Ignite Creation Date:
2025-12-24 @ 7:52 PM
Ignite Modification Date:
2026-01-04 @ 8:44 AM
Study NCT ID:
NCT02968004
Status:
COMPLETED
Last Update Posted:
2025-07-20
First Post:
2016-11-13
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Safety and Efficacy Phase 3 Study of Long-acting hGH (MOD-4023) in Growth Hormone Deficient Children
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Germany', 'Italy', 'Turkey (Türkiye)']}, 'interventionBrowseModule': {'meshes': [{'id': 'C000634267', 'term': 'MOD-4023'}, {'id': 'C000723339', 'term': 'somatrogon'}, {'id': 'D019382', 'term': 'Human Growth Hormone'}], 'ancestors': [{'id': 'D013006', 'term': 'Growth Hormone'}, {'id': 'D010908', 'term': 'Pituitary Hormones, Anterior'}, {'id': 'D010907', 'term': 'Pituitary Hormones'}, {'id': 'D036361', 'term': 'Peptide Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'contact@opko.com', 'phone': '3055754100', 'title': 'OPKO Health, Inc.', 'organization': 'OPKO Health, Inc.'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '1 year for Main Study Phase. Up to 6 years for OLE Phase.', 'eventGroups': [{'id': 'EG000', 'title': 'MOD-4023', 'description': 'Once weekly subcutaneous injection of long acting r-hGH (MOD-4023)\n\nMOD-4023: Once weekly subcutaneous injection using pre-filled pen device.', 'otherNumAtRisk': 109, 'deathsNumAtRisk': 109, 'otherNumAffected': 92, 'seriousNumAtRisk': 109, 'deathsNumAffected': 0, 'seriousNumAffected': 3}, {'id': 'EG001', 'title': 'Genotropin', 'description': 'Once daily subcutaneous injection of somatropin (r-hGH; Genotropin)\n\nSomatropin: Once daily subcutaneous injection of Genotropin', 'otherNumAtRisk': 115, 'deathsNumAtRisk': 115, 'otherNumAffected': 90, 'seriousNumAtRisk': 115, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG002', 'title': 'MOD-4023 in OLE Phase', 'description': 'Once weekly subcutaneous injection of long acting r-hGH (MOD-4023)\n\nMOD-4023: Once weekly subcutaneous injection using pre-filled pen device.', 'otherNumAtRisk': 212, 'deathsNumAtRisk': 212, 'otherNumAffected': 175, 'seriousNumAtRisk': 212, 'deathsNumAffected': 0, 'seriousNumAffected': 14}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 115, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 212, 'numAffected': 5}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Basophilia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 115, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 212, 'numAffected': 6}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Eosinophilia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 115, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 212, 'numAffected': 11}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Iron Deficiency Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 115, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 212, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 115, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 212, 'numAffected': 5}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 115, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 212, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Ear Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 115, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 212, 'numAffected': 7}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypothyroidism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 115, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 212, 'numAffected': 12}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Conjunctivitis Allergic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 115, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 212, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Myopia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 115, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 212, 'numAffected': 6}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Abdominal Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 115, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 212, 'numAffected': 9}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Abdominal Pain Upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 115, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 212, 'numAffected': 12}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 115, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 212, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dental Caries', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 115, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 212, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 115, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 212, 'numAffected': 14}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 115, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 212, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Toothache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 115, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 212, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 115, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 212, 'numAffected': 23}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Injection Site Erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 115, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 212, 'numAffected': 11}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Injection Site Induration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 115, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 212, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Injection Site Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 43}, {'groupId': 'EG001', 'numAtRisk': 115, 'numAffected': 29}, {'groupId': 'EG002', 'numAtRisk': 212, 'numAffected': 66}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Injection Site Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 115, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 212, 'numAffected': 6}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Injection Site Swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 115, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 212, 'numAffected': 6}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 115, 'numAffected': 16}, {'groupId': 'EG002', 'numAtRisk': 212, 'numAffected': 40}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Vaccination Site Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 115, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 212, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Seasonal Allergy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 115, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 212, 'numAffected': 6}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 115, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 212, 'numAffected': 15}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Conjunctivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 115, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 212, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Corona Virus Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 115, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 212, 'numAffected': 37}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Enterobiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 115, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 212, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 115, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 212, 'numAffected': 8}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Gastroenteritis Viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 115, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 212, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 115, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 212, 'numAffected': 22}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Molluscum Contagiosum', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 115, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 212, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 115, 'numAffected': 29}, {'groupId': 'EG002', 'numAtRisk': 212, 'numAffected': 66}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Otitis Externa', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 115, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 212, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Otitis Media', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 115, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 212, 'numAffected': 9}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Otitis Media Acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 115, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 212, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 115, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 212, 'numAffected': 7}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pharyngitis Streptococcal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 115, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 212, 'numAffected': 7}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 115, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 212, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Rhinitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 115, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 212, 'numAffected': 10}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 115, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 212, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Tonsillitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 115, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 212, 'numAffected': 6}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Upper Respiratory Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 115, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 212, 'numAffected': 7}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Viral Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 115, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 212, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Viral Pharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 115, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 212, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Viral Upper Respiratory Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 115, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 212, 'numAffected': 12}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Arthropod Bite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 115, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 212, 'numAffected': 3}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 115, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 212, 'numAffected': 5}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 115, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 212, 'numAffected': 5}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Ligament Sprain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 115, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 212, 'numAffected': 7}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Limb Injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 115, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 212, 'numAffected': 6}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Skin Abrasion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 115, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 212, 'numAffected': 6}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Traumatic Fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 115, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 212, 'numAffected': 5}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Blood Creatine Phosphokinase Increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 115, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 212, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Blood Thyroid Stimulating Hormone Decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 115, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 212, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Coronavirus Test Positive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 115, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 212, 'numAffected': 15}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Free Fatty Acids Increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 115, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 212, 'numAffected': 11}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Insulin-Like Growth Factor Increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 115, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 212, 'numAffected': 5}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Low Density Lipoprotein Decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 115, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 212, 'numAffected': 5}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Thyroxine Free Decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 115, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 212, 'numAffected': 7}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypertriglyceridaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 115, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 212, 'numAffected': 3}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypoinsulinaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 115, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 212, 'numAffected': 6}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Iron Deficiency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 115, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 212, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 115, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 212, 'numAffected': 10}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pain In Extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 115, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 212, 'numAffected': 10}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Scoliosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 115, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 212, 'numAffected': 8}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 115, 'numAffected': 25}, {'groupId': 'EG002', 'numAtRisk': 212, 'numAffected': 41}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Attention Deficit/Hyperactivity Disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 115, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 212, 'numAffected': 7}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 115, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 212, 'numAffected': 24}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nasal Congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 115, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 212, 'numAffected': 8}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Oropharyngeal Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 115, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 212, 'numAffected': 18}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Rhinitis Allergic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 115, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 212, 'numAffected': 