Ignite Creation Date:
2025-12-24 @ 10:03 PM
Ignite Modification Date:
2025-12-24 @ 10:03 PM
Study NCT ID:
NCT05723835
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-11-21
First Post:
2023-01-29
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
A Research Study Looking at How Safe Somapacitan is and How Well it Works in Children Who Need Help to Grow - REAL 9
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2025-10-14', 'type': 'ESTIMATED'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D014424', 'term': 'Turner Syndrome'}, {'id': 'D009634', 'term': 'Noonan Syndrome'}], 'ancestors': [{'id': 'D006059', 'term': 'Gonadal Dysgenesis'}, {'id': 'D012734', 'term': 'Disorders of Sex Development'}, {'id': 'D014564', 'term': 'Urogenital Abnormalities'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D058533', 'term': 'Sex Chromosome Disorders of Sex Development'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D006330', 'term': 'Heart Defects, Congenital'}, {'id': 'D018376', 'term': 'Cardiovascular Abnormalities'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D025064', 'term': 'Sex Chromosome Disorders'}, {'id': 'D025063', 'term': 'Chromosome Disorders'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D006058', 'term': 'Gonadal Disorders'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D019465', 'term': 'Craniofacial Abnormalities'}, {'id': 'D009139', 'term': 'Musculoskeletal Abnormalities'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000718308', 'term': 'somapacitan'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinicaltrials@novonordisk.com', 'phone': '(+1) 866-867-7178', 'title': 'Clinical Reporting Office (2834)', 'organization': 'Novo Nordisk A/S'}, 'certainAgreement': {'otherDetails': 'At the end of the trial, one or more scientific publications may be prepared collaboratively by the investigator(s) and Novo Nordisk. Novo Nordisk reserves the right to postpone publication and/or communication for up to 60 days to protect intellectual property.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'From Baseline (Week 0) up to Week 94 (approximately, Data cut off date: 24Nov2024)', 'description': 'An AE is any untoward medical occurrence in a clinical study participant that is temporally associated with the use of study drug, whether or not considered related to the study treatment. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom or disease (new or exacerbated) temporally associated with the use of an study treatment. Safety analysis set included all participants who were exposed to study treatment.', 'eventGroups': [{'id': 'EG000', 'title': 'SGA_somapacitan (GH Treatment Naïve)', 'description': 'Participants with small for gestational age who were treatment naïve subcutaneously received a dose of 0.24 mg/kg/week somapacitan once weekly for 26-week main phase followed by an ongoing 130-week extension phase I.', 'otherNumAtRisk': 4, 'deathsNumAtRisk': 4, 'otherNumAffected': 3, 'seriousNumAtRisk': 4, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'SGA_somapacitan (Previously Treated With GH)', 'description': 'Participants with small for gestational age who were previously treated with GH, subcutaneously received a dose of 0.24 mg/kg/week somapacitan once weekly for 26-week main phase followed by an ongoing 130-week extension phase I.', 'otherNumAtRisk': 8, 'deathsNumAtRisk': 8, 'otherNumAffected': 5, 'seriousNumAtRisk': 8, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG002', 'title': 'TS_somapacitan (GH Treatment Naïve)', 'description': 'Participants with Turner syndrome who were treatment naïve subcutaneously received a dose of 0.24 mg/kg/week somapacitan once weekly for 26-week main phase followed by an ongoing 130-week extension phase I.', 'otherNumAtRisk': 3, 'deathsNumAtRisk': 3, 'otherNumAffected': 2, 'seriousNumAtRisk': 3, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'TS_somapacitan (Previously Treated With GH)', 'description': 'Participants with Turner syndrome who were previously treated with GH, subcutaneously received a dose of 0.24 mg/kg/week somapacitan once weekly for 26-week main phase followed by an ongoing 130-week extension phase I.', 'otherNumAtRisk': 8, 'deathsNumAtRisk': 8, 'otherNumAffected': 7, 'seriousNumAtRisk': 8, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG004', 'title': 'NS_somapacitan (GH Treatment Naïve)', 'description': 'Participants with Noonan syndrome who were treatment naïve subcutaneously received a dose of 0.24 mg/kg/week somapacitan once weekly for 26-week main phase followed by an ongoing 130-week extension phase I.', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 4, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG005', 'title': 'NS_somapacitan (Previously Treated With GH)', 'description': 'Participants with Noonan syndrome who were previously treated with GH, subcutaneously received a dose of 0.24 mg/kg/week somapacitan once weekly for 26-week main phase followed by an ongoing 130-week extension phase I.', 'otherNumAtRisk': 7, 'deathsNumAtRisk': 7, 'otherNumAffected': 6, 'seriousNumAtRisk': 7, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG006', 'title': 'ISS_somapacitan (GH Treatment Naïve)', 'description': 'Participants with idiopathic short stature who were treatment naïve subcutaneously received a dose of 0.24 mg/kg/week somapacitan once weekly for 26-week main phase followed by an ongoing 130-week extension phase I.', 'otherNumAtRisk': 2, 'deathsNumAtRisk': 2, 'otherNumAffected': 2, 'seriousNumAtRisk': 2, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG007', 'title': 'ISS_somapacitan (Previously Treated With GH)', 'description': 'Participants with idiopathic short stature who were were previously treated with GH, subcutaneously received a dose of 0.24 mg/kg/week somapacitan once weekly for 26-week main phase followed by an ongoing 130-week extension phase I.', 'otherNumAtRisk': 9, 'deathsNumAtRisk': 9, 'otherNumAffected': 8, 'seriousNumAtRisk': 9, 'deathsNumAffected': 0, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 9, 'numEvents': 3, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Accidental overdose', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 9, 'numEvents': 3, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Accidental underdose', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 9, 'numEvents': 14, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Acne', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Aortic valve incompetence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 2, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Asthma exercise induced', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Avulsion fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Blood thyroid stimulating hormone increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'COVID-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Cardiac imaging procedure abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Coccydynia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Concussion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 7, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 9, 'numEvents': 3, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Costochondritis', 'stats': [{'groupId': 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{'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 3, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 9, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Viral pharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 8, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Wheezing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}], 'seriousEvents': [{'term': 'Conduction disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Gastrointestinal microorganism overgrowth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Gastrooesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Adverse Events (AEs) Reported in Children Born Small for Gestational Age- Weeks 0 to 26', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'SGA_somapacitan (GH Treatment Naïve)', 'description': 'Participants with small for gestational age who were treatment naïve subcutaneously received a dose of 0.24 mg/kg/week somapacitan once weekly for 26-week main phase followed by an ongoing 130-week extension phase I.'}, {'id': 'OG001', 'title': 'SGA_somapacitan (Previously Treated With GH)', 'description': 'Participants with small for gestational age who were previously treated with GH, subcutaneously received a dose of 0.24 mg/kg/week somapacitan once weekly for 26-week main phase followed by an ongoing 130-week extension phase I.'}], 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From baseline (Week 0) to Week 26', 'description': 'This outcome measure reported number of AEs in children with short stature for indication SGA. Children with SGA are born small for gestational age with insufficient catch-up growth by 2 years of age or older. An AE is any untoward medical occurrence in a clinical study participant that is temporally associated with the use of study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom or disease (new or exacerbated) temporally associated with the use of an study treatment.', 'unitOfMeasure': 'Events', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis set included all participants who were exposed to study treatment.'}, {'type': 'PRIMARY', 'title': 'Number of Adverse Events Reported for Turner Syndrome (TS)- Weeks 0 to 26', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'TS_somapacitan (GH Treatment Naïve)', 'description': 'Participants with Turner syndrome who were treatment naïve subcutaneously received a dose of 0.24 mg/kg/week somapacitan once weekly for 26-week main phase followed by an ongoing 130-week extension phase I.'}, {'id': 'OG001', 'title': 'TS_somapacitan (Previously Treated With GH)', 'description': 'Participants with Turner syndrome who were previously treated with GH, subcutaneously received a dose of 0.24 mg/kg/week somapacitan once weekly for 26-week main phase followed by an ongoing 130-week extension phase I.'}], 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From baseline (Week 0) to Week 26', 'description': 'This outcome measure reported number of AEs in participants with short stature for indication TS. TS is a chromosomal disorder which leads to short stature. An AE is any untoward medical occurrence in a clinical study participant that is temporally associated with the use of study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom or disease (new or exacerbated) temporally associated with the use of an study treatment.', 'unitOfMeasure': 'Events', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis set included all participants who were exposed to study treatment.'}, {'type': 'PRIMARY', 'title': 'Number of Adverse Events Reported for Noonan Syndrome- Weeks 0 to 26', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'NS_somapacitan (GH Treatment Naïve)', 'description': 'Participants with Noonan syndrome who were treatment naïve subcutaneously received a dose of 0.24 mg/kg/week somapacitan once weekly for 26-week main phase followed by an ongoing 130-week extension phase I.'}, {'id': 'OG001', 'title': 'NS_somapacitan (Previously Treated With GH)', 'description': 'Participants with Noonan syndrome who were previously treated with GH, subcutaneously received a dose of 0.24 mg/kg/week somapacitan once weekly for 26-week main phase followed by an ongoing 130-week extension phase I.'}], 'classes': [{'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From baseline (Week 0) to Week 26', 'description': 'This outcome measure reported number of AEs in participants with short stature for indication NS which is a genetically heterogeneous developmental disorder characterized by postnatally reduced growth and other major disorders. An AE is any untoward medical occurrence in a clinical study participant that is temporally associated with the use of study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom or disease (new or exacerbated) temporally associated with the use of an study treatment.', 'unitOfMeasure': 'Events', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis set included all participants who were exposed to study treatment.'}, {'type': 'PRIMARY', 'title': 'Number of Adverse Events Reported for Idiopathic Short Stature (ISS)- Weeks 0 to 26', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ISS_somapacitan (GH Treatment Naïve)', 'description': 'Participants with idiopathic short stature who were treatment naïve subcutaneously received a dose of 0.24 mg/kg/week somapacitan once weekly for 26-week main phase followed by an ongoing 130-week extension phase I.'}, {'id': 'OG001', 'title': 'ISS_somapacitan (Previously Treated With GH)', 'description': 'Participants with idiopathic short stature who were were previously treated with GH, subcutaneously received a dose of 0.24 mg/kg/week somapacitan once weekly for 26-week main phase followed by an ongoing 130-week extension phase I.'}], 'classes': [{'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From baseline (Week 0) to Week 26', 'description': 'This outcome measure reported number of AEs in participants with short stature for indication ISS. ISS describes short children with normal GH secretion. ISS is a condition in which the height of the individual is more than 2 standard deviations below the corresponding mean height for a given age, sex and population, without evidence of systemic, endocrine, nutritional or chromosomal abnormalities. An AE is any untoward medical occurrence in a clinical study participant that is temporally associated with the use of study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom or disease (new or exacerbated) temporally associated with the use of an study treatment.', 'unitOfMeasure': 'Events', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis set included all participants who were exposed to study treatment.'}, {'type': 'SECONDARY', 'title': 'Number of Adverse Events Possibly or Probably Related to Somapacitan Reported for Children Born Small for Gestational Age', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'SGA_somapacitan (GH Treatment Naïve)', 'description': 'Participants with small for gestational age who were treatment naïve subcutaneously received a dose of 0.24 mg/kg/week somapacitan once weekly for 26-week main phase followed by an ongoing 130-week extension phase I.'