Small for Gestational Age (SGA)
Conditions
Keywords
Genotropin, Somatropin, Long Term Follow-Up, Special Investigation, Small for Gestational Age, SGA
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.
Interventions
DRUGSomatropin
0.23 mg to 0.48 mg/kg/week
Sponsors
Pfizer
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
2 Years to 20 Years
Healthy volunteers
No
Inclusion criteria
* A patient who was administered Somatropin (Genotropin).
Exclusion criteria
* N/A.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Height Standard Deviation (SD) Score for Chronological Age From Baseline at Year 10 | 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 7 | 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 | 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. |
| Number of Participants With Adverse Drug Reaction (ADR) | 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 | 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 2 | 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 | 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 4 | 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 5 | 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 6 | 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 7 | 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 | 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 | 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 | 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 | 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 4 | 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 | 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 | 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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. Near final height was defined as the height at one of the following conditions: the annual height velocity became less than 2 cm/year after reaching the maximum height in puberty, bone age reached 17 years old and older for male and 15 years old and older for female, or the reason for discontinuation was that subject reached the near final height or had epiphyseal closure. |
| 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 | 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. Near final height was defined as the height at one of the following conditions: the annual height velocity became less than 2 cm/year after reaching the maximum height in puberty, bone age reached 17 years old and older for male and 15 years old and older for female, or the reason for discontinuation was that subject reached the near final height or had epiphyseal closure. |
Participant flow
Pre-assignment details
It is a retrospective study. Data was collected for participants from July 2005 - February 2017(approximately over 11 years 6 months).
Participants by arm
| Arm | Count |
|---|---|
| Genotropin [Somatropin (Genetical Recombination)] Participants who received Genotropin treatment in a real world clinic setting as prescribed in clinical practice from July 2005 - February 2017. Data was observed retrospectively. | 482 |
| Total | 482 |
Baseline characteristics
| Characteristic | Genotropin [Somatropin (Genetical Recombination)] | — |
|---|---|---|
| Age, Customized ≥5 and <7 years | 95 Participants | — |
| Age, Customized <5 years | 220 Participants | — |
| Age, Customized ≥7 years | 167 Participants | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Sex/Gender, Customized Female | 242 Participants | — |
| Sex/Gender, Customized Male | 240 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 1 / 482 |
| other Total, other adverse events | 105 / 482 |
| serious Total, serious adverse events | 32 / 482 |
Outcome results
Primary
Change in Height Standard Deviation (SD) Score for Chronological Age From Baseline at 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.
Time frame: Baseline, Year 1
Population: The efficacy analysis set comprised of participants in the safety analysis set who had effectiveness evaluation at least once. Here Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Genotropin [Somatropin (Genetical Recombination)] | Change in Height Standard Deviation (SD) Score for Chronological Age From Baseline at Year 1 | 0.6 SD score | Standard Deviation 0.36 |
Primary
Change in Height Standard Deviation (SD) Score for Chronological Age From Baseline at 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.
Time frame: Baseline, Year 10
Population: The efficacy analysis set comprised of participants in the safety analysis set who had effectiveness evaluation at least once. Here Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Genotropin [Somatropin (Genetical Recombination)] | Change in Height Standard Deviation (SD) Score for Chronological Age From Baseline at Year 10 | 1.8 SD score |
Primary
Change in Height Standard Deviation (SD) Score for Chronological Age From Baseline at 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.
Time frame: Baseline, Year 2
Population: The efficacy analysis set comprised of participants in the safety analysis set who had effectiveness evaluation at least once. Here Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Genotropin [Somatropin (Genetical Recombination)] | Change in Height Standard Deviation (SD) Score for Chronological Age From Baseline at Year 2 | 0.9 SD score | Standard Deviation 0.49 |
Primary
Change in Height Standard Deviation (SD) Score for Chronological Age From Baseline at 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.
Time frame: Baseline, Year 3
Population: The efficacy analysis set comprised of participants in the safety analysis set who had effectiveness evaluation at least once. Here Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Genotropin [Somatropin (Genetical Recombination)] | Change in Height Standard Deviation (SD) Score for Chronological Age From Baseline at Year 3 | 1.1 SD score | Standard Deviation 0.51 |
Primary
Change in Height Standard Deviation (SD) Score for Chronological Age From Baseline at 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.
