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| ID | Type | Description | Link |
|---|---|---|---|
| A6281016 |
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See termination reason in detailed description.
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This trial terminated on 10-Jun-2011 due to prolonged issues with drug accountability and data collection discrepancies. The decision to terminate was not based on any safety concerns.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Somatropin | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Somatropin | Drug | liquid, daily, until final height 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 According to Chronological Age (SDS/CA) at Year 3 | Height was measured using a wall mounted device (example, Harpenden stadiometer). Height SDS/CA was obtained by measuring the height, subtracting chronological age- and gender-appropriate mean height and dividing the result by standard deviation of that mean (as obtained from chronological age- and gender-specific population reference data). SDS indicated how many standard deviations higher (in case of positive SDS) or lower (in case of negative SDS) participant's value was relative to the mean of the reference population. | Baseline, Year 3 |
| Change From Baseline in Height Standard Deviation Score According to Chronological Age (SDS/CA) at Final Height | Height was measured using a wall mounted device (example, Harpenden stadiometer). Height SDS/CA was obtained by measuring the height, subtracting chronological age- and gender-appropriate mean height and dividing the result by standard deviation of that mean (as obtained from chronological age- and gender-specific population reference data). SDS indicated how many standard deviations higher (in case of positive SDS) or lower (in case of negative SDS) participant's value was relative to the mean of the reference population. | Baseline, when final height was reached (assessed up to Year 11) |
| Change From Baseline in Weight Standard Deviation Score (SDS) at Final Height | Body weight was measured using a balance scale. Weight SDS was obtained by measuring the weight, subtracting age- and gender-appropriate mean weight and dividing the result by standard deviation of that mean (as obtained from age- and gender-specific population reference data). SDS indicated how many standard deviations higher (in case of positive SDS) or lower (in case of negative SDS) participant's value was relative to the mean of the reference population. | Baseline, when final height was reached (assessed up to Year 11) |
| Puberty Stage at Final Height | Pubertal stage (graded from I to V for breast development and pubic hair development) according to the Tanner's method was collected. A low stage (Stage I) corresponds to a pre-pubertal stage and a high stage (Stage V) to an adult stage. |
| Measure | Description | Time Frame |
|---|---|---|
| Bone Age | Bone age was determined by the Greulich and Pyle method using left wrist and hand X-ray. | Baseline, Year 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 |
| Lean Body Mass | Lean body mass, a measurement of body composition, was assessed by Dual Energy X-ray Absorptiometry (DEXA) scan. |
| Measure | Description | Time Frame |
|---|---|---|
| Growth Velocity (GV) | Growth velocity measures the annual rate of increase in height. | Baseline, Year 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 |
| Growth Velocity Standard Deviation Score According to Chronological Age (GV [SDS/CA]) |
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 |
|---|---|---|---|---|---|---|
| Pfizer Investigational Site | Paris | 75019 | France | |||
| Pfizer Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29029101 | Derived | David H, Aupiais C, Louveau B, Quartier P, Jacqz-Aigrain E, Carel JC, Simon D. Growth Outcomes After GH Therapy of Patients Given Long-Term Corticosteroids for Juvenile Idiopathic Arthritis. J Clin Endocrinol Metab. 2017 Dec 1;102(12):4578-4587. doi: 10.1210/jc.2017-01455. |
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Somatropin- Up To Year 3 (Juvenile Idiopathic Arthritis) | Participants with juvenile idiopathic arthritis (JIA) received somatropin (Genotropin, Genotonorm) 1.4 International Units per kilogram per week (IU/kg/week), equivalent to 0.46 milligram/kg/week (mg/kg/week), divided in 7 daily doses subcutaneously for up to 3 years. After treatment for 3 years, participants in this group were assigned to Somatropin- After Year 3 group. |
| FG001 | Somatropin- Up To Year 3 (Nephrotic Syndrome) | Participants with nephrotic syndrome (NeS) received somatropin (Genotropin, Genotonorm) 1.4 IU/kg/week, equivalent to 0.46 mg/kg/week, divided in 7 daily doses subcutaneously for up to 3 years. After treatment for 3 years, participants in this group were assigned to Somatropin- After Year 3 group. |
| FG002 | Somatropin- After Year 3 | Participants with JIA/NeS, who consented to receive treatment beyond 3 years, received somatropin (Genotropin, Genotonorm) 1.4 IU/kg/week, equivalent to 0.46 mg/kg/week divided in 7 daily doses subcutaneously until the additional study drug dose evaluation visit and thereafter received somatropin (Genotropin, Genotonorm) up to 50 microgram (mcg)/kg/day subcutaneously until the final height (FH) was reached or up to Year 11. Final height was confirmed to have been achieved if the growth velocity was less than or equal to 1.5 centimeter (cm) per year during the preceding 12 months and bone age was greater than or equal to 17 years for boys and 15 years for girls. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1 (up to 3 Years) |
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| Between Period 1 and Period 2 |
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| Period 2 (After 3 Years) |
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| ID | Title | Description |
|---|---|---|
| BG000 | Somatropin- Up To Year 3 (Juvenile Idiopathic Arthritis) | Participants with juvenile idiopathic arthritis (JIA) received somatropin (Genotropin, Genotonorm) 1.4 International Units per kilogram per week (IU/kg/week), equivalent to 0.46 milligram/kg/week (mg/kg/week), divided in 7 daily doses subcutaneously for up to 3 years. After treatment for 3 years, participants in this group were assigned to Somatropin- After Year 3 group. |
| 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 Height Standard Deviation Score According to Chronological Age (SDS/CA) at Year 3 | Height was measured using a wall mounted device (example, Harpenden stadiometer). Height SDS/CA was obtained by measuring the height, subtracting chronological age- and gender-appropriate mean height and dividing the result by standard deviation of that mean (as obtained from chronological age- and gender-specific population reference data). SDS indicated how many standard deviations higher (in case of positive SDS) or lower (in case of negative SDS) participant's value was relative to the mean of the reference population. | Full Analysis Set (FAS) up to Year 3: included all participants who had at least 1 post-baseline height measurement and were treated with the study drug for at least 1 year. | Posted | Median | Inter-Quartile Range | Standard Deviation Score (SDS) | Baseline, Year 3 |
|
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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.