}, {'id': 'OG001', 'title': 'SGA_somapacitan (Previously Treated With GH)', 'description': 'Participants with small for gestational age who were previously treated with GH, subcutaneously received a dose of 0.24 mg/kg/week somapacitan once weekly for 26-week main phase followed by an ongoing 130-week extension phase I.'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From baseline (Week 0) to Week 26', 'description': 'This outcome measure reported number of AEs possibly or probably related to somapacitan reported in children with short stature for indication SGA. Children with SGA are born small for gestational age with insufficient catch-up growth by 2 years of age or older. An AE is any untoward medical occurrence in a clinical study participant that is temporally associated with the use of study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom or disease (new or exacerbated) temporally associated with the use of an study treatment.', 'unitOfMeasure': 'Events', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis set included all participants who were exposed to study treatment.'}, {'type': 'SECONDARY', 'title': 'Number of Adverse Events Possibly or Probably Related to Somapacitan Reported for Turner Syndrome', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'TS_somapacitan (GH Treatment Naïve)', 'description': 'Participants with Turner syndrome who were treatment naïve subcutaneously received a dose of 0.24 mg/kg/week somapacitan once weekly for 26-week main phase followed by an ongoing 130-week extension phase I.'}, {'id': 'OG001', 'title': 'TS_somapacitan (Previously Treated With GH)', 'description': 'Participants with Turner syndrome who were previously treated with GH, subcutaneously received a dose of 0.24 mg/kg/week somapacitan once weekly for 26-week main phase followed by an ongoing 130-week extension phase I.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From baseline (Week 0) to Week 26', 'description': 'This outcome measure reported number of AEs possibly or probably related to somapacitan reported in participants with short stature for indication TS. TS is a chromosomal disorder which leads to short stature. An AE is any untoward medical occurrence in a clinical study participant that is temporally associated with the use of study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom or disease (new or exacerbated) temporally associated with the use of an study treatment.', 'unitOfMeasure': 'Events', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis set included all participants who were exposed to study treatment.'}, {'type': 'SECONDARY', 'title': 'Number of Adverse Events Possibly or Probably Related to Somapacitan Reported for Noonan Syndrome', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'NS_somapacitan (GH Treatment Naïve)', 'description': 'Participants with Noonan syndrome who were treatment naïve subcutaneously received a dose of 0.24 mg/kg/week somapacitan once weekly for 26-week main phase followed by an ongoing 130-week extension phase I.'}, {'id': 'OG001', 'title': 'NS_somapacitan (Previously Treated With GH)', 'description': 'Participants with Noonan syndrome who were previously treated with GH, subcutaneously received a dose of 0.24 mg/kg/week somapacitan once weekly for 26-week main phase followed by an ongoing 130-week extension phase I.'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From baseline (Week 0) to Week 26', 'description': 'This outcome measure reported number of AEs possibly or probably related to somapacitan reported in participants with short stature for indication NS. An NS is a genetically heterogeneous developmental disorder characterized by postnatally reduced growth and other major disorders. An AE is any untoward medical occurrence in a clinical study participant that is temporally associated with the use of study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom or disease (new or exacerbated) temporally associated with the use of an study treatment.', 'unitOfMeasure': 'Events', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis set included all participants who were exposed to study treatment.'}, {'type': 'SECONDARY', 'title': 'Number of Adverse Events Possibly or Probably Related to Somapacitan Reported for Idiopathic Short Stature', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ISS_somapacitan (GH Treatment Naïve)', 'description': 'Participants with idiopathic short stature who were treatment naïve subcutaneously received a dose of 0.24 mg/kg/week somapacitan once weekly for 26-week main phase followed by an ongoing 130-week extension phase I.'}, {'id': 'OG001', 'title': 'ISS_somapacitan (Previously Treated With GH)', 'description': 'Participants with idiopathic short stature who were were previously treated with GH, subcutaneously received a dose of 0.24 mg/kg/week somapacitan once weekly for 26-week main phase followed by an ongoing 130-week extension phase I.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From baseline (Week 0) to Week 26', 'description': 'This outcome measure reported number of AEs possibly or probably related to somapacitan in participants with short stature for indication ISS. ISS describes short children with normal GH secretion and it is a condition in which the height of the individual is more than 2 standard deviations below the corresponding mean height for a given age, sex and population, without evidence of systemic, endocrine, nutritional or chromosomal abnormalities. An AE is any untoward medical occurrence in a clinical study participant that is temporally associated with the use of study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom or disease (new or exacerbated) temporally associated with the use of an study treatment.', 'unitOfMeasure': 'Events', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis set included all participants who were exposed to study treatment.'}, {'type': 'SECONDARY', 'title': 'Number of Adverse Events Reported Long-term Safety for Children Born Small for Gestational Age- Weeks 0 to 156', 'timeFrame': 'From baseline (Week 0) to Week 156', 'description': 'This outcome measure reported long-term safety in terms of number of AEs in children with short stature for indication SGA. Children with SGA are born small for gestational age with insufficient catch-up growth by 2 years of age or older. An AE is any untoward medical occurrence in a clinical study participant that is temporally associated with the use of study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom or disease (new or exacerbated) temporally associated with the use of an study treatment.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants', 'anticipatedPostingDate': '2027-12'}, {'type': 'SECONDARY', 'title': 'Number of Adverse Events Reported Long-term Safety for Turner Syndrome- Weeks 0 to 156', 'timeFrame': 'From baseline (Week 0) to Week 156', 'description': 'This outcome measure reported long-term safety in terms of number of AEs in participants with short stature for indication TS. TS is a chromosomal disorder which leads to short stature. An AE is any untoward medical occurrence in a clinical study participant that is temporally associated with the use of study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom or disease (new or exacerbated) temporally associated with the use of an study treatment.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants', 'anticipatedPostingDate': '2027-12'}, {'type': 'SECONDARY', 'title': 'Number of Adverse Events Reported Long-term Safety for Noonan Syndrome- Weeks 0 to 156', 'timeFrame': 'From baseline (Week 0) to Week 156', 'description': 'This outcome measure reported long-term safety in terms of number of AEs in participants with short stature for indication NS which is a genetically heterogeneous developmental disorder characterized by postnatally reduced growth and other major disorders. An AE is any untoward medical occurrence in a clinical study participant that is temporally associated with the use of study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom or disease (new or exacerbated) temporally associated with the use of an study treatment.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants', 'anticipatedPostingDate': '2027-12'}, {'type': 'SECONDARY', 'title': 'Number of Adverse Events Reported Long-term Safety for Idiopathic Short Stature- Weeks 0 to 156', 'timeFrame': 'From baseline (Week 0) to Week 156', 'description': 'This outcome measure reported long-term safety in terms of number of AEs in participants with short stature for indication ISS. ISS describes short children with normal GH secretion. ISS is a condition in which the height of the individual is more than 2 standard deviations below the corresponding mean height for a given age, sex and population, without evidence of systemic, endocrine, nutritional or chromosomal abnormalities. An AE is any untoward medical occurrence in a clinical study participant that is temporally associated with the use of study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom or disease (new or exacerbated) temporally associated with the use of an study treatment.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants', 'anticipatedPostingDate': '2027-12'}, {'type': 'SECONDARY', 'title': 'Height Velocity Reported Children Born Small for Gestational Age', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'SGA_somapacitan (GH Treatment Naïve)', 'description': 'Participants with small for gestational age who were treatment naïve subcutaneously received a dose of 0.24 mg/kg/week somapacitan once weekly for 26-week main phase followed by an ongoing 130-week extension phase I.'}, {'id': 'OG001', 'title': 'SGA_somapacitan (Previously Treated With GH)', 'description': 'Participants with small for gestational age who were previously treated with GH, subcutaneously received a dose of 0.24 mg/kg/week somapacitan once weekly for 26-week main phase followed by an ongoing 130-week extension phase I.'}], 'classes': [{'categories': [{'measurements': [{'value': '11.3', 'spread': '3.8', 'groupId': 'OG000'}, {'value': '9.5', 'spread': '2.0', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From Baseline (Week 0) to Week 26', 'description': 'This outcome measure reported height velocity in children with short stature for indication SGA. Height velocity at week 26 was derived as: (height at 26 weeks visit - height at baseline)/ (time from baseline to 26 weeks visit in years).', 'unitOfMeasure': 'centimeters per year (cm/year)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set included all participants assigned to study intervention.'}, {'type': 'SECONDARY', 'title': 'Height Velocity Reported for Turner Syndrome', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'TS_somapacitan (GH Treatment Naïve)', 'description': 'Participants with Turner syndrome who were treatment naïve subcutaneously received a dose of 0.24 mg/kg/week somapacitan once weekly for 26-week main phase followed by an ongoing 130-week extension phase I.'}, {'id': 'OG001', 'title': 'TS_somapacitan (Previously Treated With GH)', 'description': 'Participants with Turner syndrome who were previously treated with GH, subcutaneously received a dose of 0.24 mg/kg/week somapacitan once weekly for 26-week main phase followed by an ongoing 130-week extension phase I.'}], 'classes': [{'categories': [{'measurements': [{'value': '10.2', 'spread': '2.2', 'groupId': 'OG000'}, {'value': '5.8', 'spread': '2.0', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From Baseline (Week 0) to Week 26', 'description': 'This outcome measure reported height velocity in children with short stature for indication TS. Height velocity at week 26 was derived as: (height at 26 weeks visit - height at baseline)/ (time from baseline to 26 weeks visit in years).', 'unitOfMeasure': 'cm/year', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set included all participants assigned to study intervention.'}, {'type': 'SECONDARY', 'title': 'Height Velocity Reported for Noonan Syndrome', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'NS_somapacitan (GH Treatment Naïve)', 'description': 'Participants with Noonan syndrome who were treatment naïve subcutaneously received a dose of 0.24 mg/kg/week somapacitan once weekly for 26-week main phase followed by an ongoing 130-week extension phase I.'}, {'id': 'OG001', 'title': 'NS_somapacitan (Previously Treated With GH)', 'description': 'Participants with Noonan syndrome who were previously treated with GH, subcutaneously received a dose of 0.24 mg/kg/week somapacitan once weekly for 26-week main phase followed by an ongoing 130-week extension phase I.'}], 'classes': [{'categories': [{'measurements': [{'value': '9.1', 'spread': '2.3', 'groupId': 'OG000'}, {'value': '6.4', 'spread': '2.0', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From Baseline (Week 0) to Week 26', 'description': 'This outcome measure reported height velocity in children with short stature for indication NS. Height velocity at week 26 was derived as: (height at 26 weeks visit - height at baseline)/(time from baseline to 26 weeks visit in years).', 'unitOfMeasure': 'cm/year', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set included all participants assigned to study intervention.'}, {'type': 'SECONDARY', 'title': 'Height Velocity Reported for Idiopathic Short Stature', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ISS_somapacitan (GH Treatment Naïve)', 'description': 'Participants with idiopathic short stature who were treatment naïve subcutaneously received a dose of 0.24 mg/kg/week somapacitan once weekly for 26-week main phase followed by an ongoing 130-week extension phase I.'}, {'id': 'OG001', 'title': 'ISS_somapacitan (Previously Treated With GH)', 'description': 'Participants with idiopathic short stature who were were previously treated with GH, subcutaneously received a dose of 0.24 mg/kg/week somapacitan once weekly for 26-week main phase followed by an ongoing 130-week extension phase I.'}], 'classes': [{'categories': [{'measurements': [{'value': '9.2', 'spread': '3.5', 'groupId': 'OG000'}, {'value': '7.9', 'spread': '2.4', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From Baseline (Week 0) to Week 26', 'description': 'This outcome measure reported height velocity in children with short stature for indication ISS. Height velocity at week 26 was derived as: (height at 26 weeks visit - height at baseline)/ (time from baseline to 26 weeks visit in years).', 'unitOfMeasure': 'cm/year', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set included all participants assigned to study intervention.'