Ignite Creation Date:
2025-12-24 @ 11:29 PM
Ignite Modification Date:
2026-02-06 @ 1:18 AM
Study NCT ID:
NCT00572156
Status:
TERMINATED
Last Update Posted:
2023-03-30
First Post:
2007-12-10
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
rhGH and rhIGF-1 Combination Therapy in Children With Short Stature Associated With IGF-1 Deficiency
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['France']}, 'conditionBrowseModule': {'meshes': [{'id': 'C563867', 'term': 'Insulin-Like Growth Factor I Deficiency'}, {'id': 'D011628', 'term': 'Puberty, Delayed'}], 'ancestors': [{'id': 'D006058', 'term': 'Gonadal Disorders'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019382', 'term': 'Human Growth Hormone'}, {'id': 'C000604197', 'term': 'mecasermin'}, {'id': 'D007267', 'term': 'Injections'}], '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'}, {'id': 'D004333', 'term': 'Drug Administration Routes'}, {'id': 'D004358', 'term': 'Drug Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinical.trials@ipsen.com', 'phone': 'clinical.trials@ipsen.com', 'title': 'Medical Director, Endocrinology', 'organization': 'Ipsen'}, 'certainAgreement': {'restrictionType': 'LTE60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'The study was prematurely terminated once the last subject had completed three years of treatment (compared to the six years planned in protocol Amendment) for strategic reasons.'}}, 'adverseEventsModule': {'timeFrame': 'Approximate up to 4 years', 'description': 'Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy.\n\nSafety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.', 'eventGroups': [{'id': 'EG000', 'title': '1. rhGH Alone', 'description': 'Nutropin AQ® (Somatropin \\[rDNA origin\\]): rhGH (Somatropin) 45µg/kg once daily injection', 'otherNumAtRisk': 26, 'otherNumAffected': 26, 'seriousNumAtRisk': 26, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': '2. 45 rhGH + 50 rhIGF-1', 'description': 'Increlex® (Mecasermin \\[rDNA origin\\] injection) + Nutropin AQ® (Somatropin \\[rDNA origin\\]): rhGH (Somatropin) 45µg/kg and rhIGF-1 (Mecasermin) 50µg/kg once daily injections', 'otherNumAtRisk': 27, 'otherNumAffected': 27, 'seriousNumAtRisk': 27, 'seriousNumAffected': 1}, {'id': 'EG002', 'title': '3. 45 rhGH + 100 rhIGF-1', 'description': 'Increlex® (Mecasermin \\[rDNA origin\\] injection) + Nutropin AQ® (Somatropin \\[rDNA origin\\]): rhGH 45µg/kg and rhIGF-1 100µg/kg once daily injections', 'otherNumAtRisk': 27, 'otherNumAffected': 27, 'seriousNumAtRisk': 27, 'seriousNumAffected': 2}, {'id': 'EG003', 'title': '4. 45 rhGH + 150 rhIGF-1', 'description': 'Increlex® (Mecasermin \\[rDNA origin\\] injection) + Nutropin AQ® (Somatropin \\[rDNA origin\\]): rhGH 45µg/kg and rhIGF-1 150µg/kg once daily injection', 'otherNumAtRisk': 26, 'otherNumAffected': 26, 'seriousNumAtRisk': 26, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 23, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 19, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 27, 'numEvents': 31, 'numAffected': 9}, {'groupId': 'EG003', 'numAtRisk': 26, 'numEvents': 37, 'numAffected': 13}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v11.0'}, {'term': 'Otitis media', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 7, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 27, 'numEvents': 5, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 26, 'numEvents': 19, 'numAffected': 9}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v11.0'}, {'term': 'Viral infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 10, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 7, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 27, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 26, 'numEvents': 21, 'numAffected': 8}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v11.0'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 27, 'numEvents': 9, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 26, 'numEvents': 10, 'numAffected': 6}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v11.0'}, {'term': 'Pharyngitis streptococcal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 13, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 17, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 27, 'numEvents': 9, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 26, 'numEvents': 14, 'numAffected': 6}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v11.0'}, {'term': 'Gastroenteritis viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 8, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 9, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 27, 'numEvents': 4, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 26, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v11.0'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 27, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 26, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v11.0'}, {'term': 'Ear infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 5, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 4, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 27, 'numEvents': 6, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 26, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v11.0'}, {'term': 'Otitis externa', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 26, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v11.0'}, {'term': 'Molluscum contagiosum', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 26, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v11.0'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 3, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 27, 'numEvents': 4, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 26, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v11.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 27, 'numEvents': 15, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 26, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v11.0'}, {'term': 'Pharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 26, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v11.0'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 25, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 14, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 27, 'numEvents': 5, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 26, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v11.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numEvents': 3, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 26, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v11.0'}, {'term': 'Varicella', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 26, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v11.0'}, {'term': 'Tonsillitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 27, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v11.0'}, {'term': 'Viral upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v11.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 17, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 27, 'numEvents': 12, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 26, 'numEvents': 19, 'numAffected': 12}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v11.0'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 11, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 8, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 27, 'numEvents': 7, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 26, 'numEvents': 11, 'numAffected': 7}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v11.0'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 27, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 26, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v11.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 10, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 27, 'numEvents': 7, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 26, 'numEvents': 11, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v11.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 27, 'numEvents': 6, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 26, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v11.0'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 26, 'numEvents': 4, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v11.0'}, {'term': 'Stomach discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 27, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 26, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v11.0'}, {'term': 'Abdominal discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v11.0'}, {'term': 'Toothache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v11.