5}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Rhinorrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 115, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 212, 'numAffected': 12}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 115, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 212, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 115, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 212, 'numAffected': 4}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Rash generalised', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 115, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 212, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Urticaria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 115, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 212, 'numAffected': 5}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Lymphadenitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 115, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 212, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Adrenal Insufficiency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 115, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 212, 'numAffected': 1}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Delayed Puberty', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 115, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 212, 'numAffected': 1}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Abdominal Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 115, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 212, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Noninfective Sialoadenitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 115, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 212, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Appendicitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 115, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 212, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Croup Infectious', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 115, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 212, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Diverticulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 115, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 212, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Peritonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 115, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 212, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pharyngitis Streptococcal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 115, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 212, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Chronic tonsillitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 115, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 212, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 115, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 212, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 115, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 212, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Tonsillitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 115, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 212, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Ureterolithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 115, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 212, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Scrotal Varicose Veins', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 115, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 212, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Adenoidal Hypertrophy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 115, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 212, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Urticaria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 115, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 212, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': "Kawasaki's Disease", 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 115, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 212, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '2'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Annual Height Velocity in Main Study Phase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '109', 'groupId': 'OG000'}, {'value': '115', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MOD-4023', 'description': 'Once weekly subcutaneous injection of long acting r-hGH (MOD-4023)\n\nMOD-4023: Once weekly subcutaneous injection using pre-filled pen device.'}, {'id': 'OG001', 'title': 'Genotropin', 'description': 'Once daily subcutaneous injection of somatropin (r-hGH; Genotropin)\n\nSomatropin: Once daily subcutaneous injection of Genotropin'}], 'classes': [{'categories': [{'measurements': [{'value': '10.10', 'groupId': 'OG000', 'lowerLimit': '9.58', 'upperLimit': '10.63'}, {'value': '9.78', 'groupId': 'OG001', 'lowerLimit': '9.29', 'upperLimit': '10.26'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '52 weeks', 'description': 'Annual Height Velocity in cm. Annual Height Velocity at 12 months is based on the difference between the heights at 12 months and baseline.', 'unitOfMeasure': 'cm/year', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Annual Height Velocity in OLE Phase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '104', 'groupId': 'OG000'}, {'value': '108', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MOD-4023', 'description': 'Once weekly subcutaneous injection of long acting r-hGH (MOD-4023)\n\nMOD-4023: Once weekly subcutaneous injection using pre-filled pen device.'}, {'id': 'OG001', 'title': 'Genotropin', 'description': 'Once daily subcutaneous injection of somatropin (r-hGH; Genotropin)\n\nSomatropin: Once daily subcutaneous injection of Genotropin'}], 'classes': [{'title': 'OLE Month 0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '104', 'groupId': 'OG000'}, {'value': '108', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '10.27', 'spread': '2.38', 'groupId': 'OG000'}, {'value': '9.72', 'spread': '2.50', 'groupId': 'OG001'}]}]}, {'title': 'OLE Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'OG000'}, {'value': '82', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '8.03', 'spread': '1.81', 'groupId': 'OG000'}, {'value': '8.21', 'spread': '1.87', 'groupId': 'OG001'}]}]}, {'title': 'OLE Month 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}, {'value': '84', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7.78', 'spread': '1.91', 'groupId': 'OG000'}, {'value': '8.05', 'spread': '1.77', 'groupId': 'OG001'}]}]}, {'title': 'OLE Month 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '83', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6.90', 'spread': '1.80', 'groupId': 'OG000'}, {'value': '7.14', 'spread': '1.69', 'groupId': 'OG001'}]}]}, {'title': 'OLE Month 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6.19', 'spread': '1.62', 'groupId': 'OG000'}, {'value': '6.86', 'spread': '2.08', 'groupId': 'OG001'}]}]}, {'title': 'OLE Month 60', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.05', 'spread': '1.10', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to 60 months', 'description': 'Annualized Height Velocity (cm/year) in OLE Phase', 'unitOfMeasure': 'cm/year', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set'}, {'type': 'SECONDARY', 'title': 'Height Velocity at 6 Months in Main Study Phase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '109', 'groupId': 'OG000'}, {'value': '115', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MOD-4023', 'description': 'Once weekly subcutaneous injection of long acting r-hGH (MOD-4023)\n\nMOD-4023: Once weekly subcutaneous injection using pre-filled pen device.'