Clinical trial · Observational
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
NCT01098500CI-TRIAL-00027880completedResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Tyrosine kinase inhibitors | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Cancer patients
- description
- 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
- interventionNames
- Drug: Tyrosine kinase inhibitors
Primary outcomes (4)
- measure
- Number of Patients With ALT (Alanine Transaminase) >=3x (Times) Upper Limit of Normal (ULN)
- timeFrame
- Study period was October 1, 2004-June 30, 2009. Patients had at least 91 days of follow-up post index date.
- 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).
- measure
- Incidence of ALT >=3x ULN
- timeFrame
- Study period was October 1, 2004-June 30, 2009. Patients had at least 91 days of follow-up post index date.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.