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| ID | Type | Description | Link |
|---|---|---|---|
| 2006-002506-58 | EudraCT Number |
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This study is performed to investigate the long-term safety, in particular the diabetogenic potential and immunogenicity of rhGH therapy in short children born small for gestational age (SGA).
Prospective, open label, non-comparative, multicenter study. Short children born SGA were to be treated until they reached final height, but treatment could be discontinued earlier if medically indicated or if there was inadequate response to treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Omnitrope | Experimental | All enrolled patients received Omnitrope. The median daily dose varied between 0.0340 and 0.0351 mg/kg/day and the maximum range was 0.000 to 0.040 mg/kg/day over all visits. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Omnitrope | Drug | All enrolled patients received Omnitrope. The median daily dose varied between 0.0340 and 0.0351 mg/kg/day and the maximum range was 0.000 to 0.040 mg/kg/day over all visits. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Development of Diabetes in Short Children Born SGA During Treatment | The development of diabetes in short children born SGA during treatment was evaluated based on the carbohydrate metabolism parameters FPG, HbA1c and OGTT (basal and 2-h plasma glucose). Only cases which were confirmed by the investigator were included. | throughout the study, approximately 13 years |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change in Height (H) (cm) From Baseline | Mean change in Height from baseline for all patients was reported. | Baseline, 3 months, 1 year, 2 years, 5 years and 9 years |
| Mean Change in Height Standard Deviation Score Over Time From Baseline |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sandoz Biopharmaceuticals | Sandoz GmbH | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sandoz Investigational Site | Edegem | Antwerpen | 2650 | Belgium | ||
| Sandoz Investigational Site |
Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.
This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
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This study was not randomized. All enrolled patients received Omnitrope
Study was carried out in 31 centers in 7 countries (Poland, Romania, Hungary, Czech Republic, Germany, Belgium and Georgia).
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| ID | Title | Description |
|---|---|---|
| FG000 | Omnitrope | All enrolled patients received Omnitrope. The median daily dose varied between 0.0340 and 0.0351 mg/kg/day and the maximum range was 0.000 to 0.040 mg/kg/day over all visits. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 7, 2020 | Sep 20, 2022 |
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|
SDS reflects the deviation of a measured value from the mean value of normally growing children of the same sex and chronological age, expressed in units of the standard deviation (SD) of normally growing children of the same sex and chronological age. SDS was calculated according to the formula SDS=(X1-X2)/SD, where X1 is the measured value, X2 the mean value for the relevant chronological age and sex, and SD the reference standard deviation for the relevant sex and age. Refer to SAP page 14 for the formula and to Appendix B (H SDS) and D (HV SDS) for the applied reference Table.
In general, a negative SDS indicates that the value is below average or mean and a positive value means it is above the average or mean. The calculated mean change compared to baseline reflects the catch-up growth over time towards average normal growth starting from below average.
| Baseline, 3 months, 0.5 year, 9 months, 1 year, 1.25 years, 1.5 years, 1.75 years, 2 years, 3 years, 4 years, 5 years, 6 years, 7 years, 8 years, 9 years, 10 years, 11 years, 12 years, 12.5 years |
| Mean Change in Height Velocity (HV) (cm/Year) Over Time From Baseline | Mean change in Height velocity (HV) (cm/year) over time from baseline was reported. | Baseline, 3 months, 1 year, 2 years, 5 years and 9 years |
| Mean Change in Height Velocity Standard Deviation Score (HV SDS) Over Time From Baseline | SDS reflects the deviation of a measured value from the mean value of normally growing children of the same sex and chronological age, expressed in units of the standard deviation (SD) of normally growing children of the same sex and chronological age. SDS was calculated according to the formula SDS=(X1-X2)/SD, where X1 is the measured value, X2 the mean value for the relevant chronological age and sex, and SD the reference standard deviation for the relevant sex and age. Refer to SAP page 14 for the formula and to Appendix B (H SDS) and D (HV SDS) for the applied reference Table. In general, a negative SDS indicates that the value is below average or mean and a positive value means it is above the average or mean. The calculated mean change compared to baseline reflects the initial high increase in height velocity which remains positive over years, but is decreasing over time. | Baseline, 3 months, 0.5 year, 9 months, 1 year, 1.25 years, 1.5 years, 1.75 years, 2 years, 3 years, 4 years, 5 years, 6 years, 7 years, 8 years, 9 years, 10 years, 11 years, 12 years, 12.5 years |