}, {'type': 'SECONDARY', 'title': 'Change in Height Standard Deviation Scores (SDS) Reported for Children Born Small for Gestational Age', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'SGA_somapacitan (GH Treatment Naïve)', 'description': 'Participants with small for gestational age who were treatment naïve subcutaneously received a dose of 0.24 mg/kg/week somapacitan once weekly for 26-week main phase followed by an ongoing 130-week extension phase I.'}, {'id': 'OG001', 'title': 'SGA_somapacitan (Previously Treated With GH)', 'description': 'Participants with small for gestational age who were previously treated with GH, subcutaneously received a dose of 0.24 mg/kg/week somapacitan once weekly for 26-week main phase followed by an ongoing 130-week extension phase I.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.50', 'spread': '0.21', 'groupId': 'OG000'}, {'value': '0.24', 'spread': '0.13', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Week 0), Week 26', 'description': 'This outcome measure reported height standard deviation scores in children with short stature for indication SGA. Height SDS at Week 26 was derived as the Height SDS value at baseline (Week 0) subtracted from the Height SDS value at Week 26. Height SDS is derived as: Height SDSi = ({\\[Heighti/population median\\]\\^Skewness}-1)/(Skewness∗population SD); where i indicates the visit and SD indicates the standard deviation (SD). The population median and standard deviation are the ones corresponding to the age at visit i. The population median and standard deviation and skewness are based on reference data. The score ranges from -10 (minimum) to +10 (maximum), where the greater value indicated greater height. The positive score indicates that the value is closer to or above the reference population compared to baseline.', 'unitOfMeasure': 'standard deviation score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set included all participants assigned to study intervention.'}, {'type': 'SECONDARY', 'title': 'Change in Height Standard Deviation Scores Reported for Turner Syndrome', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'TS_somapacitan (GH Treatment Naïve)', 'description': 'Participants with Turner syndrome who were treatment naïve subcutaneously received a dose of 0.24 mg/kg/week somapacitan once weekly for 26-week main phase followed by an ongoing 130-week extension phase I.'}, {'id': 'OG001', 'title': 'TS_somapacitan (Previously Treated With GH)', 'description': 'Participants with Turner syndrome who were previously treated with GH, subcutaneously received a dose of 0.24 mg/kg/week somapacitan once weekly for 26-week main phase followed by an ongoing 130-week extension phase I.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.40', 'spread': '0.30', 'groupId': 'OG000'}, {'value': '0.00', 'spread': '0.23', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Week 0), Week 26', 'description': 'This outcome measure reported height standard deviation scores in children with short stature for indication TS. Height SDS at Week 26 was derived as the Height SDS value at baseline (Week 0) subtracted from the Height SDS value at Week 26. Height SDS is derived as: Height SDSi = ({\\[Heighti/population median\\]\\^Skewness}-1)/(Skewness∗population SD); where i indicates the visit. The population median and standard deviation are the ones corresponding to the age at visit i. The population median and standard deviation and skewness are based on reference data. The score ranges from -10 (minimum) to +10 (maximum), where the greater value indicated greater height. The positive score indicates that the value is closer to or above the reference population compared to baseline.', 'unitOfMeasure': 'standard deviation score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set included all participants assigned to study intervention.'}, {'type': 'SECONDARY', 'title': 'Change in Height Standard Deviation Scores Reported for Noonan Syndrome', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'NS_somapacitan (GH Treatment Naïve)', 'description': 'Participants with Noonan syndrome who were treatment naïve subcutaneously received a dose of 0.24 mg/kg/week somapacitan once weekly for 26-week main phase followed by an ongoing 130-week extension phase I.'}, {'id': 'OG001', 'title': 'NS_somapacitan (Previously Treated With GH)', 'description': 'Participants with Noonan syndrome who were previously treated with GH, subcutaneously received a dose of 0.24 mg/kg/week somapacitan once weekly for 26-week main phase followed by an ongoing 130-week extension phase I.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.35', 'spread': '0.26', 'groupId': 'OG000'}, {'value': '0.11', 'spread': '0.14', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Week 0), Week 26', 'description': 'This outcome measure reported height standard deviation scores in children with short stature for indication NS. Height SDS at Week 26 was derived as the Height SDS value at baseline (Week 0) subtracted from the Height SDS value at Week 26. Height SDS is derived as: Height SDSi = ({\\[Heighti/population median\\]\\^Skewness}-1)/(Skewness∗population SD); where i indicates the visit. The population median and standard deviation are the ones corresponding to the age at visit i. The population median and standard deviation and skewness are based on reference data. The score ranges from -10 (minimum) to +10 (maximum), where the greater value indicated greater height. The positive score indicates that the value is closer to or above the reference population compared to baseline.', 'unitOfMeasure': 'standard deviation score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set included all participants assigned to study intervention.'}, {'type': 'SECONDARY', 'title': 'Change in Height Standard Deviation Scores Reported for Idiopathic Short Stature', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ISS_somapacitan (GH Treatment Naïve)', 'description': 'Participants with idiopathic short stature who were treatment naïve subcutaneously received a dose of 0.24 mg/kg/week somapacitan once weekly for 26-week main phase followed by an ongoing 130-week extension phase I.'}, {'id': 'OG001', 'title': 'ISS_somapacitan (Previously Treated With GH)', 'description': 'Participants with idiopathic short stature who were were previously treated with GH, subcutaneously received a dose of 0.24 mg/kg/week somapacitan once weekly for 26-week main phase followed by an ongoing 130-week extension phase I.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.22', 'spread': '0.15', 'groupId': 'OG000'}, {'value': '0.14', 'spread': '0.18', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Week 0), Week 26', 'description': 'This outcome measure reported height standard deviation scores in children with short stature for indication ISS. Height SDS at Week 26 was derived as the Height SDS value at baseline (Week 0) subtracted from the Height SDS value at Week 26. Height SDS is derived as: Height SDSi = ({\\[Heighti/population median\\]\\^Skewness}-1)/(Skewness∗population SD); where i indicates the visit. The population median and standard deviation are the ones corresponding to the age at visit i. The population median and standard deviation and skewness are based on reference data. The score ranges from -10 (minimum) to +10 (maximum), where the greater value indicated greater height. The positive score indicates that the value is closer to or above the reference population compared to baseline.', 'unitOfMeasure': 'standard deviation score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set included all participants assigned to study intervention.'}, {'type': 'SECONDARY', 'title': 'Change in Height Velocity Standard Deviation Scores Reported Separately for Children Born Small for Gestational Age', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'SGA_somapacitan (GH Treatment Naïve)', 'description': 'Participants with small for gestational age who were treatment naïve subcutaneously received a dose of 0.24 mg/kg/week somapacitan once weekly for 26-week main phase followed by an ongoing 130-week extension phase I.'}, {'id': 'OG001', 'title': 'SGA_somapacitan (Previously Treated With GH)', 'description': 'Participants with small for gestational age who were previously treated with GH, subcutaneously received a dose of 0.24 mg/kg/week somapacitan once weekly for 26-week main phase followed by an ongoing 130-week extension phase I.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.53', 'spread': '2.49', 'groupId': 'OG000'}, {'value': '1.04', 'spread': '1.18', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Week 0), Week 26', 'description': 'This outcome measure reported change in height velocity SDS in children with short stature for indication SGA. Change in height velocity SDS at week 26 was calculated as the height velocity SDS value at baseline Week 0 subtracted from the height velocity SDS value at Week 26. Height Velocity SDS is derived as: HV SDSi = (HVi - population mean HV)/population SD; where i indicates the visit. The population mean and standard deviation corresponding to the age at visit i. The score ranges from -10 (minimum) to +10 (maximum), where the greater value indicated greater height velocity. The positive score indicated that the value is closer to or above the reference population compared to baseline.', 'unitOfMeasure': 'standard deviation score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set included all participants assigned to study intervention.'}, {'type': 'SECONDARY', 'title': 'Change in Height Velocity Standard Deviation Scores Reported Separately for Turner Syndrome', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'TS_somapacitan (GH Treatment Naïve)', 'description': 'TS\\_somapacitan (GH Treatment Naïve) Participants with Turner syndrome who were treatment naïve subcutaneously received a dose of 0.24 mg/kg/week somapacitan once weekly for 26-week main phase followed by an ongoing 130-week extension phase I.'}, {'id': 'OG001', 'title': 'TS_somapacitan (Previously Treated With GH)', 'description': 'Participants with Turner syndrome who were previously treated with GH, subcutaneously received a dose of 0.24 mg/kg/week somapacitan once weekly for 26-week main phase followed by an ongoing 130-week extension phase I.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.45', 'spread': '1.41', 'groupId': 'OG000'}, {'value': '-0.48', 'spread': '1.84', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Week 0), Week 26', 'description': 'This outcome measure reported change in height velocity SDS in children with short stature for indication TS. Change in height velocity SDS at week 26 was calculated as the height velocity SDS value at baseline (Week 0) subtracted from the height velocity SDS value at Week 26. Height Velocity SDS is derived as: HV SDSi = (HVi - population mean HV)/population SD; where i indicates the visit. The population mean and standard deviation corresponding to the age at visit i. The score ranges from -10 (minimum) to +10 (maximum), where the greater value indicated greater height velocity. The positive score indicated that the value is closer to or above the reference population compared to baseline.', 'unitOfMeasure': 'standard deviation score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set included all participants assigned to study intervention.'}, {'type': 'SECONDARY', 'title': 'Change in Height Velocity Standard Deviation Scores Reported for Noonan Syndrome', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'NS_somapacitan (GH Treatment Naïve)', 'description': 'Participants with Noonan syndrome who were treatment naïve subcutaneously received a dose of 0.24 mg/kg/week somapacitan once weekly for 26-week main phase followed by an ongoing 130-week extension phase I.'}, {'id': 'OG001', 'title': 'NS_somapacitan (Previously Treated With GH)', 'description': 'Participants with Noonan syndrome who were previously treated with GH, subcutaneously received a dose of 0.24 mg/kg/week somapacitan once weekly for 26-week main phase followed by an ongoing 130-week extension phase I.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.43', 'spread': '2.75', 'groupId': 'OG000'}, {'value': '0.22', 'spread': '0.93', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Week 0), Week 26', 'description': 'This outcome measure reported change in height velocity SDS in children with short stature for indication NS. Change in height velocity SDS at Week 26 was the Height Velocity SDS value at baseline (Week 0) subtracted from the Height Velocity SDS value at Week 26. Height Velocity SDS is derived as: HV SDSi = (HVi - population mean HV)/population SD; where i indicates the visit. The population mean and standard deviation corresponding to the age at visit i. The score ranges from -10 (minimum) to +10 (maximum), where the greater value indicated greater height velocity. The positive score indicated that the value is closer to or above the reference population compared to baseline.', 'unitOfMeasure': 'standard deviation score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set included all participants assigned to study intervention.'}, {'type': 'SECONDARY', 'title': 'Change in Height Velocity Standard Deviation Scores Reported Separately for Idiopathic Short Stature', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ISS_somapacitan (GH Treatment Naïve)', 'description': 'Participants with idiopathic short stature who were treatment naïve subcutaneously received a dose of 0.24 mg/kg/week somapacitan once weekly for 26-week main phase followed by an ongoing 130-week extension phase I.'}, {'id': 'OG001', 'title': 'ISS_somapacitan (Previously Treated With GH)', 'description': 'Participants with idiopathic short stature who were were previously treated with GH, subcutaneously received a dose of 0.24 mg/kg/week somapacitan once weekly for 26-week main phase followed by an ongoing 130-week extension phase I.