Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
To show an increase in annual growth rate 3 years after Visit 2. Annual growth rate in standard deviation (SD) after 3 years will be compared to growth rate before the start of GH treatment.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Somatropin | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Somatropin | Drug | Adapted dosage based on IGF 1 level and weight Form: liquid; Dosage and Frequency: from 0.0033mg/kg/day to 0.0067 mg/kg/day; Duration: 3 years |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Annual Growth Rate Standard Deviation Score (SDS) for Chronological Age (CA) at Month 36 in Intent-to-Treat (ITT) Population | Change in annual growth rate (AGR) standard deviation score (SDS) for chronological age (CA) derived by subtracting AGR SDS CA at baseline from each time point (Yx) value. AGR at Yx= (height Yx-height Y[x-1])/([date of Yx-date of Y{x-1}]/365.25). AGR as SDS calculated using Sempe reference means and standard deviations (SD) for growth rate. AGR SDS CA (for both baseline and Yx)= (AGR-reference mean for growth rate CA)/reference SD for growth rate CA. CA calculated as integer (Date of height measurement-Date of birth)/365.25*12. SDS indicates how similar participant was to reference population. | Baseline, Month 36 |
| Change From Baseline in Annual Growth Rate Standard Deviation Score (SDS) for Chronological Age (CA) at Month 36 in Per-Protocol (PP) Population | Change in annual growth rate (AGR) standard deviation score (SDS) for chronological age (CA) derived by subtracting AGR SDS CA at baseline from each time point (Yx) value. AGR at Yx= (height Yx-height Y[x-1])/([date of Yx-date of Y{x-1}]/365.25). AGR as SDS calculated using Sempe reference means and standard deviations (SD) for growth rate. AGR SDS CA (for both baseline and Yx)= (AGR-reference mean for growth rate CA)/reference SD for growth rate CA. CA calculated as integer (Date of height measurement-Date of birth)/365.25*12. SDS indicates how similar participant was to reference population. | Baseline, Month 36 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Annual Growth Rate at Month 12, Month 24 and Month 36 in ITT Population | Change in AGR at Yx was derived by subtracting AGR at baseline from Yx value. Annual growth rate was calculated each year and rescaled to 1 year if the interval between Yx and Y[x-1] was not 365 days, as long as a participant remained in the study. AGR at Yx was calculated using the previous height measurements (Y[x-1]) and height recorded at Yx (AGR Yx = [height Yx-height Y{x-1}] / ([date of Yx - date of Y{x-1}] /365.25). |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Investigational Site | Annemasse | 74107 | France | |||
| Pfizer Investigational Site |
Not provided
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Genotonorm | Genotonorm (recombinant somatropin) up to maximum of 50 microgram/kilogram/day (mcg/kg/day) subcutaneously as decided by the investigator, divided in 7 daily doses for up to 3 years. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Genotonorm | Genotonorm (recombinant somatropin) up to maximum of 50 microgram/kilogram/day (mcg/kg/day) subcutaneously as decided by the investigator, divided in 7 daily doses for up to 3 years. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean |
| 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 | Change From Baseline in Annual Growth Rate Standard Deviation Score (SDS) for Chronological Age (CA) at Month 36 in Intent-to-Treat (ITT) Population | Change in annual growth rate (AGR) standard deviation score (SDS) for chronological age (CA) derived by subtracting AGR SDS CA at baseline from each time point (Yx) value. AGR at Yx= (height Yx-height Y[x-1])/([date of Yx-date of Y{x-1}]/365.25). AGR as SDS calculated using Sempe reference means and standard deviations (SD) for growth rate. AGR SDS CA (for both baseline and Yx)= (AGR-reference mean for growth rate CA)/reference SD for growth rate CA. CA calculated as integer (Date of height measurement-Date of birth)/365.25*12. SDS indicates how similar participant was to reference population. | Intent to Treat (ITT) set included all participants who received at least 1 dose of study medication and had at least 1 evaluation of height after start of study medication. Here 'N' (Number of participants analyzed) signifies those participants who were evaluable for this measure and "n" signifies participants evaluated at that time point. | Posted | Mean | Standard Deviation | SDS | Baseline, Month 36 |