| Mean Change in Serum IGF-1 Level (Nmol/L) From Baseline | Mean change in serum IGF-1 level (nmol/L) from baseline was reported. | Baseline, 3 months, 1 year, 2 years, 5 years and 9 years |
| Mean Change in IGFBP-3 Levels (Nmol/L) From Baseline | Mean change in IGFBP-3 levels (nmol/L) from baseline was reported. | Baseline, 3 months, 1 year, 2 years, 5 years and 9 years |
| Number of Participants With the Development of Anti-rhGH Antibodies During Omnitrope Treatment | Number of participants with the development of anti-rhGH antibodies with positive test result were reported. | throughout the study, approximately 13 years |
| Prague |
| Prague |
| 150 06 |
| Czechia |
| Sandoz Investigational Site | Hradec Králové | 500 05 | Czechia |
| Sandoz Investigational Site | Ústà nad Labem | 400 11 | Czechia |
| Sandoz Investigational Site | Tbilisi | 144 | Georgia |
| Sandoz Investigational Site | Munich | Bavaria | 80337 | Germany |
| Sandoz Investigational Site | Sankt Augustin | North Rhine-Westphalia | 53757 | Germany |
| Sandoz Investigational Site | Szeged | Csongrád megye | 6720 | Hungary |
| Sandoz Investigational Site | Budapest | 1023 | Hungary |
| Sandoz Investigational Site | Budapest | 1094 | Hungary |
| Sandoz Investigational Site | Győr | 9024 | Hungary |
| Sandoz Investigational Site | Miskolc | 3526 | Hungary |
| Sandoz Investigational Site | Poznan | Greater Poland Voivodeship | 60-572 | Poland |
| Sandoz Investigational Site | Bydgoszcz | Kuyavian-Pomeranian Voivodeship | 85-667 | Poland |
| Sandoz Investigational Site | Wroclaw | Lower Silesian Voivodeship | 50-368 | Poland |
| Sandoz Investigational Site | Rzeszów | Podkarpackie Voivodeship | 35-301 | Poland |
| Sandoz Investigational Site | Katowice | Silesian Voivodeship | 40-752 | Poland |
| Sandoz Investigational Site | Zabrze | Silesian Voivodeship | 41-800 | Poland |
| Sandoz Investigational Site | Gdansk | 80-952 | Poland |
| Sandoz Investigational Site | Katowice | 40-752 | Poland |
| Sandoz Investigational Site | Krakow | 30-663 | Poland |
| Sandoz Investigational Site | Lodz | 93-338 | Poland |
| Sandoz Investigational Site | Szczecin | 71-252 | Poland |
| Sandoz Investigational Site | Warsaw | 04-730 | Poland |
| Sandoz Investigational Site | Wroclaw | 51-312 | Poland |
| Sandoz Investigational Site | Kielce | Świętokrzyskie Voivodeship | 25734 | Poland |
| Sandoz Investigational Site | Cluj-Napoca | Cluj | 400370 | Romania |
| Sandoz Investigational Site | Bucharest | 011461 | Romania |
| Sandoz Investigational Site | Bucharest | 020395 | Romania |
| Sandoz Investigational Site | Craiova | 200642 | Romania |
| Sandoz Investigational Site | Iași | 700111 | Romania |
| Full Analysis Set (FAS) | The FAS followed the ITT principle and comprised all patients who received at least 1 dose of study medication |
|
| Safety Analysis Set (SAS) | The SAF comprised all patients who received at least 1 dose of study medication and had at least 1 post-baseline safety assessment |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Omnitrope | All enrolled patients received Omnitrope. The median daily dose varied between 0.0340 and 0.0351 mg/kg/day and the maximum range was 0.000 to 0.040 mg/kg/day over all visits. |
| 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 |
| |||||||||||||||||||||||
| Race/Ethnicity, Customized | Number | 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 | Number of Participants With Development of Diabetes in Short Children Born SGA During Treatment | The development of diabetes in short children born SGA during treatment was evaluated based on the carbohydrate metabolism parameters FPG, HbA1c and OGTT (basal and 2-h plasma glucose). Only cases which were confirmed by the investigator were included. | Safety analysis set: SAF comprised all patients who received at least 1 dose of study medication and had at least 1 post-baseline safety assessment | Posted | Count of Participants | Participants | throughout the study, approximately 13 years |
|
|
| ||||||||||||||||||||||||||
| Secondary | Mean Change in Height (H) (cm) From Baseline | Mean change in Height from baseline for all patients was reported. | Full analysis set: FAS followed the ITT principle and comprised all patients who received at least 1 dose of study medication. Not all patients may have outcome data for all visits. | Posted | Mean | 95% Confidence Interval | cm | Baseline, 3 months, 1 year, 2 years, 5 years and 9 years |
