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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Somatropin | Patients administered Somatropin. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Somatropin | Drug | 0.23 mg to 0.48 mg/kg/week |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Approximately 11.58 years |
| 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. | Baseline, Year 1 |
| 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. | Baseline, Year 2 |
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
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It is a retrospective study. Data was collected for participants from July 2005 - February 2017(approximately over 11 years 6 months).
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Participants enrolled in this study.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | The safety analysis set comprised of participants who satisfied the inclusion criteria and had received Genotropin. | Posted | Number | Participants | Approximately 11.58 years |
|
Approximately 11.58 years
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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute sinusitis | Infections and infestations | MedDRA 19.1 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Lymphadenitis | Blood and lymphatic system disorders | MedDRA 19.1 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 2, 2013 | Feb 26, 2018 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 27, 2016 | Feb 26, 2018 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D019382 | Human Growth Hormone |
| ID | Term |
|---|---|
| D013006 | Growth Hormone |
| D010908 | Pituitary Hormones, Anterior |
| D010907 | Pituitary Hormones |
| D036361 | Peptide Hormones |
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| Baseline, Year 3 |
| 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. | Baseline, Year 4 |
| 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. | Baseline, Year 5 |
| 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. | Baseline, Year 6 |
| 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. | Baseline, Year 7 |
| 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. | Baseline, Year 10 |
| 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. | Baseline, Year 1 |
| 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. | Baseline, Year 2 |
| 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. | Baseline, Year 3 |
| 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. | Baseline, Year 4 |
| 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. | Baseline, Year 5 |
| 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. | Baseline, Year 6 |
| 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. | Baseline, Year 7 |
| 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. | Baseline, Year 9 |
| 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. | Baseline, Year 10 |
| 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 | 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. | Baseline, At Puberty, At Near Final Height within the span of approximately maximum of 11.58 years |
| Participants |
|
| Sex/Gender, Customized | Number | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | SD score | Baseline, Year 1 |
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|
| 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. | 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. | Posted | Mean | Standard Deviation | SD score | Baseline, Year 2 |
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| 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. | 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. | Posted | Mean | Standard Deviation | SD score | Baseline, Year 3 |
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| 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. | 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. | Posted | Mean | Standard Deviation | SD score | Baseline, Year 4 |
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| 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. | 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. | Posted | Mean | Standard Deviation | SD score | Baseline, Year 5 |
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| 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. | 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. | Posted | Mean | Standard Deviation | SD score | Baseline, Year 6 |
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| 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. | 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. | Posted | Mean | Standard Deviation | SD score | Baseline, Year 7 |
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| 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. | 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. | Posted | Mean | Standard Deviation | SD score | Baseline, Year 10 |