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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 | Somatropin- Up To Year 3 (Juvenile Idiopathic Arthritis) | Participants with juvenile idiopathic arthritis (JIA) received somatropin (Genotropin, Genotonorm) 1.4 International Units per kilogram per week (IU/kg/week), equivalent to 0.46 milligram/kg/week (mg/kg/week), divided in 7 daily doses subcutaneously for up to 3 years. After treatment for 3 years, participants in this group were assigned to Somatropin- After Year 3 group. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypercoagulation | Blood and lymphatic system disorders | MedDRA | Non-systematic Assessment |
Results for secondary and other pre-specified endpoints (except IGF-1) are reported for only up to 3 years because data beyond Year 3 was not summarized as the study was terminated due to Good Clinical Practice (GCP) non-compliance issues.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
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| ID | Term |
|---|---|
| D004700 | Endocrine System Diseases |
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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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| When final height was reached (assessed up to Year 11) |
| Baseline, Year 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 |
| Annual Percent Change in Lean Body Mass at Year 1, 2 and 3 | Lean body mass, a measurement of body composition, was assessed by DEXA scan. Annual percent change: (Lean body mass at current year minus lean body mass at previous year) divided by lean body mass at previous year, multiplied by 100. | Baseline, Year 1, 2, 3 |
| Percent Change From Baseline in Lean Body Mass at Year 3 | Lean body mass, a measurement of body composition, was assessed by DEXA scan. Percent change: (Lean body mass at Year 3 minus lean body mass at baseline) divided by lean body mass at baseline, multiplied by 100. | Baseline, Year 3 |
| Lean Body Mass as Percentage of Total Weight | Lean body mass, a measurement of body composition, was assessed by DEXA scan. | Baseline, Year 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 |
| Lean Body Mass Standard Deviation Score According to Chronological Age (SDS/CA) | Lean body mass was assessed by DEXA scan. Lean body mass SDS/CA was obtained by measuring lean body mass, subtracting the chronological age- and gender-appropriate mean lean body mass and dividing the result by standard deviation of that mean (as obtained from chronological age- and gender-specific population reference data). SDS indicated how many standard deviations higher (in case of positive SDS) or lower (in case of negative SDS) participant's value was relative to the mean of the reference population. | Baseline, Year 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 |
| Fat Mass | Fat mass, a measurement of body composition, was assessed by DEXA scan. | Baseline, Year 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 |
| Annual Percent Change in Fat Mass at Year 1, 2 and 3 | Fat mass, a measurement of body composition, was assessed by DEXA scan. Annual percent change: (Fat mass at current year minus fat mass at previous year) divided by fat mass at previous year, multiplied by 100. | Baseline, Year 1, 2, 3 |
| Percent Change From Baseline in Fat Mass at Year 3 | Fat mass, a measurement of body composition, was assessed by DEXA scan. Percent change: (Fat mass at Year 3 minus fat mass at baseline) divided by fat mass at baseline, multiplied by 100. | Baseline, Year 3 |
| Fat Mass as Percentage of Total Weight | Fat mass, a measurement of body composition, was assessed by DEXA scan. | Baseline, Year 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 |
| Fat Mass Standard Deviation Score According to Chronological Age (SDS/CA) | Fat mass was assessed by DEXA scan. Fat mass SDS/CA was obtained by measuring fat mass, subtracting chronological age- and gender-appropriate mean fat mass and dividing the result by standard deviation of that mean (as obtained from chronological age- and gender-specific population reference data). SDS indicated how many standard deviations higher (in case of positive SDS) or lower (in case of negative SDS) participant's value was relative to the mean of the reference population. | Baseline, Year 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 |
| Apparent Bone Mineral Density of Lumbar Spine (BMAD [LS]) | BMAD (LS) was assessed by DEXA scan. | Baseline, Year 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 |
| Apparent Bone Mineral Density Standard Deviation Score of Lumbar Spine According to Chronological Age (BMAD [LS] [SDS/CA]) | BMAD (LS) was assessed by DEXA scan. BMAD (LS) (SDS/CA) was obtained by measuring the BMAD (LS), subtracting chronological age- and gender-appropriate mean BMAD (LS) and dividing the result by standard deviation of that mean (as obtained from chronological age- and gender-specific population reference data). SDS indicated how many standard deviations higher (in case of positive SDS) or lower (in case of negative SDS) participant's value was relative to the mean of the reference population. | Baseline, Year 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 |
| Apparent Bone Mineral Density Standard Deviation Score of Lumber Spine According to Tanner Puberty Stage (BMAD [LS] [SDS/Tanner Puberty Stage]) | BMAD (LS) was assessed by DEXA scan. BMAD (LS) (SDS/Tanner Puberty Stage) was obtained by measuring BMAD (LS), subtracting Tanner puberty stage- and gender-appropriate mean BMAD (LS) and dividing the result by standard deviation of that mean (as obtained from Tanner puberty stage- and gender-specific population reference data). SDS indicated how many standard deviations higher (in case of positive SDS) or lower (in case of negative SDS) participant's value was relative to the mean of the reference population. | Baseline, Year 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 |
| Bone Mineral Density of Total Body (BMD [TB]) | BMD (TB) was assessed by DEXA scan. | Baseline, Year 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 |
| Bone Mineral Density of Lumbar Spine (BMD [LS]) | BMD (LS) was assessed by DEXA scan. | Baseline, Year 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 |
| Bone Mineral Content of Total Body (BMC [TB]) | DEXA scan of BMC was used to evaluate potential bone effects of treatment. BMC is an estimate of the amount of mineral (such as calcium) in the bone. | Baseline, Year 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 |