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 17, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 27, 'numAffected': 15}, {'groupId': 'EG002', 'numAtRisk': 27, 'numEvents': 22, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 26, 'numEvents': 19, 'numAffected': 13}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v11.0'}, {'term': 'Injection site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 26, 'numEvents': 6, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v11.0'}, {'term': 'Malaise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 26, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v11.0'}, {'term': 'Injection site bruising', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 27, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 26, 'numEvents': 5, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v11.0'}, {'term': 'Injection site hypertrophy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 8, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 27, 'numEvents': 13, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 26, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v11.0'}, {'term': 'Injection site induration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 27, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 26, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v11.0'}, {'term': 'Influenza like illness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 26, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v11.0'}, {'term': 'Injection site erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 26, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v11.0'}, {'term': 'Injection site urticaria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 27, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 26, 'numEvents': 5, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v11.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 1, 'numAffected': 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{'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 27, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 26, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v11.0'}, {'term': 'Hepatic enzyme increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v11.0'}, {'term': 'Thyroxine free decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v11.0'}, {'term': 'Weight decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v11.0'}, {'term': 'Skin papilloma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 26, 'numEvents': 5, 'numAffected': 4}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v11.0'}, {'term': 'Gynaecomastia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 26, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v11.0'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 26, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v11.0'}, {'term': 'Affective disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v11.0'}, {'term': 'Attention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v11.0'}, {'term': 'Ear pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 27, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 26, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v11.0'}, {'term': 'Lymphadenopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 7, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 27, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 26, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v11.0'}, {'term': 'Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 26, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v11.0'}, {'term': 'Enuresis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 27, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v11.0'}, {'term': 'Pollakiuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v11.0'}], 'seriousEvents': [{'term': 'Intracranial pressure increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v11.0'}, {'term': 'Forearm fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v11.0'}, {'term': 'Evans syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v11.0'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 3, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v11.0'}, {'term': 'Viral infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v11.0'}, {'term': 'Gastroenteritis viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v11.0'}, {'term': 'Hematuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v11.0'}, {'term': 'Papilledema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 26, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v11.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Height Velocity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '27', 'groupId': 'OG002'}, {'value': '26', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'rhGH Alone', 'description': 'Nutropin AQ® (Somatropin \\[rDNA origin\\]): rhGH (Somatropin) 45µg/kg once daily injection'}, {'id': 'OG001', 'title': '45 rhGH + 50 rhIGF-1', 'description': 'Increlex® (Mecasermin \\[rDNA origin\\] injection) + Nutropin AQ® (Somatropin \\[rDNA origin\\]): rhGH (Somatropin) 45µg/kg and rhIGF-1 (Mecasermin) 50µg/kg once daily injections'}, {'id': 'OG002', 'title': '45 rhGH + 100 rhIGF-1', 'description': 'Increlex® (Mecasermin \\[rDNA origin\\] injection) + Nutropin AQ® (Somatropin \\[rDNA origin\\]): rhGH 45µg/kg and rhIGF-1 100µg/kg once daily injections'}, {'id': 'OG003', 'title': '45 rhGH + 150 rhIGF-1', 'description': 'Increlex® (Mecasermin \\[rDNA origin\\] injection) + Nutropin AQ® (Somatropin \\[rDNA origin\\]): rhGH 45µg/kg and rhIGF-1 150µg/kg once daily injection'}], 'classes': [{'categories': [{'measurements': [{'value': '9.3', 'spread': '1.7', 'groupId': 'OG000'}, {'value': '10.1', 'spread': '1.3', 'groupId': 'OG001'}, {'value': '9.7', 'spread': '2.5', 'groupId': 'OG002'}, {'value': '11.2', 'spread': '2.1', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'First year of treatment', 'unitOfMeasure': 'cm/y', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified Intent-To-Treat (MITT): MITT population comprised all subjects who were randomized and had at least one post-baseline height measurement.\n\n\\[n= 25,27,27,26\\]'}, {'type': 'SECONDARY', 'title': 'Height Velocity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '27', 'groupId': 'OG002'}, {'value': '26', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'rhGH Alone', 'description': 'Nutropin AQ® (Somatropin \\[rDNA origin\\]): rhGH (Somatropin) 45µg/kg once daily injection'}, {'id': 'OG001', 'title': '45 rhGH + 50 rhIGF-1', 'description': 'Increlex® (Mecasermin \\[rDNA origin\\] injection) + Nutropin AQ® (Somatropin \\[rDNA origin\\]): rhGH (Somatropin) 45µg/kg and rhIGF-1 (Mecasermin) 50µg/kg once daily injections'}, {'id': 'OG002', 'title': '45 rhGH + 100 rhIGF-1', 'description': 'Increlex® (Mecasermin \\[rDNA origin\\] injection) + Nutropin AQ® (Somatropin \\[rDNA origin\\]): rhGH 45µg/kg and rhIGF-1 100µg/kg once daily injections'}, {'id': 'OG003', 'title': '45 rhGH + 150 rhIGF-1', 'description': 'Increlex® (Mecasermin \\[rDNA origin\\] injection) + Nutropin AQ® (Somatropin \\[rDNA origin\\]): rhGH 45µg/kg and rhIGF-1 150µg/kg once daily injection'}], 'classes': [{'title': 'Year 2 height velocity [n= 24,25,22,24]', 'categories': [{'measurements': [{'value': '8.4', 'spread': '1.3', 'groupId': 'OG000'}, {'value': '9.1', 'spread': '1.2', 'groupId': 'OG001'}, {'value': '9.4', 'spread': '1.6', 'groupId': 'OG002'}, {'value': '10.1', 'spread': '1.8', 'groupId': 'OG003'}]}]}, {'title': 'Year 3 height velocity [n= 22,22,20,22]', 'categories': [{'measurements': [{'value': '8.0', 'spread': '1.1', 'groupId': 'OG000'}, {'value': '8.4', 'spread': '1.0', 'groupId': 'OG001'}, {'value': '8.9', 'spread': '1.3', 'groupId': 'OG002'}, {'value': '9.2', 'spread': '1.5', 'groupId': 'OG003'}]}]}, {'title': 'Year 4 height velocity [n= 17,16,15,16]', 'categories': [{'measurements': [{'value': '7.7', 'spread': '0.9', 'groupId': 'OG000'}, {'value': '8.1', 'spread': '0.8', 'groupId': 'OG001'}, {'value': '8.4', 'spread': '1.2', 'groupId': 'OG002'}, {'value': '8.3', 'spread': '1.3', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Second, third and fourth year', 'unitOfMeasure': 'cm/y', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified Intent-To-Treat (MITT): MITT population comprised all subjects who were randomized and had at least one post-baseline height measurement.'}, {'type': 'SECONDARY', 'title': 'Cumulative Change in Height Standard Deviation Score (SDS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '27', 'groupId': 'OG002'}, {'value': '26', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'rhGH Alone', 'description': 'Nutropin AQ® (Somatropin \\[rDNA origin\\]): rhGH (Somatropin) 45µg/kg once daily injection'}, {'id': 'OG001', 'title': '45 rhGH + 50 rhIGF-1', 'description': 'Increlex® (Mecasermin \\[rDNA origin\\] injection) + Nutropin AQ® (Somatropin \\[rDNA origin\\]): rhGH (Somatropin) 45µg/kg and rhIGF-1 (Mecasermin) 50µg/kg once daily injections'}, {'id': 'OG002', 'title': '45 rhGH + 100 rhIGF-1', 'description': 'Increlex® (Mecasermin \\[rDNA origin\\] injection) + Nutropin AQ® (Somatropin \\[rDNA origin\\]): rhGH 45µg/kg and rhIGF-1 100µg/kg once daily injections'}, {'id': 'OG003', 'title': '45 rhGH + 150 rhIGF-1', 'description': 'Increlex® (Mecasermin \\[rDNA origin\\] injection) + Nutropin AQ® (Somatropin \\[rDNA origin\\]): rhGH 45µg/kg and rhIGF-1 150µg/kg once daily injection'}], 'classes': [{'title': 'First year [n= 25,27,27,26]', 'categories': [{'measurements': [{'value': '0.7', 'spread': '0.3', 'groupId': 'OG000'}, {'value': '0.9', 'spread': '0.2', 'groupId': 'OG001'}, {'value': '0.8', 'spread': '0.4', 'groupId': 'OG002'}, {'value': '1.0', 'spread': '0.4', 'groupId': 'OG003'}]}]}, {'title': 'Second year [n= 24,25,22,24]', 'categories': [{'measurements': [{'value': '1.0', 'spread': '0.4', 'groupId': 'OG000'}, {'value': '1.4', 'spread': '0.4', 'groupId': 'OG001'}, {'value': '1.4', 'spread': '0.5', 'groupId': 'OG002'}, {'value': '1.6', 'spread': '0.6', 'groupId': 'OG003'}]}]}, {'title': 'Third year [n=22,22,20,22]', 'categories': [{'measurements': [{'value': '1.3', 'spread': '0.5', 'groupId': 'OG000'}, {'value': '1.6', 'spread': '0.4', 'groupId': 'OG001'}, {'value': '1.8', 'spread': '0.7', 'groupId': 'OG002'}, {'value': '1.9', 'spread': '0.6', 'groupId': 'OG003'}]}]}, {'title': 'Fourth year [n=17,16,15,16]', 'categories': [{'measurements': [{'value': '1.5', 'spread': '0.5', 'groupId': 'OG000'}, {'value': '1.8', 'spread': '0.5', 'groupId': 'OG001'}, {'value': '2.1', 'spread': '0.8', 'groupId': 'OG002'}, {'value': '2.0', 'spread': '0.7', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'First, second, third and fourth year', 'description': "Height was measured standing and without shoes, and recorded as the mean of three measurements (the subject being repositioned each time) by the same observer using a Harpenden or other wall-mounted stadiometer which was to be calibrated prior to measurement of each subject and a calibration log kept.