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.89', 'spread': '0.85', 'groupId': 'OG000'}, {'value': '-0.32', 'spread': '1.90', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Week 0), Week 26', 'description': 'This outcome measure reported change in height velocity SDS in children with short stature for indication ISS. Change in height velocity SDS at Week 26 was the Height Velocity SDS value at baseline (Week 0) subtracted from the Height Velocity SDS value at Week 26. Height Velocity SDS is derived as: HV SDSi = (HVi - population mean HV)/population SD; where i indicates the visit. The population mean and standard deviation corresponding to the age at visit i. The score ranges from -10 (minimum) to +10 (maximum), where the greater value indicated greater height velocity. The positive score indicated that the value is closer to or above the reference population compared to baseline.', 'unitOfMeasure': 'standard deviation score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set included all participants assigned to study intervention.'}, {'type': 'SECONDARY', 'title': 'Change in Insulin-like Growth Factor 1 (IGF-1) Standard Deviation Score Reported for Children Born Small for Gestational Age', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'SGA_somapacitan (GH Treatment Naïve)', 'description': 'Participants with small for gestational age who were treatment naïve subcutaneously received a dose of 0.24 mg/kg/week somapacitan once weekly for 26-week main phase followed by an ongoing 130-week extension phase I.'}, {'id': 'OG001', 'title': 'SGA_somapacitan (Previously Treated With GH)', 'description': 'Participants with small for gestational age who were previously treated with GH, subcutaneously received a dose of 0.24 mg/kg/week somapacitan once weekly for 26-week main phase followed by an ongoing 130-week extension phase I.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.61', 'spread': '1.52', 'groupId': 'OG000'}, {'value': '1.39', 'spread': '1.14', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Week 0), Week 26', 'description': 'This outcome measure reported change in IGF-1 SDS in children with short stature for indication SGA. Change in IGF-I SDS was derived as IGF-1 SDS value at baseline Week 0 subtracted from the IGF-I SDS value at Week 26. IGF-I SDS is derived as: IGF - I SDSi = ({\\[IGF - I i\\]/population median}\\^Skewness - 1)/ Skewness ∗ population SD; where i indicates the visit. The population median and standard deviation are the ones corresponding to the age at visit i. The score ranges from -10 (minimum) to +10 (maximum), where the greater value indicated greater IGF-1. The positive score indicated that the value is closer to or above the reference population compared to baseline.', 'unitOfMeasure': 'standard deviation score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set included all participants assigned to study intervention.'}, {'type': 'SECONDARY', 'title': 'Change in Insulin-like Growth Factor 1 Standard Deviation Score Reported for Turner Syndrome', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'TS_somapacitan (GH Treatment Naïve)', 'description': 'TS\\_somapacitan (GH Treatment Naïve) Participants with Turner syndrome who were treatment naïve subcutaneously received a dose of 0.24 mg/kg/week somapacitan once weekly for 26-week main phase followed by an ongoing 130-week extension phase I.'}, {'id': 'OG001', 'title': 'TS_somapacitan (Previously Treated With GH)', 'description': 'Participants with Turner syndrome who were previously treated with GH, subcutaneously received a dose of 0.24 mg/kg/week somapacitan once weekly for 26-week main phase followed by an ongoing 130-week extension phase I.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.88', 'spread': '0.43', 'groupId': 'OG000'}, {'value': '-0.09', 'spread': '1.52', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Week 0), Week 26', 'description': 'This outcome measure reported change in IGF-1 SDS in children with short stature for indication TS. Change in IGF-I SDS was derived as IGF-1 SDS value at baseline Week 0 subtracted from the IGF-I SDS value at Week 26. IGF-I SDS is derived as: IGF - I SDSi = ({\\[IGF - I i\\]/population median}\\^Skewness - 1)/ Skewness ∗ population SD; where i indicates the visit. The population median and standard deviation are the ones corresponding to the age at visit i. The score ranges from -10 (minimum) to +10 (maximum), where the greater value indicated greater IGF-1. The positive score indicated that the value is closer to or above the reference population compared to baseline.', 'unitOfMeasure': 'standard deviation score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set included all participants assigned to study intervention.'}, {'type': 'SECONDARY', 'title': 'Change in Insulin-like Growth Factor 1 Standard Deviation Score Reported for Noonan Syndrome', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'NS_somapacitan (GH Treatment Naïve)', 'description': 'Participants with Noonan syndrome who were treatment naïve subcutaneously received a dose of 0.24 mg/kg/week somapacitan once weekly for 26-week main phase followed by an ongoing 130-week extension phase I.'}, {'id': 'OG001', 'title': 'NS_somapacitan (Previously Treated With GH)', 'description': 'Participants with Noonan syndrome who were previously treated with GH, subcutaneously received a dose of 0.24 mg/kg/week somapacitan once weekly for 26-week main phase followed by an ongoing 130-week extension phase I.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.01', 'spread': '1.38', 'groupId': 'OG000'}, {'value': '2.23', 'spread': '1.87', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Week 0), Week 26', 'description': 'This outcome measure reported change in IGF-1 SDS in children with short stature for indication NS. Change in IGF-I SDS was derived as IGF-1 SDS value at baseline Week 0 subtracted from the IGF-I SDS value at Week 26. IGF-I SDS is derived as: IGF - I SDSi = ({\\[IGF - I i\\]/population median}\\^Skewness - 1)/ Skewness ∗ population SD; where i indicates the visit. The population median and standard deviation are the ones corresponding to the age at visit i. The score ranges from -10 (minimum) to +10 (maximum), where the greater value indicated greater IGF-1. The positive score indicated that the value is closer to or above the reference population compared to baseline.', 'unitOfMeasure': 'standard deviation score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set included all participants assigned to study intervention.'}, {'type': 'SECONDARY', 'title': 'Change in Insulin-like Growth Factor 1 Standard Deviation Score Reported Separately for Idiopathic Short Stature', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ISS_somapacitan (GH Treatment Naïve)', 'description': 'Participants with idiopathic short stature who were treatment naïve subcutaneously received a dose of 0.24 mg/kg/week somapacitan once weekly for 26-week main phase followed by an ongoing 130-week extension phase I.'}, {'id': 'OG001', 'title': 'ISS_somapacitan (Previously Treated With GH)', 'description': 'Participants with idiopathic short stature who were were previously treated with GH, subcutaneously received a dose of 0.24 mg/kg/week somapacitan once weekly for 26-week main phase followed by an ongoing 130-week extension phase I.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.79', 'spread': '0.52', 'groupId': 'OG000'}, {'value': '1.66', 'spread': '1.28', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Week 0), Week 26', 'description': 'This outcome measure reported change in IGF-1 SDS in children with short stature for indication ISS. Change in IGF-I SDS was derived as IGF-1 SDS value at baseline Week 0 subtracted from the IGF-I SDS value at Week 26. IGF-I SDS is derived as: IGF - I SDSi = ({\\[IGF - I i\\]/population median}\\^Skewness - 1)/ Skewness ∗ population SD; where i indicates the visit. The population median and standard deviation are the ones corresponding to the age at visit i. The score ranges from -10 (minimum) to +10 (maximum), where the greater value indicated greater IGF-1. The positive score indicated that the value is closer to or above the reference population compared to baseline.', 'unitOfMeasure': 'standard deviation score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set included all participants assigned to study intervention.'}, {'type': 'SECONDARY', 'title': 'Change in Insulin-like Growth Factor Binding Protein-3 (IGFBP-3) SDS Reported for Children Born Small for Gestational Age', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'SGA_somapacitan (GH Treatment Naïve)', 'description': 'Participants with small for gestational age who were treatment naïve subcutaneously received a dose of 0.24 mg/kg/week somapacitan once weekly for 26-week main phase followed by an ongoing 130-week extension phase I.'}, {'id': 'OG001', 'title': 'SGA_somapacitan (Previously Treated With GH)', 'description': 'Participants with small for gestational age who were previously treated with GH, subcutaneously received a dose of 0.24 mg/kg/week somapacitan once weekly for 26-week main phase followed by an ongoing 130-week extension phase I.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.69', 'spread': '0.93', 'groupId': 'OG000'}, {'value': '1.22', 'spread': '1.00', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (week 0), Week 26', 'description': 'This outcome measure reported change in IGFBP-3 scores in children with short stature for indication SGA. Change in IGFBP-3 SCS at Week 26 was derived as the IGFBP-3 SDS value at baseline Week 0 subtracted from IGFBP-3 SDS value at Week 26. IGFBP-3 SDS is derived as: IGFBP - 3 SDSi = ({\\[IGFBP - 3 i/population median\\]\\^Skewness} - 1)/Skewness ∗ population SD; where i indicates the visit. The population median and standard deviation are the ones corresponding to the age at visit i. The score ranges from -10 (minimum) to +10 (maximum), where the greater value indicated greater IGFBP-3. The positive score indicated that the value is closer to or above the reference population compared to baseline.', 'unitOfMeasure': 'standard deviation score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set included all participants assigned to study intervention.'}, {'type': 'SECONDARY', 'title': 'Change in Insulin-like Growth Factor Binding Protein-3 SDS Reported for Turner Syndrome', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'TS_somapacitan (GH Treatment Naïve)', 'description': 'TS\\_somapacitan (GH Treatment Naïve) Participants with Turner syndrome who were treatment naïve subcutaneously received a dose of 0.24 mg/kg/week somapacitan once weekly for 26-week main phase followed by an ongoing 130-week extension phase I.'}, {'id': 'OG001', 'title': 'TS_somapacitan (Previously Treated With GH)', 'description': 'Participants with Turner syndrome who were previously treated with GH, subcutaneously received a dose of 0.24 mg/kg/week somapacitan once weekly for 26-week main phase followed by an ongoing 130-week extension phase I.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.39', 'spread': '0.48', 'groupId': 'OG000'}, {'value': '0.05', 'spread': '1.45', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Week 0), Week 26', 'description': 'This outcome measure reported change in IGFBP-3 scores in children with short stature for indication TS. Change in IGFBP-3 SCS at Week 26 was derived as the IGFBP-3 SDS value at baseline Week 0 subtracted from IGFBP-3 SDS value at Week 26. IGFBP-3 SDS is derived as: IGFBP - 3 SDSi = ({\\[IGFBP - 3 i/population median\\]\\^Skewness} - 1)/Skewness ∗ population SD; where i indicates the visit. The population median and standard deviation are the ones corresponding to the age at visit i. The score ranges from -10 (minimum) to +10 (maximum), where the greater value indicated greater IGFBP-3. The positive score indicated that the value is closer to or above the reference population compared to baseline.', 'unitOfMeasure': 'standard deviation score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Full analysis set included all participants assigned to study intervention. Here 'Number of participants analysed' signifies number of participants with available data for particular timepoint."}, {'type': 'SECONDARY', 'title': 'Change in Insulin-like Growth Factor Binding Protein-3 SDS Reported for Noonan Syndrome', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'NS_somapacitan (GH Treatment Naïve)', 'description': 'Participants with Noonan syndrome who were treatment naïve subcutaneously received a dose of 0.24 mg/kg/week somapacitan once weekly for 26-week main phase followed by an ongoing 130-week extension phase I.'}, {'id': 'OG001', 'title': 'NS_somapacitan (Previously Treated With GH)', 'description': 'Participants with Noonan syndrome who were previously treated with GH, subcutaneously received a dose of 0.24 mg/kg/week somapacitan once weekly for 26-week main phase followed by an ongoing 130-week extension phase I.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.66', 'spread': '0.97', 'groupId': 'OG000'}, {'value': '0.67', 'spread': '1.08', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Week 0), Week 26', 'description': 'This outcome measure reported change in IGFBP-3 scores in children with short stature for indication NS. Change in IGFBP-3 SCS at Week 26 was derived as the IGFBP-3 SDS value at baseline Week 0 subtracted from IGFBP-3 SDS value at Week 26. IGFBP-3 SDS is derived as: IGFBP - 3 SDSi = ({\\[IGFBP - 3 i/population median\\]\\^Skewness} - 1)/Skewness ∗ population SD; where i indicates the visit. The population median and standard deviation are the ones corresponding to the age at visit i. The score ranges from -10 (minimum) to +10 (maximum), where the greater value indicated greater IGFBP-3. The positive score indicated that the value is closer to or above the reference population compared to baseline.', 'unitOfMeasure': 'standard deviation score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set included all participants assigned to study intervention.'}, {'type': 'SECONDARY', 'title': 'Change in Insulin-like Growth Factor Binding Protein-3 SDS Reported for Idiopathic Short Stature', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ISS_somapacitan (GH Treatment Naïve)', 'description': 'Participants with idiopathic short stature who were treatment naïve subcutaneously received a dose of 0.24 mg/kg/week somapacitan once weekly for 26-week main phase followed by an ongoing 130-week extension phase I.'}, {'id': 'OG001', 'title': 'ISS_somapacitan (Previously Treated With GH)', 'description': 'Participants with idiopathic short stature who were were previously treated with GH, subcutaneously received a dose of 0.24 mg/kg/week somapacitan once weekly for 26-week main phase followed by an ongoing 130-week extension phase I.