Neurofibroma, Plexiform, Neurofibromatosis 1
Conditions
Brief summary
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.
Interventions
None listed
Sponsors
AstraZeneca
Study design
Observational model
CASE_ONLY
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
3 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
1. Patients treated with Koselugo (Selumetinib) under the approved label in South Korea 2. Provision of signed and dated written informed consent by the patient or legally acceptable representative
Exclusion criteria
1. Patients treated with Koselugo (Selumetinib) under the approved label in South Korea 2. Provision of signed and dated written informed consent by the patient or legally acceptable representative
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adverse events (AEs) rate | 1 year | 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 |
| Physeal dysplasia occurance rate | 1 year | To assess the safety of the study drug for patients prescribed with the study drug under the approved indication(s) in Korea |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Descriptive analysis with the physician qualitative assessments by overall disease status of NF-1 and status of clinically significant PNs, respectively. - Improving - Progression - Stable | 1 year | To assess the effectiveness of the study drug for patients prescribed with the study drug under the approved indication(s) in Korea |
Countries
South Korea
Contacts
CONTACTAstraZeneca Clinical Study Information Center
Outcome results
None listed