|
Not provided
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Genotonorm | Genotonorm (recombinant somatropin) up to maximum of 50 microgram/kilogram/day (mcg/kg/day) subcutaneously as decided by the investigator, divided in 7 daily doses for up to 3 years. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cryptorchism | Congenital, familial and genetic disorders | MedDRA v14.1 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA v14.1 | Non-systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
Not provided
| ID | Term |
|---|---|
| D004700 | Endocrine System Diseases |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D019382 | Human Growth Hormone |
| ID | Term |
|---|---|
| D013006 | Growth Hormone |
| D010908 | Pituitary Hormones, Anterior |
| D010907 | Pituitary Hormones |
| D036361 | Peptide Hormones |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Baseline, Month 12, Month 24, Month 36 |
| Change From Baseline in Annual Growth Rate at Month 12, Month 24, Month 36 in PP Population | Change in AGR at Yx was derived by subtracting AGR at baseline from Yx value. Annual growth rate was calculated each year and rescaled to 1 year if the interval between Yx and Y[x-1] was not 365 days, as long as a participant remained in the study. AGR at Yx was calculated using the previous height measurements (Y[x-1]) and height recorded at Yx (AGR Yx = [height Yx-height Y{x-1}] / ([date of Yx - date of Y{x-1}] /365.25). | Baseline, Month 12, Month 24, Month 36 |
| Height | Height was measured using a wall mounted device (example, Harpenden stadiometer). The standing height of the participant was measured two times and the mean of these measurements was recorded. | Baseline, Month 12, Month 24, Month 36 |
| Change From Baseline in Height at Month 12, Month 24 and Month 36 | Height was measured using a wall mounted device (example, Harpenden stadiometer). The standing height of the participant was measured two times and the mean of these measurements was recorded. | Baseline, Month 12, Month 24, Month 36 |
| Mean Height Standard Deviation Score (SDS) for Chronological Age (CA) | Height was measured using a wall mounted device (example, Harpenden stadiometer). The standing height of the participant was measured two times and the mean of these measurements was recorded. Height SDS CA Yx = (height Yx - reference mean for CA Yx) / reference SD for CA Yx. Height in SDS was calculated using Sempe reference means and SD for height. CA calculated as integer (Date of height measurement-Date of birth)/365.25*12. SDS indicates how similar the participant was to the reference population. | Baseline, Month 12, Month 24, Month 36 |
| Change From Baseline in Height Standard Deviation Score (SDS) for Chronological Age (CA) at Month 12, Month 24 and Month 36 | Change in height SDS CA was derived by subtracting height SDS CA at baseline from Yx value. Height SDS CA (for both baseline and Yx) = (height - reference mean for CA)/reference SD for CA. Height in SDS was calculated using Sempe reference means and SD for height. CA calculated as integer (Date of height measurement - Date of birth)/365.25*12. SDS indicates how similar the participant was to the reference population. | Baseline, Month 12, Month 24, Month 36 |
| Mean Height Standard Deviation Score (SDS) for Bone Age (BA) | Height SDS BA Yx = (height Yx - reference mean for BA Yx) / reference SD for BA Yx. Height in SDS was calculated using Sempe reference means and SD for height. BA was estimated locally using an X-ray from the left wrist and hand. SDS indicates how similar the participant was to the reference population. | Baseline, Month 12, Month 24, Month 36 |
| Change From Baseline in Height Standard Deviation Score (SDS) for Bone Age (BA) at Month 12, Month 24 and Month 36 | Change in height SDS BA was derived by subtracting height SDS BA at baseline from Yx value. Height SDS BA (for both baseline and Yx) = (height-reference mean for BA)/reference SD for BA. Height in SDS was calculated using Sempe reference means and SD for height. BA was estimated locally using an X-ray from the left wrist and hand. SDS indicates how similar the participant was to the reference population. | Baseline, Month 12, Month 24, Month 36 |