| Annual Percent Change in Bone Mineral Content of Total Body (BMC [TB]) at Year 1, 2 and 3 | BMC is an estimate of the amount of mineral (such as calcium) in the bone. Annual percent change: (BMC [TB] at current year minus BMC [TB] at previous year) divided by BMC [TB] at previous year, multiplied by 100. | Baseline, Year 1, 2, 3 |
| Percent Change From Baseline in Bone Mineral Content of Total Body (BMC [TB]) at Year 3 | BMC is an estimate of the amount of mineral (such as calcium) in the bone. Percent change: (BMC [TB] at Year 3 minus BMC [TB] at baseline) divided by BMC [TB] at baseline, multiplied by 100. | Baseline, Year 3 |
| Bone Mineral Content Standard Deviation Score of Total Body According to Chronological Age (BMC [TB] [SDS/CA]) | BMC (TB) was measured by DEXA scan. BMC (TB) (SDS/CA) was obtained by measuring BMC (TB), subtracting the chronological age- and gender-appropriate mean BMC (TB) and dividing the result by standard deviation of that mean (as obtained from chronological age- and gender-specific population reference data). SDS indicated how many standard deviations higher (in case of positive SDS) or lower (in case of negative SDS) participant's value was relative to the mean of the reference population. | Baseline, Year 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 |
| Bone Mineral Content Standard Deviation Score of Total Body According to Tanner Puberty Stage (BMC [TB] [SDS/Tanner Puberty Stage]) | BMC (TB) was measured by DEXA scan. BMC (TB) (SDS/Tanner Puberty Stage) was obtained by measuring BMC (TB), subtracting the Tanner puberty stage- and gender-appropriate mean BMC (TB) and dividing the result by standard deviation of that mean (as obtained from Tanner puberty stage- and gender-specific population reference data). SDS indicated how many standard deviations higher (in case of positive SDS) or lower (in case of negative SDS) participant's value was relative to the mean of the reference population. | Baseline, Year 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 |
GV measures the annual rate of increase in height. GV (SDS/CA) was obtained by measuring GV, subtracting the chronological age- and gender-appropriate mean GV and dividing the result by standard deviation of that mean (as obtained from chronological age- and gender-specific population reference data). SDS indicated how many standard deviations higher (in case of positive SDS) or lower (in case of negative SDS) participant's value was relative to the mean of the reference population.
| Baseline, Year 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 |
| Growth Velocity Standard Deviation Score According to Bone Age (GV [SDS/BA]) | GV measures the annual rate of increase in height. GV (SDS/BA) was obtained by measuring GV, subtracting the bone age- and gender-appropriate mean GV and dividing the result by standard deviation of that mean (as obtained from bone age- and gender-specific population reference data). SDS indicated how many standard deviations higher (in case of positive SDS) or lower (in case of negative SDS) participant's value was relative to the mean of the reference population. | Baseline, Year 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 |
| Insulin-like Growth Factor-1 (IGF-1) Concentration up to Year 3 | Baseline, Year 1, 2, 3 |
| Insulin-like Growth Factor-1 (IGF-1) Concentration After Year 3 | Year 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5, 9, 9.5, 10; 0.5 and 1 year after somatropin discontinuation, Final Height (assessed up to Year 11) |
| Paris |
| 75743 |
| France |
| Withdrawal by Subject |
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| Other |
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| COMPLETED |
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| NOT COMPLETED |
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| NOT COMPLETED |
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| BG001 | Somatropin- Up To Year 3 (Nephrotic Syndrome) | Participants with nephrotic syndrome (NeS) received somatropin (Genotropin, Genotonorm) 1.4 IU/kg/week, equivalent to 0.46 mg/kg/week, divided in 7 daily doses subcutaneously for up to 3 years. After treatment for 3 years, participants in this group were assigned to Somatropin- After Year 3 group. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
Participants with juvenile idiopathic arthritis (JIA) received somatropin (Genotropin, Genotonorm) 1.4 International Units per kilogram per week (IU/kg/week), equivalent to 0.46 milligram/kg/week (mg/kg/week), divided in 7 daily doses subcutaneously for up to 3 years. After treatment for 3 years, participants in this group were assigned to Somatropin- After Year 3 group. |
| OG001 | Somatropin- Up To Year 3 (Nephrotic Syndrome) | Participants with nephrotic syndrome (NeS) received somatropin (Genotropin, Genotonorm) 1.4 IU/kg/week, equivalent to 0.46 mg/kg/week, divided in 7 daily doses subcutaneously for up to 3 years. After treatment for 3 years, participants in this group were assigned to Somatropin- After Year 3 group. |
|
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| Primary | Change From Baseline in Height Standard Deviation Score According to Chronological Age (SDS/CA) at Final Height | Height was measured using a wall mounted device (example, Harpenden stadiometer). Height SDS/CA was obtained by measuring the height, subtracting chronological age- and gender-appropriate mean height and dividing the result by standard deviation of that mean (as obtained from chronological age- and gender-specific population reference data). SDS indicated how many standard deviations higher (in case of positive SDS) or lower (in case of negative SDS) participant's value was relative to the mean of the reference population. | FAS- after Year 3: included all participants who received at least 1 dose of the study treatment and who had at least 1 post-baseline height measurement. Here, 'n' signifies those participants who were evaluable for this measure at given time points. | Posted | Median | Full Range | SDS | Baseline, when final height was reached (assessed up to Year 11) |
