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The objectives of the re-examination system in Korea is to re-confirm the clinical usefulness of the product through collecting, reviewing, identifying and verifying the safety and efficacy information about the product in general practice in Korea.
This surveillance is conducted for preparing application material for re-examination under the Pharmaceutical Affairs Laws, the Regulations on Safety of Pharmaceuticals, etc. and the Re-examination Regulation for New Drugs and Others.
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NCT# stands for National Clinical Trial number. This is a unique identification code given to each clinical trial registered on ClinicalTrials.gov. The format is "NCT" followed by an 8-digit number (for example, NCT00000419). Also called the ClinicalTrials.gov identifier.
Each clinical study has its own guidelines for who may participate, called eligibility criteria. These factors can include your age, sex, overall health, type and stage of disease, and personal treatment history. However, only the research study staff can determine if you qualify to enroll in the study.
Condition
HER2-positive Locally Advanced Unresectable, Metastatic Breast Cancer
Sex
Male or Female
Age
18+ years