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.22', 'spread': '0.18', 'groupId': 'OG000'}, {'value': '1.08', 'spread': '1.43', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Week 0), Week 26', 'description': 'This outcome measure reported change in IGFBP-3 scores in children with short stature for indication ISS. Change in IGFBP-3 SCS at Week 26 was derived as the IGFBP-3 SDS value at baseline Week 0 subtracted from IGFBP-3 SDS value at Week 26. IGFBP-3 SDS is derived as: IGFBP - 3 SDSi = ({\\[IGFBP - 3 i/population median\\]\\^Skewness} - 1)/Skewness ∗ population SD; where i indicates the visit. The population median and standard deviation are the ones corresponding to the age at visit i. The score ranges from -10 (minimum) to +10 (maximum), where the greater value indicated greater IGFBP-3. The positive score indicated that the value is closer to or above the reference population compared to baseline.', 'unitOfMeasure': 'standard deviation score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set included all participants assigned to study intervention.'}, {'type': 'SECONDARY', 'title': 'Weekly Average Somapacitan Concentration (Cavg) Reported for Children Born Small for Gestational Age', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'SGA_somapacitan (GH Treatment Naïve)', 'description': 'Participants with small for gestational age who were treatment naïve subcutaneously received a dose of 0.24 mg/kg/week somapacitan once weekly for 26-week main phase followed by an ongoing 130-week extension phase I.'}, {'id': 'OG001', 'title': 'SGA_somapacitan (Previously Treated With GH)', 'description': 'Participants with small for gestational age who were previously treated with GH, subcutaneously received a dose of 0.24 mg/kg/week somapacitan once weekly for 26-week main phase followed by an ongoing 130-week extension phase I.'}], 'classes': [{'title': 'Week 4', 'categories': [{'measurements': [{'value': '518.948', 'spread': '58.993', 'groupId': 'OG000'}, {'value': '339.226', 'spread': '205.265', 'groupId': 'OG001'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '1.800', 'spread': '0.857', 'groupId': 'OG000'}, {'value': '2.204', 'spread': '0.556', 'groupId': 'OG001'}]}]}, {'title': 'Week 13', 'categories': [{'measurements': [{'value': '62.280', 'spread': '92.161', 'groupId': 'OG000'}, {'value': '78.530', 'spread': '79.022', 'groupId': 'OG001'}]}]}, {'title': 'Week 20', 'categories': [{'measurements': [{'value': '2.345', 'spread': '1.331', 'groupId': 'OG000'}, {'value': '4.123', 'spread': '3.263', 'groupId': 'OG001'}]}]}, {'title': 'Week 26', 'categories': [{'measurements': [{'value': '5.928', 'spread': '4.904', 'groupId': 'OG000'}, {'value': '8.364', 'spread': '5.075', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Weeks 4, 8, 13, 20 and 26', 'description': 'The steady state pharmacokinetics in terms of Cavg was evaluated for once-weekly somapacitan in children born small for gestational age who were either naïve or non-naïve to GH treatment.', 'unitOfMeasure': 'nanograms per milliliter (ng/mL)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set included all participants assigned to study intervention.'}, {'type': 'SECONDARY', 'title': 'Weekly Average Somapacitan Concentration (Cavg) Reported for Turner Syndrome', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'TS_somapacitan (GH Treatment Naïve)', 'description': 'Participants with Turner syndrome who were treatment naïve subcutaneously received a dose of 0.24 mg/kg/week somapacitan once weekly for 26-week main phase followed by an ongoing 130-week extension phase I.'}, {'id': 'OG001', 'title': 'TS_somapacitan (Previously Treated With GH)', 'description': 'Participants with Turner syndrome who were previously treated with GH, subcutaneously received a dose of 0.24 mg/kg/week somapacitan once weekly for 26-week main phase followed by an ongoing 130-week extension phase I.'}], 'classes': [{'title': 'Week 4', 'categories': [{'measurements': [{'value': '287.777', 'spread': '191.086', 'groupId': 'OG000'}, {'value': '384.130', 'spread': '252.372', 'groupId': 'OG001'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '2.187', 'spread': '0.335', 'groupId': 'OG000'}, {'value': '3.285', 'spread': '2.018', 'groupId': 'OG001'}]}]}, {'title': 'Week 13', 'categories': [{'measurements': [{'value': '75.400', 'spread': '125.123', 'groupId': 'OG000'}, {'value': '93.753', 'spread': '162.274', 'groupId': 'OG001'}]}]}, {'title': 'Week 20', 'categories': [{'measurements': [{'value': '2.487', 'spread': '1.232', 'groupId': 'OG000'}, {'value': '2.871', 'spread': '1.018', 'groupId': 'OG001'}]}]}, {'title': 'Week 26', 'categories': [{'measurements': [{'value': '4.363', 'spread': '2.890', 'groupId': 'OG000'}, {'value': '8.574', 'spread': '5.304', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Weeks 4, 8, 13, 20 and 26', 'description': 'The steady state pharmacokinetics in terms of Cavg was evaluated for once-weekly somapacitan in children with Turner Syndrome who were either naïve or non-naïve to GH treatment.', 'unitOfMeasure': 'nanograms per milliliter (ng/mL)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set included all participants assigned to study intervention.'}, {'type': 'SECONDARY', 'title': 'Weekly Average Somapacitan Concentration (Cavg) Reported for Noonan Syndrome', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'NS_somapacitan (GH Treatment Naïve)', 'description': 'Participants with Noonan syndrome who were treatment naïve subcutaneously received a dose of 0.24 mg/kg/week somapacitan once weekly for 26-week main phase followed by an ongoing 130-week extension phase I.'}, {'id': 'OG001', 'title': 'NS_somapacitan (Previously Treated With GH)', 'description': 'Participants with Noonan syndrome who were previously treated with GH, subcutaneously received a dose of 0.24 mg/kg/week somapacitan once weekly for 26-week main phase followed by an ongoing 130-week extension phase I.'}], 'classes': [{'title': 'Week 4', 'categories': [{'measurements': [{'value': '249.278', 'spread': '225.237', 'groupId': 'OG000'}, {'value': '254.626', 'spread': '175.518', 'groupId': 'OG001'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '3.102', 'spread': '2.197', 'groupId': 'OG000'}, {'value': '31.343', 'spread': '58.845', 'groupId': 'OG001'}]}]}, {'title': 'Week 13', 'categories': [{'measurements': [{'value': '102.647', 'spread': '164.113', 'groupId': 'OG000'}, {'value': '134.501', 'spread': '188.934', 'groupId': 'OG001'}]}]}, {'title': 'Week 20', 'categories': [{'measurements': [{'value': '34.043', 'spread': '69.759', 'groupId': 'OG000'}, {'value': '3.869', 'spread': '2.376', 'groupId': 'OG001'}]}]}, {'title': 'Week 26', 'categories': [{'measurements': [{'value': '13.057', 'spread': '22.222', 'groupId': 'OG000'}, {'value': '42.834', 'spread': '58.984', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Weeks 4, 8, 13, 20 and 26', 'description': 'The steady state pharmacokinetics in terms of Cavg was evaluated for once-weekly somapacitan in children with Noonan Syndrome who were either naïve or non-naïve to GH treatment.', 'unitOfMeasure': 'nanograms per milliliter (ng/mL)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set included all participants assigned to study intervention.'}, {'type': 'SECONDARY', 'title': 'Weekly Average Somapacitan Concentration (Cavg) Reported for Idiopathic Short Stature', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ISS_somapacitan (GH Treatment Naïve)', 'description': 'Participants with idiopathic short stature who were treatment naïve subcutaneously received a dose of 0.24 mg/kg/week somapacitan once weekly for 26-week main phase followed by an ongoing 130-week extension phase I.'}, {'id': 'OG001', 'title': 'ISS_somapacitan (Previously Treated With GH)', 'description': 'Participants with idiopathic short stature who were were previously treated with GH, subcutaneously received a dose of 0.24 mg/kg/week somapacitan once weekly for 26-week main phase followed by an ongoing 130-week extension phase I.'}], 'classes': [{'title': 'Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '344.415', 'spread': '313.128', 'groupId': 'OG000'}, {'value': '401.444', 'spread': '178.512', 'groupId': 'OG001'}]}]}, {'title': 'Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9.535', 'spread': '0.940', 'groupId': 'OG000'}, {'value': '57.152', 'spread': '145.426', 'groupId': 'OG001'}]}]}, {'title': 'Week 13', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '403.525', 'spread': '156.235', 'groupId': 'OG000'}, {'value': '74.361', 'spread': '65.211', 'groupId': 'OG001'}]}]}, {'title': 'Week 20', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7.070', 'spread': '3.564', 'groupId': 'OG000'}, {'value': '4.876', 'spread': '4.495', 'groupId': 'OG001'}]}]}, {'title': 'Week 26', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '16.630', 'spread': 'NA', 'comment': "Since only a single participant was assessed in this arm, the standard deviation could not be calculated and is reported as 'Not Applicable'.", 'groupId': 'OG000'}, {'value': '16.461', 'spread': '15.509', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Weeks 4, 8, 13, 20 and 26', 'description': 'The steady state pharmacokinetics in terms of Cavg was evaluated for once-weekly somapacitan in children with idiopathic short stature who were either naïve or non-naïve to GH treatment.', 'unitOfMeasure': 'nanograms per milliliter (ng/mL)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Full analysis set included all participants assigned to study intervention. Here, 'Number Analyzed' signifies number of participants with available data for particular timepoint."}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'SGA_somapacitan (GH Treatment Naïve)', 'description': 'Participants with small for gestational age who were treatment naïve subcutaneously received a dose of 0.24 mg/kg/week somapacitan once weekly for 26-week main phase followed by an ongoing 130-week extension phase I.'}, {'id': 'FG001', 'title': 'SGA_somapacitan (Previously Treated With GH)', 'description': 'Participants with small for gestational age who were previously treated with GH, subcutaneously received a dose of 0.24 mg/kg/week somapacitan once weekly for 26-week main phase followed by an ongoing 130-week extension phase I.'}, {'id': 'FG002', 'title': 'TS_somapacitan (GH Treatment Naïve)', 'description': 'Participants with Turner syndrome who were treatment naïve subcutaneously received a dose of 0.24 mg/kg/week somapacitan once weekly for 26-week main phase followed by an ongoing 130-week extension phase I.'}, {'id': 'FG003', 'title': 'TS_somapacitan (Previously Treated With GH)', 'description': 'Participants with Turner syndrome who were previously treated with GH, subcutaneously received a dose of 0.24 mg/kg/week somapacitan once weekly for 26-week main phase followed by an ongoing 130-week extension phase I.'}, {'id': 'FG004', 'title': 'NS_somapacitan (GH Treatment Naïve)', 'description': 'Participants with Noonan syndrome who were treatment naïve subcutaneously received a dose of 0.24 mg/kg/week somapacitan once weekly for 26-week main phase followed by an ongoing 130-week extension phase I.'}, {'id': 'FG005', 'title': 'NS_somapacitan (Previously Treated With GH)', 'description': 'Participants with Noonan syndrome who were previously treated with GH, subcutaneously received a dose of 0.24 mg/kg/week somapacitan once weekly for 26-week main phase followed by an ongoing 130-week extension phase I.'}, {'id': 'FG006', 'title': 'ISS_somapacitan (GH Treatment Naïve)', 'description': 'Participants with idiopathic short stature who were treatment naïve subcutaneously received a dose of 0.24 mg/kg/week somapacitan once weekly for 26-week main phase followed by an ongoing 130-week extension phase I.'}, {'id': 'FG007', 'title': 'ISS_somapacitan (Previously Treated With GH)', 'description': 'Participants with idiopathic short stature who were were previously treated with GH, subcutaneously received a dose of 0.24 mg/kg/week somapacitan once weekly for 26-week main phase followed by an ongoing 130-week extension phase I.'}], 'periods': [{'title': 'Main Trial Period: Weeks 0 to 26', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '8'}, {'groupId': 'FG004', 'numSubjects': '6'}, {'groupId': 'FG005', 'numSubjects': '7'}, {'groupId': 'FG006', 'numSubjects': '2'}, {'groupId': 'FG007', 'numSubjects': '9'}]}, {'type': 'Full Analysis Set (FAS)', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '8'}, {'groupId': 'FG004', 'numSubjects': '6'}, {'groupId': 'FG005', 'numSubjects': '7'}, {'groupId': 'FG006', 'numSubjects': '2'}, {'groupId': 'FG007', 'numSubjects': '9'}]}, {'type': 'Safety Analysis Set (SAS)', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '8'}, {'groupId': 'FG004', 'numSubjects': '6'}, {'groupId': 'FG005', 'numSubjects': '7'}, {'groupId': 'FG006', 'numSubjects': '2'}, {'groupId': 'FG007', 'numSubjects': '9'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '8'}, {'groupId': 'FG004', 'numSubjects': '6'}, {'groupId': 'FG005', 'numSubjects': '7'}, {'groupId': 'FG006', 'numSubjects': '2'}, {'groupId': 'FG007', 'numSubjects': '9'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}]}]}, {'title': 'Extension I Period: Weeks 39 Upto 156', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '8'}, {'groupId': 'FG004', 'numSubjects': '6'}, {'groupId': 'FG005', 'numSubjects': '7'}, {'groupId': 'FG006', 'numSubjects': '2'}, {'groupId': 'FG007', 'numSubjects': '9'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '8'}, {'groupId': 'FG004', 'numSubjects': '6'}, {'groupId': 'FG005', 'numSubjects': '7'}, {'groupId': 'FG006', 'numSubjects': '2'}, {'groupId': 'FG007', 'numSubjects': '9'}]}], 'dropWithdraws': [{'type': 'Study is ongoing, data is reported till data cut-off 24 Nov 2024', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '8'}, {'groupId': 'FG004', 'numSubjects': '6'}, {'groupId': 'FG005', 'numSubjects': '7'}, {'groupId': 'FG006', 'numSubjects': '2'}, {'groupId': 'FG007', 'numSubjects': '9'}]}]}], 'recruitmentDetails': 'Participants were screened and assigned to treatment across 14 sites in 5 countries.', 'preAssignmentDetails': 'A total of 47 participants with short stature either born small for gestational age(SGA), Noonan syndrome(NS), Turner syndrome(TS), or idiopathic short stature(ISS) were either treatment naïve or previously treated with growth hormone(GH) were enrolled \\& exposed to once weekly dosing of somapacitan 0.24 milligrams per kilogram per week(mg/kg/week).