\n\nThe SDS was calculated as: SDS=\\[(value /M)\\^L - 1\\] / LS; using power (L), Mean (M) and coefficient of variation (S). The reference values were dependent on gender in addition to age and were selected at the age the closest below subject's age. SDS scores were calculated using L, M and S as defined in the National Center for Health Statistics 2000 data as provided by the Center for Disease Control (Kuczmarski, Ogden et al. 2002)", 'unitOfMeasure': 'SDS', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified Intent-To-Treat (MITT): MITT population comprised all subjects who were randomized and had at least one post-baseline height measurement.'}, {'type': 'SECONDARY', 'title': 'Predicted Adult Height (PAH)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '27', 'groupId': 'OG002'}, {'value': '26', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'rhGH Alone', 'description': 'Nutropin AQ® (Somatropin \\[rDNA origin\\]): rhGH (Somatropin) 45µg/kg once daily injection'}, {'id': 'OG001', 'title': '45 rhGH + 50 rhIGF-1', 'description': 'Increlex® (Mecasermin \\[rDNA origin\\] injection) + Nutropin AQ® (Somatropin \\[rDNA origin\\]): rhGH (Somatropin) 45µg/kg and rhIGF-1 (Mecasermin) 50µg/kg once daily injections'}, {'id': 'OG002', 'title': '45 rhGH + 100 rhIGF-1', 'description': 'Increlex® (Mecasermin \\[rDNA origin\\] injection) + Nutropin AQ® (Somatropin \\[rDNA origin\\]): rhGH 45µg/kg and rhIGF-1 100µg/kg once daily injections'}, {'id': 'OG003', 'title': '45 rhGH + 150 rhIGF-1', 'description': 'Increlex® (Mecasermin \\[rDNA origin\\] injection) + Nutropin AQ® (Somatropin \\[rDNA origin\\]): rhGH 45µg/kg and rhIGF-1 150µg/kg once daily injection'}], 'classes': [{'title': 'Baseline (day 1) [n=25,27,27,26]', 'categories': [{'measurements': [{'value': '-1.67', 'spread': '0.51', 'groupId': 'OG000'}, {'value': '-1.83', 'spread': '0.58', 'groupId': 'OG001'}, {'value': '-1.69', 'spread': '0.59', 'groupId': 'OG002'}, {'value': '-1.76', 'spread': '0.73', 'groupId': 'OG003'}]}]}, {'title': 'Year 1 [n= 24,25,22,25]', 'categories': [{'measurements': [{'value': '-1.12', 'spread': '0.57', 'groupId': 'OG000'}, {'value': '-1.22', 'spread': '0.58', 'groupId': 'OG001'}, {'value': '-0.99', 'spread': '0.55', 'groupId': 'OG002'}, {'value': '-1.01', 'spread': '0.80', 'groupId': 'OG003'}]}]}, {'title': 'Year 2 [n= 22,21,20,22]', 'categories': [{'measurements': [{'value': '-0.96', 'spread': '0.56', 'groupId': 'OG000'}, {'value': '-0.81', 'spread': '0.55', 'groupId': 'OG001'}, {'value': '-0.66', 'spread': '0.56', 'groupId': 'OG002'}, {'value': '-0.69', 'spread': '0.91', 'groupId': 'OG003'}]}]}, {'title': 'Year 3 [n=21,19,19,20]', 'categories': [{'measurements': [{'value': '-0.78', 'spread': '0.63', 'groupId': 'OG000'}, {'value': '-0.65', 'spread': '0.60', 'groupId': 'OG001'}, {'value': '-0.42', 'spread': '0.62', 'groupId': 'OG002'}, {'value': '-0.64', 'spread': '0.98', 'groupId': 'OG003'}]}]}, {'title': 'Year 4 [n=3,4,4,3]', 'categories': [{'measurements': [{'value': '-1.22', 'spread': '0.59', 'groupId': 'OG000'}, {'value': '-0.44', 'spread': '0.81', 'groupId': 'OG001'}, {'value': '0.49', 'spread': '0.60', 'groupId': 'OG002'}, {'value': '-0.07', 'spread': '0.89', 'groupId': 'OG003'}]}]}, {'title': 'Mid-parental target height [n=25,27,27,26]', 'categories': [{'measurements': [{'value': '-0.51', 'spread': '0.38', 'groupId': 'OG000'}, {'value': '-0.64', 'spread': '0.52', 'groupId': 'OG001'}, {'value': '-0.53', 'spread': '0.50', 'groupId': 'OG002'}, {'value': '-0.47', 'spread': '0.51', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At baseline (Day 1), year 1,2,3 and 4', 'description': "Predicted Adult Height calculated by method, Roche-Wainer-Thissen (RWT) and mid-parental target height SDS.\n\nThe SDS was calculated as: SDS=\\[(value /M)\\^L - 1\\] / LS; using power (L), Mean (M) and coefficient of variation (S). The reference values were dependent on gender in addition to age and were selected at the age the closest below subject's age. SDS scores were calculated using L, M and S as defined in the National Center for Health Statistics 2000 data as provided by the Center for Disease Control (Kuczmarski, Ogden et al. 2002)", 'unitOfMeasure': 'SDS', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Completers, the completer population consists of all subjects that remained in the study until a specific time point (ie; Year 1, Year 2, Year 3 and Year 4).'}, {'type': 'SECONDARY', 'title': 'Total Change From Baseline (Day 1) in BMI SDS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '27', 'groupId': 'OG002'}, {'value': '26', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'rhGH Alone', 'description': 'Nutropin AQ® (Somatropin \\[rDNA origin\\]): rhGH (Somatropin) 45µg/kg once daily injection'}, {'id': 'OG001', 'title': '45 rhGH + 50 rhIGF-1', 'description': 'Increlex® (Mecasermin \\[rDNA origin\\] injection) + Nutropin AQ® (Somatropin \\[rDNA origin\\]): rhGH (Somatropin) 45µg/kg and rhIGF-1 (Mecasermin) 50µg/kg once daily injections'}, {'id': 'OG002', 'title': '45 rhGH + 100 rhIGF-1', 'description': 'Increlex® (Mecasermin \\[rDNA origin\\] injection) + Nutropin AQ® (Somatropin \\[rDNA origin\\]): rhGH 45µg/kg and rhIGF-1 100µg/kg once daily injections'}, {'id': 'OG003', 'title': '45 rhGH + 150 rhIGF-1', 'description': 'Increlex® (Mecasermin \\[rDNA origin\\] injection) + Nutropin AQ® (Somatropin \\[rDNA origin\\]): rhGH 45µg/kg and rhIGF-1 150µg/kg once daily injection'}], 'classes': [{'title': 'Change from day 1 to year 1 [n= 24,25,22,25]', 'categories': [{'measurements': [{'value': '0.24', 'spread': '0.43', 'groupId': 'OG000'}, {'value': '0.31', 'spread': '0.39', 'groupId': 'OG001'}, {'value': '0.36', 'spread': '0.41', 'groupId': 'OG002'}, {'value': '0.54', 'spread': '0.40', 'groupId': 'OG003'}]}]}, {'title': 'Change from day 1 to year 2 [n= 22,21,20,22]', 'categories': [{'measurements': [{'value': '0.31', 'spread': '0.49', 'groupId': 'OG000'}, {'value': '0.57', 'spread': '0.41', 'groupId': 'OG001'}, {'value': '0.49', 'spread': '0.44', 'groupId': 'OG002'}, {'value': '0.59', 'spread': '0.46', 'groupId': 'OG003'}]}]}, {'title': 'Change from day 1 to year 3 [n=21,19,19,20]', 'categories': [{'measurements': [{'value': '0.35', 'spread': '0.58', 'groupId': 'OG000'}, {'value': '0.62', 'spread': '0.43', 'groupId': 'OG001'}, {'value': '0.49', 'spread': '0.59', 'groupId': 'OG002'}, {'value': '0.71', 'spread': '0.54', 'groupId': 'OG003'}]}]}, {'title': 'Change from day 1 to year 4 [n=3,5,5,4]', 'categories': [{'measurements': [{'value': '0.27', 'spread': '0.52', 'groupId': 'OG000'}, {'value': '0.64', 'spread': '0.58', 'groupId': 'OG001'}, {'value': '0.65', 'spread': '0.90', 'groupId': 'OG002'}, {'value': '1.20', 'spread': '0.91', 'groupId': 'OG003'}]}]}, {'title': 'Change from day 1 to visit 23 [n=25,27,27,26]', 'categories': [{'measurements': [{'value': '0.34', 'spread': '0.54', 'groupId': 'OG000'}, {'value': '0.45', 'spread': '0.45', 'groupId': 'OG001'}, {'value': '0.42', 'spread': '0.53', 'groupId': 'OG002'}, {'value': '0.64', 'spread': '0.60', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At year 1,2,3,4 and end of study (visit 23) versus baseline (day 1)', 'description': "BMI was calculated by weight divided by height squared and measured as kilogram per square meter (kg/m\\^2).\n\nThe SDS was calculated as: SDS=\\[(value /M)\\^L - 1\\] / LS; using power (L), Mean (M) and coefficient of variation (S). The reference values were dependent on gender in addition to age and were selected at the age the closest below subject's age. SDS scores were calculated using L, M and S as defined in the National Center for Health Statistics 2000 data as provided by the Center for Disease Control (Kuczmarski, Ogden et al. 2002)", 'unitOfMeasure': 'SDS', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Completers, the completer population consists of all subjects that remained in the study until a specific time point (ie; Year 1, Year 2, Year 3 and Year 4).'