Elevation Reached During Follow-up |
82; 8; 10; 0; 1 | — |
| SECONDARY Median Time to the Maximum ALT Elevation During Follow-up |
4; 8; 3; 0; 7 | — |
| SECONDARY Maximum AST Elevation Reached During Follow-up |
87; 8; 3; 2; 1 | — |
| SECONDARY Median Time to the Maximum AST Elevation During Follow-up |
4; 5; 3; 7; 7 | — |
| SECONDARY Maximum ALP Elevation Reached During Follow-up |
61; 7; 4; 3; 0 | — |
| SECONDARY Median Time to the Maximum ALP Elevation During Follow-up |
5; 3; 11; 8; 0 | — |
| SECONDARY Maximum BIL Elevation Reached During Follow-up |
46; 9; 8; 4; 3 | — |
| SECONDARY Median Time to the Maximum BIL Elevation During Follow-up |
3; 3; 4; 8; 6 | — |
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).
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT01098500). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.