\n\n26-week main phase is followed by 130-week extension phase I. Study was ongoing at data cut-off date(24Nov2024).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}, {'value': '6', 'groupId': 'BG004'}, {'value': '7', 'groupId': 'BG005'}, {'value': '2', 'groupId': 'BG006'}, {'value': '9', 'groupId': 'BG007'}, {'value': '47', 'groupId': 'BG008'}]}], 'groups': [{'id': 'BG000', 'title': 'SGA_somapacitan (GH Treatment Naïve)', 'description': 'Participants with small for gestational age who were treatment naïve subcutaneously received a dose of 0.24 mg/kg/week somapacitan once weekly for 26-week main phase followed by an ongoing 130-week extension phase I.'}, {'id': 'BG001', 'title': 'SGA_somapacitan (Previously Treated With GH)', 'description': 'Participants with small for gestational age who were previously treated with GH, subcutaneously received a dose of 0.24 mg/kg/week somapacitan once weekly for 26-week main phase followed by an ongoing 130-week extension phase I.'}, {'id': 'BG002', 'title': 'TS_somapacitan (GH Treatment Naïve)', 'description': 'Participants with Turner syndrome who were treatment naïve subcutaneously received a dose of 0.24 mg/kg/week somapacitan once weekly for 26-week main phase followed by an ongoing 130-week extension phase I.'}, {'id': 'BG003', 'title': 'TS_somapacitan (Previously Treated With GH)', 'description': 'Participants with Turner syndrome who were previously treated with GH, subcutaneously received a dose of 0.24 mg/kg/week somapacitan once weekly for 26-week main phase followed by an ongoing 130-week extension phase I.'}, {'id': 'BG004', 'title': 'NS_somapacitan (GH Treatment Naïve)', 'description': 'Participants with Noonan syndrome who were treatment naïve subcutaneously received a dose of 0.24 mg/kg/week somapacitan once weekly for 26-week main phase followed by an ongoing 130-week extension phase I.'}, {'id': 'BG005', 'title': 'NS_somapacitan (Previously Treated With GH)', 'description': 'Participants with Noonan syndrome who were previously treated with GH, subcutaneously received a dose of 0.24 mg/kg/week somapacitan once weekly for 26-week main phase followed by an ongoing 130-week extension phase I.'}, {'id': 'BG006', 'title': 'ISS_somapacitan (GH Treatment Naïve)', 'description': 'Participants with idiopathic short stature who were treatment naïve subcutaneously received a dose of 0.24 mg/kg/week somapacitan once weekly for 26-week main phase followed by an ongoing 130-week extension phase I.'}, {'id': 'BG007', 'title': 'ISS_somapacitan (Previously Treated With GH)', 'description': 'Participants with idiopathic short stature who were were previously treated with GH, subcutaneously received a dose of 0.24 mg/kg/week somapacitan once weekly for 26-week main phase followed by an ongoing 130-week extension phase I.'}, {'id': 'BG008', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '12.50', 'spread': '2.08', 'groupId': 'BG000'}, {'value': '11.75', 'spread': '1.67', 'groupId': 'BG001'}, {'value': '10.67', 'spread': '1.15', 'groupId': 'BG002'}, {'value': '11.00', 'spread': '1.20', 'groupId': 'BG003'}, {'value': '12.67', 'spread': '2.07', 'groupId': 'BG004'}, {'value': '12.29', 'spread': '1.50', 'groupId': 'BG005'}, {'value': '14.50', 'spread': '0.71', 'groupId': 'BG006'}, {'value': '11.44', 'spread': '1.24', 'groupId': 'BG007'}, {'value': '11.87', 'spread': '1.67', 'groupId': 'BG008'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '6', 'groupId': 'BG007'}, {'value': '26', 'groupId': 'BG008'}]}, {'title': 'Male', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}, {'value': '5', 'groupId': 'BG005'}, {'value': '2', 'groupId': 'BG006'}, {'value': '3', 'groupId': 'BG007'}, {'value': '21', 'groupId': 'BG008'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '2', 'groupId': 'BG008'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '6', 'groupId': 'BG004'}, {'value': '7', 'groupId': 'BG005'}, {'value': '2', 'groupId': 'BG006'}, {'value': '9', 'groupId': 'BG007'}, {'value': '45', 'groupId': 'BG008'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}]}, {'title': 'Asian', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '1', 'groupId': 'BG006'}, {'value': '3', 'groupId': 'BG007'}, {'value': '11', 'groupId': 'BG008'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}]}, {'title': 'White', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}, {'value': '5', 'groupId': 'BG004'}, {'value': '6', 'groupId': 'BG005'}, {'value': '1', 'groupId': 'BG006'}, {'value': '6', 'groupId': 'BG007'}, {'value': '36', 'groupId': 'BG008'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Full analysis set included all participants assigned to study intervention.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2024-11-19', 'size': 6092729, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2025-06-06T06:56', 'hasProtocol': True}, {'date': '2022-06-24', 'size': 433776, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2025-06-06T06:56', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 47}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2023-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2027-10-29', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-07', 'studyFirstSubmitDate': '2023-01-29', 'resultsFirstSubmitDate': '2025-09-24', 'studyFirstSubmitQcDate': '2023-01-29', 'lastUpdatePostDateStruct': {'date': '2025-11-21', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2025-11-07', 'studyFirstPostDateStruct': {'date': '2023-02-13', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-11-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2024-06-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Adverse Events (AEs) Reported in Children Born Small for Gestational Age- Weeks 0 to 26', 'timeFrame': 'From baseline (Week 0) to Week 26', 'description': 'This outcome measure reported number of AEs in children with short stature for indication SGA. Children with SGA are born small for gestational age with insufficient catch-up growth by 2 years of age or older. An AE is any untoward medical occurrence in a clinical study participant that is temporally associated with the use of study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom or disease (new or exacerbated) temporally associated with the use of an study treatment.'}, {'measure': 'Number of Adverse Events Reported for Turner Syndrome (TS)- Weeks 0 to 26', 'timeFrame': 'From baseline (Week 0) to Week 26', 'description': 'This outcome measure reported number of AEs in participants with short stature for indication TS. TS is a chromosomal disorder which leads to short stature. An AE is any untoward medical occurrence in a clinical study participant that is temporally associated with the use of study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom or disease (new or exacerbated) temporally associated with the use of an study treatment.'}, {'measure': 'Number of Adverse Events Reported for Noonan Syndrome- Weeks 0 to 26', 'timeFrame': 'From baseline (Week 0) to Week 26', 'description': 'This outcome measure reported number of AEs in participants with short stature for indication NS which is a genetically heterogeneous developmental disorder characterized by postnatally reduced growth and other major disorders. An AE is any untoward medical occurrence in a clinical study participant that is temporally associated with the use of study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom or disease (new or exacerbated) temporally associated with the use of an study treatment.'}, {'measure': 'Number of Adverse Events Reported for Idiopathic Short Stature (ISS)- Weeks 0 to 26', 'timeFrame': 'From baseline (Week 0) to Week 26', 'description': 'This outcome measure reported number of AEs in participants with short stature for indication ISS. ISS describes short children with normal GH secretion. ISS is a condition in which the height of the individual is more than 2 standard deviations below the corresponding mean height for a given age, sex and population, without evidence of systemic, endocrine, nutritional or chromosomal abnormalities. An AE is any untoward medical occurrence in a clinical study participant that is temporally associated with the use of study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom or disease (new or exacerbated) temporally associated with the use of an study treatment.'}], 'secondaryOutcomes': [{'measure': 'Number of Adverse Events Possibly or Probably Related to Somapacitan Reported for Children Born Small for Gestational Age', 'timeFrame': 'From baseline (Week 0) to Week 26', 'description': 'This outcome measure reported number of AEs possibly or probably related to somapacitan reported in children with short stature for indication SGA. Children with SGA are born small for gestational age with insufficient catch-up growth by 2 years of age or older. An AE is any untoward medical occurrence in a clinical study participant that is temporally associated with the use of study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom or disease (new or exacerbated) temporally associated with the use of an study treatment.'}, {'measure': 'Number of Adverse Events Possibly or Probably Related to Somapacitan Reported for Turner Syndrome', 'timeFrame': 'From baseline (Week 0) to Week 26', 'description': 'This outcome measure reported number of AEs possibly or probably related to somapacitan reported in participants with short stature for indication TS. TS is a chromosomal disorder which leads to short stature. An AE is any untoward medical occurrence in a clinical study participant that is temporally associated with the use of study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom or disease (new or exacerbated) temporally associated with the use of an study treatment.'}, {'measure': 'Number of Adverse Events Possibly or Probably Related to Somapacitan Reported for Noonan Syndrome', 'timeFrame': 'From baseline (Week 0) to Week 26', 'description': 'This outcome measure reported number of AEs possibly or probably related to somapacitan reported in participants with short stature for indication NS. An NS is a genetically heterogeneous developmental disorder characterized by postnatally reduced growth and other major disorders. An AE is any untoward medical occurrence in a clinical study participant that is temporally associated with the use of study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom or disease (new or exacerbated) temporally associated with the use of an study treatment.'}, {'measure': 'Number of Adverse Events Possibly or Probably Related to Somapacitan Reported for Idiopathic Short Stature', 'timeFrame': 'From baseline (Week 0) to Week 26', 'description': 'This outcome measure reported number of AEs possibly or probably related to somapacitan in participants with short stature for indication ISS. ISS describes short children with normal GH secretion and it is a condition in which the height of the individual is more than 2 standard deviations below the corresponding mean height for a given age, sex and population, without evidence of systemic, endocrine, nutritional or chromosomal abnormalities. An AE is any untoward medical occurrence in a clinical study participant that is temporally associated with the use of study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom or disease (new or exacerbated) temporally associated with the use of an study treatment.'}, {'measure': 'Number of Adverse Events Reported Long-term Safety for Children Born Small for Gestational Age- Weeks 0 to 156', 'timeFrame': 'From baseline (Week 0) to Week 156', 'description': 'This outcome measure reported long-term safety in terms of number of AEs in children with short stature for indication SGA. Children with SGA are born small for gestational age with insufficient catch-up growth by 2 years of age or older. An AE is any untoward medical occurrence in a clinical study participant that is temporally associated with the use of study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom or disease (new or exacerbated) temporally associated with the use of an study treatment.'}, {'measure': 'Number of Adverse Events Reported Long-term Safety for Turner Syndrome- Weeks 0 to 156', 'timeFrame': 'From baseline (Week 0) to Week 156', 'description': 'This outcome measure reported long-term safety in terms of number of AEs in participants with short stature for indication TS. TS is a chromosomal disorder which leads to short stature. An AE is any untoward medical occurrence in a clinical study participant that is temporally associated with the use of study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom or disease (new or exacerbated) temporally associated with the use of an study treatment.'}, {'measure': 'Number of Adverse Events Reported Long-term Safety for Noonan Syndrome- Weeks 0 to 156', 'timeFrame': 'From baseline (Week 0) to Week 156', 'description': 'This outcome measure reported long-term safety in terms of number of AEs in participants with short stature for indication NS which is a genetically heterogeneous developmental disorder characterized by postnatally reduced growth and other major disorders. An AE is any untoward medical occurrence in a clinical study participant that is temporally associated with the use of study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom or disease (new or exacerbated) temporally associated with the use of an study treatment.'}, {'measure': 'Number of Adverse Events Reported Long-term Safety for Idiopathic Short Stature- Weeks 0 to 156', 'timeFrame': 'From baseline (Week 0) to Week 156', 'description': 'This outcome measure reported long-term safety in terms of number of AEs in participants with short stature for indication ISS. ISS describes short children with normal GH secretion. ISS is a condition in which the height of the individual is more than 2 standard deviations below the corresponding mean height for a given age, sex and population, without evidence of systemic, endocrine, nutritional or chromosomal abnormalities. An AE is any untoward medical occurrence in a clinical study participant that is temporally associated with the use of study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom or disease (new or exacerbated) temporally associated with the use of an study treatment.'