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| ID | Type | Description | Link |
|---|---|---|---|
| 2004-002992-17 | EudraCT Number |
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To estimate the evolution of height and growth rate over 5 years of growth hormone (GH) treatment To estimate the prognostic factors of growth rate with GH treatment To confirm the good clinical and biological safety of GH treatment in such children
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Somatropin | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Somatropin | Drug | Liquid, daily, during 3 years and extended to 5 years Dosage: 0,46 mg/kg/week - the maximum dose should not exceed 50 µg/kg/day |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Height Standard Deviation Score (SDS) for Chronological Age (CA) at Month 36: Full Analysis Population | 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; Yx refers to the value at particular timepoint x. 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. | Baseline, Month 36 |
| Change From Baseline in Height Standard Deviation Score (SD) for Chronological Age (CA) at Month 36: Per Protocol (PP) Population | 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; Yx refers to the value at particular timepoint x. 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. | Baseline, Month 36 |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Height | The standing height measurements were performed 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, 24, 36, 48, 60 |
| Mean Height Standard Deviation Score (SDS) for Bone Age (BA) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. AEs include both SAEs and non-SAEs. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital Nord | Amiens | 80030 | France | |||
| Centre Hospitalier Intercommunal d'Annemasse-Bonneville, Service de Pédiatrie et Néonatologie |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30910221 | Derived | Basmaison O, Ranchin B, Zouater H, Robertson A, Gomez R, Koppiker N. Efficacy and safety of recombinant growth hormone treatment in children with growth retardation related to long-term glucocorticosteroid therapy. Ann Endocrinol (Paris). 2019 Sep;80(4):202-210. doi: 10.1016/j.ando.2019.02.001. Epub 2019 Mar 4. |
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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The reason 'Study Terminated by Sponsor' mentioned in the participant flow indicates the termination of study at a site (due to Good Clinical Practice [GCP] compliance issues) and does not reflect the overall status of study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Genotonorm | Genotonorm 0.46 milligram per kilogram (mg/kg) administered weekly, divided into 7 daily subcutaneous injections (maximum dose not exceeding 50 microgram [mcg]/kg/day) for up to 60 months. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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The standing height measurements were performed 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 BA Yx = (height Yx - reference mean for BA Yx) / reference SD for BA Yx; Yx refers to the value at particular timepoint x. 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. |
| Baseline, Month 12, 24, 36, 48, 60 |
| Annual Growth Rate (AGR) | AGR at Yx was derived by subtracting AGR at baseline from Yx value. AGR was calculated each year and re scaled 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). Yx refers to the value at particular timepoint x. | Baseline, Month 12, 24, 36, 48, 60 |
| Growth Rate (GR) Standard Deviation Score (SDS) for Bone Age (BA) | GR SDS BA Yx = (GR Yx - reference mean for BA Yx) / reference SD for BA Yx; Yx refers to the value at particular timepoint x. GR in SDS was calculated using Sempe reference means and SD for GR. BA was estimated locally using an X-ray from the left wrist and hand. | Month 12, 24, 36, 48, 60 |
| Growth Rate (GR) Standard Deviation Score (SDS) for Chronological Age (CA) | GR SDS CA Yx = (GR Yx - reference mean for CA Yx) / reference SD for CA Yx; Yx refers to the value at particular timepoint x. GR in SDS was calculated using Sempe reference means and SD for GR. CA calculated as integer (Date of height measurement-Date of birth)/365.25*12. | Baseline, Month 12, 24, 36, 48, 60 |
| Body Mass Index (BMI) | BMI was calculated by weight divided by height squared and measured as kilogram per square meter (kg/m^2). | Baseline, Month 12, 24, 36, 48, 60 |
| Change From Baseline in Height at Month 12, 24, 36, 48 and 60 | The standing height measurements were performed 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, 24, 36, 48, 60 |
| Change From Baseline in Height Standard Deviation Score (SDS) for Chronological Age (CA) at Month 12, 24, 48 and 60 | The standing height measurements were performed 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; Yx refers to the value at particular timepoint x. 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. | Baseline, Month 12, 24, 48, 60 |
| Change From Baseline in Height Standard Deviation Score (SDS) for Bone Age (BA) at Month 12, 24, 36, 48 and 60 | The standing height measurements were performed 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 BA Yx = (height Yx - reference mean for BA Yx) / reference SD for BA Yx; Yx refers to the value at particular timepoint x. 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. | Baseline, Month 12, 24, 36, 48, 60 |
| Change From Baseline in Bone Age (BA) at Month 12, 24, 36, 48 and 60 | BA was estimated locally using an X-ray from the left wrist and hand. | Baseline, Month 12, 24, 36, 48, 60 |
