Postmarketing Hepatic Monitoring for Pazopanib Using Observational Databases
N/A
18 Years
N/A
18 Years
N/A
Open (Enrolling)
Both
Carcinoma, Renal Cell
Both
Carcinoma, Renal Cell
Trial Information
Postmarketing Hepatic Monitoring for Pazopanib Using Observational Databases
Inclusion Criteria:
- In the prescriber compliance analysis, all adult (18+ years) new users of pazopanib
with an indication of RCC will be eligible for the analysis.
- In the liver enzyme elevation analysis, all adult (18+ years) new users of pazopanib,
sunitinib, bevacizumab, and sorafenib in monotherapy for any cancer type who have a
baseline liver enzyme value will be eligible for the analysis.
- In the drug-induced liver injury analyses, all adult (18+ years) new users of
pazopanib, sunitinib, bevacizumab, and sorafenib with RCC (as defined by ICD-9 codes)
will be longitudinally followed up in order to capture occurrences of liver enzyme
elevations consistent with Hy's Law and ICD-9 codes indicative of possible ALF to
evaluate for drug-induced liver injury.
Exclusion Criteria:
- N/A
Type of Study:
Observational
Study Design:
Observational Model: Cohort, Time Perspective: Retrospective
Outcome Measure:
Prescriber compliance with pazopanib label guidelines for liver monitoring
Outcome Description:
Prescriber compliance with pazopanib label guidelines for liver monitoring
Outcome Time Frame:
Over four years of treatment with pazopanib
Safety Issue:
Yes
Principal Investigator
GSK Clinical Trials
Investigator Role:
Study Director
Investigator Affiliation:
GlaxoSmithKline
Authority:
United States: No Health Authority
Study ID:
114430
NCT ID:
NCT01449825
Start Date:
December 2010
Completion Date:
December 2014
Related Keywords:
- Carcinoma, Renal Cell
- hepatic safety
- prescriber compliance
- pazopanib
- epidemiology
- Carcinoma
- Carcinoma, Renal Cell
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