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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Participants receiving Ngenla | Participants receiving Ngenla according to label |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ngenla | Drug | As provided in real world practice |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of adverse events (AEs) | up to 28 days after last dose |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in Annualized Height Velocity in cm/year | baseline, up to 12 months | |
| Change from baseline in Height Standard Deviation Score | baseline, up to 12 months | |
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Inclusion Criteria:
- 1. Children and adolescents from 3 years of age with growth disturbance due to insufficient secretion of growth hormone who have received treatment with somotarogon or have been determined to start treatment with somatrogon according to the approved indications of the medicinal product;
2. Evidence of a personally signed and dated informed consent document indicating that the patient or their parent(s)/legal guardian, if applicable, have been informed of all pertinent aspects of the study.
Exclusion Criteria:
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The study will be performed in patients who have received at least 1 dose of Ngenla® pre-filled pen injection for the following indications as per local product label. (Treatment of children and adolescents from 3 years of age with growth disturbance due to insufficient secretion of growth hormone)
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer | Seoul | South Korea |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
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| Change from baseline in Bone Maturation (BM) |
| baseline, up to 12 months |