| 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, 24, 36, 48, 60 |
| Baseline up to 28 days after last study treatment |
| Number of Participants With Significant Changes in Physical Examinations | Number of participants with clinically significant physical examinations changes since previous visit were reported. Physical examination including estimation of pubertal stage and blood pressure measurement; | Baseline, Month 12, 24, 36, 48, 60, End of Treatment (EOT) |
| Number of Participants With at Least 1 Medical or Surgical History | Screening |
| Number of Participants Who Received Concomitant Medications | Baseline up to Month 60 |
| Fasting Serum Insulin Like Growth Factor-1 (IGF-1) Levels | Screening, Month 6, 12, 18, 24, 30, 36, 42, 48, 54, 60 |
| Fasting and Postprandial Plasma Glucose Levels at Month 12, 24, 36, 48 and 60 | Fasting and 2 hours plasma glucose levels were assessed using standard oral glucose tolerance test (OGTT). | Screening, Month 12, 24, 36, 48, 60 |
| Annemasse |
| 74107 |
| France |
| Hôpital Saint Jacques | Besançon | 25030 | France |
| Groupe hospitalier Est- Hôpital Femme, Mère, Enfant | Bron | 69677 | France |
| Groupe hospitalier Est-Hôpital Femme, Mère, Enfant | Bron | 69677 | France |
| CHU d'Estaing | Clermont-Ferrand | 63003 | France |
| CHU de Grenoble, Hôpital Couple enfant. | Grenoble | 38043 | France |
| CHU Timone Enfants | Marseille | 13385 | France |
| Hôpital Arnaud De Villeneuve | Montpellier | 34059 | France |
| CHU de Nantes, Hôpital Mère Enfant | Nantes | 44093 | France |
| Hôpital Lenval | Nice | 06200 | France |
| Hôpital Robert Debré | Paris | 75019 | France |
| Hôpital Armand Trousseau | Paris | 75571 | France |
| Groupe Hospitalier Necker - Enfants Malades | Paris | 75743 | France |
| Centre de Perharidy | Roscoff | 29684 | France |
| CHU Charles Nicolle | Rouen | 76031 | France |
| Service de Pédiatrie- Centre Hospitalier Intercommunal | Saint-Germain-en-Laye | 78105 | France |
| Hôpital des Enfants | Toulouse | 31059 | France |
| CHU Tours - Centre Pediatrique Gatien de Cocheville | Tours | 37044 | France |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Safety analysis set included all participants (including a site with GCP issues) who had received at least 1 study dose of growth hormone (GH).
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| ID | Title | Description |
|---|---|---|
| BG000 | Genotonorm | Genotonorm 0.46 milligram per kilogram (mg/kg) administered weekly, divided into 7 daily subcutaneous injections (maximum dose not exceeding 50 microgram [mcg]/kg/day) for up to 60 months. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| 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 Height Standard Deviation Score (SDS) for Chronological Age (CA) at Month 36: Full Analysis Population | 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; Yx refers to the value at particular timepoint x. 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. | Full analysis set (FAS) included all participants (excluding a site with GCP issues) who had received at least 1 injection of GH and had at least 1 post-Baseline measurement of height. Here "n" signifies those participants who were evaluable for the specified time point. | Posted | Mean | Standard Deviation | Standard Deviation Score (SDS) | Baseline, Month 36 |
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| Primary | Change From Baseline in Height Standard Deviation Score (SD) for Chronological Age (CA) at Month 36: Per Protocol (PP) Population | 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; Yx refers to the value at particular timepoint x. 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. | PP analysis set included all participants (excluding a site with GCP issues) who received at least 1 dose of GH, had at least 1 subsequent rating of height, no major protocol violation till first 3 years post initiation of treatment and total GH treatment duration of 36 months or more. "n"=participants evaluable at the specified time point. | Posted | Mean | Standard Deviation | SDS | Baseline, Month 36 |
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| Secondary | Mean Height | The standing height measurements were performed 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. | FAS included all participants (excluding a site with GCP issues) who had received at least 1 injection of GH and had at least 1 post-Baseline measurement of height. Here "n" signifies those participants who were evaluable for the specified time point. | Posted | Mean | Standard Deviation | centimeters (cm) | Baseline, Month 12, 24, 36, 48, 60 |
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| Secondary | Mean Height Standard Deviation Score (SDS) for Bone Age (BA) | The standing height measurements were performed 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 BA Yx = (height Yx - reference mean for BA Yx) / reference SD for BA Yx; Yx refers to the value at particular timepoint x. 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. | FAS included all participants (excluding a site with GCP issues) who had received at least 1 injection of GH and had at least 1 post-Baseline measurement of height. Here "n" signifies those participants who were evaluable for the specified time point. | Posted | Mean | Standard Deviation | SDS | Baseline, Month 12, 24, 36, 48, 60 |