}, {'measure': 'Height Velocity Reported Children Born Small for Gestational Age', 'timeFrame': 'From Baseline (Week 0) to Week 26', 'description': 'This outcome measure reported height velocity in children with short stature for indication SGA. Height velocity at week 26 was derived as: (height at 26 weeks visit - height at baseline)/ (time from baseline to 26 weeks visit in years).'}, {'measure': 'Height Velocity Reported for Turner Syndrome', 'timeFrame': 'From Baseline (Week 0) to Week 26', 'description': 'This outcome measure reported height velocity in children with short stature for indication TS. Height velocity at week 26 was derived as: (height at 26 weeks visit - height at baseline)/ (time from baseline to 26 weeks visit in years).'}, {'measure': 'Height Velocity Reported for Noonan Syndrome', 'timeFrame': 'From Baseline (Week 0) to Week 26', 'description': 'This outcome measure reported height velocity in children with short stature for indication NS. Height velocity at week 26 was derived as: (height at 26 weeks visit - height at baseline)/(time from baseline to 26 weeks visit in years).'}, {'measure': 'Height Velocity Reported for Idiopathic Short Stature', 'timeFrame': 'From Baseline (Week 0) to Week 26', 'description': 'This outcome measure reported height velocity in children with short stature for indication ISS. Height velocity at week 26 was derived as: (height at 26 weeks visit - height at baseline)/ (time from baseline to 26 weeks visit in years).'}, {'measure': 'Change in Height Standard Deviation Scores (SDS) Reported for Children Born Small for Gestational Age', 'timeFrame': 'Baseline (Week 0), Week 26', 'description': 'This outcome measure reported height standard deviation scores in children with short stature for indication SGA. Height SDS at Week 26 was derived as the Height SDS value at baseline (Week 0) subtracted from the Height SDS value at Week 26. Height SDS is derived as: Height SDSi = ({\\[Heighti/population median\\]\\^Skewness}-1)/(Skewness∗population SD); where i indicates the visit and SD indicates the standard deviation (SD). The population median and standard deviation are the ones corresponding to the age at visit i. The population median and standard deviation and skewness are based on reference data. The score ranges from -10 (minimum) to +10 (maximum), where the greater value indicated greater height. The positive score indicates that the value is closer to or above the reference population compared to baseline.'}, {'measure': 'Change in Height Standard Deviation Scores Reported for Turner Syndrome', 'timeFrame': 'Baseline (Week 0), Week 26', 'description': 'This outcome measure reported height standard deviation scores in children with short stature for indication TS. Height SDS at Week 26 was derived as the Height SDS value at baseline (Week 0) subtracted from the Height SDS value at Week 26. Height SDS is derived as: Height SDSi = ({\\[Heighti/population median\\]\\^Skewness}-1)/(Skewness∗population SD); where i indicates the visit. The population median and standard deviation are the ones corresponding to the age at visit i. The population median and standard deviation and skewness are based on reference data. The score ranges from -10 (minimum) to +10 (maximum), where the greater value indicated greater height. The positive score indicates that the value is closer to or above the reference population compared to baseline.'}, {'measure': 'Change in Height Standard Deviation Scores Reported for Noonan Syndrome', 'timeFrame': 'Baseline (Week 0), Week 26', 'description': 'This outcome measure reported height standard deviation scores in children with short stature for indication NS. Height SDS at Week 26 was derived as the Height SDS value at baseline (Week 0) subtracted from the Height SDS value at Week 26. Height SDS is derived as: Height SDSi = ({\\[Heighti/population median\\]\\^Skewness}-1)/(Skewness∗population SD); where i indicates the visit. The population median and standard deviation are the ones corresponding to the age at visit i. The population median and standard deviation and skewness are based on reference data. The score ranges from -10 (minimum) to +10 (maximum), where the greater value indicated greater height. The positive score indicates that the value is closer to or above the reference population compared to baseline.'}, {'measure': 'Change in Height Standard Deviation Scores Reported for Idiopathic Short Stature', 'timeFrame': 'Baseline (Week 0), Week 26', 'description': 'This outcome measure reported height standard deviation scores in children with short stature for indication ISS. Height SDS at Week 26 was derived as the Height SDS value at baseline (Week 0) subtracted from the Height SDS value at Week 26. Height SDS is derived as: Height SDSi = ({\\[Heighti/population median\\]\\^Skewness}-1)/(Skewness∗population SD); where i indicates the visit. The population median and standard deviation are the ones corresponding to the age at visit i. The population median and standard deviation and skewness are based on reference data. The score ranges from -10 (minimum) to +10 (maximum), where the greater value indicated greater height. The positive score indicates that the value is closer to or above the reference population compared to baseline.'}, {'measure': 'Change in Height Velocity Standard Deviation Scores Reported Separately for Children Born Small for Gestational Age', 'timeFrame': 'Baseline (Week 0), Week 26', 'description': 'This outcome measure reported change in height velocity SDS in children with short stature for indication SGA. Change in height velocity SDS at week 26 was calculated as the height velocity SDS value at baseline Week 0 subtracted from the height velocity SDS value at Week 26. Height Velocity SDS is derived as: HV SDSi = (HVi - population mean HV)/population SD; where i indicates the visit. The population mean and standard deviation corresponding to the age at visit i. The score ranges from -10 (minimum) to +10 (maximum), where the greater value indicated greater height velocity. The positive score indicated that the value is closer to or above the reference population compared to baseline.'}, {'measure': 'Change in Height Velocity Standard Deviation Scores Reported Separately for Turner Syndrome', 'timeFrame': 'Baseline (Week 0), Week 26', 'description': 'This outcome measure reported change in height velocity SDS in children with short stature for indication TS. Change in height velocity SDS at week 26 was calculated as the height velocity SDS value at baseline (Week 0) subtracted from the height velocity SDS value at Week 26. Height Velocity SDS is derived as: HV SDSi = (HVi - population mean HV)/population SD; where i indicates the visit. The population mean and standard deviation corresponding to the age at visit i. The score ranges from -10 (minimum) to +10 (maximum), where the greater value indicated greater height velocity. The positive score indicated that the value is closer to or above the reference population compared to baseline.'}, {'measure': 'Change in Height Velocity Standard Deviation Scores Reported for Noonan Syndrome', 'timeFrame': 'Baseline (Week 0), Week 26', 'description': 'This outcome measure reported change in height velocity SDS in children with short stature for indication NS. Change in height velocity SDS at Week 26 was the Height Velocity SDS value at baseline (Week 0) subtracted from the Height Velocity SDS value at Week 26. Height Velocity SDS is derived as: HV SDSi = (HVi - population mean HV)/population SD; where i indicates the visit. The population mean and standard deviation corresponding to the age at visit i. The score ranges from -10 (minimum) to +10 (maximum), where the greater value indicated greater height velocity. The positive score indicated that the value is closer to or above the reference population compared to baseline.'}, {'measure': 'Change in Height Velocity Standard Deviation Scores Reported Separately for Idiopathic Short Stature', 'timeFrame': 'Baseline (Week 0), Week 26', 'description': 'This outcome measure reported change in height velocity SDS in children with short stature for indication ISS. Change in height velocity SDS at Week 26 was the Height Velocity SDS value at baseline (Week 0) subtracted from the Height Velocity SDS value at Week 26. Height Velocity SDS is derived as: HV SDSi = (HVi - population mean HV)/population SD; where i indicates the visit. The population mean and standard deviation corresponding to the age at visit i. The score ranges from -10 (minimum) to +10 (maximum), where the greater value indicated greater height velocity. The positive score indicated that the value is closer to or above the reference population compared to baseline.'}, {'measure': 'Change in Insulin-like Growth Factor 1 (IGF-1) Standard Deviation Score Reported for Children Born Small for Gestational Age', 'timeFrame': 'Baseline (Week 0), Week 26', 'description': 'This outcome measure reported change in IGF-1 SDS in children with short stature for indication SGA. Change in IGF-I SDS was derived as IGF-1 SDS value at baseline Week 0 subtracted from the IGF-I SDS value at Week 26. IGF-I SDS is derived as: IGF - I SDSi = ({\\[IGF - I i\\]/population median}\\^Skewness - 1)/ Skewness ∗ population SD; where i indicates the visit. The population median and standard deviation are the ones corresponding to the age at visit i. The score ranges from -10 (minimum) to +10 (maximum), where the greater value indicated greater IGF-1. The positive score indicated that the value is closer to or above the reference population compared to baseline.'}, {'measure': 'Change in Insulin-like Growth Factor 1 Standard Deviation Score Reported for Turner Syndrome', 'timeFrame': 'Baseline (Week 0), Week 26', 'description': 'This outcome measure reported change in IGF-1 SDS in children with short stature for indication TS. Change in IGF-I SDS was derived as IGF-1 SDS value at baseline Week 0 subtracted from the IGF-I SDS value at Week 26. IGF-I SDS is derived as: IGF - I SDSi = ({\\[IGF - I i\\]/population median}\\^Skewness - 1)/ Skewness ∗ population SD; where i indicates the visit. The population median and standard deviation are the ones corresponding to the age at visit i. The score ranges from -10 (minimum) to +10 (maximum), where the greater value indicated greater IGF-1. The positive score indicated that the value is closer to or above the reference population compared to baseline.'}, {'measure': 'Change in Insulin-like Growth Factor 1 Standard Deviation Score Reported for Noonan Syndrome', 'timeFrame': 'Baseline (Week 0), Week 26', 'description': 'This outcome measure reported change in IGF-1 SDS in children with short stature for indication NS. Change in IGF-I SDS was derived as IGF-1 SDS value at baseline Week 0 subtracted from the IGF-I SDS value at Week 26. IGF-I SDS is derived as: IGF - I SDSi = ({\\[IGF - I i\\]/population median}\\^Skewness - 1)/ Skewness ∗ population SD; where i indicates the visit. The population median and standard deviation are the ones corresponding to the age at visit i. The score ranges from -10 (minimum) to +10 (maximum), where the greater value indicated greater IGF-1. The positive score indicated that the value is closer to or above the reference population compared to baseline.'}, {'measure': 'Change in Insulin-like Growth Factor 1 Standard Deviation Score Reported Separately for Idiopathic Short Stature', 'timeFrame': 'Baseline (Week 0), Week 26', 'description': 'This outcome measure reported change in IGF-1 SDS in children with short stature for indication ISS. Change in IGF-I SDS was derived as IGF-1 SDS value at baseline Week 0 subtracted from the IGF-I SDS value at Week 26. IGF-I SDS is derived as: IGF - I SDSi = ({\\[IGF - I i\\]/population median}\\^Skewness - 1)/ Skewness ∗ population SD; where i indicates the visit. The population median and standard deviation are the ones corresponding to the age at visit i. The score ranges from -10 (minimum) to +10 (maximum), where the greater value indicated greater IGF-1. The positive score indicated that the value is closer to or above the reference population compared to baseline.'}, {'measure': 'Change in Insulin-like Growth Factor Binding Protein-3 (IGFBP-3) SDS Reported for Children Born Small for Gestational Age', 'timeFrame': 'Baseline (week 0), Week 26', 'description': 'This outcome measure reported change in IGFBP-3 scores in children with short stature for indication SGA. Change in IGFBP-3 SCS at Week 26 was derived as the IGFBP-3 SDS value at baseline Week 0 subtracted from IGFBP-3 SDS value at Week 26. IGFBP-3 SDS is derived as: IGFBP - 3 SDSi = ({\\[IGFBP - 3 i/population median\\]\\^Skewness} - 1)/Skewness ∗ population SD; where i indicates the visit. The population median and standard deviation are the ones corresponding to the age at visit i. The score ranges from -10 (minimum) to +10 (maximum), where the greater value indicated greater IGFBP-3. The positive score indicated that the value is closer to or above the reference population compared to baseline.'}, {'measure': 'Change in Insulin-like Growth Factor Binding Protein-3 SDS Reported for Turner Syndrome', 'timeFrame': 'Baseline (Week 0), Week 26', 'description': 'This outcome measure reported change in IGFBP-3 scores in children with short stature for indication TS. Change in IGFBP-3 SCS at Week 26 was derived as the IGFBP-3 SDS value at baseline Week 0 subtracted from IGFBP-3 SDS value at Week 26. IGFBP-3 SDS is derived as: IGFBP - 3 SDSi = ({\\[IGFBP - 3 i/population median\\]\\^Skewness} - 1)/Skewness ∗ population SD; where i indicates the visit. The population median and standard deviation are the ones corresponding to the age at visit i. The score ranges from -10 (minimum) to +10 (maximum), where the greater value indicated greater IGFBP-3. The positive score indicated that the value is closer to or above the reference population compared to baseline.'}, {'measure': 'Change in Insulin-like Growth Factor Binding Protein-3 SDS Reported for Noonan Syndrome', 'timeFrame': 'Baseline (Week 0), Week 26', 'description': 'This outcome measure reported change in IGFBP-3 scores in children with short stature for indication NS. Change in IGFBP-3 SCS at Week 26 was derived as the IGFBP-3 SDS value at baseline Week 0 subtracted from IGFBP-3 SDS value at Week 26. IGFBP-3 SDS is derived as: IGFBP - 3 SDSi = ({\\[IGFBP - 3 i/population median\\]\\^Skewness} - 1)/Skewness ∗ population SD; where i indicates the visit. The population median and standard deviation are the ones corresponding to the age at visit i. The score ranges from -10 (minimum) to +10 (maximum), where the greater value indicated greater IGFBP-3. The positive score indicated that the value is closer to or above the reference population compared to baseline.'