| Change From Baseline in Annual Growth Rate Standard Deviation Score (SDS) for Chronological Age (CA) at Month 12 and Month 24 in ITT Population | Change in AGR SDS for CA derived by subtracting AGR SDS CA at baseline from Yx value. AGR at Yx= (height Yx-height Y[x-1])/([date of Yx-date of Y{x-1}]/365.25). AGR as SDS calculated using Sempe reference means and standard deviations (SD) for growth rate. AGR SDS CA (for both baseline and Yx)= (AGR-reference mean for growth rate CA)/reference SD for growth rate CA. CA calculated as integer (Date of height measurement-Date of birth)/365.25*12. SDS indicates how similar participant was to reference population. | Baseline, Month 12, Month 24 |
| Change From Baseline in Annual Growth Rate Standard Deviation Score (SDS) for Chronological Age (CA) at Month 12 and Month 24 in PP Population | Change in annual growth rate (AGR) standard deviation score (SDS) for chronological age (CA) derived by subtracting AGR SDS CA at baseline from each time point (Yx) value. AGR at Yx= (height Yx-height Y[x-1])/([date of Yx-date of Y{x-1}]/365.25). AGR as SDS calculated using Sempe reference means and standard deviations (SD) for growth rate. AGR SDS CA (for both baseline and Yx)= (AGR-reference mean for growth rate CA)/reference SD for growth rate CA. CA calculated as integer (Date of height measurement-Date of birth)/365.25*12. SDS indicates how similar participant was to reference population. | Baseline, Month 12, Month 24 |
| Mean Growth Rate Standard Deviation Score (SDS) for Bone Age (BA) | AGR at Yx was derived by subtracting AGR at baseline from Yx value. AGR was calculated each year and rescaled to 1 year if the interval between Yx and Y[x-1] was not 365 days, as long as a participant remained in the study. AGR at Yx = [height Yx-height Y{x-1}] / ([date of Yx - date of Y{x-1}] /365.25). GR in SDS was calculated using Sempe reference means and SD for growth. BA was estimated locally using an X-ray from the left wrist and hand. SDS indicates how similar the participant was to the reference population. | Month 12, Month 24, Month 36 |
| Body Mass Index (BMI) | BMI was used to measure body fat based on height and weight. It was calculated as body weight (kilogram) divided by the height (meter) squared. | Baseline, Month 12, Month 24, Month 36 |
| Change From Baseline in Body Mass Index (BMI) at Month 12, Month 24 and Month 36 | BMI was used to measure body fat based on height and weight. It was calculated as body weight (kilogram) divided by the height (meter) squared. | Baseline, Month 12, Month 24, Month 36 |
| Change From Baseline in Bone Age (BA) at Month 12, Month 24 and Month 36 | BA was estimated locally using an X-ray from the left wrist and hand. | Baseline, Month 12, Month 24, Month 36 |
| Ratio of Bone Age (BA) to Chronological Age (CA) | BA was estimated locally using an X-ray from the left wrist and hand. CA at the date of corresponding X-ray (Date of X-ray - Date of birth)/365.25. Ratio of BA/CA at each annual study visit was calculated. | Baseline, Month 12, Month 24, Month 36 |
| Besançon |
| 25030 |
| France |
| Pfizer Investigational Site | Bordeaux | 33000 | France |
| Pfizer Investigational Site | Bordeaux | 33076 | France |
| Pfizer Investigational Site | Bron | 69677 | France |
| Pfizer Investigational Site | Dijon | 21000 | France |
| Pfizer Investigational Site | Grenoble | 38043 | France |
| Pfizer Investigational Site | Lorient | 56100 | France |
| Pfizer Investigational Site | Lyon | 69322 | France |
| Pfizer Investigational Site | Marseille | 13385 | France |
| Pfizer Investigational Site | Montpellier | 34059 | France |
| Pfizer Investigational Site | Paris | 75015 | France |
| Pfizer Investigational Site | Paris | 75019 | France |
| Pfizer Investigational Site | Paris | 75571 | France |
| Pfizer Investigational Site | Paris | 75674 Cedex | France |
| Pfizer Investigational Site | Pringy | 74374 | France |
| Pfizer Investigational Site | Toulouse | 31026 | France |
| Pfizer Investigational Site | Vandœuvre-lès-Nancy | 54511 | France |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Title |
|---|
| Description |
|---|
| OG000 | Genotonorm | Genotonorm (recombinant somatropin) up to maximum of 50 microgram/kilogram/day (mcg/kg/day) subcutaneously as decided by the investigator, divided in 7 daily doses for up to 3 years. |
|
|
