Ignite Creation Date:
2025-12-25 @ 1:27 AM
Ignite Modification Date:
2025-12-31 @ 11:39 AM
Study NCT ID:
NCT01947894
Status:
COMPLETED
Last Update Posted:
2019-11-20
First Post:
2013-06-18
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Prospective Non-Interventional Study Protocol With Primary Data Collection - Assessment Of The Long Term Treatment Outcomes Of Genotropin Treatment In Growth Hormone Deficiency (GHD) Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004393', 'term': 'Dwarfism, Pituitary'}], 'ancestors': [{'id': 'D004392', 'term': 'Dwarfism'}, {'id': 'D001848', 'term': 'Bone Diseases, Developmental'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D001849', 'term': 'Bone Diseases, Endocrine'}, {'id': 'D007018', 'term': 'Hypopituitarism'}, {'id': 'D010900', 'term': 'Pituitary Diseases'}, {'id': 'D007027', 'term': 'Hypothalamic Diseases'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrials.gov_Inquiries@pfizer.com', 'phone': '1-800-718-1021', 'title': 'Pfizer ClinicalTrials.gov Call Center', 'organization': 'Pfizer Inc.'}, 'certainAgreement': {'otherDetails': 'Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Baseline up to 28 days after last dose of Genotropin treatment (maximum up to 5 years)', 'description': 'Same event may appear as an AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Participants treated with at least 1 dose of Genotropin were evaluated for safety.', 'eventGroups': [{'id': 'EG000', 'title': 'KIMS Adult Onset Growth Hormone Deficiency (GHD)', 'description': 'Participants were diagnosed with GHD before 2013, were previously treated with Genotropin and were followed in KIMS®. Participants continued to be diagnosed with GHD as per current medical standards, who aged greater than or equal to (\\>=) 18 years, received Genotropin treatment in a real world clinic setting as prescribed in clinical practice and were followed up/observed for long-term Genotropin therapy treatment outcomes in this study. KIMS® (Pfizer international metabolic database), have data for long-term safety and treatment outcomes of adult participants treated with Genotropin in a real-world clinical setting between 1994 and 2012.', 'otherNumAtRisk': 246, 'deathsNumAtRisk': 246, 'otherNumAffected': 66, 'seriousNumAtRisk': 246, 'deathsNumAffected': 12, 'seriousNumAffected': 57}, {'id': 'EG001', 'title': 'Naive Adult Onset GHD', 'description': 'Participants who were newly diagnosed with GHD as per current medical standards, aged \\>=18 years, received Genotropin treatment in a real world clinic setting as prescribed in clinical practice and were followed up/observed for long-term Genotropin therapy treatment outcomes in this study.', 'otherNumAtRisk': 41, 'deathsNumAtRisk': 41, 'otherNumAffected': 14, 'seriousNumAtRisk': 41, 'deathsNumAffected': 1, 'seriousNumAffected': 5}, {'id': 'EG002', 'title': 'Childhood Onset Growth Hormone Deficiency (CO-GHD)', 'description': 'Participants were diagnosed with CO-GHD before 2013. Participants aged \\>=18 years and continued to be diagnosed with GHD as per current medical standards, received Genotropin treatment in a real world clinic setting as prescribed in clinical practice and were followed up/observed for long-term Genotropin therapy treatment outcomes in this study.', 'otherNumAtRisk': 87, 'deathsNumAtRisk': 87, 'otherNumAffected': 15, 'seriousNumAtRisk': 87, 'deathsNumAffected': 0, 'seriousNumAffected': 10}], 'otherEvents': [{'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 246, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 87, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 246, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 87, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Visual field defect', 'stats': [{'groupId': 'EG000', 'numAtRisk': 246, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 87, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 246, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 87, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Sciatica', 'stats': [{'groupId': 'EG000', 'numAtRisk': 246, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 87, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Dementia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 246, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 87, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Hypoaesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 246, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 87, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Tremor', 'stats': [{'groupId': 'EG000', 'numAtRisk': 246, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 87, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Somnolence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 246, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 87, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Carotid artery stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 246, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 87, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Memory impairment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 246, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 87, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 246, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 87, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 246, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 87, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Pharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 246, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 87, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 246, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 87, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 246, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 87, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 246, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 87, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Upper respiratory track infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 246, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 87, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Tonsillitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 246, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 87, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Tooth infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 246, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 87, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Pulpitis dental', 'stats': [{'groupId': 'EG000', 'numAtRisk': 246, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 87, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Malaria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 246, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 87, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 246, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 87, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Intervertebral disc protrusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 246, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 87, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 246, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 87, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 246, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 87, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Tendonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 246, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 87, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Tendon pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 246, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 87, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Spinal stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 246, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 87, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 246, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 87, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Exostosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 246, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 87, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Osteoporosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 246, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 87, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Osteitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 246, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 87, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 246, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 87, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': "Dupuytren's contracture", 'stats': [{'groupId': 'EG000', 'numAtRisk': 246, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 87, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Bone pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 246, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 87, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Musculoskeletal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 246, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 87, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Muscle haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 246, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 87, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 246, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 87, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 246, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 87, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 246, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 87, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Peripheral swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 246, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 87, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Prostatic specific antigen increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 246, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 87, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Haemoglobin decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 246, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 87, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Weight increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 246, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 87, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Weight decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 246, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 87, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Colonoscopy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 246, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 87, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Hepatic enzyme increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 246, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 87, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Blood prolactin increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 246, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 87, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Blood testosterone increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 246, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 87, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Blood homocysteine increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 246, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 87, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Blood folate decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 246, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 87, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 246, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 87, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 246, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 87, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 246, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 87, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 246, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 87, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Haematemesis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 246, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 87, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, 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'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Adverse drug reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 246, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 87, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Dysplasia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 246, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 87, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 246, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 87, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Corneal abrasion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 246, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 87, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Medication error', 'stats': [{'groupId': 'EG000', 'numAtRisk': 246, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 87, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Strangulated incisional hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 246, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 87, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Pelvic fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 246, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 87, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Head injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 246, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 87, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 246, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 87, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Melaena', 'stats': [{'groupId': 'EG000', 'numAtRisk': 246, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 87, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 246, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 87, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 246, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 87, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 246, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 87, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 246, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 87, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Rotator cuff syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 246, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 87, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 246, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 87, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Abnormal behaviour', 'stats': [{'groupId': 'EG000', 'numAtRisk': 246, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 87, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Major depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 246, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 87, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Macular degeneration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 246, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 87, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Retinal detachment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 246, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 87, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Hyponatraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 246, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 87, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Orthostatic hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 246, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 87, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Aortic dissection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 246, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 87, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Neurofibromatosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 246, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 87, 'numAffected': 0}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 246, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 87, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Cholecystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 246, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 87, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Ovarian cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 246, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 87, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Amputation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 246, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 87, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants Classified According to Insulin-like Growth Factor (IGF-I) Assessments', 'denoms': [{'units': 'Participants', 'counts': [{'value': '246', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}, {'value': '87', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'KIMS Adult Onset Growth Hormone Deficiency (GHD)', 'description': 'Participants were diagnosed with GHD before 2013, were previously treated with Genotropin and were followed in KIMS®. Participants continued to be diagnosed with GHD as per current medical standards, who aged greater than or equal to (\\>=) 18 years, received Genotropin treatment in a real world clinic setting as prescribed in clinical practice and were followed up/observed for long-term Genotropin therapy treatment outcomes in this study. KIMS® (Pfizer international metabolic database), have data for long-term safety and treatment outcomes of adult participants treated with Genotropin in a real-world clinical setting between 1994 and 2012.'}, {'id': 'OG001', 'title': 'Naive Adult Onset GHD', 'description': 'Participants who were newly diagnosed with GHD as per current medical standards, aged \\>=18 years, received Genotropin treatment in a real world clinic setting as prescribed in clinical practice and were followed up/observed for long-term Genotropin therapy treatment outcomes in this study.'}, {'id': 'OG002', 'title': 'Childhood Onset Growth Hormone Deficiency (CO-GHD)', 'description': 'Participants were diagnosed with CO-GHD before 2013. Participants aged \\>=18 years and continued to be diagnosed with GHD as per current medical standards, received Genotropin treatment in a real world clinic setting as prescribed in clinical practice and were followed up/observed for long-term Genotropin therapy treatment outcomes in this study.'}], 'classes': [{'categories': [{'title': 'IGF-I LLN', 'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}, {'title': 'IGF-I ULN', 'measurements': [{'value': '63', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}]}, {'title': 'IGF-I ULN within reference range', 'measurements': [{'value': '159', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '47', 'groupId': 'OG002'}]}, {'title': 'IGF-I Unknown', 'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 5 years (after baseline visit)', 'description': "IGF-I along with growth hormone helps promote normal bone and tissue growth and development. Categories for assessment for participant's post-baseline IGF-I values: (1) IGF-I LLN = if any of assessments of IGF-I post-baseline visit was lower than lower limit of normal (LLN); (2) IGF-I ULN = If any of assessments of IGF-I post-baseline visit was greater than upper level of normal (ULN); (3) IGF-I unknown = no IGF-I reported; (4) Within reference range = IGF-I levels within normal range. Following is normal reference range of IGF-I in nanogram per milliliter. 18 Years of age (Y): Male =162-541, Female =170-640; 19 Y: Male =138-442, Female =147-527; 20 Y: Male =122-384,Female =132-457; 21-25 Y=116-341; 26-30 Y=117-321; 31-35 Y=113-297; 36-40 Y=106-277; 41-45 Y =98-261; 46-50 Y=91-246; 51-55 Y=84-233; 56-60 Y=78-220; 61-65 Y=72-207; 66-70 Y=67-195; 71-75 Y=62-184; 76-80 Y=57-172; \\>80 Y=53-162. There was no differentiation for male and female in normal range of IGF-I after 20 years of age.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS) included all correctly enrolled participants who received at least 1 dose of Genotropin. Erroneously enrolled participants were excluded from FAS, as they did not meet the inclusion criteria or met an exclusion criterion, which was discovered after enrolment to the study.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '246', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}, {'value': '87', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'KIMS Adult Onset Growth Hormone Deficiency (GHD)', 'description': 'Participants were diagnosed with GHD before 2013, were previously treated with Genotropin and were followed in KIMS®. Participants continued to be diagnosed with GHD as per current medical standards, who aged greater than or equal to (\\>=) 18 years, received Genotropin treatment in a real world clinic setting as prescribed in clinical practice and were followed up/observed for long-term Genotropin therapy treatment outcomes in this study. KIMS® (Pfizer international metabolic database), have data for long-term safety and treatment outcomes of adult participants treated with Genotropin in a real-world clinical setting between 1994 and 2012.'}, {'id': 'OG001', 'title': 'Naive Adult Onset GHD', 'description': 'Participants who were newly diagnosed with GHD as per current medical standards, aged \\>=18 years, received Genotropin treatment in a real world clinic setting as prescribed in clinical practice and were followed up/observed for long-term Genotropin therapy treatment outcomes in this study.'}, {'id': 'OG002', 'title': 'Childhood Onset Growth Hormone Deficiency (CO-GHD)', 'description': 'Participants were diagnosed with CO-GHD before 2013. Participants aged \\>=18 years and continued to be diagnosed with GHD as per current medical standards, received Genotropin treatment in a real world clinic setting as prescribed in clinical practice and were followed up/observed for long-term Genotropin therapy treatment outcomes in this study.'}], 'classes': [{'title': 'AEs', 'categories': [{'measurements': [{'value': '103', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}]}]}, {'title': 'SAEs', 'categories': [{'measurements': [{'value': '57', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline up to 5 years', 'description': 'An AE was any untoward medical occurrence in a participant who received Genotropin without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. A treatment emergent AE was defined as an event that emerged during the treatment period that was absent before treatment, or worsened during the treatment period relative to the pretreatment state. AEs included both serious and non-serious AEs.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis set included all enrolled participants who received at least 1 dose of Genotropin.'}, {'type': 'SECONDARY', 'title': 'Number of Treatment Related Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '103', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'KIMS Adult Onset Growth Hormone Deficiency (GHD)', 'description': 'Participants were diagnosed with GHD before 2013, were previously treated with Genotropin and were followed in KIMS®. Participants continued to be diagnosed with GHD as per current medical standards, who aged greater than or equal to (\\>=) 18 years, received Genotropin treatment in a real world clinic setting as prescribed in clinical practice and were followed up/observed for long-term Genotropin therapy treatment outcomes in this study. KIMS® (Pfizer international metabolic database), have data for long-term safety and treatment outcomes of adult participants treated with Genotropin in a real-world clinical setting between 1994 and 2012.'}, {'id': 'OG001', 'title': 'Naive Adult Onset GHD', 'description': 'Participants who were newly diagnosed with GHD as per current medical standards, aged \\>=18 years, received Genotropin treatment in a real world clinic setting as prescribed in clinical practice and were followed up/observed for long-term Genotropin therapy treatment outcomes in this study.'