As part of a post-approval commitment, the Korean health authority requests a study to characterize safety and effectiveness in patients treated with Koselugo (Selumetinib), an oral selective inhibitor of MAPK kinase (MEK) 1 and 2, by physicians in routine clinical practice settings. This study is designed to assess the known safety profile or identify previously unsuspected adverse reactions and evaluate the effectiveness of Koselugo under conditions of routine daily medical practice in Korea. This study will provide information on the Korean patient population that is treated with the study drug.
Study Type
OBSERVATIONAL
Enrollment
200
Research Site
Busan, South Korea
RECRUITINGResearch Site
Chungcheongbuk-do, South Korea
RECRUITINGResearch Site
Daejeon, South Korea
RECRUITINGResearch Site
Gyeonggi-do, South Korea
RECRUITINGResearch Site
Incheon, South Korea
RECRUITINGResearch Site
Jeonnam, South Korea
RECRUITINGResearch Site
Seoul, South Korea
SUSPENDEDResearch Site
Seoul, South Korea
RECRUITINGResearch Site
Seoul, South Korea
COMPLETEDResearch Site
Seoul, South Korea
NOT_YET_RECRUITING...and 2 more locations
Adverse events (AEs) rate
To assess the safety (Adverse events (AEs), serious AEs (SAEs), adverse drug reactions (ADRs), serious ADRs (SADRs), unexpected AEs/ADRs) of the study drug for patients prescribed with the study drug under the approved indication(s) in Korea
Time frame: 1 year
Physeal dysplasia occurance rate
To assess the safety of the study drug for patients prescribed with the study drug under the approved indication(s) in Korea
Time frame: 1 year
Descriptive analysis with the physician qualitative assessments by overall disease status of NF-1 and status of clinically significant PNs, respectively. - Improving - Progression - Stable
To assess the effectiveness of the study drug for patients prescribed with the study drug under the approved indication(s) in Korea
Time frame: 1 year
AstraZeneca Clinical Study Information Center
CONTACT
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