AN INVESTIGATION INTENDED TO EVALUATE THE LONG-TERM EFFICACY AND SAFETY OF GENOTROPIN IN CHILDREN WITH SGA DWARFISM WITHOUT EPIPHYSEAL CLOSURE. (RETROSPECTIVE STUDY)
Overview
- Phase
- Not Applicable
- Intervention
- Somatropin
- Conditions
- Small for Gestational Age (SGA)
- Sponsor
- Pfizer
- Enrollment
- 482
- Primary Endpoint
- Number of Participants With Adverse Drug Reaction (ADR)
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief 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).
Detailed Description
All the patients whom an investigator prescribes Genotropin should be registered consecutively until the number of subjects reaches target number in order to extract patients enrolled into the investigation at random.
Investigators
Eligibility Criteria
Inclusion Criteria
- •A patient who was administered Somatropin (Genotropin).
Exclusion Criteria
- Not provided
Arms & Interventions
Somatropin
Patients administered Somatropin.
Intervention: Somatropin
Outcomes
Primary Outcomes
Number of Participants With Adverse Drug Reaction (ADR)
Time Frame: Approximately 11.58 years
An adverse drug reaction (ADR) was any untoward medical occurrence attributed to Genotropin in a participant who received Genotropin. A serious ADR (SADR) was an ADR resulting in any of the following out comes or deemed significant for any other reason: death; life-threatening experience (immediate risk of dying); initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly. Relatedness to Genotropin was assessed by the physician.
Change in Height Velocity Standard Deviation (SD) Score for Chronological Age From Baseline At Year 1
Time Frame: Baseline, Year 1
Change in height Velocity SD score from baseline was calculated. Height Velocity SD score = (Height - Standard height for chronological age of gender) / SD. An SD score indicates how far a participant's score deviates from the mean of the reference population; an SD score higher than the mean gives a positive SD score whereas an SD score lower than the mean gives a negative SD score. SD score indicates how similar participant was to reference population.
Change in Height Velocity Standard Deviation (SD) Score for Chronological Age From Baseline at Year 4
Time Frame: Baseline, Year 4
Change in height Velocity SD score from baseline was calculated. Height Velocity SD score = (Height - Standard height for chronological age of gender) / SD. An SD score indicates how far a participant's score deviates from the mean of the reference population; an SD score higher than the mean gives a positive SD score whereas an SD score lower than the mean gives a negative SD score. SD score indicates how similar participant was to reference population.
Change in Height Velocity Standard Deviation (SD) Score for Chronological Age From Baseline at Year 6
Time Frame: Baseline, Year 6
Change in height Velocity SD score from baseline was calculated. Height Velocity SD score = (Height - Standard height for chronological age of gender) / SD. An SD score indicates how far a participant's score deviates from the mean of the reference population; an SD score higher than the mean gives a positive SD score whereas an SD score lower than the mean gives a negative SD score. SD score indicates how similar participant was to reference population.
Change in Height Velocity Standard Deviation (SD) Score for Chronological Age From Baseline at Year 2
Time Frame: Baseline, Year 2
Change in height Velocity SD score from baseline was calculated. Height Velocity SD score = (Height - Standard height for chronological age of gender) / SD. An SD score indicates how far a participant's score deviates from the mean of the reference population; an SD score higher than the mean gives a positive SD score whereas an SD score lower than the mean gives a negative SD score. SD score indicates how similar participant was to reference population.
Change in Height Velocity Standard Deviation (SD) Score for Chronological Age From Baseline at Year 3
Time Frame: Baseline, Year 3
Change in height Velocity SD score from baseline was calculated. Height Velocity SD score = (Height - Standard height for chronological age of gender) / SD. An SD score indicates how far a participant's score deviates from the mean of the reference population; an SD score higher than the mean gives a positive SD score whereas an SD score lower than the mean gives a negative SD score. SD score indicates how similar participant was to reference population.
Change in Height Velocity Standard Deviation (SD) Score for Chronological Age From Baseline at Year 5
Time Frame: Baseline, Year 5
Change in height Velocity SD score from baseline was calculated. Height Velocity SD score = (Height - Standard height for chronological age of gender) / SD. An SD score indicates how far a participant's score deviates from the mean of the reference population; an SD score higher than the mean gives a positive SD score whereas an SD score lower than the mean gives a negative SD score. SD score indicates how similar participant was to reference population.
Change in Height Velocity Standard Deviation (SD) Score for Chronological Age From Baseline at Year 7
Time Frame: Baseline, Year 7
Change in height Velocity SD score from baseline was calculated. Height Velocity SD score = (Height - Standard height for chronological age of gender) / SD. An SD score indicates how far a participant's score deviates from the mean of the reference population; an SD score higher than the mean gives a positive SD score whereas an SD score lower than the mean gives a negative SD score. SD score indicates how similar participant was to reference population.