}, {'id': 'OG002', 'title': 'Childhood Onset Growth Hormone Deficiency (CO-GHD)', 'description': 'Participants were diagnosed with CO-GHD before 2013. Participants aged \\>=18 years and continued to be diagnosed with GHD as per current medical standards, received Genotropin treatment in a real world clinic setting as prescribed in clinical practice and were followed up/observed for long-term Genotropin therapy treatment outcomes in this study.'}], 'classes': [{'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline up to 5 years', 'description': 'Treatment-related AEs refer to AEs that have a causal relationship with the treatment or usage. If there was any relationship between AE and Genotropin treatment,that was judged by investigator.', 'unitOfMeasure': 'adverse events', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis set included all enrolled participants who received at least 1 dose of Genotropin. "Overall Number of Participants Analyzed" = number of participants evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Number of Adverse Events Leading to Withdrawal of Genotropin Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '103', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'KIMS Adult Onset Growth Hormone Deficiency (GHD)', 'description': 'Participants were diagnosed with GHD before 2013, were previously treated with Genotropin and were followed in KIMS®. Participants continued to be diagnosed with GHD as per current medical standards, who aged greater than or equal to (\\>=) 18 years, received Genotropin treatment in a real world clinic setting as prescribed in clinical practice and were followed up/observed for long-term Genotropin therapy treatment outcomes in this study. KIMS® (Pfizer international metabolic database), have data for long-term safety and treatment outcomes of adult participants treated with Genotropin in a real-world clinical setting between 1994 and 2012.'}, {'id': 'OG001', 'title': 'Naive Adult Onset GHD', 'description': 'Participants who were newly diagnosed with GHD as per current medical standards, aged \\>=18 years, received Genotropin treatment in a real world clinic setting as prescribed in clinical practice and were followed up/observed for long-term Genotropin therapy treatment outcomes in this study.'}, {'id': 'OG002', 'title': 'Childhood Onset Growth Hormone Deficiency (CO-GHD)', 'description': 'Participants were diagnosed with CO-GHD before 2013. Participants aged \\>=18 years and continued to be diagnosed with GHD as per current medical standards, received Genotropin treatment in a real world clinic setting as prescribed in clinical practice and were followed up/observed for long-term Genotropin therapy treatment outcomes in this study.'}], 'classes': [{'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline up to 5 years', 'description': 'An AE is any untoward medical occurrence in a participant administered a medicinal product that need not necessarily have a causal relationship with the product treatment or usage. An SAE is any untoward medical occurrence in a participant administered a medicinal or nutritional product at any dose that resulted to death, life-threatening, hospitalization or prolongation of hospitalization, persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions); and congenital anomaly/birth defect.', 'unitOfMeasure': 'adverse events', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis set included all enrolled participants who received at least 1 dose of Genotropin. "Overall Number of Participants Analyzed" = number of participants evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Who Discontinued Study Due to Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '246', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}, {'value': '87', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'KIMS Adult Onset Growth Hormone Deficiency (GHD)', 'description': 'Participants were diagnosed with GHD before 2013, were previously treated with Genotropin and were followed in KIMS®. Participants continued to be diagnosed with GHD as per current medical standards, who aged greater than or equal to (\\>=) 18 years, received Genotropin treatment in a real world clinic setting as prescribed in clinical practice and were followed up/observed for long-term Genotropin therapy treatment outcomes in this study. KIMS® (Pfizer international metabolic database), have data for long-term safety and treatment outcomes of adult participants treated with Genotropin in a real-world clinical setting between 1994 and 2012.'}, {'id': 'OG001', 'title': 'Naive Adult Onset GHD', 'description': 'Participants who were newly diagnosed with GHD as per current medical standards, aged \\>=18 years, received Genotropin treatment in a real world clinic setting as prescribed in clinical practice and were followed up/observed for long-term Genotropin therapy treatment outcomes in this study.'}, {'id': 'OG002', 'title': 'Childhood Onset Growth Hormone Deficiency (CO-GHD)', 'description': 'Participants were diagnosed with CO-GHD before 2013. Participants aged \\>=18 years and continued to be diagnosed with GHD as per current medical standards, received Genotropin treatment in a real world clinic setting as prescribed in clinical practice and were followed up/observed for long-term Genotropin therapy treatment outcomes in this study.'}], 'classes': [{'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline up to 5 years', 'description': 'An AE is any untoward medical occurrence in a participant administered a medicinal product that need not necessarily have a causal relationship with the product treatment or usage. An SAE is any untoward medical occurrence in a participant administered a medicinal or nutritional product at any dose that resulted to death, life-threatening, hospitalization or prolongation of hospitalization, persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions); and congenital anomaly/birth defect. Participants who discontinued study due to AEs were reported.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis set included all enrolled participants who received at least 1 dose of Genotropin.'}, {'type': 'SECONDARY', 'title': 'Weight of Participants at Baseline, Years 1, 2, 3, 4 and 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '246', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}, {'value': '87', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'KIMS Adult Onset Growth Hormone Deficiency (GHD)', 'description': 'Participants were diagnosed with GHD before 2013, were previously treated with Genotropin and were followed in KIMS®. Participants continued to be diagnosed with GHD as per current medical standards, who aged greater than or equal to (\\>=) 18 years, received Genotropin treatment in a real world clinic setting as prescribed in clinical practice and were followed up/observed for long-term Genotropin therapy treatment outcomes in this study. KIMS® (Pfizer international metabolic database), have data for long-term safety and treatment outcomes of adult participants treated with Genotropin in a real-world clinical setting between 1994 and 2012.'}, {'id': 'OG001', 'title': 'Naive Adult Onset GHD', 'description': 'Participants who were newly diagnosed with GHD as per current medical standards, aged \\>=18 years, received Genotropin treatment in a real world clinic setting as prescribed in clinical practice and were followed up/observed for long-term Genotropin therapy treatment outcomes in this study.'}, {'id': 'OG002', 'title': 'Childhood Onset Growth Hormone Deficiency (CO-GHD)', 'description': 'Participants were diagnosed with CO-GHD before 2013. Participants aged \\>=18 years and continued to be diagnosed with GHD as per current medical standards, received Genotropin treatment in a real world clinic setting as prescribed in clinical practice and were followed up/observed for long-term Genotropin therapy treatment outcomes in this study.