}, {'type': 'SECONDARY', 'title': 'Skeletal Maturation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '27', 'groupId': 'OG002'}, {'value': '26', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'rhGH Alone', 'description': 'Nutropin AQ® (Somatropin \\[rDNA origin\\]): rhGH (Somatropin) 45µg/kg once daily injection'}, {'id': 'OG001', 'title': '45 rhGH + 50 rhIGF-1', 'description': 'Increlex® (Mecasermin \\[rDNA origin\\] injection) + Nutropin AQ® (Somatropin \\[rDNA origin\\]): rhGH (Somatropin) 45µg/kg and rhIGF-1 (Mecasermin) 50µg/kg once daily injections'}, {'id': 'OG002', 'title': '45 rhGH + 100 rhIGF-1', 'description': 'Increlex® (Mecasermin \\[rDNA origin\\] injection) + Nutropin AQ® (Somatropin \\[rDNA origin\\]): rhGH 45µg/kg and rhIGF-1 100µg/kg once daily injections'}, {'id': 'OG003', 'title': '45 rhGH + 150 rhIGF-1', 'description': 'Increlex® (Mecasermin \\[rDNA origin\\] injection) + Nutropin AQ® (Somatropin \\[rDNA origin\\]): rhGH 45µg/kg and rhIGF-1 150µg/kg once daily injection'}], 'classes': [{'title': 'Baseline [n=25,27,27,26]', 'categories': [{'measurements': [{'value': '7.6', 'spread': '1.8', 'groupId': 'OG000'}, {'value': '7.3', 'spread': '1.9', 'groupId': 'OG001'}, {'value': '7.2', 'spread': '2.0', 'groupId': 'OG002'}, {'value': '7.4', 'spread': '2.0', 'groupId': 'OG003'}]}]}, {'title': 'Year 1 [n= 24,25,22,25]', 'categories': [{'measurements': [{'value': '9.0', 'spread': '1.9', 'groupId': 'OG000'}, {'value': '8.5', 'spread': '1.9', 'groupId': 'OG001'}, {'value': '8.4', 'spread': '2.2', 'groupId': 'OG002'}, {'value': '8.5', 'spread': '2.1', 'groupId': 'OG003'}]}]}, {'title': 'Year 2 [n= 22,21,20,22]', 'categories': [{'measurements': [{'value': '10.3', 'spread': '2.0', 'groupId': 'OG000'}, {'value': '9.6', 'spread': '2.1', 'groupId': 'OG001'}, {'value': '9.8', 'spread': '2.4', 'groupId': 'OG002'}, {'value': '9.9', 'spread': '2.2', 'groupId': 'OG003'}]}]}, {'title': 'Year 3 [n=21,19,19,20]', 'categories': [{'measurements': [{'value': '11.4', 'spread': '2.0', 'groupId': 'OG000'}, {'value': '10.9', 'spread': '2.2', 'groupId': 'OG001'}, {'value': '11.4', 'spread': '2.4', 'groupId': 'OG002'}, {'value': '10.9', 'spread': '2.2', 'groupId': 'OG003'}]}]}, {'title': 'Year 4 [n=3,4,5,3]', 'categories': [{'measurements': [{'value': '12.4', 'spread': '1.0', 'groupId': 'OG000'}, {'value': '10.9', 'spread': '1.8', 'groupId': 'OG001'}, {'value': '12.2', 'spread': '3.0', 'groupId': 'OG002'}, {'value': '12.5', 'spread': '2.1', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At baseline(day 1), year 1,2,3 and 4', 'description': "Assessed by bone age. Bone age was determined by the radiograph.\n\nThe SDS was calculated as: SDS=\\[(value /M)\\^L - 1\\] / LS; using power (L), Mean (M) and coefficient of variation (S). The reference values were dependent on gender in addition to age and were selected at the age the closest below subject's age. SDS scores were calculated using L, M and S as defined in the National Center for Health Statistics 2000 data as provided by the Center for Disease Control (Kuczmarski, Ogden et al. 2002)", 'unitOfMeasure': 'SDS', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Completers, the completer population consists of all subjects that remained in the study until a specific time point (ie; Year 1, Year 2, Year 3 and Year 4).'}, {'type': 'SECONDARY', 'title': 'Changes From Baseline (Day 1) in Serum Concentrations of Growth Hormone (GH)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '27', 'groupId': 'OG002'}, {'value': '26', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'rhGH Alone', 'description': 'Nutropin AQ® (Somatropin \\[rDNA origin\\]): rhGH (Somatropin) 45µg/kg once daily injection'}, {'id': 'OG001', 'title': '45 rhGH + 50 rhIGF-1', 'description': 'Increlex® (Mecasermin \\[rDNA origin\\] injection) + Nutropin AQ® (Somatropin \\[rDNA origin\\]): rhGH (Somatropin) 45µg/kg and rhIGF-1 (Mecasermin) 50µg/kg once daily injections'}, {'id': 'OG002', 'title': '45 rhGH + 100 rhIGF-1', 'description': 'Increlex® (Mecasermin \\[rDNA origin\\] injection) + Nutropin AQ® (Somatropin \\[rDNA origin\\]): rhGH 45µg/kg and rhIGF-1 100µg/kg once daily injections'}, {'id': 'OG003', 'title': '45 rhGH + 150 rhIGF-1', 'description': 'Increlex® (Mecasermin \\[rDNA origin\\] injection) + Nutropin AQ® (Somatropin \\[rDNA origin\\]): rhGH 45µg/kg and rhIGF-1 150µg/kg once daily injection'}], 'classes': [{'title': 'Day 1 (Baseline) [n=23,25,18,25]', 'categories': [{'measurements': [{'value': '1.1', 'spread': '2.2', 'groupId': 'OG000'}, {'value': '2.9', 'spread': '8.1', 'groupId': 'OG001'}, {'value': '2.4', 'spread': '4.5', 'groupId': 'OG002'}, {'value': '1.9', 'spread': '2.3', 'groupId': 'OG003'}]}]}, {'title': 'Year 1 (Trough) [n=23,25,18,25]', 'categories': [{'measurements': [{'value': '1.7', 'spread': '2.1', 'groupId': 'OG000'}, {'value': '3.5', 'spread': '12.9', 'groupId': 'OG001'}, {'value': '2.1', 'spread': '3.2', 'groupId': 'OG002'}, {'value': '1.4', 'spread': '2.1', 'groupId': 'OG003'}]}]}, {'title': 'Year 2 (Trough) [n=21,20,16,20]', 'categories': [{'measurements': [{'value': '4.0', 'spread': '6.0', 'groupId': 'OG000'}, {'value': '2.2', 'spread': '4.2', 'groupId': 'OG001'}, {'value': '2.7', 'spread': '3.9', 'groupId': 'OG002'}, {'value': '1.4', 'spread': '1.2', 'groupId': 'OG003'}]}]}, {'title': 'Year 3 (Trough) [n=20,18,15,20]', 'categories': [{'measurements': [{'value': '2.8', 'spread': '5.1', 'groupId': 'OG000'}, {'value': '1.3', 'spread': '1.6', 'groupId': 'OG001'}, {'value': '1.5', 'spread': '1.4', 'groupId': 'OG002'}, {'value': '1.9', 'spread': '3.5', 'groupId': 'OG003'}]}]}, {'title': 'Year 4 (Trough) [n=3,5,4,3]', 'categories': [{'measurements': [{'value': '1.2', 'spread': '0.3', 'groupId': 'OG000'}, {'value': '0.5', 'spread': '0.4', 'groupId': 'OG001'}, {'value': '3.0', 'spread': '2.9', 'groupId': 'OG002'}, {'value': '1.1', 'spread': '0.6', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At Baseline (Day 1), Year 1,2,3 and 4', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified Intent-to-Treat (MITT) Population comprised all subjects who were randomized and had at least one post-baseline height measurement.'}, {'type': 'SECONDARY', 'title': 'Changes From Baseline (Day 1) in Serum Concentrations of Insulin-Like Growth Factor-1 (IGF-1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '27', 'groupId': 'OG002'}, {'value': '26', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'rhGH Alone', 'description': 'Nutropin AQ® (Somatropin \\[rDNA origin\\]): rhGH (Somatropin) 45µg/kg once daily injection'}, {'id': 'OG001', 'title': '45 rhGH + 50 rhIGF-1', 'description': 'Increlex® (Mecasermin \\[rDNA origin\\] injection) + Nutropin AQ® (Somatropin \\[rDNA origin\\]): rhGH (Somatropin) 45µg/kg and rhIGF-1 (Mecasermin) 50µg/kg once daily injections'}, {'id': 'OG002', 'title': '45 rhGH + 100 rhIGF-1', 'description': 'Increlex® (Mecasermin \\[rDNA origin\\] injection) + Nutropin AQ® (Somatropin \\[rDNA origin\\]): rhGH 45µg/kg and rhIGF-1 100µg/kg once daily injections'}, {'id': 'OG003', 'title': '45 rhGH + 150 rhIGF-1', 'description': 'Increlex® (Mecasermin \\[rDNA origin\\] injection) + Nutropin AQ® (Somatropin \\[rDNA origin\\]): rhGH 45µg/kg and rhIGF-1 150µg/kg once daily injection'}], 'classes': [{'title': 'Day 1 (Baseline) [n= 24,25,22,25]', 'categories': [{'measurements': [{'value': '108.3', 'spread': '39.8', 'groupId': 'OG000'}, {'value': '87.1', 'spread': '31.0', 'groupId': 'OG001'}, {'value': '100.2', 'spread': '41.4', 'groupId': 'OG002'}, {'value': '96.7', 'spread': '38.8', 'groupId': 'OG003'}]}]}, {'title': 'Year 1 (Trough) [n= 24,25,22,25]', 'categories': [{'measurements': [{'value': '278.2', 'spread': '95.5', 'groupId': 'OG000'}, {'value': '326.9', 'spread': '108.9', 'groupId': 'OG001'}, {'value': '397.8', 'spread': '185.4', 'groupId': 'OG002'}, {'value': '296.0', 'spread': '126.8', 'groupId': 'OG003'}]}]}, {'title': 'Year 2 (Trough) [n= 22,21,20,22]', 'categories': [{'measurements': [{'value': '312.8', 'spread': '97.2', 'groupId': 'OG000'}, {'value': '427.2', 'spread': '178.5', 'groupId': 'OG001'}, {'value': '539.3', 'spread': '195.9', 'groupId': 'OG002'}, {'value': '466.4', 'spread': '178.6', 'groupId': 'OG003'}]}]}, {'title': 'Year 3 (Trough)[n= 21,19,19, 20]', 'categories': [{'measurements': [{'value': '335.3', 'spread': '110.0', 'groupId': 'OG000'}, {'value': '404.9', 'spread': '104.4', 'groupId': 'OG001'}, {'value': '462.2', 'spread': '156.4', 'groupId': 'OG002'}, {'value': '441.3', 'spread': '226.0', 'groupId': 'OG003'}]}]}, {'title': 'Year 4 (Trough)[n= 3,5,5,3]', 'categories': [{'measurements': [{'value': '347.7', 'spread': '130.7', 'groupId': 'OG000'}, {'value': '363.6', 'spread': '125.4', 'groupId': 'OG001'}, {'value': '546.2', 'spread': '265.8', 'groupId': 'OG002'}, {'value': '607.7', 'spread': '65.0', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At Baseline (Day 1), Year 1,2,3 and 4', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified Intent-to-Treat (MITT) Population comprised all subjects who were randomized and had at least one post-baseline height measurement.'