}, {'id': 'OG001', 'title': 'Genotropin', 'description': 'Once daily subcutaneous injection of somatropin (r-hGH; Genotropin)\n\nSomatropin: Once daily subcutaneous injection of Genotropin'}], 'classes': [{'categories': [{'measurements': [{'value': '10.59', 'groupId': 'OG000', 'lowerLimit': '9.96', 'upperLimit': '11.22'}, {'value': '10.04', 'groupId': 'OG001', 'lowerLimit': '9.47', 'upperLimit': '10.62'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'After 6 months of treatment', 'description': 'Height velocity in cm measured after 6 months of treatment. Annualized Height velocity after 6 months is calculated based on the difference between the heights at 6 months and baseline.', 'unitOfMeasure': 'cm/year', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Height Standard Deviation Score (SDS) in Main Study Phase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '109', 'groupId': 'OG000'}, {'value': '115', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MOD-4023', 'description': 'Once weekly subcutaneous injection of long acting r-hGH (MOD-4023)\n\nMOD-4023: Once weekly subcutaneous injection using pre-filled pen device.'}, {'id': 'OG001', 'title': 'Genotropin', 'description': 'Once daily subcutaneous injection of somatropin (r-hGH; Genotropin)\n\nSomatropin: Once daily subcutaneous injection of Genotropin'}], 'classes': [{'title': 'SDS at 6 months', 'categories': [{'measurements': [{'value': '0.54', 'groupId': 'OG000', 'lowerLimit': '0.48', 'upperLimit': '0.61'}, {'value': '0.48', 'groupId': 'OG001', 'lowerLimit': '0.42', 'upperLimit': '0.54'}]}]}, {'title': 'SDS at 12 months', 'categories': [{'measurements': [{'value': '0.92', 'groupId': 'OG000', 'lowerLimit': '0.82', 'upperLimit': '1.02'}, {'value': '0.87', 'groupId': 'OG001', 'lowerLimit': '0.78', 'upperLimit': '0.96'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'After 6 and 12 months', 'description': 'Change in height Standard Deviation Score (SDS) after 6 and 12 months is calculated based on the difference between the heights at 6 and 12 months and baseline.', 'unitOfMeasure': 'Standard Deviation Score', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Two subjects discontinued, one from each group.'}, {'type': 'SECONDARY', 'title': 'Change in Bone Maturation (BM) in Main Study Phase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '104', 'groupId': 'OG000'}, {'value': '102', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MOD-4023', 'description': 'Once weekly subcutaneous injection of long acting r-hGH (MOD-4023)\n\nMOD-4023: Once weekly subcutaneous injection using pre-filled pen device.'}, {'id': 'OG001', 'title': 'Genotropin', 'description': 'Once daily subcutaneous injection of somatropin (r-hGH; Genotropin)\n\nSomatropin: Once daily subcutaneous injection of Genotropin'}], 'classes': [{'categories': [{'measurements': [{'value': '0.05', 'spread': '0.09', 'groupId': 'OG000'}, {'value': '0.06', 'spread': '0.1', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '52 weeks', 'description': 'Annual change in bone age measurements as per Gruelich-Pyle method', 'unitOfMeasure': 'ratio of bone age to chronologic age', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '5 participants of MOD-4023 and 13 participants of Genotropin did not have bone age measurements at 12 months.'}, {'type': 'SECONDARY', 'title': 'Insulin-like Growth Factor-1 (IGF-1) Standard Deviation Score (SDS) in Main Study Phase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '109', 'groupId': 'OG000'}, {'value': '115', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MOD-4023', 'description': 'Once weekly subcutaneous injection of long acting r-hGH (MOD-4023)\n\nMOD-4023: Once weekly subcutaneous injection using pre-filled pen device.'}, {'id': 'OG001', 'title': 'Genotropin', 'description': 'Once daily subcutaneous injection of somatropin (r-hGH; Genotropin)\n\nSomatropin: Once daily subcutaneous injection of Genotropin'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '109', 'groupId': 'OG000'}, {'value': '115', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.95', 'spread': '0.89', 'groupId': 'OG000'}, {'value': '-1.72', 'spread': '0.90', 'groupId': 'OG001'}]}]}, {'title': 'At 12 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '107', 'groupId': 'OG000'}, {'value': '110', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.65', 'spread': '1.32', 'groupId': 'OG000'}, {'value': '-0.69', 'spread': '1.09', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and at 12 months', 'description': 'Via central lab analysis', 'unitOfMeasure': 'Standard Deviation Score (SDS)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "2 subjects in MOD-4023 and 5 subjects in Genotropin didn't have the measurements at 12 months"}, {'type': 'SECONDARY', 'title': 'Change in Height Standard Deviation Score (SDS) in OLE Phase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '104', 'groupId': 'OG000'}, {'value': '108', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MOD-4023', 'description': 'Once weekly subcutaneous injection of long acting r-hGH (MOD-4023)\n\nMOD-4023: Once weekly subcutaneous injection using pre-filled pen device.'}, {'id': 'OG001', 'title': 'Genotropin', 'description': 'Once daily subcutaneous injection of somatropin (r-hGH; Genotropin)\n\nSomatropin: Once daily subcutaneous injection of Genotropin'}], 'classes': [{'title': 'Baseline (from Main Study Phase)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '104', 'groupId': 'OG000'}, {'value': '108', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-2.95', 'spread': '1.30', 'groupId': 'OG000'}, {'value': '-2.79', 'spread': '1.31', 'groupId': 'OG001'}]}]}, {'title': 'OLE Month 0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '104', 'groupId': 'OG000'}, {'value': '108', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.95', 'spread': '0.55', 'groupId': 'OG000'}, {'value': '0.85', 'spread': '0.52', 'groupId': 'OG001'}]}]}, {'title': 'OLE Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'OG000'}, {'value': '82', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.38', 'spread': '0.78', 'groupId': 'OG000'}, {'value': '1.34', 'spread': '0.71', 'groupId': 'OG001'}]}]}, {'title': 'OLE Month 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}, {'value': '84', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.57', 'spread': '0.77', 'groupId': 'OG000'}, {'value': '1.66', 'spread': '0.78', 'groupId': 'OG001'}]}]}, {'title': 'OLE Month 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '83', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.81', 'spread': '0.85', 'groupId': 'OG000'}, {'value': '1.93', 'spread': '0.85', 'groupId': 'OG001'}]}]}, {'title': 'OLE Month 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.96', 'spread': '0.67', 'groupId': 'OG000'}, {'value': '2.04', 'spread': '0.81', 'groupId': 'OG001'}]}]}, {'title': 'OLE Month 60', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.14', 'spread': '0.38', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '60 months', 'description': 'Change in height Standard Deviation Score (SDS) at each time point is calculated based on the difference between the time point and baseline.', 'unitOfMeasure': 'Standard Deviation Score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set'}, {'type': 'SECONDARY', 'title': 'Insulin-like Growth Factor-1 (IGF-1) Standard Deviation Score (SDS) in OLE Phase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '104', 'groupId': 'OG000'}, {'value': '108', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MOD-4023', 'description': 'Once weekly subcutaneous injection of long acting r-hGH (MOD-4023)\n\nMOD-4023: Once weekly subcutaneous injection using pre-filled pen device.'