|
| ||||||||||||||||||||||||||
| Secondary | Mean Change in Height Standard Deviation Score Over Time From Baseline | SDS reflects the deviation of a measured value from the mean value of normally growing children of the same sex and chronological age, expressed in units of the standard deviation (SD) of normally growing children of the same sex and chronological age. SDS was calculated according to the formula SDS=(X1-X2)/SD, where X1 is the measured value, X2 the mean value for the relevant chronological age and sex, and SD the reference standard deviation for the relevant sex and age. Refer to SAP page 14 for the formula and to Appendix B (H SDS) and D (HV SDS) for the applied reference Table. In general, a negative SDS indicates that the value is below average or mean and a positive value means it is above the average or mean. The calculated mean change compared to baseline reflects the catch-up growth over time towards average normal growth starting from below average. | Full analysis set: FAS followed the ITT principle and comprised all patients who received at least 1 dose of study medication. Not all patients may have outcome data for all visits. | Posted | Mean | 95% Confidence Interval | SDS | Baseline, 3 months, 0.5 year, 9 months, 1 year, 1.25 years, 1.5 years, 1.75 years, 2 years, 3 years, 4 years, 5 years, 6 years, 7 years, 8 years, 9 years, 10 years, 11 years, 12 years, 12.5 years |
| |||||||||||||||||||||||||||
| Secondary | Mean Change in Height Velocity (HV) (cm/Year) Over Time From Baseline | Mean change in Height velocity (HV) (cm/year) over time from baseline was reported. | Full analysis set: FAS followed the ITT principle and comprised all patients who received at least 1 dose of study medication. Not all patients may have outcome data for all visits. | Posted | Mean | 95% Confidence Interval | cm/year | Baseline, 3 months, 1 year, 2 years, 5 years and 9 years |
|
| ||||||||||||||||||||||||||
| Secondary | Mean Change in Height Velocity Standard Deviation Score (HV SDS) Over Time From Baseline | SDS reflects the deviation of a measured value from the mean value of normally growing children of the same sex and chronological age, expressed in units of the standard deviation (SD) of normally growing children of the same sex and chronological age. SDS was calculated according to the formula SDS=(X1-X2)/SD, where X1 is the measured value, X2 the mean value for the relevant chronological age and sex, and SD the reference standard deviation for the relevant sex and age. Refer to SAP page 14 for the formula and to Appendix B (H SDS) and D (HV SDS) for the applied reference Table. In general, a negative SDS indicates that the value is below average or mean and a positive value means it is above the average or mean. The calculated mean change compared to baseline reflects the initial high increase in height velocity which remains positive over years, but is decreasing over time. | Full analysis set: FAS followed the ITT principle and comprised all patients who received at least 1 dose of study medication. Not all patients may have outcome data for all visits. | Posted | Mean | 95% Confidence Interval | SDS | Baseline, 3 months, 0.5 year, 9 months, 1 year, 1.25 years, 1.5 years, 1.75 years, 2 years, 3 years, 4 years, 5 years, 6 years, 7 years, 8 years, 9 years, 10 years, 11 years, 12 years, 12.5 years |
| |||||||||||||||||||||||||||
| Secondary | Mean Change in Serum IGF-1 Level (Nmol/L) From Baseline | Mean change in serum IGF-1 level (nmol/L) from baseline was reported. | Full analysis set: FAS followed the ITT principle and comprised all patients who received at least 1 dose of study medication. Not all patients may have outcome data for all visits. | Posted | Mean | 95% Confidence Interval | nmol/L | Baseline, 3 months, 1 year, 2 years, 5 years and 9 years |
|
| ||||||||||||||||||||||||||
| Secondary | Mean Change in IGFBP-3 Levels (Nmol/L) From Baseline | Mean change in IGFBP-3 levels (nmol/L) from baseline was reported. | Full analysis set: FAS followed the ITT principle and comprised all patients who received at least 1 dose of study medication. Not all patients may have outcome data for all visits. | Posted | Mean | 95% Confidence Interval | nmol/L | Baseline, 3 months, 1 year, 2 years, 5 years and 9 years |
|
| ||||||||||||||||||||||||||
| Secondary | Number of Participants With the Development of Anti-rhGH Antibodies During Omnitrope Treatment | Number of participants with the development of anti-rhGH antibodies with positive test result were reported. | Safety analysis set: SAF comprised all patients who received at least 1 dose of study medication and had at least 1 post-baseline safety assessment | Posted | Count of Participants | Participants | throughout the study, approximately 13 years |
|
|
Adverse events were collected from first dose of study treatment to end of the study i.e. up to 13 years.