Change in Height Velocity Standard Deviation (SD) Score for Chronological Age From Baseline at Year 10
Time Frame: Baseline, Year 10
Change in height Velocity SD score from baseline was calculated. Height Velocity SD score = (Height - Standard height for chronological age of gender) / SD. An SD score indicates how far a participant's score deviates from the mean of the reference population; an SD score higher than the mean gives a positive SD score whereas an SD score lower than the mean gives a negative SD score. SD score indicates how similar participant was to reference population.
Change in Height Standard Deviation (SD) Score for Chronological Age From Baseline at Year 1
Time Frame: Baseline, Year 1
Change in height SD score from baseline was calculated. Height SD score = (Height - Standard height for chronological age of gender) / SD. An SD score indicates how far a participant's score deviates from the mean of the reference population; an SD score higher than the mean gives a positive SD score whereas an SD score lower than the mean gives a negative SD score. SD score indicates how similar participant was to reference population.
Change in Height Standard Deviation (SD) Score for Chronological Age From Baseline at Year 2
Time Frame: Baseline, Year 2
Change in height SD score from baseline was calculated. Height SD score = (Height - Standard height for chronological age of gender) / SD. An SD score indicates how far a participant's score deviates from the mean of the reference population; an SD score higher than the mean gives a positive SD score whereas an SD score lower than the mean gives a negative SD score. SD score indicates how similar participant was to reference population.
Change in Height Standard Deviation (SD) Score for Chronological Age From Baseline at Year 3
Time Frame: Baseline, Year 3
Change in height SD score from baseline was calculated. Height SD score = (Height - Standard height for chronological age of gender) / SD. An SD score indicates how far a participant's score deviates from the mean of the reference population; an SD score higher than the mean gives a positive SD score whereas an SD score lower than the mean gives a negative SD score. SD score indicates how similar participant was to reference population.
Change in Height Standard Deviation (SD) Score for Chronological Age From Baseline at Year 7
Time Frame: Baseline, Year 7
Change in height SD score from baseline was calculated. Height SD score = (Height - Standard height for chronological age of gender) / SD. An SD score indicates how far a participant's score deviates from the mean of the reference population; an SD score higher than the mean gives a positive SD score whereas an SD score lower than the mean gives a negative SD score. SD score indicates how similar participant was to reference population.
Change in Height Standard Deviation (SD) Score for Chronological Age From Baseline at Year 9
Time Frame: Baseline, Year 9
Change in height SD score from baseline was calculated. Height SD score = (Height - Standard height for chronological age of gender) / SD. An SD score indicates how far a participant's score deviates from the mean of the reference population; an SD score higher than the mean gives a positive SD score whereas an SD score lower than the mean gives a negative SD score. SD score indicates how similar participant was to reference population.
Change in Height Standard Deviation (SD) Score for Chronological Age From Baseline at Year 10
Time Frame: Baseline, Year 10
Change in height SD score from baseline was calculated. Height SD score = (Height - Standard height for chronological age of gender) / SD. An SD score indicates how far a participant's score deviates from the mean of the reference population; an SD score higher than the mean gives a positive SD score whereas an SD score lower than the mean gives a negative SD score. SD score indicates how similar participant was to reference population.
Change in Height Standard Deviation (SD) Score for Chronological Age From Baseline at Year 4
Time Frame: Baseline, Year 4
Change in height SD score from baseline was calculated. Height SD score = (Height - Standard height for chronological age of gender) / SD. An SD score indicates how far a participant's score deviates from the mean of the reference population; an SD score higher than the mean gives a positive SD score whereas an SD score lower than the mean gives a negative SD score. SD score indicates how similar participant was to reference population.
Change in Height Standard Deviation (SD) Score for Chronological Age From Baseline at Year 5
Time Frame: Baseline, Year 5
Change in height SD score from baseline was calculated. Height SD score = (Height - Standard height for chronological age of gender) / SD. An SD score indicates how far a participant's score deviates from the mean of the reference population; an SD score higher than the mean gives a positive SD score whereas an SD score lower than the mean gives a negative SD score. SD score indicates how similar participant was to reference population.
Change in Height Standard Deviation (SD) Score for Chronological Age From Baseline at Year 6
Time Frame: Baseline, Year 6
Change in height SD score from baseline was calculated. Height SD score = (Height - Standard height for chronological age of gender) / SD. An SD score indicates how far a participant's score deviates from the mean of the reference population; an SD score higher than the mean gives a positive SD score whereas an SD score lower than the mean gives a negative SD score. SD score indicates how similar participant was to reference population.
Secondary Outcomes
- Height Standard Deviation (SD) Score at Puberty and at Near Final Height in Participants Who Reached Near Final Height(Baseline, At Puberty, At Near Final Height within the span of approximately maximum of 11.58 years)
- Change in Height Standard Deviation (SD) Score at Puberty and at Near Final Height in Participants Who Reached Near Final Height From Baseline(Baseline, At Puberty, At Near Final Height within the span of approximately maximum of 11.58 years)