Special Investigation Of Genotropin Long Follow-Up For Patients With A Small For Gestational Age "Scoped for Japanese"

• Sponsor: Pfizer (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01897766
• Collaborator: (none)
• Enrollment: 482
• Actual Duration (Months): 45

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Small for Gestational Age (SGA)	Drug: Somatropin

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.

Study Design

• Study Type: Observational
• Actual Enrollment: 482 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: AN INVESTIGATION INTENDED TO EVALUATE THE LONG-TERM EFFICACY AND SAFETY OF GENOTROPIN IN CHILDREN WITH SGA DWARFISM WITHOUT EPIPHYSEAL CLOSURE. (RETROSPECTIVE STUDY)
• Actual Study Start Date: Sep 5, 2013
• Actual Primary Completion Date: Feb 28, 2017
• Actual Study Completion Date: Jun 7, 2017

Arms and Interventions

Arm	Intervention/Treatment
Somatropin Patients administered Somatropin.	Drug: Somatropin; 0.23 mg to 0.48 mg/kg/week; Other Names: Genotropin

Outcome Measures

Primary Outcome Measures

1. 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.

2. 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.

3. 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.

4. 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.

5. 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.

6. 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.

7. 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.

8. 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.

9. 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.

10. 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.

11. 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.

12. 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.

13. 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.

14. 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.

15. 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.

16. 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.

17. 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.

18. 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.

Secondary Outcome Measures

1. 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.

2. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 2 Years to 20 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• A patient who was administered Somatropin (Genotropin).

Exclusion Criteria:

• N/A.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Pfizer

Investigators

• Study Director: Pfizer CT.gov Call Center, Pfizer

Study Documents (Full-Text)

• Study Protocol - Jul 2, 2013
• Statistical Analysis Plan - Oct 27, 2016

More Information

Additional Information:

• To obtain contact information for a study center near you, click here.

Publications

None provided.

• Responsible Party: Pfizer
• ClinicalTrials.gov Identifier: NCT01897766
• Other Study ID Numbers: A6281314
• First Posted: Jul 12, 2013
• Last Update Posted: Feb 11, 2020
• Last Verified: Jan 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Pfizer: Genotropin; Somatropin; Long Term Follow-Up; Special Investigation; Small for Gestational Age; SGA

Study Results

Participant Flow

Pre-assignment Detail	It is a retrospective study. Data was collected for participants from July 2005 - February 2017(approximately over 11 years 6 months).

Arm/Group Title	Genotropin [Somatropin (Genetical Recombination)]
Arm/Group Description	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.
Period Title: Overall Study
STARTED	482
COMPLETED	482
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Genotropin [Somatropin (Genetical Recombination)]
Arm/Group Description	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.
Overall Participants	482
Age, Customized (Number) [Number]
<5 years	220 45.6%
≥5 and <7 years	95 19.7%
≥7 years	167 34.6%
Sex/Gender, Customized (Number) [Number]
Male	240 49.8%
Female	242 50.2%
Race and Ethnicity Not Collected (Count of Participants)

Outcome Measures

1. Primary Outcome

Title	Number of Participants With Adverse Drug Reaction (ADR)
Description	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

Outcome Measure Data

Analysis Population Description

The safety analysis set comprised of participants who satisfied the inclusion criteria and had received Genotropin.

Arm/Group Title	Genotropin [Somatropin (Genetical Recombination)]
Arm/Group Description	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.
Measure Participants	482
ADR	24 5%
SADR	4 0.8%

2. Primary Outcome

Title	Change in Height Velocity Standard Deviation (SD) Score for Chronological Age From Baseline At Year 1
Description	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

Outcome Measure Data

Analysis Population Description

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/Group Title	Genotropin [Somatropin (Genetical Recombination)]
Arm/Group Description	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.
Measure Participants	324
Mean (Standard Deviation) [SD score]	4.1 (3.06)

3. Primary Outcome

Title	Change in Height Velocity Standard Deviation (SD) Score for Chronological Age From Baseline at Year 2
Description	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

Outcome Measure Data

Analysis Population Description

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/Group Title	Genotropin [Somatropin (Genetical Recombination)]
Arm/Group Description	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.
Measure Participants	243
Mean (Standard Deviation) [SD score]	3.0 (2.92)

4. Primary Outcome

Title	Change in Height Velocity Standard Deviation (SD) Score for Chronological Age From Baseline at Year 3
Description	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

Outcome Measure Data

Analysis Population Description

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/Group Title	Genotropin [Somatropin (Genetical Recombination)]
Arm/Group Description	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.
Measure Participants	169
Mean (Standard Deviation) [SD score]	2.5 (2.53)

5. Primary Outcome

Title	Change in Height Velocity Standard Deviation (SD) Score for Chronological Age From Baseline at Year 4
Description	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