Any signs or symptoms were collected from first dose of study treatment to end of the study i.e. up to 13 years.
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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 | Omnitrope | All enrolled patients received Omnitrope. The median daily dose varied between 0.0340 and 0.0351 mg/kg/day and the maximum range was 0.000 to 0.040 mg/kg/day over all visits. | 1 | 277 | 74 | 277 | 210 | 277 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA Version 24.1 | Systematic Assessment |
| |
| Lymphadenitis | Blood and lymphatic system disorders | MedDRA Version 24.1 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA Version 24.1 | Systematic Assessment |
| |
| Ventricular arrhythmia | Cardiac disorders | MedDRA Version 24.1 | Systematic Assessment |
| |
| Congenital arterial malformation | Congenital, familial and genetic disorders | MedDRA Version 24.1 | Systematic Assessment |
| |
| Developmental hip dysplasia | Congenital, familial and genetic disorders | MedDRA Version 24.1 | Systematic Assessment |
| |
| Gilbert's syndrome | Congenital, familial and genetic disorders | MedDRA Version 24.1 | Systematic Assessment |
| |
| Tympanic membrane perforation | Ear and labyrinth disorders | MedDRA Version 24.1 | Systematic Assessment |
| |
| Precocious puberty | Endocrine disorders | MedDRA Version 24.1 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA Version 24.1 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA Version 24.1 | Systematic Assessment |
| |
| Aphthous ulcer | Gastrointestinal disorders | MedDRA Version 24.1 | Systematic Assessment |
| |
| Chronic gastritis | Gastrointestinal disorders | MedDRA Version 24.1 | Systematic Assessment |
| |
| Duodenal ulcer | Gastrointestinal disorders | MedDRA Version 24.1 | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA Version 24.1 | Systematic Assessment |
| |
| Eosinophilic oesophagitis | Gastrointestinal disorders | MedDRA Version 24.1 | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA Version 24.1 | Systematic Assessment |
| |
| Inguinal hernia | Gastrointestinal disorders | MedDRA Version 24.1 | Systematic Assessment |
| |
| Malabsorption | Gastrointestinal disorders | MedDRA Version 24.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA Version 24.1 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA Version 24.1 | Systematic Assessment |
| |
| Face oedema | General disorders | MedDRA Version 24.1 | Systematic Assessment |
| |
| Obstruction | General disorders | MedDRA Version 24.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA Version 24.1 | Systematic Assessment |
| |
| Hyperbilirubinaemia | Hepatobiliary disorders | MedDRA Version 24.1 | Systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA Version 24.1 | Systematic Assessment |
| |
| Bacterial sepsis | Infections and infestations | MedDRA Version 24.1 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA Version 24.1 | Systematic Assessment |
| |
| Ear infection | Infections and infestations | MedDRA Version 24.1 | Systematic Assessment |
| |
| Epididymitis | Infections and infestations | MedDRA Version 24.1 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA Version 24.1 | Systematic Assessment |
| |
| Giardiasis | Infections and infestations | MedDRA Version 24.1 | Systematic Assessment |
| |
| Helicobacter infection | Infections and infestations | MedDRA Version 24.1 | Systematic Assessment |
| |
| Infectious mononucleosis | Infections and infestations | MedDRA Version 24.1 | Systematic Assessment |
| |
| Laryngitis | Infections and infestations | MedDRA Version 24.1 | Systematic Assessment |
| |
| Orchitis | Infections and infestations | MedDRA Version 24.1 | Systematic Assessment |
| |
| Otitis media | Infections and infestations | MedDRA Version 24.1 | Systematic Assessment |
| |
| Otitis media acute | Infections and infestations | MedDRA Version 24.1 | Systematic Assessment |
| |
| Otitis media chronic | Infections and infestations | MedDRA Version 24.1 | Systematic Assessment |
| |
| Peritonitis | Infections and infestations | MedDRA Version 24.1 | Systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA Version 24.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA Version 24.1 | Systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA Version 24.1 | Systematic Assessment |
| |
| Rhinitis | Infections and infestations | MedDRA Version 24.1 | Systematic Assessment |