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| Primary | Change From Baseline in Weight Standard Deviation Score (SDS) at Final Height | Body weight was measured using a balance scale. Weight SDS was obtained by measuring the weight, subtracting age- and gender-appropriate mean weight and dividing the result by standard deviation of that mean (as obtained from age- and gender-specific population reference data). SDS indicated how many standard deviations higher (in case of positive SDS) or lower (in case of negative SDS) participant's value was relative to the mean of the reference population. | FAS- after Year 3: included all participants who received at least one dose of the study treatment and who had at least one post-baseline height measurement. Here, 'n' signifies those participants who were evaluable for this measure at given time point. | Posted | Median | Full Range | SDS | Baseline, when final height was reached (assessed up to Year 11) |
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| Primary | Puberty Stage at Final Height | Pubertal stage (graded from I to V for breast development and pubic hair development) according to the Tanner's method was collected. A low stage (Stage I) corresponds to a pre-pubertal stage and a high stage (Stage V) to an adult stage. | FAS- after Year 3: included all participants who received at least one dose of study treatment and who had at least one post-baseline height measurement. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n'=participants who were evaluable for given components of puberty assessment. | Posted | Number | participants | When final height was reached (assessed up to Year 11) |
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| Secondary | Bone Age | Bone age was determined by the Greulich and Pyle method using left wrist and hand X-ray. | FAS up to Year 3: included all participants who had at least one post-baseline height measurement and were treated with the study drug for at least 1 year. Here, 'n' signifies those participants who were evaluable for this measure at given time points for each group, respectively. | Posted | Median | Inter-Quartile Range | years | Baseline, Year 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 |
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| Secondary | Lean Body Mass | Lean body mass, a measurement of body composition, was assessed by Dual Energy X-ray Absorptiometry (DEXA) scan. | FAS up to Year 3: included all participants who had at least one post-baseline height measurement and were treated with the study drug for at least 1 year. Here, 'n' signifies those participants who were evaluable for this measure at the given time point for each group respectively. | Posted | Median | Inter-Quartile Range | kilogram (kg) | Baseline, Year 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 |
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| Secondary | Annual Percent Change in Lean Body Mass at Year 1, 2 and 3 | Lean body mass, a measurement of body composition, was assessed by DEXA scan. Annual percent change: (Lean body mass at current year minus lean body mass at previous year) divided by lean body mass at previous year, multiplied by 100. | FAS up to Year 3: included all participants who had at least one post-baseline height measurement and were treated with the study drug for at least 1 year. Here, 'n' signifies those participants who were evaluable for this measure at the given time point for each group respectively. | Posted | Median | Inter-Quartile Range | percent change | Baseline, Year 1, 2, 3 |
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| Secondary | Percent Change From Baseline in Lean Body Mass at Year 3 | Lean body mass, a measurement of body composition, was assessed by DEXA scan. Percent change: (Lean body mass at Year 3 minus lean body mass at baseline) divided by lean body mass at baseline, multiplied by 100. | FAS up to Year 3: included all participants who had at least one post-baseline height measurement and were treated with the study drug for at least 1 year. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. | Posted | Median | Inter-Quartile Range | percent change | Baseline, Year 3 |
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| Secondary | Lean Body Mass as Percentage of Total Weight | Lean body mass, a measurement of body composition, was assessed by DEXA scan. | FAS up to Year 3: included all participants who had at least one post-baseline height measurement and were treated with the study drug for at least 1 year. Here, 'n' signifies those participants who were evaluable for this measure at the given time point for each group respectively. | Posted | Median | Inter-Quartile Range | percentage of total weight | Baseline, Year 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 |
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| Secondary | Lean Body Mass Standard Deviation Score According to Chronological Age (SDS/CA) | Lean body mass was assessed by DEXA scan. Lean body mass SDS/CA was obtained by measuring lean body mass, subtracting the chronological age- and gender-appropriate mean lean body mass and dividing the result by standard deviation of that mean (as obtained from chronological age- and gender-specific population reference data). SDS indicated how many standard deviations higher (in case of positive SDS) or lower (in case of negative SDS) participant's value was relative to the mean of the reference population. | FAS up to Year 3: included all participants who had at least one post-baseline height measurement and were treated with the study drug for at least 1 year. Here, 'n' signifies those participants who were evaluable for this measure at the given time point for each group respectively. | Posted | Median | Inter-Quartile Range | SDS | Baseline, Year 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 |
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| Secondary | Fat Mass | Fat mass, a measurement of body composition, was assessed by DEXA scan. | FAS up to Year 3: included all participants who had at least one post-baseline height measurement and were treated with the study drug for at least 1 year. Here, 'n' signifies those participants who were evaluable for this measure at the given time point for each group respectively. | Posted | Median | Inter-Quartile Range | kg | Baseline, Year 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 |
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| Secondary | Annual Percent Change in Fat Mass at Year 1, 2 and 3 | Fat mass, a measurement of body composition, was assessed by DEXA scan. Annual percent change: (Fat mass at current year minus fat mass at previous year) divided by fat mass at previous year, multiplied by 100. | FAS up to Year 3: included all participants who had at least one post-baseline height measurement and were treated with the study drug for at least 1 year. Here, 'n' signifies those participants who were evaluable for this measure at the given time point for each group respectively. | Posted | Median | Inter-Quartile Range | percent change | Baseline, Year 1, 2, 3 |