}, {'type': 'SECONDARY', 'title': 'Changes From Baseline (Day 1) in Serum Concentrations of Insulin-Like Growth Factor Binding Protein-1 (IGFBP-1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '27', 'groupId': 'OG002'}, {'value': '26', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'rhGH Alone', 'description': 'Nutropin AQ® (Somatropin \\[rDNA origin\\]): rhGH (Somatropin) 45µg/kg once daily injection'}, {'id': 'OG001', 'title': '45 rhGH + 50 rhIGF-1', 'description': 'Increlex® (Mecasermin \\[rDNA origin\\] injection) + Nutropin AQ® (Somatropin \\[rDNA origin\\]): rhGH (Somatropin) 45µg/kg and rhIGF-1 (Mecasermin) 50µg/kg once daily injections'}, {'id': 'OG002', 'title': '45 rhGH + 100 rhIGF-1', 'description': 'Increlex® (Mecasermin \\[rDNA origin\\] injection) + Nutropin AQ® (Somatropin \\[rDNA origin\\]): rhGH 45µg/kg and rhIGF-1 100µg/kg once daily injections'}, {'id': 'OG003', 'title': '45 rhGH + 150 rhIGF-1', 'description': 'Increlex® (Mecasermin \\[rDNA origin\\] injection) + Nutropin AQ® (Somatropin \\[rDNA origin\\]): rhGH 45µg/kg and rhIGF-1 150µg/kg once daily injection'}], 'classes': [{'title': 'Day 1 (Baseline) [n= 24,24,21,24]', 'categories': [{'measurements': [{'value': '87.8', 'spread': '54.5', 'groupId': 'OG000'}, {'value': '102.5', 'spread': '37.2', 'groupId': 'OG001'}, {'value': '95.7', 'spread': '50.0', 'groupId': 'OG002'}, {'value': '122.4', 'spread': '53.7', 'groupId': 'OG003'}]}]}, {'title': 'Year 1 (Trough) [n= 24,24,21,24]', 'categories': [{'measurements': [{'value': '45.7', 'spread': '38.0', 'groupId': 'OG000'}, {'value': '63.8', 'spread': '50.1', 'groupId': 'OG001'}, {'value': '68.2', 'spread': '61.6', 'groupId': 'OG002'}, {'value': '88.8', 'spread': '47.4', 'groupId': 'OG003'}]}]}, {'title': 'Year 2 (Trough) [n= 22,21,19,20]', 'categories': [{'measurements': [{'value': '59.4', 'spread': '45.6', 'groupId': 'OG000'}, {'value': '58.2', 'spread': '47.7', 'groupId': 'OG001'}, {'value': '53.3', 'spread': '35.3', 'groupId': 'OG002'}, {'value': '71.7', 'spread': '46.1', 'groupId': 'OG003'}]}]}, {'title': 'Year 3 (Trough) [n= 21,19,18,19]', 'categories': [{'measurements': [{'value': '46.1', 'spread': '35.2', 'groupId': 'OG000'}, {'value': '60.4', 'spread': '52.5', 'groupId': 'OG001'}, {'value': '53.2', 'spread': '34.8', 'groupId': 'OG002'}, {'value': '84.7', 'spread': '53.5', 'groupId': 'OG003'}]}]}, {'title': 'Year 4 (Trough) [n= 3,5,5,3]', 'categories': [{'measurements': [{'value': '100.0', 'spread': '60.4', 'groupId': 'OG000'}, {'value': '46.8', 'spread': '58.0', 'groupId': 'OG001'}, {'value': '49.2', 'spread': '20.7', 'groupId': 'OG002'}, {'value': '49.0', 'spread': '26.9', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At Baseline (Day 1), Year 1,2,3 and 4', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified Intent-to-Treat (MITT) Population comprised all subjects who were randomized and had at least one post-baseline height measurement.'}, {'type': 'SECONDARY', 'title': 'Changes From Baseline (Day 1) in Serum Concentrations of Insulin-Like Growth Factor Binding Protein-3 (IGFPB-3)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '27', 'groupId': 'OG002'}, {'value': '26', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'rhGH Alone', 'description': 'Nutropin AQ® (Somatropin \\[rDNA origin\\]): rhGH (Somatropin) 45µg/kg once daily injection'}, {'id': 'OG001', 'title': '45 rhGH + 50 rhIGF-1', 'description': 'Increlex® (Mecasermin \\[rDNA origin\\] injection) + Nutropin AQ® (Somatropin \\[rDNA origin\\]): rhGH (Somatropin) 45µg/kg and rhIGF-1 (Mecasermin) 50µg/kg once daily injections'}, {'id': 'OG002', 'title': '45 rhGH + 100 rhIGF-1', 'description': 'Increlex® (Mecasermin \\[rDNA origin\\] injection) + Nutropin AQ® (Somatropin \\[rDNA origin\\]): rhGH 45µg/kg and rhIGF-1 100µg/kg once daily injections'}, {'id': 'OG003', 'title': '45 rhGH + 150 rhIGF-1', 'description': 'Increlex® (Mecasermin \\[rDNA origin\\] injection) + Nutropin AQ® (Somatropin \\[rDNA origin\\]): rhGH 45µg/kg and rhIGF-1 150µg/kg once daily injection'}], 'classes': [{'title': 'Day 1 (Baseline) [n= 24,25,22,25]', 'categories': [{'measurements': [{'value': '2204.2', 'spread': '387.3', 'groupId': 'OG000'}, {'value': '2160.0', 'spread': '421.3', 'groupId': 'OG001'}, {'value': '2113.6', 'spread': '486.3', 'groupId': 'OG002'}, {'value': '2196.0', 'spread': '612.0', 'groupId': 'OG003'}]}]}, {'title': 'Year 1 (Trough) [n= 24,25,22,25]', 'categories': [{'measurements': [{'value': '2954.2', 'spread': '618.5', 'groupId': 'OG000'}, {'value': '2784.0', 'spread': '755.9', 'groupId': 'OG001'}, {'value': '2677.3', 'spread': '548.5', 'groupId': 'OG002'}, {'value': '2624.0', 'spread': '598.8', 'groupId': 'OG003'}]}]}, {'title': 'Year 2 (Trough) [n= 22,21,20,22]', 'categories': [{'measurements': [{'value': '2813.6', 'spread': '399.2', 'groupId': 'OG000'}, {'value': '2942.9', 'spread': '552.8', 'groupId': 'OG001'}, {'value': '3060.0', 'spread': '703.7', 'groupId': 'OG002'}, {'value': '2754.5', 'spread': '600.6', 'groupId': 'OG003'}]}]}, {'title': 'Year 3 (Trough) [n= 21,19,19,20]', 'categories': [{'measurements': [{'value': '3404.8', 'spread': '476.9', 'groupId': 'OG000'}, {'value': '3431.6', 'spread': '718.1', 'groupId': 'OG001'}, {'value': '3373.7', 'spread': '479.4', 'groupId': 'OG002'}, {'value': '3260.0', 'spread': '908.1', 'groupId': 'OG003'}]}]}, {'title': 'Year 4 (Trough) [n= 3,5,5,3]', 'categories': [{'measurements': [{'value': '3733.3', 'spread': '378.6', 'groupId': 'OG000'}, {'value': '3260.0', 'spread': '709.2', 'groupId': 'OG001'}, {'value': '3620.0', 'spread': '957.6', 'groupId': 'OG002'}, {'value': '3466.7', 'spread': '461.9', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At Baseline (Day 1), Year 1,2,3 and 4', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified Intent-to-Treat (MITT) Population comprised all subjects who were randomized and had at least one post-baseline height measurement.'}, {'type': 'SECONDARY', 'title': 'Changes From Baseline (Day 1) in Serum Concentrations of Acid-Labile Subunit (ALS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '27', 'groupId': 'OG002'}, {'value': '26', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'rhGH Alone', 'description': 'Nutropin AQ® (Somatropin \\[rDNA origin\\]): rhGH (Somatropin) 45µg/kg once daily injection'}, {'id': 'OG001', 'title': '45 rhGH + 50 rhIGF-1', 'description': 'Increlex® (Mecasermin \\[rDNA origin\\] injection) + Nutropin AQ® (Somatropin \\[rDNA origin\\]): rhGH (Somatropin) 45µg/kg and rhIGF-1 (Mecasermin) 50µg/kg once daily injections'}, {'id': 'OG002', 'title': '45 rhGH + 100 rhIGF-1', 'description': 'Increlex® (Mecasermin \\[rDNA origin\\] injection) + Nutropin AQ® (Somatropin \\[rDNA origin\\]): rhGH 45µg/kg and rhIGF-1 100µg/kg once daily injections'}, {'id': 'OG003', 'title': '45 rhGH + 150 rhIGF-1', 'description': 'Increlex® (Mecasermin \\[rDNA origin\\] injection) + Nutropin AQ® (Somatropin \\[rDNA origin\\]): rhGH 45µg/kg and rhIGF-1 150µg/kg once daily injection'}], 'classes': [{'title': 'Day 1 (Baseline) [n=25,26,26,25]', 'categories': [{'measurements': [{'value': '10.6', 'spread': '3.0', 'groupId': 'OG000'}, {'value': '10.0', 'spread': '3.4', 'groupId': 'OG001'}, {'value': '10.9', 'spread': '3.0', 'groupId': 'OG002'}, {'value': '11.0', 'spread': '4.1', 'groupId': 'OG003'}]}]}, {'title': 'Year 1 (Trough) [n=24,24,21,24]', 'categories': [{'measurements': [{'value': '16.0', 'spread': '4.0', 'groupId': 'OG000'}, {'value': '12.7', 'spread': '2.3', 'groupId': 'OG001'}, {'value': '14.0', 'spread': '3.9', 'groupId': 'OG002'}, {'value': '11.5', 'spread': '2.8', 'groupId': 'OG003'}]}]}, {'title': 'Year 2 (Trough) [n= 22,21,19,20]', 'categories': [{'measurements': [{'value': '15.2', 'spread': '4.3', 'groupId': 'OG000'}, {'value': '14.3', 'spread': '5.2', 'groupId': 'OG001'}, {'value': '15.7', 'spread': '4.0', 'groupId': 'OG002'}, {'value': '13.7', 'spread': '4.5', 'groupId': 'OG003'}]}]}, {'title': 'Year 3 (Trough) [n= 21,18,18,19]', 'categories': [{'measurements': [{'value': '13.7', 'spread': '2.3', 'groupId': 'OG000'}, {'value': '13.0', 'spread': '3.2', 'groupId': 'OG001'}, {'value': '12.9', 'spread': '2.7', 'groupId': 'OG002'}, {'value': '11.2', 'spread': '4.0', 'groupId': 'OG003'}]}]}, {'title': 'Year 4 (Trough) [n= 3,5,5,3]', 'categories': [{'measurements': [{'value': '13.7', 'spread': '1.5', 'groupId': 'OG000'}, {'value': '12.0', 'spread': '2.2', 'groupId': 'OG001'}, {'value': '12.0', 'spread': '3.0', 'groupId': 'OG002'}, {'value': '13.7', 'spread': '2.1', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At Baseline (Day 1), Year 1,2,3 and 4', 'unitOfMeasure': 'mg/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified Intent-to-Treat (MITT) Population comprised all subjects who were randomized and had at least one post-baseline height measurement.'