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| Name | Class |
|---|---|
| Syntactx | NETWORK |
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The purpose of this study is to determine whether the addition of selective pharmacogenomic (PGx) testing as determined by Urine Drug Testing (UDT) adds a clinical benefit as evidenced by a reduction in Target Drug-related Adverse Events (TDRAE) over the period following enrollment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard of Care (SOC Arm) | Other | Standard of Care UDT |
|
| Selective PGx Testing (Test Arm) | Other | Standard of Care UDT with selective PGx testing |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Urine diagnostic testing as SOC, drug regimen changes per SOC | Other |
| ||
| Urine diagnostic testing with selective PGx testing, drug regimen changes based on PGx test results |
| Measure | Description | Time Frame |
|---|---|---|
| The proportion of subjects who experience target drug-related adverse events (TDRAE) over the 90-day period following enrollment | 90 days |
| Measure | Description | Time Frame |
|---|---|---|
| All TDRAE as quantified within each of the four classes of medications | 90 days | |
| TDRAE driving a change in the subject's drug regimen (dose change, discontinuation, substation, or addition of a new drug) | 90 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Donald H. Deaton, Jr., DO | Recruiting | Tazewell | Tennessee | 37879 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22356329 | Background | Phimister EG, Feero WG, Guttmacher AE. Realizing genomic medicine. N Engl J Med. 2012 Feb 23;366(8):757-9. doi: 10.1056/NEJMe1200749. No abstract available. | |
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| Other |
|
| Severe TDRAE, defined as a TDRAE that meets the criteria for a Serious Adverse Event | 90 days |
| Ineffective therapeutic response, determined by the Investigator | 90 days |
| Supra-therapeutic response, as determined by the Investigator | 90 days |
| Frequency of subjects with changes in drug regimen | 90 days |
| Healthcare resource utilization, as measured by the number of outpatient clinic visits, emergency room/urgent care visits, and hospitalizations; tabulated over the 90-day period following enrollment | 90 days |
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| ID | Term |
|---|---|
| D009123 | Muscle Hypotonia |
| ID | Term |
|---|---|
| D020879 | Neuromuscular Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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