| Primary | Change From Baseline in Annual Growth Rate Standard Deviation Score (SDS) for Chronological Age (CA) at Month 36 in Per-Protocol (PP) Population | Change in annual growth rate (AGR) standard deviation score (SDS) for chronological age (CA) derived by subtracting AGR SDS CA at baseline from each time point (Yx) value. AGR at Yx= (height Yx-height Y[x-1])/([date of Yx-date of Y{x-1}]/365.25). AGR as SDS calculated using Sempe reference means and standard deviations (SD) for growth rate. AGR SDS CA (for both baseline and Yx)= (AGR-reference mean for growth rate CA)/reference SD for growth rate CA. CA calculated as integer (Date of height measurement-Date of birth)/365.25*12. SDS indicates how similar participant was to reference population. | Per Protocol (PP) analysis set included all participants in the ITT set without a major protocol violation. Here 'N' (Number of participants analyzed) signifies those participants who were evaluable for this measure and "n" signifies participants evaluated at that time point. | Posted | Mean | Standard Deviation | SDS | Baseline, Month 36 |
|
|
|
| Secondary | Change From Baseline in Annual Growth Rate at Month 12, Month 24 and Month 36 in ITT Population | Change in AGR at Yx was derived by subtracting AGR at baseline from Yx value. Annual growth rate was calculated each year and rescaled to 1 year if the interval between Yx and Y[x-1] was not 365 days, as long as a participant remained in the study. AGR at Yx was calculated using the previous height measurements (Y[x-1]) and height recorded at Yx (AGR Yx = [height Yx-height Y{x-1}] / ([date of Yx - date of Y{x-1}] /365.25). | ITT set included all participants who received at least 1 dose of study medication and had at least 1 evaluation of height after start of study medication. Here 'N' (Number of participants analyzed) signifies those participants who were evaluable for this measure and "n" signifies participants evaluated at that time point. | Posted | Mean | Standard Deviation | centimeter per year (cm/year) | Baseline, Month 12, Month 24, Month 36 |
|
|
|
| Secondary | Change From Baseline in Annual Growth Rate at Month 12, Month 24, Month 36 in PP Population | Change in AGR at Yx was derived by subtracting AGR at baseline from Yx value. Annual growth rate was calculated each year and rescaled to 1 year if the interval between Yx and Y[x-1] was not 365 days, as long as a participant remained in the study. AGR at Yx was calculated using the previous height measurements (Y[x-1]) and height recorded at Yx (AGR Yx = [height Yx-height Y{x-1}] / ([date of Yx - date of Y{x-1}] /365.25). | PP analysis set included all participants in the ITT set without a major protocol violation. Here 'N' (Number of participants analyzed) signifies those participants who were evaluable for this measure and "n" signifies participants evaluated at that time point. | Posted | Mean | Standard Deviation | cm/year | Baseline, Month 12, Month 24, Month 36 |
|
|
|
| Secondary | Height | Height was measured using a wall mounted device (example, Harpenden stadiometer). The standing height of the participant was measured two times and the mean of these measurements was recorded. | ITT set included all participants who received at least 1 dose of study medication and had at least 1 evaluation of height after start of study medication. Here "n" signifies those participants evaluated at that time point. | Posted | Mean | Standard Deviation | cm | Baseline, Month 12, Month 24, Month 36 |
|
|
|
| Secondary | Change From Baseline in Height at Month 12, Month 24 and Month 36 | Height was measured using a wall mounted device (example, Harpenden stadiometer). The standing height of the participant was measured two times and the mean of these measurements was recorded. | ITT set included all participants who received at least 1 dose of study medication and had at least 1 evaluation of height after start of study medication. Here 'N' (Number of participants analyzed) signifies those participants who were evaluable for this measure and "n" signifies participants evaluated at that time point. | Posted | Mean | Standard Deviation | cm | Baseline, Month 12, Month 24, Month 36 |
|
|
|