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| Secondary | Percent Change From Baseline in Fat Mass at Year 3 | Fat mass, a measurement of body composition, was assessed by DEXA scan. Percent change: (Fat mass at Year 3 minus fat mass at baseline) divided by fat mass at baseline, multiplied by 100. | FAS up to Year 3: included all participants who had at least one post-baseline height measurement and were treated with the study drug for at least 1 year. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. | Posted | Median | Inter-Quartile Range | percent change | Baseline, Year 3 |
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| Secondary | Fat Mass as Percentage of Total Weight | Fat mass, a measurement of body composition, was assessed by DEXA scan. | FAS up to Year 3: included all participants who had at least one post-baseline height measurement and were treated with the study drug for at least 1 year. Here, 'n' signifies those participants who were evaluable for this measure at the given time point for each group respectively. | Posted | Median | Inter-Quartile Range | percentage of total weight | Baseline, Year 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 |
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| Secondary | Fat Mass Standard Deviation Score According to Chronological Age (SDS/CA) | Fat mass was assessed by DEXA scan. Fat mass SDS/CA was obtained by measuring fat mass, subtracting chronological age- and gender-appropriate mean fat mass and dividing the result by standard deviation of that mean (as obtained from chronological age- and gender-specific population reference data). SDS indicated how many standard deviations higher (in case of positive SDS) or lower (in case of negative SDS) participant's value was relative to the mean of the reference population. | FAS up to Year 3: included all participants who had at least one post-baseline height measurement and were treated with the study drug for at least 1 year. Here, 'n' signifies those participants who were evaluable for this measure at the given time point for each group respectively. | Posted | Median | Inter-Quartile Range | SDS | Baseline, Year 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 |
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|
|
| Secondary | Apparent Bone Mineral Density of Lumbar Spine (BMAD [LS]) | BMAD (LS) was assessed by DEXA scan. | FAS up to Year 3: included all participants who had at least one post-baseline height measurement and were treated with the study drug for at least 1 year. Here, 'n' signifies those participants who were evaluable for this measure at the given time point for each group respectively. | Posted | Median | Inter-Quartile Range | gram per cubic centimeter (g/cm^3) | Baseline, Year 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 |
|
|
|
| Secondary | Apparent Bone Mineral Density Standard Deviation Score of Lumbar Spine According to Chronological Age (BMAD [LS] [SDS/CA]) | BMAD (LS) was assessed by DEXA scan. BMAD (LS) (SDS/CA) was obtained by measuring the BMAD (LS), subtracting chronological age- and gender-appropriate mean BMAD (LS) and dividing the result by standard deviation of that mean (as obtained from chronological age- and gender-specific population reference data). SDS indicated how many standard deviations higher (in case of positive SDS) or lower (in case of negative SDS) participant's value was relative to the mean of the reference population. | FAS up to Year 3: included all participants who had at least one post-baseline height measurement and were treated with the study drug for at least 1 year. Here, 'n' signifies those participants who were evaluable for this measure at the given time point for each group respectively. | Posted | Median | Inter-Quartile Range | SDS | Baseline, Year 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 |
|
|
|
| Secondary | Apparent Bone Mineral Density Standard Deviation Score of Lumber Spine According to Tanner Puberty Stage (BMAD [LS] [SDS/Tanner Puberty Stage]) | BMAD (LS) was assessed by DEXA scan. BMAD (LS) (SDS/Tanner Puberty Stage) was obtained by measuring BMAD (LS), subtracting Tanner puberty stage- and gender-appropriate mean BMAD (LS) and dividing the result by standard deviation of that mean (as obtained from Tanner puberty stage- and gender-specific population reference data). SDS indicated how many standard deviations higher (in case of positive SDS) or lower (in case of negative SDS) participant's value was relative to the mean of the reference population. | FAS up to Year 3: included all participants who had at least one post-baseline height measurement and were treated with the study drug for at least 1 year. Here, 'n' signifies those participants who were evaluable for this measure at the given time point for each group respectively. | Posted | Median | Inter-Quartile Range | SDS | Baseline, Year 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 |
|
|
|
| Secondary | Bone Mineral Density of Total Body (BMD [TB]) | BMD (TB) was assessed by DEXA scan. | FAS up to Year 3: included all participants who had at least one post-baseline height measurement and were treated with the study drug for at least 1 year. Here, 'n' signifies those participants who were evaluable for this measure at the given time point for each group respectively. | Posted | Median | Inter-Quartile Range | gram per square centimeter (g/cm^2) | Baseline, Year 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 |
|
|
|
| Secondary | Bone Mineral Density of Lumbar Spine (BMD [LS]) | BMD (LS) was assessed by DEXA scan. | FAS up to Year 3: included all participants who had at least one post-baseline height measurement and were treated with the study drug for at least 1 year. Here, 'n' signifies those participants who were evaluable for this measure at the given time point for each group respectively. | Posted | Median | Inter-Quartile Range | g/cm^2 | Baseline, Year 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 |
|
|
|
| Secondary | Bone Mineral Content of Total Body (BMC [TB]) | DEXA scan of BMC was used to evaluate potential bone effects of treatment. BMC is an estimate of the amount of mineral (such as calcium) in the bone. | FAS up to Year 3: included all participants who had at least one post-baseline height measurement and were treated with the study drug for at least 1 year. Here, 'n' signifies those participants who were evaluable for this measure at the given time point for each group respectively. | Posted | Median | Inter-Quartile Range | gram | Baseline, Year 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 |