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '232', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '81', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '83.8', 'spread': '16.76', 'groupId': 'OG000'}, {'value': '82.4', 'spread': '19.68', 'groupId': 'OG001'}, {'value': '86.9', 'spread': '26.11', 'groupId': 'OG002'}]}]}, {'title': 'Year 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '168', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '51', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '83.9', 'spread': '18.09', 'groupId': 'OG000'}, {'value': '86.4', 'spread': '15.54', 'groupId': 'OG001'}, {'value': '84.3', 'spread': '25.11', 'groupId': 'OG002'}]}]}, {'title': 'Year 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '156', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '45', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '82.8', 'spread': '15.66', 'groupId': 'OG000'}, {'value': '86.8', 'spread': '15.54', 'groupId': 'OG001'}, {'value': '87.7', 'spread': '20.73', 'groupId': 'OG002'}]}]}, {'title': 'Year 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '103', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '45', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '85.4', 'spread': '18.91', 'groupId': 'OG000'}, {'value': '84.3', 'spread': '17.67', 'groupId': 'OG001'}, {'value': '89.4', 'spread': '24.08', 'groupId': 'OG002'}]}]}, {'title': 'Year 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '27', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '82.4', 'spread': '17.83', 'groupId': 'OG000'}, {'value': '97.2', 'spread': '9.20', 'groupId': 'OG001'}, {'value': '82.5', 'spread': '20.66', 'groupId': 'OG002'}]}]}, {'title': 'Year 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '79.5', 'spread': '16.00', 'groupId': 'OG000'}, {'value': '104.4', 'spread': '0.85', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Year 1, 2, 3, 4, 5', 'description': 'Weight of participants was measured in kilograms (kg).', 'unitOfMeasure': 'kg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS was analyzed. Here, "Number analyzed" = participants who were evaluable at specified time points for each arm, respectively.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Weight of Participants at Years 1, 2, 3, 4 and 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '246', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}, {'value': '87', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'KIMS Adult Onset Growth Hormone Deficiency (GHD)', 'description': 'Participants were diagnosed with GHD before 2013, were previously treated with Genotropin and were followed in KIMS®. Participants continued to be diagnosed with GHD as per current medical standards, who aged greater than or equal to (\\>=) 18 years, received Genotropin treatment in a real world clinic setting as prescribed in clinical practice and were followed up/observed for long-term Genotropin therapy treatment outcomes in this study. KIMS® (Pfizer international metabolic database), have data for long-term safety and treatment outcomes of adult participants treated with Genotropin in a real-world clinical setting between 1994 and 2012.'}, {'id': 'OG001', 'title': 'Naive Adult Onset GHD', 'description': 'Participants who were newly diagnosed with GHD as per current medical standards, aged \\>=18 years, received Genotropin treatment in a real world clinic setting as prescribed in clinical practice and were followed up/observed for long-term Genotropin therapy treatment outcomes in this study.'}, {'id': 'OG002', 'title': 'Childhood Onset Growth Hormone Deficiency (CO-GHD)', 'description': 'Participants were diagnosed with CO-GHD before 2013. Participants aged \\>=18 years and continued to be diagnosed with GHD as per current medical standards, received Genotropin treatment in a real world clinic setting as prescribed in clinical practice and were followed up/observed for long-term Genotropin therapy treatment outcomes in this study.'}], 'classes': [{'title': 'Change at Year 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '162', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'spread': '6.55', 'groupId': 'OG000'}, {'value': '-2.0', 'spread': '15.37', 'groupId': 'OG001'}, {'value': '-2.3', 'spread': '21.49', 'groupId': 'OG002'}]}]}, {'title': 'Change at Year 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '150', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '45', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.7', 'spread': '6.82', 'groupId': 'OG000'}, {'value': '-1.6', 'spread': '12.85', 'groupId': 'OG001'}, {'value': '1.0', 'spread': '5.65', 'groupId': 'OG002'}]}]}, {'title': 'Change at Year 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '98', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '40', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2.2', 'spread': '11.41', 'groupId': 'OG000'}, {'value': '-0.3', 'spread': '13.41', 'groupId': 'OG001'}, {'value': '-2.8', 'spread': '18.16', 'groupId': 'OG002'}]}]}, {'title': 'Change at Year 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-1.6', 'spread': '8.44', 'groupId': 'OG000'}, {'value': '6.6', 'spread': '7.24', 'groupId': 'OG001'}, {'value': '-0.3', 'spread': '7.52', 'groupId': 'OG002'}]}]}, {'title': 'Change at Year 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-2.2', 'spread': '8.02', 'groupId': 'OG000'}, {'value': '-12.9', 'spread': '20.22', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Year 1, 2, 3, 4, 5', 'description': 'Weight of participants was measured in kg.', 'unitOfMeasure': 'kg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS was analyzed. Here, "Number analyzed" = participants who were evaluable at specified time points for each arm, respectively.'}, {'type': 'SECONDARY', 'title': 'Height of Participants at Baseline, Years 1, 2, 3, 4 and 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '246', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}, {'value': '87', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'KIMS Adult Onset Growth Hormone Deficiency (GHD)', 'description': 'Participants were diagnosed with GHD before 2013, were previously treated with Genotropin and were followed in KIMS®. Participants continued to be diagnosed with GHD as per current medical standards, who aged greater than or equal to (\\>=) 18 years, received Genotropin treatment in a real world clinic setting as prescribed in clinical practice and were followed up/observed for long-term Genotropin therapy treatment outcomes in this study. KIMS® (Pfizer international metabolic database), have data for long-term safety and treatment outcomes of adult participants treated with Genotropin in a real-world clinical setting between 1994 and 2012.'}, {'id': 'OG001', 'title': 'Naive Adult Onset GHD', 'description': 'Participants who were newly diagnosed with GHD as per current medical standards, aged \\>=18 years, received Genotropin treatment in a real world clinic setting as prescribed in clinical practice and were followed up/observed for long-term Genotropin therapy treatment outcomes in this study.'}, {'id': 'OG002', 'title': 'Childhood Onset Growth Hormone Deficiency (CO-GHD)', 'description': 'Participants were diagnosed with CO-GHD before 2013. Participants aged \\>=18 years and continued to be diagnosed with GHD as per current medical standards, received Genotropin treatment in a real world clinic setting as prescribed in clinical practice and were followed up/observed for long-term Genotropin therapy treatment outcomes in this study.