| |
| Subcutaneous abscess | Infections and infestations | MedDRA Version 24.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA Version 24.1 | Systematic Assessment |
| |
| Abdominal injury | Injury, poisoning and procedural complications | MedDRA Version 24.1 | Systematic Assessment |
| |
| Alcohol poisoning | Injury, poisoning and procedural complications | MedDRA Version 24.1 | Systematic Assessment |
| |
| Facial bones fracture | Injury, poisoning and procedural complications | MedDRA Version 24.1 | Systematic Assessment |
| |
| Foreign body in gastrointestinal tract | Injury, poisoning and procedural complications | MedDRA Version 24.1 | Systematic Assessment |
| |
| Head injury | Injury, poisoning and procedural complications | MedDRA Version 24.1 | Systematic Assessment |
| |
| Internal injury | Injury, poisoning and procedural complications | MedDRA Version 24.1 | Systematic Assessment |
| |
| Joint dislocation | Injury, poisoning and procedural complications | MedDRA Version 24.1 | Systematic Assessment |
| |
| Ligament sprain | Injury, poisoning and procedural complications | MedDRA Version 24.1 | Systematic Assessment |
| |
| Multiple injuries | Injury, poisoning and procedural complications | MedDRA Version 24.1 | Systematic Assessment |
| |
| Procedural complication | Injury, poisoning and procedural complications | MedDRA Version 24.1 | Systematic Assessment |
| |
| Radius fracture | Injury, poisoning and procedural complications | MedDRA Version 24.1 | Systematic Assessment |
| |
| Road traffic accident | Injury, poisoning and procedural complications | MedDRA Version 24.1 | Systematic Assessment |
| |
| Skull fracture | Injury, poisoning and procedural complications | MedDRA Version 24.1 | Systematic Assessment |
| |
| Sternal fracture | Injury, poisoning and procedural complications | MedDRA Version 24.1 | Systematic Assessment |
| |
| Toxicity to various agents | Injury, poisoning and procedural complications | MedDRA Version 24.1 | Systematic Assessment |
| |
| Traumatic shock | Injury, poisoning and procedural complications | MedDRA Version 24.1 | Systematic Assessment |
| |
| Upper limb fracture | Injury, poisoning and procedural complications | MedDRA Version 24.1 | Systematic Assessment |
| |
| Cardiac murmur | Investigations | MedDRA Version 24.1 | Systematic Assessment |
| |
| Intraocular pressure increased | Investigations | MedDRA Version 24.1 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA Version 24.1 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA Version 24.1 | Systematic Assessment |
| |
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA Version 24.1 | Systematic Assessment |
| |
| Osteonecrosis | Musculoskeletal and connective tissue disorders | MedDRA Version 24.1 | Systematic Assessment |
| |
| Scoliosis | Musculoskeletal and connective tissue disorders | MedDRA Version 24.1 | Systematic Assessment |
| |
| Melanocytic naevus | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 24.1 | Systematic Assessment |
| |
| Pachydermodactyly | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 24.1 | Systematic Assessment |
| |
| Brain oedema | Nervous system disorders | MedDRA Version 24.1 | Systematic Assessment |
| |
| Coma | Nervous system disorders | MedDRA Version 24.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA Version 24.1 | Systematic Assessment |
| |
| Intellectual disability | Nervous system disorders | MedDRA Version 24.1 | Systematic Assessment |
| |
| Seizure | Nervous system disorders | MedDRA Version 24.1 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA Version 24.1 | Systematic Assessment |
| |
| Behaviour disorder | Psychiatric disorders | MedDRA Version 24.1 | Systematic Assessment |
| |
| Enuresis | Psychiatric disorders | MedDRA Version 24.1 | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA Version 24.1 | Systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | MedDRA Version 24.1 | Systematic Assessment |
| |
| Urethral fistula | Renal and urinary disorders | MedDRA Version 24.1 | Systematic Assessment |
| |
| Urethral stenosis | Renal and urinary disorders | MedDRA Version 24.1 | Systematic Assessment |
| |
| Urinary incontinence | Renal and urinary disorders | MedDRA Version 24.1 | Systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | MedDRA Version 24.1 | Systematic Assessment |
| |