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| Secondary | Annual Growth Rate (AGR) | AGR at Yx was derived by subtracting AGR at baseline from Yx value. AGR was calculated each year and re scaled 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). Yx refers to the value at particular timepoint x. | FAS included all participants (excluding a site with GCP issues) who had received at least 1 injection of GH and had at least 1 post-Baseline measurement of height. Here "n" signifies those participants who were evaluable for the specified time point. | Posted | Mean | Standard Deviation | cm/year | Baseline, Month 12, 24, 36, 48, 60 |
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| Secondary | Growth Rate (GR) Standard Deviation Score (SDS) for Bone Age (BA) | GR SDS BA Yx = (GR Yx - reference mean for BA Yx) / reference SD for BA Yx; Yx refers to the value at particular timepoint x. GR in SDS was calculated using Sempe reference means and SD for GR. BA was estimated locally using an X-ray from the left wrist and hand. | FAS included all participants (excluding a site with GCP issues) who had received at least 1 injection of GH and had at least 1 post-Baseline measurement of height. Here "n" signifies those participants who were evaluable for the specified time point. | Posted | Mean | Standard Deviation | SDS | Month 12, 24, 36, 48, 60 |
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| Secondary | Growth Rate (GR) Standard Deviation Score (SDS) for Chronological Age (CA) | GR SDS CA Yx = (GR Yx - reference mean for CA Yx) / reference SD for CA Yx; Yx refers to the value at particular timepoint x. GR in SDS was calculated using Sempe reference means and SD for GR. CA calculated as integer (Date of height measurement-Date of birth)/365.25*12. | FAS included all participants (excluding a site with GCP issues) who had received at least 1 injection of GH and had at least 1 post-Baseline measurement of height. Here "n" signifies those participants who were evaluable for the specified time point. | Posted | Mean | Standard Deviation | SDS | Baseline, Month 12, 24, 36, 48, 60 |
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| Secondary | Body Mass Index (BMI) | BMI was calculated by weight divided by height squared and measured as kilogram per square meter (kg/m^2). | FAS included all participants (excluding a site with GCP issues) who had received at least 1 injection of GH and had at least 1 post-Baseline measurement of height. Here "n" signifies those participants who were evaluable for the specified time point. | Posted | Mean | Standard Deviation | kg/m^2 | Baseline, Month 12, 24, 36, 48, 60 |
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| Secondary | Change From Baseline in Height at Month 12, 24, 36, 48 and 60 | The standing height measurements were performed 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. | FAS included all participants (excluding a site with GCP issues) who had received at least 1 injection of GH and had at least 1 post-Baseline measurement of height. Here "n" signifies those participants who were evaluable for the specified time point. | Posted | Mean | Standard Deviation | cm | Baseline, Month 12, 24, 36, 48, 60 |
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| Secondary | Change From Baseline in Height Standard Deviation Score (SDS) for Chronological Age (CA) at Month 12, 24, 48 and 60 | The standing height measurements were performed 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; Yx refers to the value at particular timepoint x. 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. | FAS included all participants (excluding a site with GCP issues) who had received at least 1 injection of GH and had at least 1 post-Baseline measurement of height. Here "n" signifies those participants who were evaluable for the specified time point. | Posted | Mean | Standard Deviation | SDS | Baseline, Month 12, 24, 48, 60 |
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| Secondary | Change From Baseline in Height Standard Deviation Score (SDS) for Bone Age (BA) at Month 12, 24, 36, 48 and 60 | The standing height measurements were performed 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 BA Yx = (height Yx - reference mean for BA Yx) / reference SD for BA Yx; Yx refers to the value at particular timepoint x. 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. | FAS included all participants (excluding a site with GCP issues) who had received at least 1 injection of GH and had at least 1 post-Baseline measurement of height. Here "n" signifies those participants who were evaluable for the specified time point. | Posted | Mean | Standard Deviation | SDS | Baseline, Month 12, 24, 36, 48, 60 |
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| Secondary | Change From Baseline in Bone Age (BA) at Month 12, 24, 36, 48 and 60 | BA was estimated locally using an X-ray from the left wrist and hand. | FAS included all participants (excluding a site with GCP issues) who had received at least 1 injection of GH and had at least 1 post-Baseline measurement of height. Here "n" signifies those participants who were evaluable for the specified time point. | Posted | Mean | Standard Deviation | months | Baseline, Month 12, 24, 36, 48, 60 |
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| 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. | FAS included all participants (excluding a site with GCP issues) who had received at least 1 injection of GH and had at least 1 post-Baseline measurement of height. Here "n" signifies those participants who were evaluable for the specified time point. | Posted | Mean | Standard Deviation | ratio | Baseline, Month 12, 24, 36, 48, 60 |