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '242', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}, {'value': '85', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '171.7', 'spread': '9.39', 'groupId': 'OG000'}, {'value': '172.2', 'spread': '10.67', 'groupId': 'OG001'}, {'value': '171.7', 'spread': '11.81', 'groupId': 'OG002'}]}]}, {'title': 'Year 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '176', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '54', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '171.9', 'spread': '9.50', 'groupId': 'OG000'}, {'value': '174.0', 'spread': '10.01', 'groupId': 'OG001'}, {'value': '170.6', 'spread': '11.88', 'groupId': 'OG002'}]}]}, {'title': 'Year 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '160', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '172.0', 'spread': '9.20', 'groupId': 'OG000'}, {'value': '172.7', 'spread': '9.90', 'groupId': 'OG001'}, {'value': '171.4', 'spread': '12.13', 'groupId': 'OG002'}]}]}, {'title': 'Year 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '122', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '47', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '172.1', 'spread': '9.68', 'groupId': 'OG000'}, {'value': '172.5', 'spread': '10.45', 'groupId': 'OG001'}, {'value': '172.8', 'spread': '11.54', 'groupId': 'OG002'}]}]}, {'title': 'Year 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '85', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '173.0', 'spread': '9.40', 'groupId': 'OG000'}, {'value': '172.5', 'spread': '7.95', 'groupId': 'OG001'}, {'value': '172.0', 'spread': '11.60', 'groupId': 'OG002'}]}]}, {'title': 'Year 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '171.0', 'spread': '11.44', 'groupId': 'OG000'}, {'value': '169.1', 'spread': '5.80', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Year 1, 2, 3, 4, 5', 'description': 'Height of participants was measured in centimeters.', 'unitOfMeasure': 'centimeters (cm)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS was analyzed. Here, "Number analyzed" = participants who were evaluable at specified time points for each arm, respectively.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Height of Participants at Years 1, 2, 3, 4 and 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '246', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}, {'value': '87', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'KIMS Adult Onset Growth Hormone Deficiency (GHD)', 'description': 'Participants were diagnosed with GHD before 2013, were previously treated with Genotropin and were followed in KIMS®. Participants continued to be diagnosed with GHD as per current medical standards, who aged greater than or equal to (\\>=) 18 years, received Genotropin treatment in a real world clinic setting as prescribed in clinical practice and were followed up/observed for long-term Genotropin therapy treatment outcomes in this study. KIMS® (Pfizer international metabolic database), have data for long-term safety and treatment outcomes of adult participants treated with Genotropin in a real-world clinical setting between 1994 and 2012.'}, {'id': 'OG001', 'title': 'Naive Adult Onset GHD', 'description': 'Participants who were newly diagnosed with GHD as per current medical standards, aged \\>=18 years, received Genotropin treatment in a real world clinic setting as prescribed in clinical practice and were followed up/observed for long-term Genotropin therapy treatment outcomes in this study.'}, {'id': 'OG002', 'title': 'Childhood Onset Growth Hormone Deficiency (CO-GHD)', 'description': 'Participants were diagnosed with CO-GHD before 2013. Participants aged \\>=18 years and continued to be diagnosed with GHD as per current medical standards, received Genotropin treatment in a real world clinic setting as prescribed in clinical practice and were followed up/observed for long-term Genotropin therapy treatment outcomes in this study.'}], 'classes': [{'title': 'Change at Year 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '174', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '53', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'spread': '0.31', 'groupId': 'OG000'}, {'value': '-0.1', 'spread': '0.78', 'groupId': 'OG001'}, {'value': '0', 'spread': '0.31', 'groupId': 'OG002'}]}]}, {'title': 'Change at Year 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '156', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'spread': '0.30', 'groupId': 'OG000'}, {'value': '-0.1', 'spread': '0.79', 'groupId': 'OG001'}, {'value': '0', 'spread': '0.17', 'groupId': 'OG002'}]}]}, {'title': 'Change at Year 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '119', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '46', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'spread': '0.60', 'groupId': 'OG000'}, {'value': '0', 'spread': '0', 'groupId': 'OG001'}, {'value': '0', 'spread': '0.35', 'groupId': 'OG002'}]}]}, {'title': 'Change at Year 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '84', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'spread': '0.56', 'groupId': 'OG000'}, {'value': '0', 'spread': '0', 'groupId': 'OG001'}, {'value': '0', 'spread': '0.21', 'groupId': 'OG002'}]}]}, {'title': 'Change at Year 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.1', 'spread': '0.52', 'groupId': 'OG000'}, {'value': '0', 'spread': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Year 1, 2, 3, 4, 5', 'description': 'Height of participants was measured in centimeters.', 'unitOfMeasure': 'centimeters (cm)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS was analyzed. Here, "Number analyzed" = participants who were evaluable at specified time points for each arm, respectively.'}, {'type': 'SECONDARY', 'title': 'Body Mass Index (BMI) of Participants at Baseline, Years 1, 2, 3, 4 and 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '246', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}, {'value': '87', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'KIMS Adult Onset Growth Hormone Deficiency (GHD)', 'description': 'Participants were diagnosed with GHD before 2013, were previously treated with Genotropin and were followed in KIMS®. Participants continued to be diagnosed with GHD as per current medical standards, who aged greater than or equal to (\\>=) 18 years, received Genotropin treatment in a real world clinic setting as prescribed in clinical practice and were followed up/observed for long-term Genotropin therapy treatment outcomes in this study. KIMS® (Pfizer international metabolic database), have data for long-term safety and treatment outcomes of adult participants treated with Genotropin in a real-world clinical setting between 1994 and 2012.'}, {'id': 'OG001', 'title': 'Naive Adult Onset GHD', 'description': 'Participants who were newly diagnosed with GHD as per current medical standards, aged \\>=18 years, received Genotropin treatment in a real world clinic setting as prescribed in clinical practice and were followed up/observed for long-term Genotropin therapy treatment outcomes in this study.'}, {'id': 'OG002', 'title': 'Childhood Onset Growth Hormone Deficiency (CO-GHD)', 'description': 'Participants were diagnosed with CO-GHD before 2013. Participants aged \\>=18 years and continued to be diagnosed with GHD as per current medical standards, received Genotropin treatment in a real world clinic setting as prescribed in clinical practice and were followed up/observed for long-term Genotropin therapy treatment outcomes in this study.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '231', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}, {'value': '80', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '28.3', 'spread': '4.76', 'groupId': 'OG000'}, {'value': '27.8', 'spread': '5.71', 'groupId': 'OG001'}, {'value': '29.6', 'spread': '8.42', 'groupId': 'OG002'}]}]}, {'title': 'Year 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '168', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '51', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '28.2', 'spread': '5.45', 'groupId': 'OG000'}, {'value': '28.3', 'spread': '5.56', 'groupId': 'OG001'}, {'value': '28.9', 'spread': '7.26', 'groupId': 'OG002'}]}]}, {'title': 'Year 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '156', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '45', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '27.9', 'spread': '4.20', 'groupId': 'OG000'}, {'value': '28.9', 'spread': '4.70', 'groupId': 'OG001'}, {'value': '29.8', 'spread': '6.08', 'groupId': 'OG002'}]}]}, {'title': 'Year 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '102', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '45', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '28.8', 'spread': '5.55', 'groupId': 'OG000'}, {'value': '28.5', 'spread': '4.70', 'groupId': 'OG001'}, {'value': '29.8', 'spread': '6.47', 'groupId': 'OG002'}]}]}, {'title': 'Year 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '27', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '27.4', 'spread': '4.09', 'groupId': 'OG000'}, {'value': '33.2', 'spread': '2.92', 'groupId': 'OG001'}, {'value': '28.2', 'spread': '7.24', 'groupId': 'OG002'}]}]}, {'title': 'Year 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '27.8', 'spread': '6.14', 'groupId': 'OG000'}, {'value': '36.6', 'spread': '2.81', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Year 1, 2, 3, 4, 5', 'description': 'BMI was defined as an index for assessing overweight and underweight and was obtained by dividing body weight in kilograms (kg) by height in meters squared (m\\^2).', 'unitOfMeasure': 'Kilogram per meter squared (kg/m^2)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS was analyzed. Here, "Number analyzed" = participants who were evaluable at specified time points for each arm, respectively.