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Clinical Trial Summary

This Non-Interventional Study (NIS) is designated as a Post Marketing Surveillance (PMS) and is a commitment to Ministry of Food and Drug Safety (MFDS), as a part of Risk Management Plan (RMP). The safety and effectiveness information of Mylotarg® will be gathered at minimum 165 subjects administered in the setting of routine practice in Korea during the initial 6 years after the approval.10


Clinical Trial Description

This is a prospective, single-arm, open-label, non-interventional, multi-centre, PMS to evaluate safety and effectiveness of Mylotarg® in patients with newly-diagnosed CD33-positive AML. As this is a Non-Interventional Study (NIS) all treatment and monitoring of the patients will be at the discretion of the investigator as part of routine practice. The study can be performed in Korean health care centers where Mylotarg® is prescribed to treat AML after obtaining informed consent from the patients as whole case enrollment method. This study is conducted to determine any problems or questions associated in regard to the following clauses under general clinical practice after marketing Mylotarg®, in accordance with the "Re-examination Guideline of New Drugs, Etc.": 1. Serious Adverse Event (SAE)/Adverse Drug Reaction (ADR) 2. Unexpected Adverse Event (AE)/Adverse Drug Reaction (ADR) that has not been reflected in the approved drug label. 3. Known Adverse Drug Reaction (ADR) 4. Non-Serious Adverse Drug Reaction (Non-SADR) 5. Other safety and effectiveness information ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05189639
Study type Observational
Source Pfizer
Contact Pfizer CT.gov Call Center
Phone 1-800-718-1021
Email [email protected]
Status Not yet recruiting
Phase
Start date February 28, 2022
Completion date December 31, 2027

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