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| Other Pre-specified | Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. AEs include both SAEs and non-SAEs. | Safety analysis set included all participants (including a site with GCP issues) who had received at least 1 study dose of GH. | Posted | Number | participants | Baseline up to 28 days after last study treatment |
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| Other Pre-specified | Number of Participants With Significant Changes in Physical Examinations | Number of participants with clinically significant physical examinations changes since previous visit were reported. Physical examination including estimation of pubertal stage and blood pressure measurement; | Safety analysis set included all participants (including a site with GCP issues) who had received at least 1 study dose of GH. | Posted | Number | participants | Baseline, Month 12, 24, 36, 48, 60, End of Treatment (EOT) |
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| Other Pre-specified | Number of Participants With at Least 1 Medical or Surgical History | Safety analysis set included all participants (including a site with GCP issues) who had received at least 1 study dose of GH. | Posted | Number | participants | Screening |
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| Other Pre-specified | Number of Participants Who Received Concomitant Medications | Safety analysis set included all participants (including a site with GCP issues) who had received at least 1 study dose of GH. | Posted | Number | participants | Baseline up to Month 60 |
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| Other Pre-specified | Fasting Serum Insulin Like Growth Factor-1 (IGF-1) Levels | Safety analysis set included all participants (including a site with GCP issues) who had received at least 1 study dose of GH. | Posted | Mean | Standard Deviation | nanogram per milliliter (ng/mL) | Screening, Month 6, 12, 18, 24, 30, 36, 42, 48, 54, 60 |
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| Other Pre-specified | Fasting and Postprandial Plasma Glucose Levels at Month 12, 24, 36, 48 and 60 | Fasting and 2 hours plasma glucose levels were assessed using standard oral glucose tolerance test (OGTT). | Safety analysis set included all participants (including a site with GCP issues) who had received at least 1 study dose of GH. | Posted | Mean | Standard Deviation | milli mole per liter (mmol/L) | Screening, Month 12, 24, 36, 48, 60 |
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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 0.46 milligram per kilogram (mg/kg) administered weekly, divided into 7 daily subcutaneous injections (maximum dose not exceeding 50 microgram [mcg]/kg/day) for up to 60 months. | 45 | 98 | 81 | 98 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Gastroenteritis | Infections and infestations | MedDRA 11.1 | Non-systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 11.1 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 11.1 | Non-systematic Assessment |
| |
| Varicella | Infections and infestations | MedDRA 11.1 | Non-systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 11.1 | Non-systematic Assessment |
| |
| Empedobacter brevis infection | Infections and infestations | MedDRA 11.1 | Non-systematic Assessment |
| |
| Erysipelas | Infections and infestations | MedDRA 11.1 | Non-systematic Assessment |
| |
| Gastroenteritis cryptosporidial | Infections and infestations | MedDRA 11.1 | Non-systematic Assessment |
| |
| Gastroenteritis rotavirus | Infections and infestations | MedDRA 11.1 | Non-systematic Assessment |
| |
| Nail bed infection | Infections and infestations | MedDRA 11.1 | Non-systematic Assessment |
| |
| Periorbital cellulitis | Infections and infestations | MedDRA 11.1 | Non-systematic Assessment |
| |
| Pertussis | Infections and infestations | MedDRA 11.1 | Non-systematic Assessment |
| |
| Skin infection | Infections and infestations | MedDRA 11.1 | Non-systematic Assessment |
| |
| Tonsillitis | Infections and infestations | MedDRA 11.1 | Non-systematic Assessment |
| |
| Nephrotic syndrome | Renal and urinary disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Proteinuria | Renal and urinary disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Aphthous stomatitis | Gastrointestinal disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Gastrointestinal disorder | Gastrointestinal disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Intestinal obstruction | Gastrointestinal disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Protein-losing gastroenteropathy | Gastrointestinal disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Rectal stenosis | Gastrointestinal disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Subileus | Gastrointestinal disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Varices oesophageal | Gastrointestinal disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Death | General disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Infusion site extravasation | General disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Benign intracranial hypertension | Nervous system disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Cerebral venous thrombosis | Nervous system disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Intracranial pressure increased | Nervous system disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Optic neuritis | Nervous system disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Syncope vasovagal | Nervous system disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Abdominal injury | Injury, poisoning and procedural complications | MedDRA 11.1 | Non-systematic Assessment |
| |
| Accident | Injury, poisoning and procedural complications | MedDRA 11.1 | Non-systematic Assessment |