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Body Mass Index of Participants at Years 1, 2, 3, 4 and 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '246', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}, {'value': '87', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'KIMS Adult Onset Growth Hormone Deficiency (GHD)', 'description': 'Participants were diagnosed with GHD before 2013, were previously treated with Genotropin and were followed in KIMS®. Participants continued to be diagnosed with GHD as per current medical standards, who aged greater than or equal to (\\>=) 18 years, received Genotropin treatment in a real world clinic setting as prescribed in clinical practice and were followed up/observed for long-term Genotropin therapy treatment outcomes in this study. KIMS® (Pfizer international metabolic database), have data for long-term safety and treatment outcomes of adult participants treated with Genotropin in a real-world clinical setting between 1994 and 2012.'}, {'id': 'OG001', 'title': 'Naive Adult Onset GHD', 'description': 'Participants who were newly diagnosed with GHD as per current medical standards, aged \\>=18 years, received Genotropin treatment in a real world clinic setting as prescribed in clinical practice and were followed up/observed for long-term Genotropin therapy treatment outcomes in this study.'}, {'id': 'OG002', 'title': 'Childhood Onset Growth Hormone Deficiency (CO-GHD)', 'description': 'Participants were diagnosed with CO-GHD before 2013. Participants aged \\>=18 years and continued to be diagnosed with GHD as per current medical standards, received Genotropin treatment in a real world clinic setting as prescribed in clinical practice and were followed up/observed for long-term Genotropin therapy treatment outcomes in this study.'}], 'classes': [{'title': 'Change at Year 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '162', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'spread': '2.67', 'groupId': 'OG000'}, {'value': '-0.4', 'spread': '4.60', 'groupId': 'OG001'}, {'value': '-0.9', 'spread': '7.79', 'groupId': 'OG002'}]}]}, {'title': 'Change at Year 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '149', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '45', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.2', 'spread': '2.25', 'groupId': 'OG000'}, {'value': '-0.5', 'spread': '3.84', 'groupId': 'OG001'}, {'value': '0.3', 'spread': '2.03', 'groupId': 'OG002'}]}]}, {'title': 'Change at Year 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '97', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '39', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.7', 'spread': '3.75', 'groupId': 'OG000'}, {'value': '-0.3', 'spread': '4.13', 'groupId': 'OG001'}, {'value': '-1.1', 'spread': '6.02', 'groupId': 'OG002'}]}]}, {'title': 'Change at Year 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.4', 'spread': '2.62', 'groupId': 'OG000'}, {'value': '1.8', 'spread': '2.43', 'groupId': 'OG001'}, {'value': '-0.1', 'spread': '2.54', 'groupId': 'OG002'}]}]}, {'title': 'Change at Year 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.7', 'spread': '2.85', 'groupId': 'OG000'}, {'value': '-4.3', 'spread': '6.78', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Year 1, 2, 3, 4, 5', 'description': 'BMI was defined as an index for assessing overweight and underweight and was obtained by dividing body weight in kilograms (kg) by height in m\\^2.', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS was analyzed. Here, "Number analyzed" = participants who were evaluable at specified time points for each arm, respectively.'}, {'type': 'SECONDARY', 'title': 'Blood Pressure (BP) of Participants at Baseline, Years 1, 2, 3, 4 and 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '246', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}, {'value': '87', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'KIMS Adult Onset Growth Hormone Deficiency (GHD)', 'description': 'Participants were diagnosed with GHD before 2013, were previously treated with Genotropin and were followed in KIMS®. Participants continued to be diagnosed with GHD as per current medical standards, who aged greater than or equal to (\\>=) 18 years, received Genotropin treatment in a real world clinic setting as prescribed in clinical practice and were followed up/observed for long-term Genotropin therapy treatment outcomes in this study. KIMS® (Pfizer international metabolic database), have data for long-term safety and treatment outcomes of adult participants treated with Genotropin in a real-world clinical setting between 1994 and 2012.'}, {'id': 'OG001', 'title': 'Naive Adult Onset GHD', 'description': 'Participants who were newly diagnosed with GHD as per current medical standards, aged \\>=18 years, received Genotropin treatment in a real world clinic setting as prescribed in clinical practice and were followed up/observed for long-term Genotropin therapy treatment outcomes in this study.'}, {'id': 'OG002', 'title': 'Childhood Onset Growth Hormone Deficiency (CO-GHD)', 'description': 'Participants were diagnosed with CO-GHD before 2013. Participants aged \\>=18 years and continued to be diagnosed with GHD as per current medical standards, received Genotropin treatment in a real world clinic setting as prescribed in clinical practice and were followed up/observed for long-term Genotropin therapy treatment outcomes in this study.'}], 'classes': [{'title': 'Supine SBP- Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '227', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '69', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '132.3', 'spread': '16.47', 'groupId': 'OG000'}, {'value': '123.6', 'spread': '13.47', 'groupId': 'OG001'}, {'value': '120.3', 'spread': '13.40', 'groupId': 'OG002'}]}]}, {'title': 'Supine SBP- Year 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '171', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '51', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '132.7', 'spread': '17.82', 'groupId': 'OG000'}, {'value': '127.4', 'spread': '16.00', 'groupId': 'OG001'}, {'value': '122.9', 'spread': '11.74', 'groupId': 'OG002'}]}]}, {'title': 'Supine SBP- Year 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '161', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '47', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '133.3', 'spread': '16.82', 'groupId': 'OG000'}, {'value': '133.5', 'spread': '21.97', 'groupId': 'OG001'}, {'value': '124.1', 'spread': '14.37', 'groupId': 'OG002'}]}]}, {'title': 'Supine SBP- Year 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '114', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '45', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '133.4', 'spread': '15.68', 'groupId': 'OG000'}, {'value': '130.4', 'spread': '20.13', 'groupId': 'OG001'}, {'value': '123.4', 'spread': '14.26', 'groupId': 'OG002'}]}]}, {'title': 'Supine SBP- Year 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '77', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '132.3', 