| Secondary | Mean Height Standard Deviation Score (SDS) for Chronological Age (CA) | Height was measured using a wall mounted device (example, Harpenden stadiometer). The standing height of the participant was measured two times and the mean of these measurements was recorded. Height SDS CA Yx = (height Yx - reference mean for CA Yx) / reference SD for CA Yx. Height in SDS was calculated using Sempe reference means and SD for height. CA calculated as integer (Date of height measurement-Date of birth)/365.25*12. SDS indicates how similar the participant was to the reference population. | ITT set included all participants who received at least 1 dose of study medication and had at least 1 evaluation of height after start of study medication. Here "n" signifies those participants evaluated at that time point. | Posted | Mean | Standard Deviation | SDS | Baseline, Month 12, Month 24, Month 36 |
|
|
|
| Secondary | Change From Baseline in Height Standard Deviation Score (SDS) for Chronological Age (CA) at Month 12, Month 24 and Month 36 | Change in height SDS CA was derived by subtracting height SDS CA at baseline from Yx value. Height SDS CA (for both baseline and Yx) = (height - reference mean for CA)/reference SD for CA. Height in SDS was calculated using Sempe reference means and SD for height. CA calculated as integer (Date of height measurement - Date of birth)/365.25*12. SDS indicates how similar the participant was to the reference population. | ITT set included all participants who received at least 1 dose of study medication and had at least 1 evaluation of height after start of study medication. Here 'N' (Number of participants analyzed) signifies those participants who were evaluable for this measure and "n" signifies participants evaluated at that time point. | Posted | Mean | Standard Deviation | SDS | Baseline, Month 12, Month 24, Month 36 |
|
|
|
| Secondary | Mean Height Standard Deviation Score (SDS) for Bone Age (BA) | Height SDS BA Yx = (height Yx - reference mean for BA Yx) / reference SD for BA Yx. Height in SDS was calculated using Sempe reference means and SD for height. BA was estimated locally using an X-ray from the left wrist and hand. SDS indicates how similar the participant was to the reference population. | ITT set included all participants who received at least 1 dose of study medication and had at least 1 evaluation of height after start of study medication. Here 'N' (Number of participants analyzed) signifies those participants who were evaluable for this measure and "n" signifies participants evaluated at that time point. | Posted | Mean | Standard Deviation | SDS | Baseline, Month 12, Month 24, Month 36 |
|
|
|
| Secondary | Change From Baseline in Height Standard Deviation Score (SDS) for Bone Age (BA) at Month 12, Month 24 and Month 36 | Change in height SDS BA was derived by subtracting height SDS BA at baseline from Yx value. Height SDS BA (for both baseline and Yx) = (height-reference mean for BA)/reference SD for BA. Height in SDS was calculated using Sempe reference means and SD for height. BA was estimated locally using an X-ray from the left wrist and hand. SDS indicates how similar the participant was to the reference population. | ITT set included all participants who received at least 1 dose of study medication and had at least 1 evaluation of height after start of study medication. Here 'N' (Number of participants analyzed) signifies those participants who were evaluable for this measure and "n" signifies participants evaluated at that time point. | Posted | Mean | Standard Deviation | SDS | Baseline, Month 12, Month 24, Month 36 |
|
|
|
| Secondary | Change From Baseline in Annual Growth Rate Standard Deviation Score (SDS) for Chronological Age (CA) at Month 12 and Month 24 in ITT Population | Change in AGR SDS for CA derived by subtracting AGR SDS CA at baseline from Yx value. AGR at Yx= (height Yx-height Y[x-1])/([date of Yx-date of Y{x-1}]/365.25). AGR as SDS calculated using Sempe reference means and standard deviations (SD) for growth rate. AGR SDS CA (for both baseline and Yx)= (AGR-reference mean for growth rate CA)/reference SD for growth rate CA. CA calculated as integer (Date of height measurement-Date of birth)/365.25*12. SDS indicates how similar participant was to reference population. | ITT set included all participants who received at least 1 dose of study medication and had at least 1 evaluation of height after start of study medication. Here 'N' (Number of participants analyzed) signifies those participants who were evaluable for this measure. | Posted | Mean | Standard Deviation | SDS | Baseline, Month 12, Month 24 |
|
|
|
