Medullary Thyroid Cancer Verification Sample Clauses

Medullary Thyroid Cancer Verification. Principal Investigators: Xxxxxxx Xxxxxxxxx, DrPH, FISPE Sr. VP SERRM (Safety, Epidemiology, Registries & Risk Management) at United BioSource Corporation Project Description: As required by the FDA, United BioSource (UBC) is conducting post-marketing surveillance on behalf of the MTC Registry Consortium (currently consisting of the following members: Novo Nordisk Inc., AstraZeneca Pharmaceuticals LP, GlaxoSmithKline LLC and Xxx Xxxxx and Company) as the sponsor of the study for GLP-1 medications to monitor any increase in medullary thyroid carcinoma which may be associated with its use. UBC has entered into surveillance agreements with many statewide registries on behalf of the Sponsors and needs to verify that there are: a) no missing MTC cases in the participating states, and b) monitor the incidence of MTC in the remaining states. NAACCR will release tabular aggregate data to UBC to assist in this important study. Since this is such a rare cancer, many cells may be smaller than six (6) on a state level. We are requesting to release tabular data with counts less than six (6). These data are for internal use by UBC only and will not be publish or presented. The following variables are reported: Counts by state by year, Counts by sex (M/F) by year (U.S.), Counts by age group by year (U.S.), Stage by year (U.S.), Counts & Rates by age group by year by sex (M/F) U.S. Note: This consent is to cover the national data shared. States actively participating in the MTC Registry will have a separate consent and/or state agreement for the data shared specifically for the registry.
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Medullary Thyroid Cancer Verification. As required by the FDA, United BioSource (UBC) is conducting post-marketing surveillance on a medication to monitor any increase in medullary thyroid carcinoma which may be associated with its use. UBC has entered into surveillance agreements with many statewide registries, and needs to verify that there are a) no missing MTC cases in the participating states, and b) monitor the incidence of MTC in the remaining states. NAACCR will release tabular aggregate data to UBC to assist in this important study. Since this is such a rare cancer, many cells may be smaller than 6 on a state level. We are requesting to release tabular data with counts less than 6. The following variables would be included: Gender, Race 1, Computed Ethnicity, Spanish / Hispanic Origin, Primary Site Code, Topography of Cancer, Morphology of Cancer Code, and Age at Diagnosis.
Sample 1

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