|
|
|
| Secondary | Annual Percent Change in Bone Mineral Content of Total Body (BMC [TB]) at Year 1, 2 and 3 | BMC is an estimate of the amount of mineral (such as calcium) in the bone. Annual percent change: (BMC [TB] at current year minus BMC [TB] at previous year) divided by BMC [TB] at previous year, multiplied by 100. | FAS up to Year 3: included all participants who had at least one post-baseline height measurement and were treated with the study drug for at least 1 year. Here, 'n' signifies those participants who were evaluable for this measure at the given time point for each group respectively. | Posted | Median | Inter-Quartile Range | percent change | Baseline, Year 1, 2, 3 |
|
|
|
| Secondary | Percent Change From Baseline in Bone Mineral Content of Total Body (BMC [TB]) at Year 3 | BMC is an estimate of the amount of mineral (such as calcium) in the bone. Percent change: (BMC [TB] at Year 3 minus BMC [TB] at baseline) divided by BMC [TB] at baseline, multiplied by 100. | FAS up to Year 3: included all participants who had at least one post-baseline height measurement and were treated with the study drug for at least 1 year. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. | Posted | Median | Inter-Quartile Range | percent change | Baseline, Year 3 |
|
|
|
| Secondary | Bone Mineral Content Standard Deviation Score of Total Body According to Chronological Age (BMC [TB] [SDS/CA]) | BMC (TB) was measured by DEXA scan. BMC (TB) (SDS/CA) was obtained by measuring BMC (TB), subtracting the chronological age- and gender-appropriate mean BMC (TB) and dividing the result by standard deviation of that mean (as obtained from chronological age- and gender-specific population reference data). SDS indicated how many standard deviations higher (in case of positive SDS) or lower (in case of negative SDS) participant's value was relative to the mean of the reference population. | FAS up to Year 3: included all participants who had at least one post-baseline height measurement and were treated with the study drug for at least 1 year. Here, 'n' signifies those participants who were evaluable for this measure at the given time point for each group respectively. | Posted | Median | Inter-Quartile Range | SDS | Baseline, Year 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 |
|
|
|
| Secondary | Bone Mineral Content Standard Deviation Score of Total Body According to Tanner Puberty Stage (BMC [TB] [SDS/Tanner Puberty Stage]) | BMC (TB) was measured by DEXA scan. BMC (TB) (SDS/Tanner Puberty Stage) was obtained by measuring BMC (TB), subtracting the Tanner puberty stage- and gender-appropriate mean BMC (TB) and dividing the result by standard deviation of that mean (as obtained from Tanner puberty stage- and gender-specific population reference data). SDS indicated how many standard deviations higher (in case of positive SDS) or lower (in case of negative SDS) participant's value was relative to the mean of the reference population. | FAS up to Year 3: included all participants who had at least one post-baseline height measurement and were treated with the study drug for at least 1 year. Here, 'n' signifies those participants who were evaluable for this measure at the given time point for each group respectively. | Posted | Median | Inter-Quartile Range | SDS | Baseline, Year 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 |
|
|
|
| Other Pre-specified | Growth Velocity (GV) | Growth velocity measures the annual rate of increase in height. | FAS up to Year 3: included all participants who had at least one post-baseline height measurement and were treated with the study drug for at least 1 year. Here, 'n' signifies those participants who were evaluable for this measure at the given time point for each group respectively. | Posted | Median | Inter-Quartile Range | cm/year | Baseline, Year 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 |
|
|
|
| Other Pre-specified | Growth Velocity Standard Deviation Score According to Chronological Age (GV [SDS/CA]) | GV measures the annual rate of increase in height. GV (SDS/CA) was obtained by measuring GV, subtracting the chronological age- and gender-appropriate mean GV and dividing the result by standard deviation of that mean (as obtained from chronological age- and gender-specific population reference data). SDS indicated how many standard deviations higher (in case of positive SDS) or lower (in case of negative SDS) participant's value was relative to the mean of the reference population. | FAS up to Year 3: included all participants who had at least one post-baseline height measurement and were treated with the study drug for at least 1 year. Here, 'n' signifies those participants who were evaluable for this measure at the given time point for each group respectively. | Posted | Median | Inter-Quartile Range | SDS | Baseline, Year 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 |
|
|
|
| Other Pre-specified | Growth Velocity Standard Deviation Score According to Bone Age (GV [SDS/BA]) | GV measures the annual rate of increase in height. GV (SDS/BA) was obtained by measuring GV, subtracting the bone age- and gender-appropriate mean GV and dividing the result by standard deviation of that mean (as obtained from bone age- and gender-specific population reference data). SDS indicated how many standard deviations higher (in case of positive SDS) or lower (in case of negative SDS) participant's value was relative to the mean of the reference population. | FAS up to Year 3: included all participants who had at least one post-baseline height measurement and were treated with the study drug for at least 1 year. Here, 'n' signifies those participants who were evaluable for this measure at the given time point for each group respectively. | Posted | Median | Inter-Quartile Range | SDS | Baseline, Year 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 |
|
|
|
| Other Pre-specified | Insulin-like Growth Factor-1 (IGF-1) Concentration up to Year 3 | FAS up to Year 3: included all participants who had at least one post-baseline height measurement and were treated with the study drug for at least 1 year. Here, 'n' signifies those participants who were evaluable for this measure at the given time point for each group respectively. | Posted | Median | Full Range | nanogram per milliliter (ng/mL) | Baseline, Year 1, 2, 3 |
|
|
|