| Secondary | Change From Baseline in Annual Growth Rate Standard Deviation Score (SDS) for Chronological Age (CA) at Month 12 and Month 24 in PP Population | Change in annual growth rate (AGR) standard deviation score (SDS) for chronological age (CA) derived by subtracting AGR SDS CA at baseline from each time point (Yx) value. AGR at Yx= (height Yx-height Y[x-1])/([date of Yx-date of Y{x-1}]/365.25). AGR as SDS calculated using Sempe reference means and standard deviations (SD) for growth rate. AGR SDS CA (for both baseline and Yx)= (AGR-reference mean for growth rate CA)/reference SD for growth rate CA. CA calculated as integer (Date of height measurement-Date of birth)/365.25*12. SDS indicates how similar participant was to reference population. | PP analysis set included all participants in the ITT set without a major protocol violation. Here 'N' (Number of participants analyzed) signifies those participants who were evaluable for this measure. | Posted | Mean | Standard Deviation | SDS | Baseline, Month 12, Month 24 |
|
|
|
| Secondary | Mean Growth Rate Standard Deviation Score (SDS) for Bone Age (BA) | AGR at Yx was derived by subtracting AGR at baseline from Yx value. AGR was calculated each year and rescaled to 1 year if the interval between Yx and Y[x-1] was not 365 days, as long as a participant remained in the study. AGR at Yx = [height Yx-height Y{x-1}] / ([date of Yx - date of Y{x-1}] /365.25). GR in SDS was calculated using Sempe reference means and SD for growth. BA was estimated locally using an X-ray from the left wrist and hand. SDS indicates how similar the participant was to the reference population. | ITT set included all participants who received at least 1 dose of study medication and had at least 1 evaluation of height after start of study medication. Here 'N' (Number of participants analyzed) signifies those participants who were evaluable for this measure and "n" signifies participants evaluated at that time point. | Posted | Mean | Standard Deviation | SDS | Month 12, Month 24, Month 36 |
|
|
|
| Secondary | Body Mass Index (BMI) | BMI was used to measure body fat based on height and weight. It was calculated as body weight (kilogram) divided by the height (meter) squared. | ITT set included all participants who received at least 1 dose of study medication and had at least 1 evaluation of height after start of study medication. Here "n" signifies those participants evaluated at that time point. | Posted | Mean | Standard Deviation | kilogram per square meter (kg/m^2) | Baseline, Month 12, Month 24, Month 36 |
|
|
|
| Secondary | Change From Baseline in Body Mass Index (BMI) at Month 12, Month 24 and Month 36 | BMI was used to measure body fat based on height and weight. It was calculated as body weight (kilogram) divided by the height (meter) squared. | ITT set included all participants who received at least 1 dose of study medication and had at least 1 evaluation of height after start of study medication. Here 'N' (Number of participants analyzed) signifies those participants who were evaluable for this measure and "n" signifies participants evaluated at that time point. | Posted | Mean | Standard Deviation | kg/m^2 | Baseline, Month 12, Month 24, Month 36 |
|
|
|
| Secondary | Change From Baseline in Bone Age (BA) at Month 12, Month 24 and Month 36 | BA was estimated locally using an X-ray from the left wrist and hand. | ITT set included all participants who received at least 1 dose of study medication and had at least 1 evaluation of height after start of study medication. Here 'N' (Number of participants analyzed) signifies those participants who were evaluable for this measure and "n" signifies participants evaluated at that time point. | Posted | Mean | Standard Deviation | years | Baseline, Month 12, Month 24, Month 36 |
|
|
|
| Secondary | Ratio of Bone Age (BA) to Chronological Age (CA) | BA was estimated locally using an X-ray from the left wrist and hand. CA at the date of corresponding X-ray (Date of X-ray - Date of birth)/365.25. Ratio of BA/CA at each annual study visit was calculated. | ITT set included all participants who received at least 1 dose of study medication and had at least 1 evaluation of height after start of study medication. Here 'N' (Number of participants analyzed) signifies those participants who were evaluable for this measure and "n" signifies those participants evaluated at that time point. | Posted | Mean | Standard Deviation | ratio | Baseline, Month 12, Month 24, Month 36 |
|
|
|
| 4 |