}, {'type': 'SECONDARY', 'title': 'Changes From Baseline (Day 1) in Serum Concentrations of Growth Hormone Binding Protein (GHBP)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '27', 'groupId': 'OG002'}, {'value': '26', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'rhGH Alone', 'description': 'Nutropin AQ® (Somatropin \\[rDNA origin\\]): rhGH (Somatropin) 45µg/kg once daily injection'}, {'id': 'OG001', 'title': '45 rhGH + 50 rhIGF-1', 'description': 'Increlex® (Mecasermin \\[rDNA origin\\] injection) + Nutropin AQ® (Somatropin \\[rDNA origin\\]): rhGH (Somatropin) 45µg/kg and rhIGF-1 (Mecasermin) 50µg/kg once daily injections'}, {'id': 'OG002', 'title': '45 rhGH + 100 rhIGF-1', 'description': 'Increlex® (Mecasermin \\[rDNA origin\\] injection) + Nutropin AQ® (Somatropin \\[rDNA origin\\]): rhGH 45µg/kg and rhIGF-1 100µg/kg once daily injections'}, {'id': 'OG003', 'title': '45 rhGH + 150 rhIGF-1', 'description': 'Increlex® (Mecasermin \\[rDNA origin\\] injection) + Nutropin AQ® (Somatropin \\[rDNA origin\\]): rhGH 45µg/kg and rhIGF-1 150µg/kg once daily injection'}], 'classes': [{'title': 'Day 1 (Baseline) [n= 25,26,25,25]', 'categories': [{'measurements': [{'value': '785.8', 'spread': '291.1', 'groupId': 'OG000'}, {'value': '735.8', 'spread': '343.5', 'groupId': 'OG001'}, {'value': '698.8', 'spread': '212.2', 'groupId': 'OG002'}, {'value': '719.0', 'spread': '261.5', 'groupId': 'OG003'}]}]}, {'title': 'Year 1 (Trough) [n= 23,24,20,24]', 'categories': [{'measurements': [{'value': '729.4', 'spread': '229.5', 'groupId': 'OG000'}, {'value': '576.9', 'spread': '211.0', 'groupId': 'OG001'}, {'value': '598.9', 'spread': '187.3', 'groupId': 'OG002'}, {'value': '530.5', 'spread': '233.5', 'groupId': 'OG003'}]}]}, {'title': 'Year 2 (Trough) [n=22,21,18,21]', 'categories': [{'measurements': [{'value': '725.6', 'spread': '308.4', 'groupId': 'OG000'}, {'value': '589.3', 'spread': '171.6', 'groupId': 'OG001'}, {'value': '562.5', 'spread': '184.4', 'groupId': 'OG002'}, {'value': '564.6', 'spread': '171.9', 'groupId': 'OG003'}]}]}, {'title': 'Year 3 (Trough) [n= 21,17,17,19]', 'categories': [{'measurements': [{'value': '672.0', 'spread': '224.4', 'groupId': 'OG000'}, {'value': '646.9', 'spread': '204.1', 'groupId': 'OG001'}, {'value': '614.3', 'spread': '210.9', 'groupId': 'OG002'}, {'value': '554.9', 'spread': '197.0', 'groupId': 'OG003'}]}]}, {'title': 'Year 4 (Trough) [n= 3,5,5,3]', 'categories': [{'measurements': [{'value': '714.0', 'spread': '38.5', 'groupId': 'OG000'}, {'value': '516.9', 'spread': '252.5', 'groupId': 'OG001'}, {'value': '798.2', 'spread': '336.1', 'groupId': 'OG002'}, {'value': '519.7', 'spread': '141.1', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At Baseline (Day 1), Year 1,2,3 and 4', 'unitOfMeasure': 'pmol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified Intent-to-Treat (MITT) Population comprised all subjects who were randomized and had at least one post-baseline height measurement.'}, {'type': 'SECONDARY', 'title': 'Summary of Adverse Events With Number of Occurrences', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '27', 'groupId': 'OG002'}, {'value': '26', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'rhGH Alone', 'description': 'Nutropin AQ® (Somatropin \\[rDNA origin\\]): rhGH (Somatropin) 45µg/kg once daily injection'}, {'id': 'OG001', 'title': '45 rhGH + 50 rhIGF-1', 'description': 'Increlex® (Mecasermin \\[rDNA origin\\] injection) + Nutropin AQ® (Somatropin \\[rDNA origin\\]): rhGH (Somatropin) 45µg/kg and rhIGF-1 (Mecasermin) 50µg/kg once daily injections'}, {'id': 'OG002', 'title': '45 rhGH + 100 rhIGF-1', 'description': 'Increlex® (Mecasermin \\[rDNA origin\\] injection) + Nutropin AQ® (Somatropin \\[rDNA origin\\]): rhGH 45µg/kg and rhIGF-1 100µg/kg once daily injections'}, {'id': 'OG003', 'title': '45 rhGH + 150 rhIGF-1', 'description': 'Increlex® (Mecasermin \\[rDNA origin\\] injection) + Nutropin AQ® (Somatropin \\[rDNA origin\\]): rhGH 45µg/kg and rhIGF-1 150µg/kg once daily injection'}], 'classes': [{'title': 'Any Adverse Event', 'categories': [{'measurements': [{'value': '381', 'groupId': 'OG000'}, {'value': '416', 'groupId': 'OG001'}, {'value': '401', 'groupId': 'OG002'}, {'value': '518', 'groupId': 'OG003'}]}]}, {'title': 'Any TEAE', 'categories': [{'measurements': [{'value': '374', 'groupId': 'OG000'}, {'value': '406', 'groupId': 'OG001'}, {'value': '392', 'groupId': 'OG002'}, {'value': '513', 'groupId': 'OG003'}]}]}, {'title': 'Severe TEAEs', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}]}, {'title': 'Moderate TEAE', 'categories': [{'measurements': [{'value': '60', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}, {'value': '57', 'groupId': 'OG002'}, {'value': '86', 'groupId': 'OG003'}]}]}, {'title': 'Mild TEAE', 'categories': [{'measurements': [{'value': '309', 'groupId': 'OG000'}, {'value': '346', 'groupId': 'OG001'}, {'value': '332', 'groupId': 'OG002'}, {'value': '424', 'groupId': 'OG003'}]}]}, {'title': 'Related TEAEs', 'categories': [{'measurements': [{'value': '27', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}, {'value': '74', 'groupId': 'OG002'}, {'value': '119', 'groupId': 'OG003'}]}]}, {'title': 'Related and Severe', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Related and Moderate', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}, {'value': '13', 'groupId': 'OG003'}]}]}, {'title': 'Related and Mild', 'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '55', 'groupId': 'OG002'}, {'value': '106', 'groupId': 'OG003'}]}]}, {'title': 'TEAEs Leading to Study Withdrawal', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '36', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}]}, {'title': 'SAEs', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'Deaths', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Approximately up to 4 years.', 'description': 'A Data Monitoring Committee (DMC) was established to monitor subject safety', 'unitOfMeasure': 'Number of events', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population: Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': '45 rhGH Alone', 'description': 'Nutropin AQ® (Somatropin \\[rDNA origin\\]): Recombinant Human Growth Hormone (rhGH) (Somatropin) 45µg/kg once daily injection'}, {'id': 'FG001', 'title': '45 rhGH + 50 rhIGF-1', 'description': 'Increlex® (Mecasermin \\[rDNA origin\\] injection) + Nutropin AQ® (Somatropin \\[rDNA origin\\]): rhGH (Somatropin) 45µg/kg and Recombinant Human Insulin-Like Growth Factor-1 (rhIGF-1) (Mecasermin) 50µg/kg once daily injections'}, {'id': 'FG002', 'title': '45 rhGH + 100 rhIGF-1', 'description': 'Increlex® (Mecasermin \\[rDNA origin\\] injection) + Nutropin AQ® (Somatropin \\[rDNA origin\\]): rhGH 45µg/kg and rhIGF-1 100µg/kg once daily injections'}, {'id': 'FG003', 'title': '45 rhGH + 150 rhIGF-1', 'description': 'Increlex® (Mecasermin \\[rDNA origin\\] injection) + Nutropin AQ® (Somatropin \\[rDNA origin\\]): rhGH 45µg/kg and rhIGF-1 150µg/kg once daily injection'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '26'}, {'groupId': 'FG001', 'numSubjects': '27'}, {'groupId': 'FG002', 'numSubjects': '27'}, {'groupId': 'FG003', 'numSubjects': '26'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '26'}, {'groupId': 'FG001', 'numSubjects': '26'}, {'groupId': 'FG002', 'numSubjects': '27'}, {'groupId': 'FG003', 'numSubjects': '25'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '2'}]}, {'type': 'Patient/Parent Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '3'}]}, {'type': 'Sponsor Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '16'}, {'groupId': 'FG002', 'numSubjects': '17'}, {'groupId': 'FG003', 'numSubjects': '19'}]}]}], 'recruitmentDetails': 'Date of first enrolment: December 2007. Date of last completed: March 2012. This was a Phase II, multicenter, randomized, open-label, parallel-group, active treatment controlled, dose selection study conducted at 27 centers in the US.', 'preAssignmentDetails': 'Study screened 155 subjects. Due to failure in screening 49 subjects were excluded from the trial before assignment to groups.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}, {'value': '26', 'groupId': 'BG003'}, {'value': '106', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': '45 rhGH Alone', 'description': 'Nutropin AQ® (Somatropin \\[rDNA origin\\]): rhGH (Somatropin) 45µg/kg once daily injection'}, {'id': 'BG001', 'title': '45 rhGH + 50 rhIGF-1', 'description': 'Increlex® (Mecasermin \\[rDNA origin\\] injection) + Nutropin AQ® (Somatropin \\[rDNA origin\\]): rhGH (Somatropin) 45µg/kg and rhIGF-1 (Mecasermin) 50µg/kg once daily injections'}, {'id': 'BG002', 'title': '45 rhGH + 100 rhIGF-1', 'description': 'Increlex® (Mecasermin \\[rDNA origin\\] injection) + Nutropin AQ® (Somatropin \\[rDNA origin\\]): rhGH 45µg/kg and rhIGF-1 100µg/kg once daily injections'}, {'id': 'BG003', 'title': '45 rhGH + 150 rhIGF-1', 'description': 'Increlex® (Mecasermin \\[rDNA origin\\] injection) + Nutropin AQ® (Somatropin \\[rDNA origin\\]): rhGH 45µg/kg and rhIGF-1 150µg/kg once daily injection'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '9.2', 'spread': '2.0', 'groupId': 'BG000'}, {'value': '8.4', 'spread': '2.0', 'groupId': 'BG001'}, {'value': '9.0', 'spread': '2.2', 'groupId': 'BG002'}, {'value': '8.8', 'spread': '2.3', 'groupId': 'BG003'}, {'value': '8.8', 'spread': '2.1', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '21', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}, {'value': '22', 'groupId': 'BG003'}, {'value': '85', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race', 'classes': [{'title': 'Asian', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '8', 'groupId': 'BG004'}]}]}, {'title': 'Black', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}]}]}, {'title': 'Hispanic', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '10', 'groupId': 'BG004'}]}]}, {'title': 'White', 'categories': [{'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}, {'value': '23', 'groupId': 'BG003'}, {'value': '79', 'groupId': 'BG004'}]}]}, {'title': 'Hispanic/White', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '5', 'groupId': 'BG004'}]}]}, {'title': 'Hawaiian or Pacific Islander/ White', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Height', 'classes': [{'categories': [{'measurements': [{'value': '-2.5', 'spread': '0.5', 'groupId': 'BG000'}, {'value': '-2.5', 'spread': '0.4', 'groupId': 'BG001'}, {'value': '-2.6', 'spread': '0.4', 'groupId': 'BG002'}, {'value': '-2.6', 'spread': '0.4', 'groupId': 'BG003'}, {'value': '-2.5', 'spread': '0.4', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'description': "Height was measured standing and without shoes, and recorded as the mean of three measurements (the subject being repositioned each time) by the same observer using a Harpenden or other wall-mounted stadiometer which was to be calibrated prior to measurement of each subject and a calibration log kept.