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| 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. | 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. | Posted | Mean | Standard Deviation | SD score | Baseline, Year 1 |
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| 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. | 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. | Posted | Mean | Standard Deviation | SD score | Baseline, Year 2 |
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| 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. | 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. | Posted | Mean | Standard Deviation | SD score | Baseline, Year 3 |
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| 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. | 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. | Posted | Mean | Standard Deviation | SD score | Baseline, Year 4 |
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| 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. | 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. | Posted | Mean | Standard Deviation | SD score | Baseline, Year 5 |
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| 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. | 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. | Posted | Mean | Standard Deviation | SD score | Baseline, Year 6 |
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| 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. | 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. | Posted | Mean | Standard Deviation | SD score | Baseline, Year 7 |
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| 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. | 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. | Posted | Mean | Standard Deviation | SD score | Baseline, Year 9 |
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| 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. | 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. | Posted | Mean | Standard Deviation | SD score | Baseline, Year 10 |
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| 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. | 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. | Posted | Mean | Standard Deviation | SD score | Baseline, At Puberty, At Near Final Height within the span of approximately maximum of 11.58 years |
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| 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. | 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. | Posted | Mean | Standard Deviation | SD score | Baseline, At Puberty, At Near Final Height within the span of approximately maximum of 11.58 years |
|
|
|
| 1 |
| 482 |
| 32 |
| 482 |
| 105 |
| 482 |
| Appendicitis | Infections and infestations | MedDRA 19.1 | Non-systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA 19.1 | Non-systematic Assessment |
|
| Campylobacter gastroenteritis | Infections and infestations | MedDRA 19.1 | Non-systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA 19.1 | Non-systematic Assessment |
|
| Meningitis bacterial | Infections and infestations | MedDRA 19.1 | Non-systematic Assessment |
|
| Otitis media | Infections and infestations | MedDRA 19.1 | Non-systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 19.1 | Non-systematic Assessment |
|
| Bone neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.1 | Non-systematic Assessment |
|
| Neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.1 | Non-systematic Assessment |
|
| Febrile convulsion | Nervous system disorders | MedDRA 19.1 | Non-systematic Assessment |
|
| Seizure | Nervous system disorders | MedDRA 19.1 | Non-systematic Assessment |
|
| Cardiac disorder | Cardiac disorders | MedDRA 19.1 | Non-systematic Assessment |
|
| Kawasaki's disease | Vascular disorders | MedDRA 19.1 | Non-systematic Assessment |
|
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Non-systematic Assessment |
|
| Sleep apnoea syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Non-systematic Assessment |
|
| Upper respiratory tract inflammation | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Non-systematic Assessment |
|
| Henoch-Schonlein purpura | Skin and subcutaneous tissue disorders | MedDRA 19.1 | Non-systematic Assessment |
|
| Osteochondrosis | Musculoskeletal and connective tissue disorders | MedDRA 19.1 | Non-systematic Assessment |
|
| Scoliosis | Musculoskeletal and connective tissue disorders | MedDRA 19.1 | Non-systematic Assessment |
|
| Synovial disorder | Musculoskeletal and connective tissue disorders | MedDRA 19.1 | Non-systematic Assessment |
|
| Cryptorchism | Congenital, familial and genetic disorders | MedDRA 19.1 | Non-systematic Assessment |
|
| Condition aggravated | General disorders | MedDRA 19.1 | Non-systematic Assessment |