| 46 |
| 21 |
| 46 |
| Laryngitis | Infections and infestations | MedDRA v14.1 | Non-systematic Assessment |
|
| Staphylococcal infection | Infections and infestations | MedDRA v14.1 | Non-systematic Assessment |
|
| Staphylococcal sepsis | Infections and infestations | MedDRA v14.1 | Non-systematic Assessment |
|
| Viral infection | Infections and infestations | MedDRA v14.1 | Non-systematic Assessment |
|
| Head injury | Injury, poisoning and procedural complications | MedDRA v14.1 | Non-systematic Assessment |
|
| Weight decreased | Investigations | MedDRA v14.1 | Non-systematic Assessment |
|
| Histiocytosis haematophagic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v14.1 | Non-systematic Assessment |
|
| Bronchopulmonary aspergillosis allergic | Infections and infestations | MedDRA v14.1 | Non-systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA v14.1 | Non-systematic Assessment |
|
| Laryngitis | Infections and infestations | MedDRA v14.1 | Non-systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA v14.1 | Non-systematic Assessment |
|
| Oral herpes | Infections and infestations | MedDRA v14.1 | Non-systematic Assessment |
|
| Tracheitis | Infections and infestations | MedDRA v14.1 | Non-systematic Assessment |
|
| Joint injury | Injury, poisoning and procedural complications | MedDRA v14.1 | Non-systematic Assessment |
|
| Ligament sprain | Injury, poisoning and procedural complications | MedDRA v14.1 | Non-systematic Assessment |
|
| Ammonia increased | Investigations | MedDRA v14.1 | Non-systematic Assessment |
|
| Glucose tolerance impaired | Metabolism and nutrition disorders | MedDRA v14.1 | Non-systematic Assessment |
|
| Insulin resistance | Metabolism and nutrition disorders | MedDRA v14.1 | Non-systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA v14.1 | Non-systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA v14.1 | Non-systematic Assessment |
|
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA v14.1 | Non-systematic Assessment |
|
| Knee deformity | Musculoskeletal and connective tissue disorders | MedDRA v14.1 | Non-systematic Assessment |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA v14.1 | Non-systematic Assessment |
|
| Rickets | Musculoskeletal and connective tissue disorders | MedDRA v14.1 | Non-systematic Assessment |
|
| Scoliosis | Musculoskeletal and connective tissue disorders | MedDRA v14.1 | Non-systematic Assessment |
|
| Melanocytic naevus | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v14.1 | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA v14.1 | Non-systematic Assessment |
|
| Loss of consciousness | Nervous system disorders | MedDRA v14.1 | Non-systematic Assessment |
|
| Abnormal behaviour | Psychiatric disorders | MedDRA v14.1 | Non-systematic Assessment |
|
| Encopresis | Psychiatric disorders | MedDRA v14.1 | Non-systematic Assessment |
|
| Enuresis | Renal and urinary disorders | MedDRA v14.1 | Non-systematic Assessment |
|
| Renal failure | Renal and urinary disorders | MedDRA v14.1 | Non-systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA v14.1 | Non-systematic Assessment |
|
| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA v14.1 | Non-systematic Assessment |
|
| Sleep apnoea syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA v14.1 | Non-systematic Assessment |
|
| Nail disorder | Skin and subcutaneous tissue disorders | MedDRA v14.1 | Non-systematic Assessment |
|
| Seborrhoeic dermatitis | Skin and subcutaneous tissue disorders | MedDRA v14.1 | Non-systematic Assessment |
|
| Skin irritation | Skin and subcutaneous tissue disorders | MedDRA v14.1 | Non-systematic Assessment |
|
| Ear tube insertion | Surgical and medical procedures | MedDRA v14.1 | Non-systematic Assessment |
|
| Haematoma | Vascular disorders | MedDRA v14.1 | 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 |
| Title | Measurements |
|---|---|
|
| Change at Month 36 (n = 26) |
|
| Title | Measurements |
|---|---|
|
| Change at Month 36 (n = 12) |
|
| Title | Measurements |
|---|---|
|
| Month 36 (n = 27) |
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Month 36 (n = 27) |
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Month 36 (n = 20) |
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Month 36 (n = 27) |
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Change at Month 36 (n = 21) |
|
| Title | Measurements |
|---|---|
|
| Month 36 (n = 23) |
|