Outcome Measure Data

Analysis Population Description

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/Group Title	Genotropin [Somatropin (Genetical Recombination)]
Arm/Group Description	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.
Measure Participants	146
Mean (Standard Deviation) [SD score]	2.6 (2.81)

6. Primary Outcome

Title	Change in Height Velocity Standard Deviation (SD) Score for Chronological Age From Baseline at Year 5
Description	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

Outcome Measure Data

Analysis Population Description

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/Group Title	Genotropin [Somatropin (Genetical Recombination)]
Arm/Group Description	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.
Measure Participants	137
Mean (Standard Deviation) [SD score]	2.3 (2.74)

7. Primary Outcome

Title	Change in Height Velocity Standard Deviation (SD) Score for Chronological Age From Baseline at Year 6
Description	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

Outcome Measure Data

Analysis Population Description

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/Group Title	Genotropin [Somatropin (Genetical Recombination)]
Arm/Group Description	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.
Measure Participants	101
Mean (Standard Deviation) [SD score]	2.4 (3.07)

8. Primary Outcome

Title	Change in Height Velocity Standard Deviation (SD) Score for Chronological Age From Baseline at Year 7
Description	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

Outcome Measure Data

Analysis Population Description

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/Group Title	Genotropin [Somatropin (Genetical Recombination)]
Arm/Group Description	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.
Measure Participants	51
Mean (Standard Deviation) [SD score]	2.4 (3.86)

9. Primary Outcome

Title	Change in Height Velocity Standard Deviation (SD) Score for Chronological Age From Baseline at Year 10
Description	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

Outcome Measure Data

Analysis Population Description

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/Group Title	Genotropin [Somatropin (Genetical Recombination)]
Arm/Group Description	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.
Measure Participants	1
Mean (Standard Deviation) [SD score]	-1.6 (NA)

10. Primary Outcome

Title	Change in Height Standard Deviation (SD) Score for Chronological Age From Baseline at Year 1
Description	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

Outcome Measure Data

Analysis Population Description

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/Group Title	Genotropin [Somatropin (Genetical Recombination)]
Arm/Group Description	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.
Measure Participants	388
Mean (Standard Deviation) [SD score]	0.6 (0.36)

11. Primary Outcome

Title	Change in Height Standard Deviation (SD) Score for Chronological Age From Baseline at Year 2
Description	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

Outcome Measure Data

Analysis Population Description

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/Group Title	Genotropin [Somatropin (Genetical Recombination)]
Arm/Group Description	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.
Measure Participants	315
Mean (Standard Deviation) [SD score]	0.9 (0.49)

12. Primary Outcome

Title	Change in Height Standard Deviation (SD) Score for Chronological Age From Baseline at Year 3
Description	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

Outcome Measure Data

Analysis Population Description

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/Group Title	Genotropin [Somatropin (Genetical Recombination)]
Arm/Group Description	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.
Measure Participants	233
Mean (Standard Deviation) [SD score]	1.1 (0.51)

13. Primary Outcome

Title	Change in Height Standard Deviation (SD) Score for Chronological Age From Baseline at Year 4
Description	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

Outcome Measure Data

Analysis Population Description

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/Group Title	Genotropin [Somatropin (Genetical Recombination)]
Arm/Group Description	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.
Measure Participants	223
Mean (Standard Deviation) [SD score]	1.3 (0.63)

14. Primary Outcome

Title	Change in Height Standard Deviation (SD) Score for Chronological Age From Baseline at Year 5
Description	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

Outcome Measure Data

Analysis Population Description

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/Group Title	Genotropin [Somatropin (Genetical Recombination)]
Arm/Group Description	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.
Measure Participants	205
Mean (Standard Deviation) [SD score]	1.3 (0.71)

15. Primary Outcome

Title	Change in Height Standard Deviation (SD) Score for Chronological Age From Baseline at Year 6
Description	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

Outcome Measure Data

Analysis Population Description

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/Group Title	Genotropin [Somatropin (Genetical Recombination)]
Arm/Group Description	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.
Measure Participants	136
Mean (Standard Deviation) [SD score]	1.4 (0.81)

16. Primary Outcome

Title	Change in Height Standard Deviation (SD) Score for Chronological Age From Baseline at Year 7
Description	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

Outcome Measure Data

Analysis Population Description

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/Group Title	Genotropin [Somatropin (Genetical Recombination)]
Arm/Group Description	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.
Measure Participants	72
Mean (Standard Deviation) [SD score]	1.4 (0.87)

17. Primary Outcome

Title	Change in Height Standard Deviation (SD) Score for Chronological Age From Baseline at Year 9
Description	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

Outcome Measure Data

Analysis Population Description

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/Group Title	Genotropin [Somatropin (Genetical Recombination)]
Arm/Group Description	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.
Measure Participants	1
Mean (Standard Deviation) [SD score]	2.1 (NA)

18. Primary Outcome

Title	Change in Height Standard Deviation (SD) Score for Chronological Age From Baseline at Year 10
Description	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