Time frame: Baseline, Year 4
Population: The efficacy analysis set comprised of participants in the safety analysis set who had effectiveness evaluation at least once. Here Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Genotropin [Somatropin (Genetical Recombination)] | Change in Height Standard Deviation (SD) Score for Chronological Age From Baseline at Year 4 | 1.3 SD score | Standard Deviation 0.63 |
Primary
Change in Height Standard Deviation (SD) Score for Chronological Age From Baseline at 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.
Time frame: Baseline, Year 5
Population: The efficacy analysis set comprised of participants in the safety analysis set who had effectiveness evaluation at least once. Here Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Genotropin [Somatropin (Genetical Recombination)] | Change in Height Standard Deviation (SD) Score for Chronological Age From Baseline at Year 5 | 1.3 SD score | Standard Deviation 0.71 |
Primary
Change in Height Standard Deviation (SD) Score for Chronological Age From Baseline at 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.
Time frame: Baseline, Year 6
Population: The efficacy analysis set comprised of participants in the safety analysis set who had effectiveness evaluation at least once. Here Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Genotropin [Somatropin (Genetical Recombination)] | Change in Height Standard Deviation (SD) Score for Chronological Age From Baseline at Year 6 | 1.4 SD score | Standard Deviation 0.81 |
Primary
Change in Height Standard Deviation (SD) Score for Chronological Age From Baseline at 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.
Time frame: Baseline, Year 7
Population: The efficacy analysis set comprised of participants in the safety analysis set who had effectiveness evaluation at least once. Here Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Genotropin [Somatropin (Genetical Recombination)] | Change in Height Standard Deviation (SD) Score for Chronological Age From Baseline at Year 7 | 1.4 SD score | Standard Deviation 0.87 |
Primary
Change in Height Standard Deviation (SD) Score for Chronological Age From Baseline at 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.
Time frame: Baseline, Year 9
Population: The efficacy analysis set comprised of participants in the safety analysis set who had effectiveness evaluation at least once. Here Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Genotropin [Somatropin (Genetical Recombination)] | Change in Height Standard Deviation (SD) Score for Chronological Age From Baseline at Year 9 | 2.1 SD score |
Primary
Change in Height Velocity Standard Deviation (SD) Score for Chronological Age From Baseline At 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.
Time frame: Baseline, Year 1
Population: The efficacy analysis set comprised of participants in the safety analysis set who had effectiveness evaluation at least once. Here Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Genotropin [Somatropin (Genetical Recombination)] | Change in Height Velocity Standard Deviation (SD) Score for Chronological Age From Baseline At Year 1 | 4.1 SD score | Standard Deviation 3.06 |
Primary
Change in Height Velocity Standard Deviation (SD) Score for Chronological Age From Baseline at 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.
Time frame: Baseline, Year 10
Population: The efficacy analysis set comprised of participants in the safety analysis set who had effectiveness evaluation at least once. Here Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Genotropin [Somatropin (Genetical Recombination)] | Change in Height Velocity Standard Deviation (SD) Score for Chronological Age From Baseline at Year 10 | -1.6 SD score |
Primary
Change in Height Velocity Standard Deviation (SD) Score for Chronological Age From Baseline at 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.
Time frame: Baseline, Year 2
Population: The efficacy analysis set comprised of participants in the safety analysis set who had effectiveness evaluation at least once. Here Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Genotropin [Somatropin (Genetical Recombination)] | Change in Height Velocity Standard Deviation (SD) Score for Chronological Age From Baseline at Year 2 | 3.0 SD score | Standard Deviation 2.92 |
Primary
Change in Height Velocity Standard Deviation (SD) Score for Chronological Age From Baseline at 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.
Time frame: Baseline, Year 3
Population: The efficacy analysis set comprised of participants in the safety analysis set who had effectiveness evaluation at least once. Here Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Genotropin [Somatropin (Genetical Recombination)] | Change in Height Velocity Standard Deviation (SD) Score for Chronological Age From Baseline at Year 3 | 2.5 SD score | Standard Deviation 2.53 |
Primary
Change in Height Velocity Standard Deviation (SD) Score for Chronological Age From Baseline at 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.
Time frame: Baseline, Year 4
Population: The efficacy analysis set comprised of participants in the safety analysis set who had effectiveness evaluation at least once. Here Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Genotropin [Somatropin (Genetical Recombination)] | Change in Height Velocity Standard Deviation (SD) Score for Chronological Age From Baseline at Year 4 | 2.6 SD score | Standard Deviation 2.81 |
Primary
Change in Height Velocity Standard Deviation (SD) Score for Chronological Age From Baseline at 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.