\n\nThe SDS calculation and description is specified in baseline characteristic for parameter 'Weight'", 'unitOfMeasure': 'Standard Deviation Score (SDS)', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Weight', 'classes': [{'categories': [{'measurements': [{'value': '-2.0', 'spread': '0.7', 'groupId': 'BG000'}, {'value': '-2.1', 'spread': '0.6', 'groupId': 'BG001'}, {'value': '-2.0', 'spread': '0.7', 'groupId': 'BG002'}, {'value': '-2.2', 'spread': '0.9', 'groupId': 'BG003'}, {'value': '-2.1', 'spread': '0.7', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'description': "Weight was recorded from a single observation of the subject in light clothing or dressing gown with shoes removed.\n\nThe SDS was calculated as: SDS=\\[(value /M)\\^L - 1\\] / LS; using power (L), Mean (M) and coefficient of variation (S). The reference values were dependent on gender in addition to age and were selected at the age the closest below subject's age. SDS scores were calculated using L, M and S as defined in the National Center for Health Statistics 2000 data as provided by the Center for Disease Control (Kuczmarski, Ogden et al. 2002)", 'unitOfMeasure': 'SDS', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Body Mass Index (BMI)', 'classes': [{'categories': [{'measurements': [{'value': '-0.3', 'spread': '0.7', 'groupId': 'BG000'}, {'value': '-0.5', 'spread': '0.7', 'groupId': 'BG001'}, {'value': '-0.4', 'spread': '0.7', 'groupId': 'BG002'}, {'value': '-0.5', 'spread': '0.8', 'groupId': 'BG003'}, {'value': '-0.4', 'spread': '0.7', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'description': "BMI was calculated by weight divided by height squared and measured as kilogram per square meter (kg/m\\^2).\n\nThe SDS was calculated as: SDS=\\[(value /M)\\^L - 1\\] / LS; using power (L), Mean (M) and coefficient of variation (S). The reference values were dependent on gender in addition to age and were selected at the age the closest below subject's age. SDS scores were calculated using L, M and S as defined in the National Center for Health Statistics 2000 data as provided by the Center for Disease Control (Kuczmarski, Ogden et al. 2002)", 'unitOfMeasure': 'SDS', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'IGF-1', 'classes': [{'categories': [{'measurements': [{'value': '-1.8', 'spread': '0.5', 'groupId': 'BG000'}, {'value': '-2.0', 'spread': '0.7', 'groupId': 'BG001'}, {'value': '-1.8', 'spread': '0.6', 'groupId': 'BG002'}, {'value': '-2.0', 'spread': '0.6', 'groupId': 'BG003'}, {'value': '-1.9', 'spread': '0.6', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'description': 'IGF-1 SDS was computed based on actual value of IGF-1, the mean reference value of IGF-1 and the SD reference value of IGF-1 as defined in the International Congress of Endocrinology, Lisbon, 2004', 'unitOfMeasure': 'SDS', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Mid-Parental target height', 'classes': [{'categories': [{'measurements': [{'value': '-0.5', 'spread': '0.4', 'groupId': 'BG000'}, {'value': '-0.6', 'spread': '0.5', 'groupId': 'BG001'}, {'value': '-0.5', 'spread': '0.5', 'groupId': 'BG002'}, {'value': '-0.5', 'spread': '0.5', 'groupId': 'BG003'}, {'value': '-0.5', 'spread': '0.5', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'description': "The mid-parental target height SDS is defined as: 0.4\\*(Mother's Height SDS+Father's Height SDS)\n\nThe SDS was calculated as: SDS=\\[(value /M)\\^L - 1\\] / LS; using power (L), Mean (M) and coefficient of variation (S). The reference values were dependent on gender in addition to age and were selected at the age the closest below subject's age. SDS scores were calculated using L, M and S as defined in the National Center for Health Statistics 2000 data as provided by the Center for Disease Control (Kuczmarski, Ogden et al. 2002)", 'unitOfMeasure': 'SDS', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Bone age imputed', 'classes': [{'categories': [{'measurements': [{'value': '7.6', 'spread': '1.7', 'groupId': 'BG000'}, {'value': '7.2', 'spread': '1.8', 'groupId': 'BG001'}, {'value': '7.2', 'spread': '2.0', 'groupId': 'BG002'}, {'value': '7.3', 'spread': '2.0', 'groupId': 'BG003'}, {'value': '7.3', 'spread': '1.9', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Height Age', 'classes': [{'categories': [{'measurements': [{'value': '6.5', 'spread': '1.6', 'groupId': 'BG000'}, {'value': '6.0', 'spread': '1.5', 'groupId': 'BG001'}, {'value': '6.4', 'spread': '1.8', 'groupId': 'BG002'}, {'value': '6.2', 'spread': '1.9', 'groupId': 'BG003'}, {'value': '6.3', 'spread': '1.7', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Max stimulated GH', 'classes': [{'categories': [{'measurements': [{'value': '17.9', 'spread': '8.9', 'groupId': 'BG000'}, {'value': '18.2', 'spread': '8.4', 'groupId': 'BG001'}, {'value': '19.5', 'spread': '6.3', 'groupId': 'BG002'}, {'value': '20.1', 'spread': '8.4', 'groupId': 'BG003'}, {'value': '18.9', 'spread': '8.0', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'IGFBP-3 SDS', 'classes': [{'categories': [{'measurements': [{'value': '-1.1', 'spread': '0.7', 'groupId': 'BG000'}, {'value': '-1.2', 'spread': '0.9', 'groupId': 'BG001'}, {'value': '-1.0', 'spread': '0.8', 'groupId': 'BG002'}, {'value': '-1.3', 'spread': '0.8', 'groupId': 'BG003'}, {'value': '-1.1', 'spread': '0.8', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'description': 'Number of subjects analysed= 26,26,27,26 (Total 105)\n\nIGFBP-3 SDS was computed based on actual value of IGFBP-3, the mean reference value of IGFBP-3 and the SD reference value of IGFBP-3 as defined in the International Congress of Endocrinology, Lisbon, 2004', 'unitOfMeasure': 'SDS', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Mother height', 'classes': [{'categories': [{'measurements': [{'value': '157', 'spread': '5', 'groupId': 'BG000'}, {'value': '157', 'spread': '5', 'groupId': 'BG001'}, {'value': '157', 'spread': '6', 'groupId': 'BG002'}, {'value': '159', 'spread': '7', 'groupId': 'BG003'}, {'value': '158', 'spread': '6', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'description': 'Number of subjects analysed= 24,23,25,25 (Total 97)', 'unitOfMeasure': 'cm', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Father height', 'classes': [{'categories': [{'measurements': [{'value': '172', 'spread': '4', 'groupId': 'BG000'}, {'value': '169', 'spread': '5', 'groupId': 'BG001'}, {'value': '173', 'spread': '7', 'groupId': 'BG002'}, {'value': '172', 'spread': '6', 'groupId': 'BG003'}, {'value': '172', 'spread': '6', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'description': 'Number of subjects analysed= 18,20,22,21 (Total = 81)', 'unitOfMeasure': 'cm', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'All Subjects'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 106}}, 'statusModule': {'whyStopped': 'The study was prematurely terminated due to strategic reasons.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2007-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'dispFirstSubmitDate': '2011-04-18', 'completionDateStruct': {'date': '2012-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-03-03', 'studyFirstSubmitDate': '2007-12-10', 'dispFirstSubmitQcDate': '2011-04-18', 'resultsFirstSubmitDate': '2015-08-06', 'studyFirstSubmitQcDate': '2007-12-10', 'dispFirstPostDateStruct': {'date': '2011-04-27', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2023-03-30', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2015-11-10', 'studyFirstPostDateStruct': {'date': '2007-12-12', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-12-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Height Velocity', 'timeFrame': 'First year of treatment'}], 'secondaryOutcomes': [{'measure': 'Height Velocity', 'timeFrame': 'Second, third and fourth year'}, {'measure': 'Cumulative Change in Height Standard Deviation Score (SDS)', 'timeFrame': 'First, second, third and fourth year', 'description': "Height was measured standing and without shoes, and recorded as the mean of three measurements (the subject being repositioned each time) by the same observer using a Harpenden or other wall-mounted stadiometer which was to be calibrated prior to measurement of each subject and a calibration log kept.