}, {'id': 'OG001', 'title': 'Genotropin', 'description': 'Once daily subcutaneous injection of somatropin (r-hGH; Genotropin)\n\nSomatropin: Once daily subcutaneous injection of Genotropin'}], 'classes': [{'title': 'Baseline (from Main Study Phase)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '104', 'groupId': 'OG000'}, {'value': '108', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '77.91', 'spread': '46.11', 'groupId': 'OG000'}, {'value': '83.10', 'spread': '41.17', 'groupId': 'OG001'}]}]}, {'title': 'OLE Month 0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '97', 'groupId': 'OG000'}, {'value': '105', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '185.9', 'spread': '107.1', 'groupId': 'OG000'}, {'value': '69.96', 'spread': '59.92', 'groupId': 'OG001'}]}]}, {'title': 'OLE Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '83', 'groupId': 'OG000'}, {'value': '86', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '255.9', 'spread': '120.0', 'groupId': 'OG000'}, {'value': '248.6', 'spread': '111.9', 'groupId': 'OG001'}]}]}, {'title': 'OLE Month 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '76', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '293.4', 'spread': '132.8', 'groupId': 'OG000'}, {'value': '295.3', 'spread': '137.5', 'groupId': 'OG001'}]}]}, {'title': 'OLE Month 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '315.6', 'spread': '139.7', 'groupId': 'OG000'}, {'value': '330.7', 'spread': '138.0', 'groupId': 'OG001'}]}]}, {'title': 'OLE Month 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '354.8', 'spread': '133.1', 'groupId': 'OG000'}, {'value': '368.9', 'spread': '124.9', 'groupId': 'OG001'}]}]}, {'title': 'OLE Month 60', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '397.5', 'spread': '85.27', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '60 Months', 'unitOfMeasure': 'Standard Deviation Score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Device', 'timeFrame': '6 weeks', 'description': 'Proportion of successful single injections out of total number of single injections using the MOD-4023 Pen in the USA', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Device', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'MOD-4023', 'description': 'Once weekly subcutaneous injection of long acting r-hGH (MOD-4023)\n\nMOD-4023: Once weekly subcutaneous injection using pre-filled pen device.'}], 'classes': [{'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '1 week', 'description': 'Proportion of successful single injections out of total number of single injections using the MOD-4023 Pen in the USA at Week 1 based on the Observer Assessment Tool (OAT)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'MOD-4023', 'description': 'Once weekly subcutaneous injection of long acting r-hGH (MOD-4023)\n\nMOD-4023: Once weekly subcutaneous injection using pre-filled pen device.\n\nNote that in the OLE Phase of the study all subjects were treated with MOD-4023. The distribution noted across different arms is in reference to the assigned drug during the Main Study Phase.'}, {'id': 'FG001', 'title': 'Genotropin', 'description': 'Once daily subcutaneous injection of somatropin (r-hGH; Genotropin)\n\nSomatropin: Once daily subcutaneous injection of Genotropin\n\nNote that in the OLE Phase of the study all subjects were treated with MOD-4023. The distribution noted across different arms is in reference to the assigned drug during the Main Study Phase.'}], 'periods': [{'title': 'Main Study Phase', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '109'}, {'groupId': 'FG001', 'numSubjects': '115'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '108'}, {'groupId': 'FG001', 'numSubjects': '114'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}, {'title': 'Open Label Extension (OLE) Year 1', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'Of 109 participants entered the Main Study Phase, 4 completed the study and 1 discontinued. Therefore, 104 entered the OLE period Year 1.', 'groupId': 'FG000', 'numSubjects': '104'}, {'comment': 'Of 115 participants entered the Main Study Phase, 6 completed the study and 1 discontinued. Therefore, 108 entered the OLE period Year 1.', 'groupId': 'FG001', 'numSubjects': '108'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '102'}, {'groupId': 'FG001', 'numSubjects': '99'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '9'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Miscellaneous', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}, {'title': 'Open Label Extension (OLE) Year 2', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'Of 104 participants entered the OLE period Year 1, 11 completed the study and 2 discontinued. Therefore, 91 entered the OLE period Year 2.', 'groupId': 'FG000', 'numSubjects': '91'}, {'comment': 'Of 108 participants entered the OLE period Year 1, 13 completed the study and 9 discontinued. Therefore, 86 entered the OLE period Year 2.', 'groupId': 'FG001', 'numSubjects': '86'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '88'}, {'groupId': 'FG001', 'numSubjects': '82'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '4'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Miscellaneous', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}, {'title': 'Open Label Extension (OLE) Year 3', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'Of 91 participants entered the OLE period Year 2, 3 discontinued. Therefore, 88 entered the OLE period Year 3.', 'groupId': 'FG000', 'numSubjects': '88'}, {'comment': 'Of 86 participants entered the OLE period Year 2, 4 discontinued. Therefore, 82 entered the OLE period Year 3.', 'groupId': 'FG001', 'numSubjects': '82'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '84'}, {'groupId': 'FG001', 'numSubjects': '80'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Prohibited Treatments', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Local Crisis', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Open Label Extension (OLE) Year 4', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'Of 88 participants entered the OLE period Year 3, 1 completed the study and 4 discontinued. Therefore, 83 entered the OLE period Year 4.', 'groupId': 'FG000', 'numSubjects': '83'}, {'comment': 'Of 82 participants entered the OLE period Year 3, 1 completed the study and 2 discontinued. Therefore, 79 entered the OLE period Year 4.', 'groupId': 'FG001', 'numSubjects': '79'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '38'}, {'groupId': 'FG001', 'numSubjects': '43'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '45'}, {'groupId': 'FG001', 'numSubjects': '36'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'Non-Compliance With Study Drug', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Sponsor Discontinuation of Study', 'reasons': [{'groupId': 'FG000', 'numSubjects': '27'}, {'groupId': 'FG001', 'numSubjects': '21'}]}, {'type': 'Bone Age Reached', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Local Crisis', 'reasons': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '9'}]}, {'type': 'Miscellaneous', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Open Label Extension (OLE) Year 5', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'Of 83 participants entered the OLE period Year 4, 14 completed the study and 45 discontinued. Therefore, 24 entered the OLE period Year 5.', 'groupId': 'FG000', 'numSubjects': '24'}, {'comment': 'Of 79 participants entered the OLE period Year 4, 15 completed the study and 36 discontinued. Therefore, 28 entered the OLE period Year 5.', 