Liver Function Test (LFT) Elevations in Cancer Patients and Users of Tyrosine Kinase Inhibitor (TKI) Drugs Using the LabRx Database
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 3,800
- 主要终点
- Incidence of Hy's Law (ALT or AST >=3x ULN and ALP <2x ULN and BIL >=2x ULN)
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Cancer patients
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
干预措施: Tyrosine kinase inhibitors (Drug)
结局指标
主要结局
Incidence of Hy's Law (ALT or AST >=3x ULN and ALP <2x ULN and BIL >=2x ULN)
时间窗: 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)
时间窗: 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
时间窗: 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)
时间窗: 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).
次要结局
- 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.)
- 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 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.)
- 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.)
- 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.)
- 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.)
- 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.)
- 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.)