| |
| Alcohol poisoning | Injury, poisoning and procedural complications | MedDRA 11.1 | Non-systematic Assessment |
| |
| Facial bones fracture | Injury, poisoning and procedural complications | MedDRA 11.1 | Non-systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 11.1 | Non-systematic Assessment |
| |
| Spinal compression fracture | Injury, poisoning and procedural complications | MedDRA 11.1 | Non-systematic Assessment |
| |
| Upper limb fracture | Injury, poisoning and procedural complications | MedDRA 11.1 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Epiphysiolysis | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Joint destruction | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Knee deformity | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Osteochondrosis | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Synovitis | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Systemic lupus erythematosus | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Type 2 diabetes mellitus | Metabolism and nutrition disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Cataract operation | Surgical and medical procedures | MedDRA 11.1 | Non-systematic Assessment |
| |
| Gastrostomy closure | Surgical and medical procedures | MedDRA 11.1 | Non-systematic Assessment |
| |
| Knee arthroplasty | Surgical and medical procedures | MedDRA 11.1 | Non-systematic Assessment |
| |
| Thoracic operation | Surgical and medical procedures | MedDRA 11.1 | Non-systematic Assessment |
| |
| Tooth extraction | Surgical and medical procedures | MedDRA 11.1 | Non-systematic Assessment |
| |
| Cataract | Eye disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Glaucoma | Eye disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Uveitis | Eye disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Visual acuity reduced | Eye disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Hypovolaemic shock | Vascular disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Intermittent claudication | Vascular disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Peripheral coldness | Vascular disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Peripheral ischaemia | Vascular disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Histiocytosis haematophagic | Blood and lymphatic system disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Lymphadenitis | Blood and lymphatic system disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Thrombotic microangiopathy | Blood and lymphatic system disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Cardiopulmonary failure | Cardiac disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Subvalvular aortic stenosis | Cardiac disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Skin ulcer | Skin and subcutaneous tissue disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Toxic skin eruption | Skin and subcutaneous tissue disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Cytolytic hepatitis | Hepatobiliary disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Graft versus host disease | Immune system disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Hypersensitivity | Immune system disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Polycystic ovaries | Reproductive system and breast disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Treatment noncompliance | Social circumstances | MedDRA 11.1 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bronchitis | Infections and infestations | MedDRA 11.1 | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 11.1 | Non-systematic Assessment |
| |
| Tonsillitis | Infections and infestations | MedDRA 11.1 | Non-systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 11.1 | Non-systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA 11.1 | Non-systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 11.1 | Non-systematic Assessment |
| |
| Rhinitis | Infections and infestations | MedDRA 11.1 | Non-systematic Assessment |
| |
| Varicella | Infections and infestations | MedDRA 11.1 | Non-systematic Assessment |
| |
| Ear infection | Infections and infestations | MedDRA 11.1 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 11.1 | Non-systematic Assessment |
| |
| Otitis media | Infections and infestations | MedDRA 11.1 | Non-systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA 11.1 | Non-systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA 11.1 | Non-systematic Assessment |
| |
| Tinea pedis | Infections and infestations | MedDRA 11.1 | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 11.1 | Non-systematic Assessment |
| |
| Viral infection | Infections and infestations | MedDRA 11.1 | Non-systematic Assessment |
| |
| Chikungunya virus infection | Infections and infestations | MedDRA 11.1 | Non-systematic Assessment |
| |
| Cystitis | Infections and infestations | MedDRA 11.1 | Non-systematic Assessment |
| |
| Dermatophytosis | Infections and infestations | MedDRA 11.1 | Non-systematic Assessment |
| |
| Eye infection toxoplasmal | Infections and infestations | MedDRA 11.1 | Non-systematic Assessment |
| |
| Fungal skin infection | Infections and infestations | MedDRA 11.1 | Non-systematic Assessment |
| |
| Gangrene | Infections and infestations | MedDRA 11.1 | Non-systematic Assessment |
| |
| Impetigo | Infections and infestations | MedDRA 11.1 | Non-systematic Assessment |
| |
| Oral fungal infection | Infections and infestations | MedDRA 11.1 | Non-systematic Assessment |
| |
| Paronychia | Infections and infestations | MedDRA 11.1 | Non-systematic Assessment |
| |
