N/A
Completed N=909
Long Term Use of Somatropin in Patients Small for Gestational Age
Source: ClinicalTrials.gov NCT00793325 ↗Enrolled (actual)
909
Serious AEs
0.9%
Results posted
Feb 2014
Primary outcomePrimary: Number of Participants With Treatment Related Adverse Events. — 44 participants
Summary
The objective of this surveillance is to collect information about 1) adverse drug reaction not expected from the LPD (unknown adverse drug reaction), 2) the incidence of adverse drug reactions in this surveillance, and 3)factors considered to affect the safety and/or efficacy of this drug.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Treatment Related Adverse Events. |
44 | — |
| PRIMARY Number of Unlisted Treatment Related Adverse Events According to Japanese Package Insert. |
26 | — |
| PRIMARY Number of Participants With Treatment Related Adverse Events of Somatropin: <15 Years of Age vs. >=15 Years of Age. |
44; 0 | =0.575 |
| PRIMARY Number of Participants With Treatment Related Adverse Events of Somatropin by Gender. |
19; 25 | =0.206 |
| PRIMARY Number of Participants With Treatment Related Adverse Events of Somatropin Based on SGA Severity. |
10; 16; 18 | =0.033 sig |
| PRIMARY Number of Participants With Treatment Related Adverse Events of Somatropin: With Past History of Any Disease vs. Without Past History of Any Disease. |
18; 26 | =0.013 sig |
| PRIMARY Number of Participants With Treatment Related Adverse Events of Somatropin: With Complications vs. Without Complications |
21; 23 | =0.009 sig |
| PRIMARY Number of Participants With Treatment Related Adverse Events of Somatropin: With Hepatic Function Disorder vs. Without Hepatic Function Disorder. |
3; 40 | <0.001 sig |
| PRIMARY Number of Participants With Treatment Related Adverse Events of Somatropin: With Renal Impairment vs. Without Renal Impairment. |
3; 40 | <0.001 sig |
| PRIMARY Number of Participants With Treatment Related Adverse Events of Somatropin: With Concomitant Drug(s) vs. Without Concomitant Drug(s). |
21; 23 | =0.003 sig |
| PRIMARY Change in the Growth Rate Standard Deviation (SD) Score for Calendar Age. |
3.9; 3.1; 2.9 | <0.001 sig |
| PRIMARY Change in Height SD Score for Calendar Age. |
0.6; 0.3; 0.3 | <0.001 sig |
Eligibility Criteria
Inclusion Criteria
- Patients need to be administered Somatropin (Genotropin®) in order to be enrolled in the surveillance.
Exclusion Criteria
- Patients not administered Somatropin (Genotropin®).
Data sourced from ClinicalTrials.gov (NCT00793325). 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. Informational only — not medical advice.