N/A
N=482
Special Investigation Of Genotropin Long Follow-Up For Patients With A Small For Gestational Age "Scoped for Japanese"
Small for Gestational Age (SGA)
Bottom Line
View on ClinicalTrials.gov: NCT01897766 ↗Enrolled (actual)
482
Serious AEs
6.6%
Results posted
Feb 2020
Primary outcome: Primary: Number of Participants With Adverse Drug Reaction (ADR) — 24; 4 Participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Somatropin (Drug)
- Age
- Pediatric, Adult · 2+ yrs
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- Feb 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Adverse Drug Reaction (ADR) |
24; 4 | — |
| PRIMARY Change in Height Velocity Standard Deviation (SD) Score for Chronological Age From Baseline At Year 1 |
4.1 | — |
| PRIMARY Change in Height Velocity Standard Deviation (SD) Score for Chronological Age From Baseline at Year 2 |
3.0 | — |
| PRIMARY Change in Height Velocity Standard Deviation (SD) Score for Chronological Age From Baseline at Year 3 |
2.5 | — |
| PRIMARY Change in Height Velocity Standard Deviation (SD) Score for Chronological Age From Baseline at Year 4 |
2.6 | — |
| PRIMARY Change in Height Velocity Standard Deviation (SD) Score for Chronological Age From Baseline at Year 5 |
2.3 | — |
| PRIMARY Change in Height Velocity Standard Deviation (SD) Score for Chronological Age From Baseline at Year 6 |
2.4 | — |
| PRIMARY Change in Height Velocity Standard Deviation (SD) Score for Chronological Age From Baseline at Year 7 |
2.4 | — |
| PRIMARY Change in Height Velocity Standard Deviation (SD) Score for Chronological Age From Baseline at Year 10 |
-1.6 | — |
| PRIMARY Change in Height Standard Deviation (SD) Score for Chronological Age From Baseline at Year 1 |
0.6 | — |
| PRIMARY Change in Height Standard Deviation (SD) Score for Chronological Age From Baseline at Year 2 |
0.9 | — |
| PRIMARY Change in Height Standard Deviation (SD) Score for Chronological Age From Baseline at Year 3 |
1.1 | — |
| PRIMARY Change in Height Standard Deviation (SD) Score for Chronological Age From Baseline at Year 4 |
1.3 | — |
| PRIMARY Change in Height Standard Deviation (SD) Score for Chronological Age From Baseline at Year 5 |
1.3 | — |
| PRIMARY Change in Height Standard Deviation (SD) Score for Chronological Age From Baseline at Year 6 |
1.4 | — |
| PRIMARY Change in Height Standard Deviation (SD) Score for Chronological Age From Baseline at Year 7 |
1.4 | — |
| PRIMARY Change in Height Standard Deviation (SD) Score for Chronological Age From Baseline at Year 9 |
2.1 | — |
| PRIMARY Change in Height Standard Deviation (SD) Score for Chronological Age From Baseline at Year 10 |
1.8 | — |
| SECONDARY Height Standard Deviation (SD) Score at Puberty and at Near Final Height in Participants Who Reached Near Final Height |
-3.1; -2.8; -2.5 | — |
| SECONDARY Change in Height Standard Deviation (SD) Score at Puberty and at Near Final Height in Participants Who Reached Near Final Height From Baseline |
0.3; 0.6 | — |
Summary
The objective of this surveillance is to collect Safety and Effectiveness information for Long term Use of Somatropin for Patients with a Small for Gestational Age (SGA).
Eligibility Criteria
Inclusion Criteria
- A patient who was administered Somatropin (Genotropin).
Exclusion Criteria
- N/A.
Data sourced from ClinicalTrials.gov (NCT01897766). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.