|
| Patella fracture | Injury, poisoning and procedural complications | MedDRA 19.1 | Non-systematic Assessment |
|
| Snake bite | Injury, poisoning and procedural complications | MedDRA 19.1 | Non-systematic Assessment |
|
| Subdural haematoma | Injury, poisoning and procedural complications | MedDRA 19.1 | Non-systematic Assessment |
|
| Sinus tachycardia | Cardiac disorders | MedDRA 19.1 | Non-systematic Assessment |
|
| Arnold-Chiari malformation | Congenital, familial and genetic disorders | MedDRA 19.1 | Non-systematic Assessment |
|
| Spine malformation | Congenital, familial and genetic disorders | MedDRA 19.1 | Non-systematic Assessment |
|
| Hyperthyroidism | Endocrine disorders | MedDRA 19.1 | Non-systematic Assessment |
|
| Hypothyroidism | Endocrine disorders | MedDRA 19.1 | Non-systematic Assessment |
|
| Thyroiditis | Endocrine disorders | MedDRA 19.1 | Non-systematic Assessment |
|
| Conjunctivitis allergic | Eye disorders | MedDRA 19.1 | Non-systematic Assessment |
|
| Colitis | Gastrointestinal disorders | MedDRA 19.1 | Non-systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 19.1 | Non-systematic Assessment |
|
| Pigmentation lip | Gastrointestinal disorders | MedDRA 19.1 | Non-systematic Assessment |
|
| Stomatitis | Gastrointestinal disorders | MedDRA 19.1 | Non-systematic Assessment |
|
| Injection site haemorrhage | General disorders | MedDRA 19.1 | Non-systematic Assessment |
|
| Injection site urticaria | General disorders | MedDRA 19.1 | Non-systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 19.1 | Non-systematic Assessment |
|
| Hepatic function abnormal | Hepatobiliary disorders | MedDRA 19.1 | Non-systematic Assessment |
|
| Food allergy | Immune system disorders | MedDRA 19.1 | Non-systematic Assessment |
|
| Seasonal allergy | Immune system disorders | MedDRA 19.1 | Non-systematic Assessment |
|
| Adenoviral upper respiratory infection | Infections and infestations | MedDRA 19.1 | Non-systematic Assessment |
|
| Beta haemolytic streptococcal infection | Infections and infestations | MedDRA 19.1 | Non-systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA 19.1 | Non-systematic Assessment |
|
| Bronchitis viral | Infections and infestations | MedDRA 19.1 | Non-systematic Assessment |
|
| Dermatitis infected | Infections and infestations | MedDRA 19.1 | Non-systematic Assessment |
|
| Ear infection | Infections and infestations | MedDRA 19.1 | Non-systematic Assessment |
|
| Erythema infectiosum | Infections and infestations | MedDRA 19.1 | Non-systematic Assessment |
|
| Exanthema subitum | Infections and infestations | MedDRA 19.1 | Non-systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA 19.1 | Non-systematic Assessment |
|
| H1N1 influenza | Infections and infestations | MedDRA 19.1 | Non-systematic Assessment |
|
| Impetigo | Infections and infestations | MedDRA 19.1 | Non-systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA 19.1 | Non-systematic Assessment |
|
| Molluscum contagiosum | Infections and infestations | MedDRA 19.1 | Non-systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 19.1 | Non-systematic Assessment |
|
| Oral herpes | Infections and infestations | MedDRA 19.1 | Non-systematic Assessment |
|
| Otitis externa | Infections and infestations | MedDRA 19.1 | Non-systematic Assessment |
|
| Otitis media | Infections and infestations | MedDRA 19.1 | Non-systematic Assessment |
|
| Otitis media acute | Infections and infestations | MedDRA 19.1 | Non-systematic Assessment |
|
| Parotitis | Infections and infestations | MedDRA 19.1 | Non-systematic Assessment |
|
| Pharyngitis | Infections and infestations | MedDRA 19.1 | Non-systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 19.1 | Non-systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA 19.1 | Non-systematic Assessment |
|
| Streptococcal infection | Infections and infestations | MedDRA 19.1 | Non-systematic Assessment |
|
| Subcutaneous abscess | Infections and infestations | MedDRA 19.1 | Non-systematic Assessment |
|
| Tonsillitis | Infections and infestations | MedDRA 19.1 | Non-systematic Assessment |
|
| Tracheobronchitis mycoplasmal | Infections and infestations | MedDRA 19.1 | Non-systematic Assessment |
|
| Varicella | Infections and infestations | MedDRA 19.1 | Non-systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA 19.1 | Non-systematic Assessment |
|
| Fracture | Injury, poisoning and procedural complications | MedDRA 19.1 | Non-systematic Assessment |
|
| Meniscus injury | Injury, poisoning and procedural complications | MedDRA 19.1 | Non-systematic Assessment |
|
| Thermal burn | Injury, poisoning and procedural complications | MedDRA 19.1 | Non-systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA 19.1 | Non-systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA 19.1 | Non-systematic Assessment |
|