| Acquired hydrocele | Reproductive system and breast disorders | MedDRA Version 24.1 | Systematic Assessment |
| |
| Intermenstrual bleeding | Reproductive system and breast disorders | MedDRA Version 24.1 | Systematic Assessment |
| |
| Testicular torsion | Reproductive system and breast disorders | MedDRA Version 24.1 | Systematic Assessment |
| |
| Varicocele | Reproductive system and breast disorders | MedDRA Version 24.1 | Systematic Assessment |
| |
| Adenoidal hypertrophy | Respiratory, thoracic and mediastinal disorders | MedDRA Version 24.1 | Systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA Version 24.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA Version 24.1 | Systematic Assessment |
| |
| Nasal septum perforation | Respiratory, thoracic and mediastinal disorders | MedDRA Version 24.1 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA Version 24.1 | Systematic Assessment |
| |
| Vitiligo | Skin and subcutaneous tissue disorders | MedDRA Version 24.1 | Systematic Assessment |
| |
| Circulatory collapse | Vascular disorders | MedDRA Version 24.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypothyroidism | Endocrine disorders | MedDRA Version 24.1 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA Version 24.1 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA Version 24.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA Version 24.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA Version 24.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA Version 24.1 | Systematic Assessment |
| |
| Hypersensitivity | Immune system disorders | MedDRA Version 24.1 | Systematic Assessment |
| |
| Seasonal allergy | Immune system disorders | MedDRA Version 24.1 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA Version 24.1 | Systematic Assessment |
| |
| Ear infection | Infections and infestations | MedDRA Version 24.1 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA Version 24.1 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA Version 24.1 | Systematic Assessment |
| |
| Laryngitis | Infections and infestations | MedDRA Version 24.1 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA Version 24.1 | Systematic Assessment |
| |
| Otitis media | Infections and infestations | MedDRA Version 24.1 | Systematic Assessment |
| |
| Otitis media acute | Infections and infestations | MedDRA Version 24.1 | Systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA Version 24.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA Version 24.1 | Systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA Version 24.1 | Systematic Assessment |
| |
| Rhinitis | Infections and infestations | MedDRA Version 24.1 | Systematic Assessment |
| |
| Scarlet fever | Infections and infestations | MedDRA Version 24.1 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA Version 24.1 | Systematic Assessment |
| |
| Tonsillitis | Infections and infestations | MedDRA Version 24.1 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA Version 24.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA Version 24.1 | Systematic Assessment |
| |
| Varicella | Infections and infestations | MedDRA Version 24.1 | Systematic Assessment |
| |
| Viral infection | Infections and infestations | MedDRA Version 24.1 | Systematic Assessment |
| |
| Insulin-like growth factor increased | Investigations | MedDRA Version 24.1 | Systematic Assessment |
| |
| Scoliosis | Musculoskeletal and connective tissue disorders | MedDRA Version 24.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA Version 24.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA Version 24.1 | Systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA Version 24.1 | Systematic Assessment |
| |
| Acne | Skin and subcutaneous tissue disorders | MedDRA Version 24.1 | Systematic Assessment |
|
The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (ie, data from all sites) in the clinical trial.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Disclosure Representative | Sandoz | +4980249080 | sandoz.disclosure@sandoz.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 28, 2022 | Sep 20, 2022 | SAP_001.pdf |
| 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
| Other: specified as Mixed ethnic origin (Arabic/ Caucasian) |
|
| Black |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
| Units | Counts |
|---|---|
| Participants |
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