Outcome Measure Data

Analysis Population Description

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/Group Title	Genotropin [Somatropin (Genetical Recombination)]
Arm/Group Description	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.
Measure Participants	1
Mean (Standard Deviation) [SD score]	1.8 (NA)

19. Secondary Outcome

Title	Height Standard Deviation (SD) Score at Puberty and at Near Final Height in Participants Who Reached Near Final Height
Description	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

Outcome Measure Data

Analysis Population Description

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/Group Title	Genotropin [Somatropin (Genetical Recombination)]
Arm/Group Description	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.
Measure Participants	34
At baseline	-3.1 (0.77)
At puberty	-2.8 (0.86)
At near final height	-2.5 (1.16)

20. Secondary Outcome

Title	Change in Height Standard Deviation (SD) Score at Puberty and at Near Final Height in Participants Who Reached Near Final Height From Baseline
Description	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

Outcome Measure Data

Analysis Population Description

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/Group Title	Genotropin [Somatropin (Genetical Recombination)]
Arm/Group Description	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.
Measure Participants	34
Change at At puberty	0.3 (0.36)
Change At near final height	0.6 (0.74)

Adverse Events

Time Frame	Approximately 11.58 years
Adverse Event Reporting Description	The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both serious and non-serious events during the study.
Arm/Group Title	Genotropin [Somatropin (Genetical Recombination)]
Arm/Group Description	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.
All Cause Mortality
	Genotropin [Somatropin (Genetical Recombination)]
	Affected / at Risk (%)	# Events
Total	1/482 (0.2%)
Serious Adverse Events
	Genotropin [Somatropin (Genetical Recombination)]
	Affected / at Risk (%)	# Events
Total	32/482 (6.6%)
Cardiac disorders
Cardiac disorder	1/482 (0.2%)
Congenital, familial and genetic disorders
Cryptorchism	1/482 (0.2%)
General disorders
Condition aggravated	2/482 (0.4%)
Infections and infestations
Acute sinusitis	1/482 (0.2%)
Appendicitis	2/482 (0.4%)
Bronchitis	1/482 (0.2%)
Campylobacter gastroenteritis	1/482 (0.2%)
Gastroenteritis	2/482 (0.4%)
Meningitis bacterial	1/482 (0.2%)
Otitis media	1/482 (0.2%)
Pneumonia	1/482 (0.2%)
Injury, poisoning and procedural complications
Patella fracture	1/482 (0.2%)
Snake bite	1/482 (0.2%)
Subdural haematoma	1/482 (0.2%)
Musculoskeletal and connective tissue disorders
Osteochondrosis	1/482 (0.2%)
Scoliosis	4/482 (0.8%)
Synovial disorder	1/482 (0.2%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bone neoplasm	1/482 (0.2%)
Neoplasm	1/482 (0.2%)
Nervous system disorders
Febrile convulsion	1/482 (0.2%)
Seizure	1/482 (0.2%)
Respiratory, thoracic and mediastinal disorders
Asthma	1/482 (0.2%)
Sleep apnoea syndrome	1/482 (0.2%)
Upper respiratory tract inflammation	1/482 (0.2%)
Skin and subcutaneous tissue disorders
Henoch-Schonlein purpura	1/482 (0.2%)
Vascular disorders
Kawasaki's disease	1/482 (0.2%)
Other (Not Including Serious) Adverse Events
	Genotropin [Somatropin (Genetical Recombination)]
	Affected / at Risk (%)	# Events
Total	150/482 (31.1%)
Eye disorders
Conjunctivitis allergic	3/482 (0.6%)
Gastrointestinal disorders
Constipation	4/482 (0.8%)
Hepatobiliary disorders
Hepatic function abnormal	5/482 (1%)
Infections and infestations
Bronchitis	18/482 (3.7%)
Gastroenteritis	14/482 (2.9%)
Impetigo	3/482 (0.6%)
Influenza	14/482 (2.9%)
Nasopharyngitis	4/482 (0.8%)
Otitis media	8/482 (1.7%)
Pharyngitis	3/482 (0.6%)
Pneumonia	3/482 (0.6%)
Investigations
Alanine aminotransferase increased	4/482 (0.8%)
Metabolism and nutrition disorders
Hyperglycaemia	3/482 (0.6%)
Musculoskeletal and connective tissue disorders
Arthralgia	4/482 (0.8%)
Scoliosis	6/482 (1.2%)
Psychiatric disorders
Attention deficit/hyperactivity disorder	5/482 (1%)
Respiratory, thoracic and mediastinal disorders
Asthma	12/482 (2.5%)
Rhinitis allergic	8/482 (1.7%)
Upper respiratory tract inflammation	18/482 (3.7%)
Skin and subcutaneous tissue disorders
Asteatosis	3/482 (0.6%)
Eczema	5/482 (1%)
Rash	3/482 (0.6%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.