}, {'measure': 'Change in Insulin-like Growth Factor Binding Protein-3 SDS Reported for Idiopathic Short Stature', 'timeFrame': 'Baseline (Week 0), Week 26', 'description': 'This outcome measure reported change in IGFBP-3 scores in children with short stature for indication ISS. Change in IGFBP-3 SCS at Week 26 was derived as the IGFBP-3 SDS value at baseline Week 0 subtracted from IGFBP-3 SDS value at Week 26. IGFBP-3 SDS is derived as: IGFBP - 3 SDSi = ({\\[IGFBP - 3 i/population median\\]\\^Skewness} - 1)/Skewness ∗ population SD; where i indicates the visit. The population median and standard deviation are the ones corresponding to the age at visit i. The score ranges from -10 (minimum) to +10 (maximum), where the greater value indicated greater IGFBP-3. The positive score indicated that the value is closer to or above the reference population compared to baseline.'}, {'measure': 'Weekly Average Somapacitan Concentration (Cavg) Reported for Children Born Small for Gestational Age', 'timeFrame': 'Weeks 4, 8, 13, 20 and 26', 'description': 'The steady state pharmacokinetics in terms of Cavg was evaluated for once-weekly somapacitan in children born small for gestational age who were either naïve or non-naïve to GH treatment.'}, {'measure': 'Weekly Average Somapacitan Concentration (Cavg) Reported for Turner Syndrome', 'timeFrame': 'Weeks 4, 8, 13, 20 and 26', 'description': 'The steady state pharmacokinetics in terms of Cavg was evaluated for once-weekly somapacitan in children with Turner Syndrome who were either naïve or non-naïve to GH treatment.'}, {'measure': 'Weekly Average Somapacitan Concentration (Cavg) Reported for Noonan Syndrome', 'timeFrame': 'Weeks 4, 8, 13, 20 and 26', 'description': 'The steady state pharmacokinetics in terms of Cavg was evaluated for once-weekly somapacitan in children with Noonan Syndrome who were either naïve or non-naïve to GH treatment.'}, {'measure': 'Weekly Average Somapacitan Concentration (Cavg) Reported for Idiopathic Short Stature', 'timeFrame': 'Weeks 4, 8, 13, 20 and 26', 'description': 'The steady state pharmacokinetics in terms of Cavg was evaluated for once-weekly somapacitan in children with idiopathic short stature who were either naïve or non-naïve to GH treatment.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['SGA', 'Turner Syndrome', 'Noonan Syndrome', 'ISS']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to find out if somapacitan is safe and how well somapacitan works in children either born small for gestational age or with Turner syndrome, Noonan syndrome or idiopathic short stature. Somapacitan is a new growth hormone medicine for treatment of low level of growth hormone. The study will last for about 3 years. During the study, the participants will be treated with somapacitan once a week. Somapacitan can be injected anytime during the day. The study doctor or nurse will show how to inject somapacitan, so that the participant knows how to do it at home.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '10 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\nApplicable to children with SGA:\n\n* Born small for gestational age (birth length below -2 SDS OR birth weight below -2 SDS OR both) (according to national standards).\n* Age:\n\n \\- Male participants: Age equal to or above 11.0 years and below 18.0 years at screening.\n\n \\- Female participants: Age equal to or above 10.0 years and below 18.0 years at screening.\n* Open epiphyses; defined as bone age less than (\\<) 14 years for females and bone age \\< 16 years for males.\n* For Growth Hormone (GH) treatment naïve participants: Impaired height defined as at least 2.5 standard deviations below the mean height for chronological age and sex at screening according to the standards of Centers for Disease Control and Prevention.\n\nApplicable to children with TS:\n\n• Diagnosis of TS according to local clinical practice.\n\n* Age:\n\n \\- Female participants: Age equal to or above 10.0 years and below 18.0 years at screening.\n* Open epiphyses; defined as bone age \\< 14 years for females and bone age \\< 16 years for males.\n* For GH treatment naïve participants: Impaired height defined as at least 2.0 standard deviation below the mean height for chronological age and sex at screening according to the standards of Centers for Disease Control and Prevention.\n* For GH treatment naïve participants: Confirmed diagnosis of TS by 30-cell (or more) lymphocyte chromosomal analysis or confirmation of TS and TS mosaicism using comparative genomic hybridization (CGH)-array.\n\nApplicable to children with NS:\n\n* Diagnosis of NS according to local clinical practice.\n* Age:\n\n * Male participants: Age equal to or above 11.0 years and below 18.0 years at screening.\n * Female participants: Age equal to or above 10.0 years and below 18.0 years at screening.\n* Open epiphyses; defined as bone age \\< 14 years for females and bone age \\< 16 years for males.\n* For GH treatment naïve participants: Clinical diagnosis of NS according to van der Burgt score list and genetic test result or confirmed mutation in any of the genes associated with NS before allocation.\n\nApplicable to children with ISS:\n\n* Age:\n\n \\- Male participants: Age equal to or above 11.0 years and below 18.0 years at screening.\n\n \\- Female participants: Age equal to or above 10.0 years and below 18.0 years at screening.\n* Open epiphyses; defined as bone age \\< 14 years for females and bone age \\< 16 years for males.\n* For GH treatment naïve participants: Impaired height defined as at least 2.5 standard deviations below the mean height for chronological age and sex at screening\n* For GH treatment naïve participants: Normal GH secretion (GH peak above 7 ng/mL) during GH stimulation test performed within 18 months prior to screening.\n* For GH treatment naïve participants: Bone age not delayed more than 2 years compared to chronological age at screening.\n\nExclusion Criteria:\n\n* Children with suspected or confirmed growth hormone deficiency according to local practice.\n* Children diagnosed with diabetes mellitus or screening values from the central laboratory.\n* Fasting plasma glucose above or equal to 126 milligrams per deciliter (mg/dL) \\[7.0 millimoles per litre (mmol/L)\\] or\n* Glycated hemoglobin (HbA1c) above or equal to 6.5%.\n* Current inflammatory diseases requiring systemic corticosteroid treatment for longer than 2 consecutive weeks within the last 3 months prior to screening.\n* Children requiring inhaled glucocorticoid therapy at a dose greater than 400 micrograms per day (µg/day) of inhaled budesonide or equivalent (i.e., 250 µg/day for fluticasone propionate) for longer than 4 consecutive weeks within the last 12 months prior to screening.\n* History or known presence of malignancy including intracranial tumours.\n\nApplicable to children with SGA:\n\n• Any known or suspected clinically significant abnormality likely to affect growth or the ability to evaluate growth with height, such as, but not limited to:\n\n* Poorly controlled or uncontrolled hormonal deficiencies.\n* Known chromosomal aneuploidy or significant gene mutations causing medical 'syndromes' with short stature, including but not limited to Laron syndrome, Prader-Willi syndrome, Russell-Silver Syndrome, skeletal dysplasias, abnormal short stature homeobox (SHOX) gene analysis or absence of GH receptors.\n\nApplicable to children with TS:\n\n• Any known or suspected clinically significant abnormality likely to affect growth or the ability to evaluate growth with height, such as, but not limited to:\n\n* Known family history of skeletal dysplasia.\n* Significant spinal abnormalities including but not limited to scoliosis, kyphosis and spina bifida variants.\n* Any other disorder that can cause short stature such as, but not limited to nutritional disorders, chronic systemic illness and chronic renal disease.\n* Mosaicism below 10%.\n* TS with Y-chromosome mosaicism where gonadectomy has not been performed.\n* New York Heart Association (NYHA) class II or above or requiring medication for any heart condition.\n\nApplicable to children with NS:\n\n• Any known or suspected clinically significant abnormality likely to affect growth or the ability to evaluate growth with height, such as, but not limited to:\n\n* Known family history of skeletal dysplasia.\n* Significant spinal abnormalities including but not limited to scoliosis, kyphosis and spina bifida variants.\n* Any other disorder that can cause short stature such as, but not limited to nutritional disorders, chronic systemic illness and chronic renal disease.\n* Noonan-related disorders including but not limited to: Noonan syndrome with multiple lentigines (formerly called 'LEOPARD' syndrome), Noonan syndrome with loose anagen hair, cardiofaciocutaneous syndrome (CFC), Costello syndrome, neurofibromatosis type 1 (NF1) and Legius syndrome.\n\nApplicable to children with ISS:\n\n• Any known or suspected clinically significant abnormality likely to affect growth or the ability to evaluate growth with height, such as, but not limited to:\n\n* Known family history of skeletal dysplasia.\n* Significant spinal abnormalities including but not limited to scoliosis, kyphosis and spina bifida variants.\n* Any other disorder that can cause short stature such as, but not limited to nutritional disorders, chronic systemic illness and chronic renal disease.\n* Poorly controlled or uncontrolled hormonal deficiencies.\n* Known chromosomal aneuploidy or significant gene mutations causing medical 'syndromes' with short stature, including but not limited to Laron syndrome, Prader-Willi syndrome, Russell-Silver Syndrome, skeletal dysplasias, abnormal SHOX gene analysis or absence of GH receptors."}, 'identificationModule': {'nctId': 'NCT05723835', 'acronym': 'REAL 9', 'briefTitle': 'A Research Study Looking at How Safe Somapacitan is and How Well it Works in Children Who Need Help to Grow - REAL 9', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novo Nordisk A/S'}, 'officialTitle': 'A Study Evaluating the Safety and Efficacy of Once-weekly Dosing of Somapacitan in a Basket Study Design in Paediatric Participants With Short Stature Either Born Small for Gestational Age or With Turner Syndrome, Noonan Syndrome or Idiopathic Short Stature', 'orgStudyIdInfo': {'id': 'NN8640-4469'}, 'secondaryIdInfos': [{'id': 'U1111-1277-9765', 'type': 'OTHER', 'domain': 'World Health Organization (WHO)'}, {'id': '2022-501055-87', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Somapacitan', 'description': 'Participants will receive Somapacitan for 26-week main phase followed by 130-week extension phase.', 'interventionNames': ['Drug: Somapacitan']}], 'interventions': [{'name': 'Somapacitan', 'type': 'DRUG', 'description': 'Somapacitan 0.24 milligrams per kilograms per week (mg/kg/week) will be administered subcutaneously (s.c.) using PDS290 pen-injector.', 'armGroupLabels': ['Somapacitan']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35233', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Univ of AL at Birmingham_BRM', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '95821', 'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'facility': 'Sutter Valley Med Fdt Ped Endo', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}, {'zip': '80112', 'city': 'Centennial', 'state': 'Colorado', 'country': 'United States', 'facility': 'Rocky Mt Ped and Endo', 'geoPoint': {'lat': 39.57916, 'lon': -104.87692}}, {'zip': '20010-2978', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': 'Childrens National Medical Ctr', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '83404-7596', 'city': 'Idaho Falls', 'state': 'Idaho', 'country': 'United States', 'facility': 'Rocky Mt Clin Res, LLC', 'geoPoint': {'lat': 43.46658, 'lon': -112.03414}}, {'zip': '55102', 'city': 'Saint Paul', 'state': 'Minnesota', 'country': 'United States', 'facility': "Children's Minnesota", 'geoPoint': {'lat': 44.94441, 'lon': -93.09327}}, {'zip': '59100', 'city': 'Lembah Pantai', 'state': 'Kuala Lumpur', 'country': 'Malaysia', 'facility': 'University Malaya Medical Centre'}, {'zip': '42300', 'city': 'Bandar Puncak Alam', 'state': 'Selangor', 'country': 'Malaysia', 'facility': 'University Technology MARA (UiTM) - Sg Buloh', 'geoPoint': {'lat': 3.2389, 'lon': 101.42793}}, {'zip': '3015 GD', 'city': 'Rotterdam', 'country': 'Netherlands', 'facility': 'Erasmus MC', 'geoPoint': {'lat': 51.9225, 'lon': 4.47917}}, {'zip': '35-301', 'city': 'Rzeszów', 'state': 'Podkarpackie Voivodeship', 'country': 'Poland', 'facility': 'Kliniczny Szpital Wojewodzki nr 2 im. Sw. Jadwigi Krolowej w Rzeszowie', 'geoPoint': {'lat': 50.04132, 'lon': 21.99901}}, {'zip': '80-952', 'city': 'Gdansk', 'country': 'Poland', 'facility': 'UCK, Klinika Pediatrii, Diabetologii i Endokrynologii,', 'geoPoint': {'lat': 54.35227, 'lon': 18.64912}}, {'zip': '93-338', 'city': 'Lodz', 'country': 'Poland', 'facility': 'Instytut Centrum Zdrowia Matki Polki', 'geoPoint': {'lat': 51.77058, 'lon': 19.47395}}, {'zip': '35-301', 'city': 'Rzeszów', 'country': 'Poland', 'facility': 'Kliniczny Szpital Wojewodzki nr 2 im. Sw. Jadwigi Krolowej w Rzeszowie', 'geoPoint': {'lat': 50.04132, 'lon': 21.99901}}, {'zip': '41-800', 'city': 'Zabrze', 'country': 'Poland', 'facility': 'SPSK nr 1 im. prof.S.Szyszko w Zabrzu', 'geoPoint': {'lat': 50.32492, 'lon': 18.78576}}, {'zip': '05505', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Asan Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '50612', 'city': 'Yangsan', 'country': 'South Korea', 'facility': 'Pusan National University Yangsan Hospital', 'geoPoint': {'lat': 35.34199, 'lon': 129.03358}}, {'zip': '08035', 'city': 'Barcelona', 'country': 'Spain', 'facility': "Hospital Vall d'Hebron", 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}], 'overallOfficials': [{'name': 'Clinical Transparency (dept. 2834)', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Novo Nordisk A/S'}]}, 'ipdSharingStatementModule': {'url': 'http://novonordisk-trials.com', 'ipdSharing': 'YES', 'description': 'According to the Novo Nordisk disclosure commitment on novonordisk-trials.com'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novo Nordisk A/S', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}