| Other Pre-specified | Insulin-like Growth Factor-1 (IGF-1) Concentration After Year 3 | FAS After year 3: included all participants who received at least 1 dose of the study treatment and who had at least 1 post-baseline height measurement. Here, 'n' signifies those participants who were evaluable for this measure at given time point. | Posted | Median | Full Range | milligram per deciliter (mg/dL) | Year 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5, 9, 9.5, 10; 0.5 and 1 year after somatropin discontinuation, Final Height (assessed up to Year 11) |
|
|
|
| 13 |
| 15 |
| 13 |
| 15 |
| EG001 | Somatropin- Up To Year 3 (Nephrotic Syndrome) | Participants with nephrotic syndrome (NeS) received somatropin (Genotropin, Genotonorm) 1.4 IU/kg/week, equivalent to 0.46 mg/kg/week, divided in 7 daily doses subcutaneously for up to 3 years. After treatment for 3 years, participants in this group were assigned to Somatropin- After Year 3 group. | 14 | 15 | 14 | 15 |
| EG002 | Somatropin- After Year 3 | Participants with JIA/NeS, who consented to receive treatment beyond 3 years, received somatropin (Genotropin, Genotonorm) 1.4 IU/kg/week, equivalent to 0.46 mg/kg/week divided in 7 daily doses subcutaneously until the additional study drug dose evaluation visit and thereafter received somatropin (Genotropin, Genotonorm) up to 50 microgram (mcg)/kg/day subcutaneously until the final height (FH) was reached or up to Year 11. Final height was confirmed to have been achieved if the growth velocity was less than or equal to 1.5 centimeter (cm) per year during the preceding 12 months and bone age was greater than or equal to 17 years for boys and 15 years for girls. | 19 | 21 | 21 | 21 |
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
|
| Biopsy kidney | Investigations | MedDRA | Non-systematic Assessment |
|
| Cellulitis | Infections and infestations | MedDRA | Non-systematic Assessment |
|
| Condition aggravated | General disorders | MedDRA | Non-systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA | Non-systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA | Non-systematic Assessment |
|
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA | Non-systematic Assessment |
|
| Disease recurrence | General disorders | MedDRA | Non-systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA | Non-systematic Assessment |
|
| Gastric perforation | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
|
| Herpes zoster | Infections and infestations | MedDRA | Non-systematic Assessment |
|
| Herpes zoster ophthalmic | Infections and infestations | MedDRA | Non-systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA | Non-systematic Assessment |
|
| Hypovolaemia | Metabolism and nutrition disorders | MedDRA | Non-systematic Assessment |
|
| Inflammation | General disorders | MedDRA | Non-systematic Assessment |
|
| Inguinal hernia | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
|
| Insulin resistant diabetes | Metabolism and nutrition disorders | MedDRA | Non-systematic Assessment |
|
| Intussusception | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
|
| Juvenile arthritis | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
|
| Nephrotic syndrome | Renal and urinary disorders | MedDRA | Non-systematic Assessment |
|
| Osteonecrosis | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
|
| Ovarian cyst | Reproductive system and breast disorders | MedDRA | Non-systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA | Non-systematic Assessment |
|
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
|
| Renal colic | Renal and urinary disorders | MedDRA | Non-systematic Assessment |
|
| Renal failure acute | Renal and urinary disorders | MedDRA | Non-systematic Assessment |
|
| Rheumatoid arthritis | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
|
| Vertigo | Ear and labyrinth disorders | MedDRA | Non-systematic Assessment |
|
| Visual acuity reduced | Eye disorders | MedDRA | Non-systematic Assessment |
|
| Wrist fracture | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
|
| Glaucoma | Eye disorders | MedDRA | Non-systematic Assessment |
|
| Keratopathy | Eye disorders | MedDRA | Non-systematic Assessment |
|
| Oedema | General disorders | MedDRA | Non-systematic Assessment |
|
| Pyrexia | General disorders | MedDRA | Non-systematic Assessment |
|
| Appendicitis | Infections and infestations | MedDRA | Non-systematic Assessment |
|
| Tooth infection | Infections and infestations | MedDRA | Non-systematic Assessment |
|
| Viral infection | Infections and infestations | MedDRA | Non-systematic Assessment |
|
| Head injury | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
|
| Toxicity to various agents | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
|
| Thyroid neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA | Non-systematic Assessment |
|
| Hip arthroplasty | Surgical and medical procedures | MedDRA | Non-systematic Assessment |
|
| Headache and abdominal pain | General disorders | MedDRA | Non-systematic Assessment |
|
| Angina pectoris | Cardiac disorders | MedDRA | Non-systematic Assessment |
|
| Auricular perichondritis | Ear and labyrinth disorders | MedDRA | Non-systematic Assessment |
|
| Deafness | Ear and labyrinth disorders | MedDRA | Non-systematic Assessment |
|
| Uveitis | Eye disorders | MedDRA | Non-systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
|
| Face oedema | General disorders | MedDRA | Non-systematic Assessment |
|
| Hyperthermia | General disorders | MedDRA | Non-systematic Assessment |
|
| Oedema | General disorders | MedDRA | Non-systematic Assessment |
|
| Pyrexia | General disorders | MedDRA | Non-systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA | Non-systematic Assessment |
|
| Diarrhoea infectious | Infections and infestations | MedDRA | Non-systematic Assessment |
|
| Ear infection | Infections and infestations | MedDRA | Non-systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA | Non-systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA | Non-systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA | Non-systematic Assessment |
|
| Pharyngitis | Infections and infestations | MedDRA | Non-systematic Assessment |
|
| Rhinitis | Infections and infestations | MedDRA | Non-systematic Assessment |
|
| Tracheobronchitis | Infections and infestations | MedDRA | Non-systematic Assessment |
|
| Viral infection | Infections and infestations | MedDRA | Non-systematic Assessment |
|
| Viral tracheitis | Infections and infestations | MedDRA | Non-systematic Assessment |
|
| Joint sprain | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
|
| Radius fracture | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