| Penile infection | Infections and infestations | MedDRA 11.1 | Non-systematic Assessment |
| |
| Pneumonia mycoplasmal | Infections and infestations | MedDRA 11.1 | Non-systematic Assessment |
| |
| Pyelonephritis | Infections and infestations | MedDRA 11.1 | Non-systematic Assessment |
| |
| Tinea versicolour | Infections and infestations | MedDRA 11.1 | Non-systematic Assessment |
| |
| Tooth abscess | Infections and infestations | MedDRA 11.1 | Non-systematic Assessment |
| |
| Tooth infection | Infections and infestations | MedDRA 11.1 | Non-systematic Assessment |
| |
| Tracheitis | Infections and infestations | MedDRA 11.1 | Non-systematic Assessment |
| |
| Trichophytosis | Infections and infestations | MedDRA 11.1 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Duodenitis | Gastrointestinal disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Gingivitis | Gastrointestinal disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Odynophagia | Gastrointestinal disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Diarrhoea haemorrhagic | Gastrointestinal disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Enterocolitis haemorrhagic | Gastrointestinal disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Gingival hypertrophy | Gastrointestinal disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Ileus | Gastrointestinal disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Intestinal polyp | Gastrointestinal disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Mouth ulceration | Gastrointestinal disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Oral disorder | Gastrointestinal disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Rectal haemorrhage | Gastrointestinal disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Juvenile arthritis | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Scoliosis | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Knee deformity | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Amyotrophy | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Joint effusion | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Joint stiffness | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Mobility decreased | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Osteoporosis | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Rheumatoid arthritis | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Tendonitis | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Acne | Skin and subcutaneous tissue disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Skin lesion | Skin and subcutaneous tissue disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Skin striae | Skin and subcutaneous tissue disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Dermatomyositis | Skin and subcutaneous tissue disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Acanthosis nigricans | Skin and subcutaneous tissue disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Cutaneous lupus erythematosus | Skin and subcutaneous tissue disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Dermal cyst | Skin and subcutaneous tissue disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Ecchymosis | Skin and subcutaneous tissue disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Eczema | Skin and subcutaneous tissue disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Hypertrichosis | Skin and subcutaneous tissue disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Ingrowing nail | Skin and subcutaneous tissue disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Rash macular | Skin and subcutaneous tissue disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Scar | Skin and subcutaneous tissue disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Skin hyperpigmentation | Skin and subcutaneous tissue disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Skin nodule | Skin and subcutaneous tissue disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Swelling face | Skin and subcutaneous tissue disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Injection site pain | General disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Malaise | General disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Mucosal inflammation | General disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Oedema | General disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Pain | General disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Cataract | Eye disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Conjunctivitis | Eye disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Ocular hypertension | Eye disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Papilloedema | Eye disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Uveitis | Eye disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Chalazion | Eye disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Eye disorder | Eye disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Myopia | Eye disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Night blindness | Eye disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Periorbital disorder | Eye disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Retinal detachment | Eye disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Visual acuity reduced | Eye disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Visual impairment | Eye disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Vitritis | Eye disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Insulin-like growth factor increased | Investigations | MedDRA 11.1 | Non-systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA 11.1 | Non-systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA 11.1 | Non-systematic Assessment |
