This non-interventional study will be performed by design of post-marketing surveillance (PMS) as an additional pharmacovigilance activity of the Risk Management Plan (RMP) for Ngenla® pre-filled pen injection, which is required by the Ministry of Food and Drug Safety (MFDS) according to the local regulation. This post-marketing surveillance will investigate the safety and effectiveness of Ngenla® pre-filled pen injection as the treatment of children and adolescents from 3 years of age with growth disturbance due to insufficient secretion of growth hormone during 6 years under the setting of routine practice in Korea.
Study Type
OBSERVATIONAL
Enrollment
565
As provided in real world practice
Pfizer
Seoul, South Korea
Incidence of adverse events (AEs)
Time frame: up to 28 days after last dose
Change from baseline in Annualized Height Velocity in cm/year
Time frame: baseline, up to 12 months
Change from baseline in Height Standard Deviation Score
Time frame: baseline, up to 12 months
Change from baseline in Bone Maturation (BM)
Time frame: baseline, up to 12 months
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