Study identifier:D1346R00004
ClinicalTrials.gov identifier:NCT05388370
EudraCT identifier:N/A
CTIS identifier:N/A
Post-Authorisation Safety Study of Paediatric Patients Initiating Selumetinib: A Multiple-Country Prospective Cohort Study.
Neurofibromatosis Type 1
Phase 4
No
-
All
125
Observational
3 Years - 17 Years
Allocation: N/A
Endpoint Classification: -
Intervention Model: -
Masking: -
Primary Purpose: -
Verified 01 Sept 2024 by AstraZeneca
AstraZeneca
-
No locations available
Arms | Assigned Interventions |
---|---|
Base Cohort The Base Cohort includes all enrolled patients aged 3 to < 18 years. | - |
Nested Prospective Cohort The Nested Prospective Cohort will include the subset of Base Cohort patients aged 8 to < 18 years who have not reached Tanner Stage V on the index date | - |