'groupId': 'FG001', 'numSubjects': '28'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '18'}, {'groupId': 'FG001', 'numSubjects': '22'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '6'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Sponsor Discontinuation of Study', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': 'Bone Age Reached,', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Closure of Epiphyseal Plates', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Local Crisis', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Open Label Extension (OLE) Year 6', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'Of 24 participants entered the OLE period Year 5, 18 completed the study and 6 discontinued. Therefore, 0 entered the OLE period Year 6.', 'groupId': 'FG000', 'numSubjects': '0'}, {'comment': 'Of 28 participants entered the OLE period Year 5, 20 completed the study and 6 discontinued. Therefore, 2 entered the OLE period Year 6.', 'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '109', 'groupId': 'BG000'}, {'value': '115', 'groupId': 'BG001'}, {'value': '224', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'MOD-4023', 'description': 'Once weekly subcutaneous injection of long acting r-hGH (MOD-4023)\n\nMOD-4023: Once weekly subcutaneous injection using pre-filled pen device.'}, {'id': 'BG001', 'title': 'Genotropin', 'description': 'Once daily subcutaneous injection of somatropin (r-hGH; Genotropin)\n\nSomatropin: Once daily subcutaneous injection of Genotropin'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '7.83', 'spread': '2.66', 'groupId': 'BG000'}, {'value': '7.61', 'spread': '2.37', 'groupId': 'BG001'}, {'value': '7.72', 'spread': '2.51', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '36', 'groupId': 'BG001'}, {'value': '63', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '82', 'groupId': 'BG000'}, {'value': '79', 'groupId': 'BG001'}, {'value': '161', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '98', 'groupId': 'BG000'}, {'value': '102', 'groupId': 'BG001'}, {'value': '200', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'categories': [{'title': 'White', 'measurements': [{'value': '81', 'groupId': 'BG000'}, {'value': '86', 'groupId': 'BG001'}, {'value': '167', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '45', 'groupId': 'BG002'}]}, {'title': 'American Indian or Alaska Native', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Other', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}, {'title': 'Unknown', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Multiracial', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Not reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Colombia', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}]}, {'title': 'Argentina', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}, {'title': 'United States', 'categories': [{'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '42', 'groupId': 'BG002'}]}]}, {'title': 'Ukraine', 'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}]}, {'title': 'United Kingdom', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}, {'title': 'Belarus', 'categories': [{'measurements': [{'value': '1', 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'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}]}, {'title': 'Israel', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}]}, {'title': 'Australia', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}, {'title': 'Bulgaria', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-04-27', 'size': 5757827, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2021-05-10T11:59', 'hasProtocol': True}, {'date': '2024-01-03', 'size': 242457, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_002.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2025-06-30T11:31', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 224}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2024-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-06-30', 'studyFirstSubmitDate': '2016-11-13', 'resultsFirstSubmitDate': '2021-05-10', 'studyFirstSubmitQcDate': '2016-11-15', 'lastUpdatePostDateStruct': {'date': '2025-07-20', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-06-22', 'studyFirstPostDateStruct': {'date': '2016-11-18', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2021-06-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Device', 'timeFrame': '6 weeks', 'description': 'Proportion of successful single injections out of total number of single injections using the MOD-4023 Pen in the USA'}, {'measure': 'Device', 'timeFrame': '1 week', 'description': 'Proportion of successful single injections out of total number of single injections using the MOD-4023 Pen in the USA at Week 1 based on the Observer Assessment Tool (OAT)'}], 'primaryOutcomes': [{'measure': 'Annual Height Velocity in Main Study Phase', 'timeFrame': '52 weeks', 'description': 'Annual Height Velocity in cm. Annual Height Velocity at 12 months is based on the difference between the heights at 12 months and baseline.'}, {'measure': 'Annual Height Velocity in OLE Phase', 'timeFrame': 'Up to 60 months', 'description': 'Annualized Height Velocity (cm/year) in OLE Phase'}], 'secondaryOutcomes': [{'measure': 'Height Velocity at 6 Months in Main Study Phase', 'timeFrame': 'After 6 months of treatment', 'description': 'Height velocity in cm measured after 6 months of treatment. Annualized Height velocity after 6 months is calculated based on the difference between the heights at 6 months and baseline.'}, {'measure': 'Change in Height Standard Deviation Score (SDS) in Main Study Phase', 'timeFrame': 'After 6 and 12 months', 'description': 'Change in height Standard Deviation Score (SDS) after 6 and 12 months is calculated based on the difference between the heights at 6 and 12 months and baseline.'}, {'measure': 'Change in Bone Maturation (BM) in Main Study Phase', 'timeFrame': '52 weeks', 'description': 'Annual change in bone age measurements as per Gruelich-Pyle method'}, {'measure': 'Insulin-like Growth Factor-1 (IGF-1) Standard Deviation Score (SDS) in Main Study Phase', 'timeFrame': 'Baseline and at 12 months', 'description': 'Via central lab analysis'}, {'measure': 'Change in Height Standard Deviation Score (SDS) in OLE Phase', 'timeFrame': '60 months', 'description': 'Change in height Standard Deviation Score (SDS) at each time point is calculated based on the difference between the time point and baseline.'}, {'measure': 'Insulin-like Growth Factor-1 (IGF-1) Standard Deviation Score (SDS) in OLE Phase', 'timeFrame': '60 Months'}]}, 'conditionsModule': {'conditions': ['Pediatric Growth Hormone Deficiency']}, 'referencesModule': {'references': [{'pmid': '38717038', 'type': 'DERIVED', 'citation': 'Gomez R, Khadilkar V, Shembalkar J, Chu DM, Ko CW, Wajnrajch MP, Wang R. Post hoc subgroup analysis of Asian children with paediatric GHD from the global phase 3 efficacy and safety study of once-weekly somatrogon vs. once-daily somatropin. J Pediatr Endocrinol Metab. 2024 May 9;37(6):525-531. doi: 10.1515/jpem-2023-0512. Print 2024 Jun 25.'}, {'pmid': '38053515', 'type': 'DERIVED', 'citation': 'Loftus J, Quitmann J, Valluri SR. Health-related quality of life in pre-pubertal children with pediatric growth hormone deficiency: 12-month results from a phase 3 clinical trial of once-weekly somatrogon versus once-daily somatropin. Curr Med Res Opin. 2024 Feb;40(2):175-184. doi: 10.1080/03007995.2023.2290623. Epub 2024 Jan 24.'}, {'pmid': '37955005', 'type': 'DERIVED', 'citation': 'Gomez R, Lamoureux R, Turner-Bowker DM, Loftus J, Maghnie M, Miller BS, Polak M, Yaworsky A. Physician experience with once-weekly somatrogon versus once-daily rhGH regimen in pediatric patients with growth hormone deficiency: a cross-sectional survey of physicians from the global phase 3 study. Front Endocrinol (Lausanne). 