| |
| Transaminases increased | Investigations | MedDRA 11.1 | Non-systematic Assessment |
| |
| Glucose tolerance impaired | Metabolism and nutrition disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Anorexia | Metabolism and nutrition disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Hypertriglyceridaemia | Metabolism and nutrition disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Obesity | Metabolism and nutrition disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Nephrotic syndrome | Renal and urinary disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Dysuria | Renal and urinary disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Enuresis | Renal and urinary disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Renal impairment | Renal and urinary disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Proteinuria | Renal and urinary disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Lung disorder | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Pharyngeal erythema | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Adenoidal hypertrophy | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Hemicephalalgia | Nervous system disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Hyperreflexia | Nervous system disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Hypotonia | Nervous system disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Migraine | Nervous system disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Haemolysis | Blood and lymphatic system disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Anaemia of chronic disease | Blood and lymphatic system disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Lymphadenitis | Blood and lymphatic system disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA 11.1 | Non-systematic Assessment |
| |
| Graft dysfunction | Injury, poisoning and procedural complications | MedDRA 11.1 | Non-systematic Assessment |
| |
| Joint injury | Injury, poisoning and procedural complications | MedDRA 11.1 | Non-systematic Assessment |
| |
| Joint sprain | Injury, poisoning and procedural complications | MedDRA 11.1 | Non-systematic Assessment |
| |
| Spinal compression fracture | Injury, poisoning and procedural complications | MedDRA 11.1 | Non-systematic Assessment |
| |
| Wound | Injury, poisoning and procedural complications | MedDRA 11.1 | Non-systematic Assessment |
| |
| Melanocytic naevus | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.1 | Non-systematic Assessment |
| |
| Acrochordon | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.1 | Non-systematic Assessment |
| |
| Skin papilloma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.1 | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Thrombosis | Vascular disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Affective disorder | Psychiatric disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Sleep disorder | Psychiatric disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Otorrhoea | Ear and labyrinth disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Tinnitus | Ear and labyrinth disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Arrhythmia | Cardiac disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Hypertrophic cardiomyopathy | Cardiac disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Cushingoid | Endocrine disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Hypersensitivity | Immune system disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Vasculitis | Immune system disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Gynaecomastia | Reproductive system and breast disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Sickle cell anaemia with crisis | Congenital, familial and genetic disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Cytolytic hepatitis | Hepatobiliary disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Hospitalisation | Surgical and medical procedures | MedDRA 11.1 | Non-systematic Assessment |
| |
| Pityriasis | Skin and subcutaneous tissue disorders | MedDRA 11.1 | Non-systematic Assessment |
|
Pfizer has the right to review disclosures, requesting 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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
| ID | Term |
|---|---|
| D004393 | Dwarfism, Pituitary |
| ID | Term |
|---|---|
| D004392 | Dwarfism |
| D001848 | Bone Diseases, Developmental |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D001849 | Bone Diseases, Endocrine |
| D007018 | Hypopituitarism |
| D010900 | Pituitary Diseases |
| D007027 | Hypothalamic Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D004700 | Endocrine System Diseases |
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 |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
Not provided
Not provided
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| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
|
| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
|
| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
| Screening (n=93) |
| |||||
| Month 6 (n=63) |
| |||||
| Month 12 (n=71) |
| |||||
| Month 18 (n=47) |
| |||||
| Month 24 (n=62) |
| |||||
| Month 30 (n=50) |
| |||||
| Month 36 (n=44) |
| |||||
| Month 42 (n=22) |
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| Month 48 (n=21) |
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| Month 54 (n=16) |
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| Month 60 (n=10) |
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|