Time frame: Baseline, Year 5
Population: The efficacy analysis set comprised of participants in the safety analysis set who had effectiveness evaluation at least once. Here Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Genotropin [Somatropin (Genetical Recombination)] | Change in Height Velocity Standard Deviation (SD) Score for Chronological Age From Baseline at Year 5 | 2.3 SD score | Standard Deviation 2.74 |
Primary
Change in Height Velocity Standard Deviation (SD) Score for Chronological Age From Baseline at 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.
Time frame: Baseline, Year 6
Population: The efficacy analysis set comprised of participants in the safety analysis set who had effectiveness evaluation at least once. Here Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Genotropin [Somatropin (Genetical Recombination)] | Change in Height Velocity Standard Deviation (SD) Score for Chronological Age From Baseline at Year 6 | 2.4 SD score | Standard Deviation 3.07 |
Primary
Change in Height Velocity Standard Deviation (SD) Score for Chronological Age From Baseline at 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.
Time frame: Baseline, Year 7
Population: The efficacy analysis set comprised of participants in the safety analysis set who had effectiveness evaluation at least once. Here Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Genotropin [Somatropin (Genetical Recombination)] | Change in Height Velocity Standard Deviation (SD) Score for Chronological Age From Baseline at Year 7 | 2.4 SD score | Standard Deviation 3.86 |
Primary
Number of Participants With Adverse Drug Reaction (ADR)
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.
Time frame: Approximately 11.58 years
Population: The safety analysis set comprised of participants who satisfied the inclusion criteria and had received Genotropin.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Genotropin [Somatropin (Genetical Recombination)] | Number of Participants With Adverse Drug Reaction (ADR) | ADR | 24 Participants |
| Genotropin [Somatropin (Genetical Recombination)] | Number of Participants With Adverse Drug Reaction (ADR) | SADR | 4 Participants |
Secondary
Change in Height Standard Deviation (SD) Score at Puberty and at Near Final Height in Participants Who Reached Near Final Height From Baseline
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. Near final height was defined as the height at one of the following conditions: the annual height velocity became less than 2 cm/year after reaching the maximum height in puberty, bone age reached 17 years old and older for male and 15 years old and older for female, or the reason for discontinuation was that subject reached the near final height or had epiphyseal closure.
Time frame: Baseline, At Puberty, At Near Final Height within the span of approximately maximum of 11.58 years
Population: The efficacy analysis set comprised of participants in the safety analysis set who had effectiveness evaluation at least once. Among the efficacy analysis set, the participants who reached near final height was analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Genotropin [Somatropin (Genetical Recombination)] | Change in Height Standard Deviation (SD) Score at Puberty and at Near Final Height in Participants Who Reached Near Final Height From Baseline | Change at At puberty | 0.3 SD score | Standard Deviation 0.36 |
| Genotropin [Somatropin (Genetical Recombination)] | Change in Height Standard Deviation (SD) Score at Puberty and at Near Final Height in Participants Who Reached Near Final Height From Baseline | Change At near final height | 0.6 SD score | Standard Deviation 0.74 |
Secondary
Height Standard Deviation (SD) Score at Puberty and at Near Final Height in Participants Who Reached Near Final Height
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. Near final height was defined as the height at one of the following conditions: the annual height velocity became less than 2 cm/year after reaching the maximum height in puberty, bone age reached 17 years old and older for male and 15 years old and older for female, or the reason for discontinuation was that subject reached the near final height or had epiphyseal closure.
Time frame: Baseline, At Puberty, At Near Final Height within the span of approximately maximum of 11.58 years
Population: The efficacy analysis set comprised of participants in the safety analysis set who had effectiveness evaluation at least once. Among the efficacy analysis set, the participants who reached near final height was analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Genotropin [Somatropin (Genetical Recombination)] | Height Standard Deviation (SD) Score at Puberty and at Near Final Height in Participants Who Reached Near Final Height | At baseline | -3.1 SD score | Standard Deviation 0.77 |
| Genotropin [Somatropin (Genetical Recombination)] | Height Standard Deviation (SD) Score at Puberty and at Near Final Height in Participants Who Reached Near Final Height | At puberty | -2.8 SD score | Standard Deviation 0.86 |
| Genotropin [Somatropin (Genetical Recombination)] | Height Standard Deviation (SD) Score at Puberty and at Near Final Height in Participants Who Reached Near Final Height | At near final height | -2.5 SD score | Standard Deviation 1.16 |