2023 Oct 17;14:1254424. doi: 10.3389/fendo.2023.1254424. eCollection 2023.'}, {'pmid': '35405011', 'type': 'DERIVED', 'citation': 'Deal CL, Steelman J, Vlachopapadopoulou E, Stawerska R, Silverman LA, Phillip M, Kim HS, Ko C, Malievskiy O, Cara JF, Roland CL, Taylor CT, Valluri SR, Wajnrajch MP, Pastrak A, Miller BS. Efficacy and Safety of Weekly Somatrogon vs Daily Somatropin in Children With Growth Hormone Deficiency: A Phase 3 Study. J Clin Endocrinol Metab. 2022 Jun 16;107(7):e2717-e2728. doi: 10.1210/clinem/dgac220.'}]}, 'descriptionModule': {'briefSummary': 'This is an open-label, randomized, multicenter, efficacy and safety study of weekly MOD-4023 compared to daily Genotropin therapy in pre-pubertal children with growth hormone deficiency.', 'detailedDescription': 'The study consists of a 12 month, open-label, randomized, active controlled, parallel group study comparing the efficacy and safety of weekly MOD-4023 to daily growth hormone (GH), Genotropin. After 12 months, subjects will have the option to enter the long term open-label extension.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '11 Years', 'minimumAge': '3 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Main Study Inclusion Criteria:\n\n1. Pre-pubertal children aged ≥3 years, and not yet 11 years for girls or not yet 12 years for boys with either isolated GHD, or GH insufficiency as part of multiple pituitary hormone deficiency.\n2. Confirmed diagnosis of GHD by two different GH provocation tests defined as a peak plasma GH level of ≤10 ng/mL.\n3. Bone age (BA) is not older than chronological age and should be less than 10 for girls and less than 11 for boys.\n4. Without prior exposure to any r-hGH therapy (naïve patients).\n5. Impaired height and height velocity defined as:\n\n * Annualized height velocity (HV) below the 25th percentile for CA (HV \\< -0.7 SDS) and gender according to sponsor calculator\n * The interval between 2 height measurements should be at least 6 months, but should not exceed 18 months prior to inclusion\n6. Baseline IGF-1 level of at least 1 SD below the mean IGF-1 level standardized for age and sex (IGF-1 SDS ≤-1)\n7. Normal calculated GFR per updated bedside Schwartz formula for pediatric patients.\n8. Children with multiple hormonal deficiencies must be on stable replacement therapies (no change in dose) for other hypothalamo-pituitary-organ axes for at least 3 months prior ICF signing.\n9. Normal 46XX karyotype for girls.\n10. Willing and able to provide written informed consent of the parent or legal guardian and written assent from patient.\n\n LT-OLE Inclusion Criteria:\n11. Completion of the main study (12 months of treatment) with adequate compliance.\n12. Willing and able to provide written informed consent of the parent or legal guardian and written assent from patient.\n13. Agree to refrain from sexual activity.\n\nMain Study Exclusion Criteria:\n\n1. Children with prior history of leukemia, lymphoma, sarcoma or any other forms of cancer.\n2. History of radiation therapy or chemotherapy.\n3. Malnourished children defined as BMI \\< -2 SDS for age and sex.\n4. Children with psychosocial dwarfism.\n5. Children born small for gestational age (SGA - birth weight and/or birth length \\<-2 SDS for gestational age).\n6. Presence of anti-hGH antibodies at screening.\n7. Any clinically significant abnormality likely to affect growth or the ability to evaluate growth, such as, but not limited to, chronic diseases like renal insufficiency, spinal cord irradiation, etc.\n8. T2 and T1 diabetic patients, who in the opinion of the investigator are not receiving standard of care treatment or are non-compliant with their prescribed treatment or who are in poor metabolic control.\n9. Chromosomal abnormalities including Turner's syndrome, Laron syndrome, Noonan syndrome, Prader-Willi syndrome, Russell-Silver syndrome, SHOX mutations/deletions and skeletal dysplasias.\n10. Concomitant administration of other treatments that may have an effect on growth such as anabolic steroids, or sex steroids, with the exception of ADHD drugs or hormone replacement therapies (thyroxin, hydrocortisone, desmopressin).\n11. Children requiring glucocorticoid therapy (e.g. for asthma) that are taking chronically a dose greater than 400 μg/d of inhaled budesonide or equivalent.\n12. Major medical conditions and/or presence of contraindication to r-hGH treatment.\n13. More than one closed epiphyses.\n14. Known or suspected HIV-positive patient, or patient with advanced diseases such as AIDS or tuberculosis.\n15. Drug, substance, or alcohol abuse.\n16. Known hypersensitivity to the components of study medication.\n17. Other causes of short stature such as celiac disease, uncontrolled primary hypothyroidism and rickets.\n18. Likely non-compliance in respect to study conduct.\n19. Participation in any other trial of an investigational agent within 30 days prior to consent.\n20. Study enrollment has been met or study is closed by sponsor prior to completion of screening process.\n\n LT-OLE Exclusion Criteria:\n21. Concomitant administration of other treatments that may have an effect on growth such as anabolic steroids, or sex steroids, with the exception of ADHD drugs or HRT (thyroxin, hydrocortisone, desmopressin).\n22. Change in medical condition during the treatment period (such as, but not limited to, development of a serious inter-current critical illness, a severe adverse drug reaction, etc.).\n23. Positive pregnancy test.\n24. Unresolved drug related (Genotropin or MOD-4023) SAE from the treatment period as per medical monitor judgement."}, 'identificationModule': {'nctId': 'NCT02968004', 'briefTitle': 'Safety and Efficacy Phase 3 Study of Long-acting hGH (MOD-4023) in Growth Hormone Deficient Children', 'organization': {'class': 'INDUSTRY', 'fullName': 'OPKO Health, Inc.'}, 'officialTitle': 'A Phase 3, Open-label, Randomized, Multicenter, 12 Months, Efficacy and Safety Study of Weekly MOD-4023 Compared to Daily Genotropin - Therapy in Pre-pubertal Children With Growth Hormone Deficiency', 'orgStudyIdInfo': {'id': 'CP-4-006'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'MOD-4023', 'description': 'Once weekly subcutaneous injection of long acting r-hGH (MOD-4023)', 'interventionNames': ['Drug: MOD-4023']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Genotropin', 'description': 'Once daily subcutaneous injection of somatropin (r-hGH; Genotropin)', 'interventionNames': ['Drug: Somatropin']}], 'interventions': [{'name': 'MOD-4023', 'type': 'DRUG', 'otherNames': ['Somatrogon'], 'description': 'Once weekly subcutaneous injection using pre-filled pen device.', 'armGroupLabels': ['MOD-4023']}, {'name': 'Somatropin', 'type': 'DRUG', 'otherNames': ['Genotropin'], 'description': 'Once daily subcutaneous injection of Genotropin using pre-filled pen device.', 'armGroupLabels': ['Genotropin']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92868', 'city': 'Orange', 'state': 'California', 'country': 'United States', 'facility': "Children's Hospital of Orange County- Children's Clinic", 'geoPoint': {'lat': 33.78779, 'lon': -117.85311}}, {'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': "Children's Hospital- Colorado", 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'zip': '80112', 'city': 'Centennial', 'state': 'Colorado', 'country': 'United States', 'facility': 'Rocky Mountain Pediatrics', 'geoPoint': {'lat': 39.57916, 'lon': -104.87692}}, {'zip': '32207', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': "Nemours Children's Health