Diagnosing Adverse Drug Reactions Registry
Status: | Recruiting |
---|---|
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 3/16/2015 |
Start Date: | November 2013 |
Contact: | Karthik Kasirajan |
Email: | kkasirajan@renrx.com |
DART Registry: Diagnosing Adverse Drug Reactions Registry
This multicenter Registry is to assess whether the use of pharmacogenomic data results in a
meaningful change in a subject's drug or dose regimen. In addition, the Registry will
evaluate the relationship between adverse drug reactions (ADR) and genotype and assess
resource utilization (emergency department visits and hospitalizations) associated with ADR.
meaningful change in a subject's drug or dose regimen. In addition, the Registry will
evaluate the relationship between adverse drug reactions (ADR) and genotype and assess
resource utilization (emergency department visits and hospitalizations) associated with ADR.
Inclusion Criteria:
- Subject has care coordinated at the treating physician's outpatient clinic;
- Subject has provided written informed consent;
- Subject is taking at least three (3) regularly scheduled medications, excluding as
needed (PRN) medications, over the counter medications and nutritional supplements;
two (2) of which are known to be affected by genetic allelic variation.
- Subject's treating physician has a clinical suspicion that the subject is
experiencing adverse signs or symptoms related to a prescribed medication or is not
achieving the intended effect from the medication.
Exclusion Criteria:
- Subject has a history of chronic renal dysfunction, Chronic Kidney Disease Stage 4 or
5;
- Subject has a history of abnormal hepatic function within the last 2 years (INR >1.2
not attributable to anticoagulant medications, AST (aspartate aminotransferase) or
ALT (alanine aminotransferase) >1.5x normal, or suspected cirrhosis);
- Subject has a history of malabsorption (short gut syndrome);
- Subject has a history of any gastric or small bowel surgery;
- Subject is currently hospitalized;
- Subject is currently being treated with intravenous medication;
- Subject underwent prior pharmacogenomic testing with results reported within the last
12 months.
Subjects may be eligible within 60 days from the date of pharmacogenomic testing.
We found this trial at
50
sites
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