Real-World Treatment Study of Koselugo (Selumetinib)
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age3-99
SponsorAstraZeneca
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients treated with Koselugo (Selumetinib) under the approved label in South Korea
Provision of signed and dated written informed consent by the patient or legally acceptable representative
Disqualifiers
Patients treated with Koselugo (Selumetinib) under the approved label in South Korea
Provision of signed and dated written informed consent by the patient or legally acceptable representative
Trial population
Patients treated with Koselugo (Selumetinib) under the approved label in South Korea.
Trial design
Design model
Case-only
Time perspective
Other
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
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 year2
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 yearSecondary outcomes
1
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 yearSponsors and contacts
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Source ClinicalTrials.gov