System", 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '33136', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'University of Miami Medical Center', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '83712', 'city': 'Boise', 'state': 'Idaho', 'country': 'United States', 'facility': "St Luke's Children's Specialty Center", 'geoPoint': {'lat': 43.6135, 'lon': -116.20345}}, {'zip': '52242', 'city': 'Iowa City', 'state': 'Iowa', 'country': 'United States', 'facility': "Children's Hospital of Iowa", 'geoPoint': {'lat': 41.66113, 'lon': -91.53017}}, {'zip': '02111', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Tufts Medical Center', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '01655', 'city': 'Worcester', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'University of Massachusettes', 'geoPoint': {'lat': 42.26259, 'lon': -71.80229}}, {'zip': '55454', 'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'facility': 'University of Minnesota', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}, {'zip': '89148', 'city': 'Las Vegas', 'state': 'Nevada', 'country': 'United States', 'facility': 'The Diabetes & Obesity Clinical Specialist', 'geoPoint': {'lat': 36.17497, 'lon': -115.13722}}, {'zip': '07962', 'city': 'Morristown', 'state': 'New Jersey', 'country': 'United States', 'facility': "Goryeb Children's Hospital", 'geoPoint': {'lat': 40.79677, 'lon': -74.48154}}, {'zip': '14222', 'city': 'Buffalo', 'state': 'New York', 'country': 'United States', 'facility': "Buffalo Children's Hospital", 'geoPoint': {'lat': 42.88645, 'lon': -78.87837}}, {'zip': '11501', 'city': 'Mineola', 'state': 'New York', 'country': 'United States', 'facility': 'Albert Einstein College of Medicine at Yeshiva University', 'geoPoint': {'lat': 40.74927, 'lon': -73.64068}}, {'zip': '45229', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': "Children's Hospital of Cincinnati / Cincinnati Center for Growth Disorders", 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '15224', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': "Children's Hospital of Pittsburgh", 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '76104', 'city': 'Fort Worth', 'state': 'Texas', 'country': 'United States', 'facility': "Cook Children's Medical Center", 'geoPoint': {'lat': 32.72541, 'lon': -97.32085}}, {'zip': '98405', 'city': 'Tacoma', 'state': 'Washington', 'country': 'United States', 'facility': "Mary Bridge Children's Hospital & Health Center", 'geoPoint': {'lat': 47.25288, 'lon': -122.44429}}, {'zip': '3100', 'city': 'Paraná', 'state': 'Entre Ríos Province', 'country': 'Argentina', 'facility': 'Hospital Materno Infantil San Roque', 'geoPoint': {'lat': -31.73271, 'lon': -60.52897}}, {'zip': '5000', 'city': 'Córdoba', 'country': 'Argentina', 'facility': 'Hospital de Ninos de la Santisima Trinidad Cordoba', 'geoPoint': {'lat': -31.40648, 'lon': -64.18853}}, {'zip': '2305', 'city': 'New Lambton Heights', 'state': 'New South Wales', 'country': 'Australia', 'facility': "John Hunter Children's Hospital", 'geoPoint': {'lat': -32.92466, 'lon': 151.69364}}, {'zip': '2145', 'city': 'Westmead', 'state': 'New South Wales', 'country': 'Australia', 'facility': "Children's Hospital at Westmead", 'geoPoint': {'lat': -33.80383, 'lon': 150.98768}}, {'zip': '6008', 'city': 'Subiaco', 'state': 'Western Australia', 'country': 'Australia', 'facility': 'PM Hospital for Children', 'geoPoint': {'lat': -31.9485, 'lon': 115.8268}}, {'zip': '220020', 'city': 'Minsk', 'country': 'Belarus', 'facility': 'Health Institution- 2nd City Pediatric Hospital', 'geoPoint': {'lat': 53.90019, 'lon': 27.56653}}, {'zip': '9010', 'city': 'Varna', 'country': 'Bulgaria', 'facility': 'MHAT Sveta Marina', 'geoPoint': {'lat': 43.21912, 'lon': 27.91024}}, {'zip': 'H3T 1C5', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Centre de recherche du CHU Sainte-Justine', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'zip': '110221', 'city': 'Bogotá', 'country': 'Colombia', 'facility': 'Dexa Diab', 'geoPoint': {'lat': 4.60971, 'lon': -74.08175}}, {'zip': '110221', 'city': 'Bogotá', 'country': 'Colombia', 'facility': 'Uniendo', 'geoPoint': {'lat': 4.60971, 'lon': -74.08175}}, {'zip': '050034', 'city': 'Medellín', 'country': 'Colombia', 'facility': 'Hospital Pablo Tobon Uribe', 'geoPoint': {'lat': 6.245, 'lon': -75.57151}}, {'zip': '6010', 'city': 'Batumi', 'country': 'Georgia', 'facility': 'Maritime Hospital JSC', 'geoPoint': {'lat': 41.64077, 'lon': 41.6306}}, {'zip': '0108', 'city': 'Tbilisi', 'country': 'Georgia', 'facility': 'Vere XXI JSC', 'geoPoint': {'lat': 41.69143, 'lon': 44.83412}}, {'zip': '11527', 'city': 'Athens', 'country': 'Greece', 'facility': "Aghia Sophia Children's Hospital", 'geoPoint': {'lat': 37.98376, 'lon': 23.72784}}, {'zip': '11527', 'city': 'Athens', 'country': 'Greece', 'facility': "General Children's Hospital of Athens P&A Kyriakou", 'geoPoint': {'lat': 37.98376, 'lon': 23.72784}}, {'zip': '560017', 'city': 'Bengaluru', 'state': 'Karnataka', 'country': 'India', 'facility': 'Manipal Hospital', 'geoPoint': {'lat': 12.97194, 'lon': 77.59369}}, {'zip': '440012', 'city': 'Nagpur', 'state': 'Maharashtra', 'country': 'India', 'facility': 'Getwell Health & Research Institute', 'geoPoint': {'lat': 21.14631, 'lon': 79.08491}}, {'zip': '411001', 'city': 'Pune', 'state': 'Maharashtra', 'country': 'India', 'facility': 'Jehangir Clinical Development Centre', 'geoPoint': {'lat': 18.51957, 'lon': 73.85535}}, {'zip': '160012', 'city': 'Chandigarh', 'state': 'Punjab', 'country': 'India', 'facility': 'Postgraduate Institute of Medical Education and Research'}, {'zip': '500001', 'city': 'Hyderabad', 'state': 'Telangna', 'country': 'India', 'facility': 'Care Hospital', 'geoPoint': {'lat': 17.38405, 'lon': 78.45636}}, {'zip': '440010', 'city': 'Nagpur', 'country': 'India', 'facility': 'Meditrina Institute of Medical Sciences', 'geoPoint': {'lat': 21.14631, 'lon': 79.08491}}, {'zip': '110029', 'city': 'New Delhi', 'country': 'India', 'facility': 'All India Institute of Medical Sciences', 'geoPoint': {'lat': 28.62137, 'lon': 77.2148}}, {'zip': '110060', 'city': 'New Delhi', 'country': 'India', 'facility': 'Sir Gangaram Hospital', 'geoPoint': {'lat': 28.62137, 'lon': 77.2148}}, {'zip': '1834111', 'city': 'Afula', 'country': 'Israel', 'facility': 'Haemek Medical Center', 'geoPoint': {'lat': 32.60907, 'lon': 35.2892}}, {'zip': '84101', 'city': 'Beersheba', 'country': 'Israel', 'facility': 'Soroka Medical Center', 'geoPoint': {'lat': 31.25181, 'lon': 34.7913}}, {'zip': '7030000', 'city': 'Be’er Ya‘aqov', 'country': 'Israel', 'facility': 'Assaf Harofeh Medical Center', 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'Reserva Territorial Atilxcayotl', 'country': 'Mexico', 'facility': 'Hospital Angeles de Puebla', 'geoPoint': {'lat': 19.04778, 'lon': -98.20723}}, {'zip': '1023', 'city': 'Grafton', 'state': 'Auckland', 'country': 'New Zealand', 'facility': 'The Liggins Institute', 'geoPoint': {'lat': -36.86029, 'lon': 174.76566}}, {'zip': '6021', 'city': 'Newtown', 'state': 'Wellington Region', 'country': 'New Zealand', 'facility': "Wellington Children's Hospital", 'geoPoint': {'lat': -41.31115, 'lon': 174.77935}}, {'zip': '80-211', 'city': 'Gdansk', 'country': 'Poland', 'facility': 'Uniwersyteckie Centrum Kliniczne in Gdansk', 'geoPoint': {'lat': 54.35227, 'lon': 18.64912}}, {'zip': '93-338', 'city': 'Lodz', 'country': 'Poland', 'facility': 'Centrum Zdrowia Matki Polki', 'geoPoint': {'lat': 51.77058, 'lon': 19.47395}}, {'zip': '450008/450106', 'city': 'Ufa', 'state': 'Bashlortostan Republic', 'country': 'Russia', 'facility': 'Bashkirian State Medical University', 'geoPoint': {'lat': 54.74306, 'lon': 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