\n\nThe SDS was calculated as: SDS=\\[(value /M)\\^L - 1\\] / LS; using power (L), Mean (M) and coefficient of variation (S). The reference values were dependent on gender in addition to age and were selected at the age the closest below subject's age. SDS scores were calculated using L, M and S as defined in the National Center for Health Statistics 2000 data as provided by the Center for Disease Control (Kuczmarski, Ogden et al. 2002)"}, {'measure': 'Predicted Adult Height (PAH)', 'timeFrame': 'At baseline (Day 1), year 1,2,3 and 4', 'description': "Predicted Adult Height calculated by method, Roche-Wainer-Thissen (RWT) and mid-parental target height SDS.\n\nThe SDS was calculated as: SDS=\\[(value /M)\\^L - 1\\] / LS; using power (L), Mean (M) and coefficient of variation (S). The reference values were dependent on gender in addition to age and were selected at the age the closest below subject's age. SDS scores were calculated using L, M and S as defined in the National Center for Health Statistics 2000 data as provided by the Center for Disease Control (Kuczmarski, Ogden et al. 2002)"}, {'measure': 'Total Change From Baseline (Day 1) in BMI SDS', 'timeFrame': 'At year 1,2,3,4 and end of study (visit 23) versus baseline (day 1)', 'description': "BMI was calculated by weight divided by height squared and measured as kilogram per square meter (kg/m\\^2).\n\nThe SDS was calculated as: SDS=\\[(value /M)\\^L - 1\\] / LS; using power (L), Mean (M) and coefficient of variation (S). The reference values were dependent on gender in addition to age and were selected at the age the closest below subject's age. SDS scores were calculated using L, M and S as defined in the National Center for Health Statistics 2000 data as provided by the Center for Disease Control (Kuczmarski, Ogden et al. 2002)"}, {'measure': 'Skeletal Maturation', 'timeFrame': 'At baseline(day 1), year 1,2,3 and 4', 'description': "Assessed by bone age. Bone age was determined by the radiograph.\n\nThe SDS was calculated as: SDS=\\[(value /M)\\^L - 1\\] / LS; using power (L), Mean (M) and coefficient of variation (S). The reference values were dependent on gender in addition to age and were selected at the age the closest below subject's age. SDS scores were calculated using L, M and S as defined in the National Center for Health Statistics 2000 data as provided by the Center for Disease Control (Kuczmarski, Ogden et al. 2002)"}, {'measure': 'Changes From Baseline (Day 1) in Serum Concentrations of Growth Hormone (GH)', 'timeFrame': 'At Baseline (Day 1), Year 1,2,3 and 4'}, {'measure': 'Changes From Baseline (Day 1) in Serum Concentrations of Insulin-Like Growth Factor-1 (IGF-1)', 'timeFrame': 'At Baseline (Day 1), Year 1,2,3 and 4'}, {'measure': 'Changes From Baseline (Day 1) in Serum Concentrations of Insulin-Like Growth Factor Binding Protein-1 (IGFBP-1)', 'timeFrame': 'At Baseline (Day 1), Year 1,2,3 and 4'}, {'measure': 'Changes From Baseline (Day 1) in Serum Concentrations of Insulin-Like Growth Factor Binding Protein-3 (IGFPB-3)', 'timeFrame': 'At Baseline (Day 1), Year 1,2,3 and 4'}, {'measure': 'Changes From Baseline (Day 1) in Serum Concentrations of Acid-Labile Subunit (ALS)', 'timeFrame': 'At Baseline (Day 1), Year 1,2,3 and 4'}, {'measure': 'Changes From Baseline (Day 1) in Serum Concentrations of Growth Hormone Binding Protein (GHBP)', 'timeFrame': 'At Baseline (Day 1), Year 1,2,3 and 4'}, {'measure': 'Summary of Adverse Events With Number of Occurrences', 'timeFrame': 'Approximately up to 4 years.', 'description': 'A Data Monitoring Committee (DMC) was established to monitor subject safety'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['IGF-1 Deficiency', 'growth', 'ISS', 'Constitutional growth delay', 'Primary IGFD', 'Primary IGF Deficiency'], 'conditions': ['Insulin-like Growth Factor-1 Deficiency']}, 'descriptionModule': {'briefSummary': 'IGF-1 (insulin-like growth factor-1) is a hormone that is normally produced in the body in response to another hormone called growth hormone. Growth Hormone is produced by a small gland at the base of the brain (the pituitary). Together IGF-1 and GH are large contributors to growth during infancy, childhood, and adolescence.\n\nChildren with IGF Deficiency are short and have an imbalance in the levels of growth hormone and IGF-1 that their body produces. Their growth hormone levels are normal or even high, but IGF-1 levels do not increase normally in response to growth hormone. As a result, they have a type of growth hormone insensitivity and an inability to grow normally.\n\nThis study is a test to see whether daily dosing with a combination of rhIGF-1 and rhGH will help children with IGFD grow taller more quickly than children treated with rhGH alone. The study medications, rhIGF-1 and rhGH, are approved by the US Food and Drug Administration (FDA) for use in some growth disorders in children, but the combination of rhIGF-1 and rhGH in children with IGF-1 deficiency (IGFD) is investigational.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '5 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Parents or legally authorized representatives must give signed informed consent before any trial-related activities\n* IGF-1 SDS of ≤ -1 for age and gender\n* Short stature, as defined by a height SDS of ≤ -2 for age and gender\n* Chronological age ≥ 5 years\n* Bone age ≤ 11 years in boys and ≤ 9 years in girls\n* GH sufficiency, defined as a maximal stimulated GH response of greater than or equal to 10 ng/mL at Visit 2 (note: upon approval of the Medical Monitor, the result of a prior GH stimulation test may satisfy this requirement).\n* Prepubertal status\n* Adequate nutrition as evidenced by a body mass index (BMI) greater than or equal to the 5th percentile for age and gender\n\nExclusion Criteria:\n\n* Severe Primary IGFD (defined as height and IGF-1 SDS ≤ 3, and stimulated GH response greater than or equal to 10 ng/mL)\n* Prior or current use of medications with the potential to alter growth patterns including GH, IGF-1, IGFBP-3, gonadotrophin agonists (e.g., Lupron), aromatase inhibitors, androgens and estrogens\n* Known or suspected allergy to rhGH, rhIGF-1 or a constituent of their formulations\n* Current use of medications for attention deficit disorder\n* A chronic health condition that requires anti-inflammatory steroids or daily medication unless approved by the Medical Monitor'}, 'identificationModule': {'nctId': 'NCT00572156', 'briefTitle': 'rhGH and rhIGF-1 Combination Therapy in Children With Short Stature Associated With IGF-1 Deficiency', 'organization': {'class': 'INDUSTRY', 'fullName': 'Ipsen'}, 'officialTitle': 'Recombinant Human Growth Hormone (rhGH) and Recombinant Human Insulin-like Growth Factor-1 rhIGF-1) Combination Therapy in Children With Short Stature Associated With IGF-1 Deficiency: A Six-year, Randomized, Multi-center, Open-label, Parallel-group, Active Treatment Controlled, Dose Selection Trial', 'orgStudyIdInfo': {'id': 'MS316'}, 'secondaryIdInfos': [{'id': '2019-000843-29', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1. rhGH Alone', 'interventionNames': ['Drug: NutropinAq® (Somatropin [rDNA origin])']}, {'type': 'EXPERIMENTAL', 'label': '2. Combination Dose', 'interventionNames': ['Drug: Increlex® (Mecasermin [rDNA origin] injection) + NutropinAq® (Somatropin [rDNA origin])']}, {'type': 'EXPERIMENTAL', 'label': '3. Combination Dose', 'interventionNames': ['Drug: Increlex® (Mecasermin [rDNA origin] injection) + NutropinAq® (Somatropin [rDNA origin])']}, {'type': 'EXPERIMENTAL', 'label': '4. Combination Dose', 'interventionNames': ['Drug: Increlex® (Mecasermin [rDNA origin] injection) + NutropinAq® (Somatropin [rDNA origin])']}], 'interventions': [{'name': 'NutropinAq® (Somatropin [rDNA origin])', 'type': 'DRUG', 'otherNames': ['GH'], 'description': 'rhGH (Somatropin) 45µg/kg once daily injection', 'armGroupLabels': ['1. rhGH Alone']}, {'name': 'Increlex® (Mecasermin [rDNA origin] injection) + NutropinAq® (Somatropin [rDNA origin])', 'type': 'DRUG', 'otherNames': ['Increlex', 'rhIGF-1', 'GH'], 'description': 'rhGH 45µg/kg and rhIGF-1 150µg/kg once daily injection', 'armGroupLabels': ['4. Combination Dose']}, {'name': 'Increlex® (Mecasermin [rDNA origin] injection) + NutropinAq® (Somatropin [rDNA origin])', 'type': 'DRUG', 'otherNames': ['Increlex', 'rhIGF-1', 'GH'], 'description': 'rhGH (Somatropin) 45µg/kg and rhIGF-1 (Mecasermin) 50µg/kg once daily injections', 'armGroupLabels': ['2. Combination Dose']}, {'name': 'Increlex® (Mecasermin [rDNA origin] injection) + NutropinAq® (Somatropin [rDNA origin])', 'type': 'DRUG', 'otherNames': ['Increlex', 'rhIGF-1', 'GH'], 'description': 'rhGH 45µg/kg and rhIGF-1 100µg/kg once daily injections', 'armGroupLabels': ['3. Combination Dose']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94005', 'city': 'Brisbane', 'state': 'California', 'country': 'United States', 'facility': 'Ipsen', 'geoPoint': {'lat': 37.68077, 'lon': -122.39997}}], 'overallOfficials': [{'name': 'Ipsen Medical Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Ipsen (formerly Tercica, Inc.)'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ipsen', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}