|
| Insulin-like growth factor increased | Investigations | MedDRA | Non-systematic Assessment |
|
| Red blood cell sedimentation rate increased | Investigations | MedDRA | Non-systematic Assessment |
|
| Anorexia | Metabolism and nutrition disorders | MedDRA | Non-systematic Assessment |
|
| Fluid retention | Metabolism and nutrition disorders | MedDRA | Non-systematic Assessment |
|
| Hypercholesterolaemia | Metabolism and nutrition disorders | MedDRA | Non-systematic Assessment |
|
| Hyperinsulinaemia | Metabolism and nutrition disorders | MedDRA | Non-systematic Assessment |
|
| Hypertriglyceridaemia | Metabolism and nutrition disorders | MedDRA | Non-systematic Assessment |
|
| Malnutrition | Metabolism and nutrition disorders | MedDRA | Non-systematic Assessment |
|
| Sodium retention | Metabolism and nutrition disorders | MedDRA | Non-systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
|
| Joint effusion | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
|
| Juvenile arthritis | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
|
| Osteopenia | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
|
| Synovitis | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA | Non-systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA | Non-systematic Assessment |
|
| Dysuria | Renal and urinary disorders | MedDRA | Non-systematic Assessment |
|
| Hypercalciuria | Renal and urinary disorders | MedDRA | Non-systematic Assessment |
|
| Nephrotic syndrome | Renal and urinary disorders | MedDRA | Non-systematic Assessment |
|
| Proteinuria | Renal and urinary disorders | MedDRA | Non-systematic Assessment |
|
| Ovarian cyst | Reproductive system and breast disorders | MedDRA | Non-systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
|
| Acanthosis nigricans | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
|
| Haematoma | Vascular disorders | MedDRA | Non-systematic Assessment |
|
| Left ventricular hypertrophy | Cardiac disorders | MedDRA | Non-systematic Assessment |
|
| Tachycardia | Cardiac disorders | MedDRA | Non-systematic Assessment |
|
| Cheilitis | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
|
| Injection site haemorrhage | General disorders | MedDRA | Non-systematic Assessment |
|
| Hypersensitivity | Immune system disorders | MedDRA | Non-systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA | Non-systematic Assessment |
|
| Hand fracture | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
|
| Ligament sprain | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
|
| Wound | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
|
| Blood human immunodeficiency virus (HIV) ribo-nucleic acid (RNA) increased | Investigations | MedDRA | Non-systematic Assessment |
|
| Blood follicle stimulating hormone increased | Investigations | MedDRA | Non-systematic Assessment |
|
| Weight increased | Investigations | MedDRA | Non-systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA | Non-systematic Assessment |
|
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA | Non-systematic Assessment |
|
| Glucose tolerance impaired | Metabolism and nutrition disorders | MedDRA | Non-systematic Assessment |
|
| Insulin resistance | Metabolism and nutrition disorders | MedDRA | Non-systematic Assessment |
|
| Mineral deficiency | Metabolism and nutrition disorders | MedDRA | Non-systematic Assessment |
|
| Vitamin D deficiency | Metabolism and nutrition disorders | MedDRA | Non-systematic Assessment |
|
| Amyotrophy | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
|
| Knee deformity | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
|
| Limb asymmetry | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
|
| Muscle atrophy | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
|
| Tendonitis | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
|
| Hypotonia | Nervous system disorders | MedDRA | Non-systematic Assessment |
|
| Presyncope | Nervous system disorders | MedDRA | Non-systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
|
| Acne | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
|
| Eczema | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
|
| Nail dystrophy | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA | Non-systematic Assessment |
|
| Joint destruction | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
|
| Bronchopneumopathy due to mycoplasm's infection | General disorders | MedDRA | Non-systematic Assessment |
|
| Fever, rhynopharyngal infection, macular exenthema and Asthenia | General disorders | MedDRA | Non-systematic Assessment |
|
| Ocular hypertony | General disorders | MedDRA | Non-systematic Assessment |
|
| Uremic rectal bleeding (pratouayia) | General disorders | MedDRA | 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 |
|---|---|
|
| Pubic hair: Stage IV (n=4) |
|
| Pubic hair: Stage V (n=4) |
|
| Breast development: Stage I (n=1) |
|
| Breast development: Stage II (n=1) |
|
| Breast development: Stage III (n=1) |
|
| Breast development: Stage IV (n=1) |
|
| Breast development: Stage V (n=1) |
|
| Year 2 (n = 15, 13) |
|
| Year 3 (n = 15, 14) |
|
| Year 2 (n = 14, 12) |
|
| Year 3 (n = 14, 11) |
|
| Annual Change at Year 3 (n = 13, 9) |
|
| Year 2 (n = 14, 12) |
|
| Year 3 (n = 14, 11) |
|
| Year 2 (n = 14, 12) |
|
| Year 3 (n = 13, 11) |
|
| Year 2 (n = 14, 12) |
|
| Year 3 (n = 14, 11) |
|
| Annual Change at Year 3 (n = 13, 9) |
|
| Year 2 (n = 14, 12) |
|
| Year 3 (n = 14, 11) |
|
| Year 2 (n = 14, 12) |
|
| Year 3 (n = 13, 11) |
|
| Year 2 (n = 15, 14) |
|
| Year 3 (n = 13, 12) |
|
| Year 2 (n = 15, 14) |
|
| Year 3 (n 12, 12) |
|
| Year 2 (n = 10, 9) |
|
| Year 3 (n = 10, 8) |
|
| Year 2 (n = 14, 11) |
|
| Year 3 (n = 13, 11) |
|
| Year 2 (n = 15, 14) |
|
| Year 3 (n = 13, 12) |
|
| Year 2 (n = 14, 11) |
|
| Year 3 (n = 13, 11) |
|
| Year 3 (n = 12, 9) |
|
| Year 2 (n = 14, 11) |
|
| Year 3 (n = 12, 11) |
|
| Year 2 (n = 9, 7) |
|
| Year 3 (n = 9, 7) |
|
| Year 2 (n = 14, 15) |
|
| Year 3 (n = 14, 14) |
|
| Year 2 (n = 14, 15) |
|
| Year 3 (n = 14, 14) |
|
| Year 2 (n = 14, 13) |
|
| Year 3 (n = 14, 14) |
|
| Year 2 (n = 15, 14) |
|
| Year 3 (n = 15, 14) |
|
| Title | Measurements |
|---|---|
|
| Year 5 (n = 17) |
|
| Year 5.5 (n = 11) |
|
| Year 6 (n = 14) |
|
| Year 6.5 (n = 8) |
|
| Year 7 (n = 8) |
|
| Year 7.5 (n = 4) |
|
| Year 8 (n = 6) |
|
| Year 8.5 (n = 2) |
|
| Year 9 (n = 2) |
|
| Year 9.5 (n = 1) |
|
| Year 10 (n = 1) |
|
| 0.5 years after somatropin discontinuation (n = 2) |
|
| 1 year after somatropin discontinuation (n = 2) |
|
| Final height (n = 3) |
|