| Blood alkaline phosphatase increased | Investigations | MedDRA 19.1 | Non-systematic Assessment |
|
| Blood cholesterol increased | Investigations | MedDRA 19.1 | Non-systematic Assessment |
|
| Blood glucose increased | Investigations | MedDRA 19.1 | Non-systematic Assessment |
|
| Blood thyroid stimulating hormone decreased | Investigations | MedDRA 19.1 | Non-systematic Assessment |
|
| Blood thyroid stimulating hormone increased | Investigations | MedDRA 19.1 | Non-systematic Assessment |
|
| Blood urea increased | Investigations | MedDRA 19.1 | Non-systematic Assessment |
|
| Blood urine present | Investigations | MedDRA 19.1 | Non-systematic Assessment |
|
| Body mass index increased | Investigations | MedDRA 19.1 | Non-systematic Assessment |
|
| Glucose urine | Investigations | MedDRA 19.1 | Non-systematic Assessment |
|
| Glycosylated haemoglobin increased | Investigations | MedDRA 19.1 | Non-systematic Assessment |
|
| Insulin-like growth factor increased | Investigations | MedDRA 19.1 | Non-systematic Assessment |
|
| Protein urine present | Investigations | MedDRA 19.1 | Non-systematic Assessment |
|
| White blood cell count increased | Investigations | MedDRA 19.1 | Non-systematic Assessment |
|
| Glucose tolerance impaired | Metabolism and nutrition disorders | MedDRA 19.1 | Non-systematic Assessment |
|
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 19.1 | Non-systematic Assessment |
|
| Hyperinsulinaemia | Metabolism and nutrition disorders | MedDRA 19.1 | Non-systematic Assessment |
|
| Hypertriglyceridaemia | Metabolism and nutrition disorders | MedDRA 19.1 | Non-systematic Assessment |
|
| Obesity | Metabolism and nutrition disorders | MedDRA 19.1 | Non-systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 19.1 | Non-systematic Assessment |
|
| Arthropathy | Musculoskeletal and connective tissue disorders | MedDRA 19.1 | Non-systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 19.1 | Non-systematic Assessment |
|
| Scoliosis | Musculoskeletal and connective tissue disorders | MedDRA 19.1 | Non-systematic Assessment |
|
| Neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.1 | Non-systematic Assessment |
|
| Neurofibroma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.1 | Non-systematic Assessment |
|
| Febrile convulsion | Nervous system disorders | MedDRA 19.1 | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 19.1 | Non-systematic Assessment |
|
| Orthostatic intolerance | Nervous system disorders | MedDRA 19.1 | Non-systematic Assessment |
|
| Seizure | Nervous system disorders | MedDRA 19.1 | Non-systematic Assessment |
|
| Attention deficit/hyperactivity disorder | Psychiatric disorders | MedDRA 19.1 | Non-systematic Assessment |
|
| Autism spectrum disorder | Psychiatric disorders | MedDRA 19.1 | Non-systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA 19.1 | Non-systematic Assessment |
|
| Tic | Psychiatric disorders | MedDRA 19.1 | Non-systematic Assessment |
|
| Orthostatic proteinuria | Renal and urinary disorders | MedDRA 19.1 | Non-systematic Assessment |
|
| Proteinuria | Renal and urinary disorders | MedDRA 19.1 | Non-systematic Assessment |
|
| Renal glycosuria | Renal and urinary disorders | MedDRA 19.1 | Non-systematic Assessment |
|
| Renal haemorrhage | Renal and urinary disorders | MedDRA 19.1 | Non-systematic Assessment |
|
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Non-systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Non-systematic Assessment |
|
| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Non-systematic Assessment |
|
| Upper respiratory tract inflammation | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Non-systematic Assessment |
|
| Asteatosis | Skin and subcutaneous tissue disorders | MedDRA 19.1 | Non-systematic Assessment |
|
| Blister | Skin and subcutaneous tissue disorders | MedDRA 19.1 | Non-systematic Assessment |
|
| Dermal cyst | Skin and subcutaneous tissue disorders | MedDRA 19.1 | Non-systematic Assessment |
|
| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA 19.1 | Non-systematic Assessment |
|
| Dermatitis atopic | Skin and subcutaneous tissue disorders | MedDRA 19.1 | Non-systematic Assessment |
|
| Eczema | Skin and subcutaneous tissue disorders | MedDRA 19.1 | Non-systematic Assessment |
|
| Eczema asteatotic | Skin and subcutaneous tissue disorders | MedDRA 19.1 | Non-systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 19.1 | Non-systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 19.1 | Non-systematic Assessment |
|
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 19.1 | Non-systematic Assessment |
|
| Oral surgery | Surgical and medical procedures | MedDRA 19.1 | Non-systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA 19.1 | Non-systematic Assessment |
|
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.
| D006728 |
| Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
|
| At near final height |
|
|
|