'spread': '14.80', 'groupId': 'OG000'}, {'value': '134.4', 'spread': '14.01', 'groupId': 'OG001'}, {'value': '127.8', 'spread': '13.97', 'groupId': 'OG002'}]}]}, {'title': 'Supine SBP- Year 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '137.4', 'spread': '17.76', 'groupId': 'OG000'}, {'value': '121.0', 'spread': '1.41', 'groupId': 'OG002'}]}]}, {'title': 'Supine DBP- Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '227', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '69', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '78.4', 'spread': '9.32', 'groupId': 'OG000'}, {'value': '75.5', 'spread': '10.76', 'groupId': 'OG001'}, {'value': '74.0', 'spread': '8.29', 'groupId': 'OG002'}]}]}, {'title': 'Supine DBP- Year 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '171', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '51', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '77.1', 'spread': '9.37', 'groupId': 'OG000'}, {'value': '73.0', 'spread': '11.00', 'groupId': 'OG001'}, {'value': '74.6', 'spread': '9.01', 'groupId': 'OG002'}]}]}, {'title': 'Supine DBP- Year 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '161', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '47', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '78.2', 'spread': '9.10', 'groupId': 'OG000'}, {'value': '75.8', 'spread': '12.32', 'groupId': 'OG001'}, {'value': '76.3', 'spread': '9.06', 'groupId': 'OG002'}]}]}, {'title': 'Supine DBP- Year 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '114', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '45', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '79.0', 'spread': '9.04', 'groupId': 'OG000'}, {'value': '77.2', 'spread': '10.99', 'groupId': 'OG001'}, {'value': '76.0', 'spread': '7.84', 'groupId': 'OG002'}]}]}, {'title': 'Supine DBP- Year 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '77', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '77.5', 'spread': '9.01', 'groupId': 'OG000'}, {'value': '80.6', 'spread': '11.91', 'groupId': 'OG001'}, {'value': '76.1', 'spread': '8.04', 'groupId': 'OG002'}]}]}, {'title': 'Supine DBP- Year 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '80.6', 'spread': '12.82', 'groupId': 'OG000'}, {'value': '70.5', 'spread': '0.71', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Year 1, 2, 3, 4, 5', 'description': 'Measurement of BP included supine systolic blood pressure (SBP) and diastolic blood pressure (DBP).', 'unitOfMeasure': 'millimeter of mercury (mmHg)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS was analyzed. Here, "Number analyzed" = participants who were evaluable at specified time points for each arm, respectively.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Blood Pressure of Participants at Years 1, 2, 3, 4 and 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '246', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}, {'value': '87', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'KIMS Adult Onset Growth Hormone Deficiency (GHD)', 'description': 'Participants were diagnosed with GHD before 2013, were previously treated with Genotropin and were followed in KIMS®. Participants continued to be diagnosed with GHD as per current medical standards, who aged greater than or equal to (\\>=) 18 years, received Genotropin treatment in a real world clinic setting as prescribed in clinical practice and were followed up/observed for long-term Genotropin therapy treatment outcomes in this study. KIMS® (Pfizer international metabolic database), have data for long-term safety and treatment outcomes of adult participants treated with Genotropin in a real-world clinical setting between 1994 and 2012.'}, {'id': 'OG001', 'title': 'Naive Adult Onset GHD', 'description': 'Participants who were newly diagnosed with GHD as per current medical standards, aged \\>=18 years, received Genotropin treatment in a real world clinic setting as prescribed in clinical practice and were followed up/observed for long-term Genotropin therapy treatment outcomes in this study.'}, {'id': 'OG002', 'title': 'Childhood Onset Growth Hormone Deficiency (CO-GHD)', 'description': 'Participants were diagnosed with CO-GHD before 2013. Participants aged \\>=18 years and continued to be diagnosed with GHD as per current medical standards, received Genotropin treatment in a real world clinic setting as prescribed in clinical practice and were followed up/observed for long-term Genotropin therapy treatment outcomes in this study.'}], 'classes': [{'title': 'Change in Supine SBP- Year 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '161', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '40', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.0', 'spread': '15.67', 'groupId': 'OG000'}, {'value': '-0.9', 'spread': '11.52', 'groupId': 'OG001'}, {'value': '3.4', 'spread': '13.52', 'groupId': 'OG002'}]}]}, {'title': 'Change in Supine SBP- Year 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '152', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.4', 'spread': '15.78', 'groupId': 'OG000'}, {'value': '6.1', 'spread': '17.48', 'groupId': 'OG001'}, {'value': '2.3', 'spread': '12.81', 'groupId': 'OG002'}]}]}, {'title': 'Change in Supine SBP- Year 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '105', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '32', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.0', 'spread': '13.84', 'groupId': 'OG000'}, {'value': '1.5', 'spread': '17.11', 'groupId': 'OG001'}, {'value': '4.3', 'spread': '12.41', 'groupId': 'OG002'}]}]}, {'title': 'Change in Supine SBP- Year 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-1.5', 'spread': '19.91', 'groupId': 'OG000'}, {'value': '10.5', 'spread': '10.65', 'groupId': 'OG001'}, {'value': '4.3', 'spread': '16.40', 'groupId': 'OG002'}]}]}, {'title': 'Change in Supine SBP- Year 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '5.7', 'spread': '19.26', 'groupId': 'OG000'}, {'value': '-4.0', 'spread': '8.49', 'groupId': 'OG002'}]}]}, {'title': 'Change in Supine DBP- Year 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '161', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '40', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-1.2', 'spread': '10.66', 'groupId': 'OG000'}, {'value': '-4.2', 'spread': '10.2', 'groupId': 'OG001'}, {'value': '0.6', 'spread': '9.83', 'groupId': 'OG002'}]}]}, {'title': 'Change in Supine DBP- Year 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '152', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.6', 'spread': '10.84', 'groupId': 'OG000'}, {'value': '0.5', 'spread': '11.81', 'groupId': 'OG001'}, {'value': '1.8', 'spread': '8.17', 'groupId': 'OG002'}]}]}, {'title': 'Change in Supine DBP- Year 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '105', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '32', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.7', 'spread': '10.44', 'groupId': 'OG000'}, {'value': '-0.4', 'spread': '8.2', 'groupId': 'OG001'}, {'value': '0.8', 'spread': '8.81', 'groupId': 'OG002'}]}]}, {'title': 'Change in Supine DBP- Year 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-1.5', 'spread': '12.07', 'groupId': 'OG000'}, {'value': '-2.8', 'spread': '9.77', 'groupId': 'OG001'}, {'value': '2.0', 'spread': '9.50', 'groupId': 'OG002'}]}]}, {'title': 'Change in Supine DBP- Year 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '3.0', 'spread': '12.36', 'groupId': 'OG000'}, {'value': '0.5', 'spread': '0.71', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Year 1, 2, 3, 4, 5', 'description': 'Measurement of BP included supine SBP and DBP.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS was analyzed. Here, "Number analyzed" = participants who were evaluable at specified time points for each arm, respectively.'}, {'type': 'SECONDARY', 'title': 'Heart Rate of Participants at Baseline, Years 1, 2, 3, 4 and 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '246', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}, {'value': '87', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'KIMS Adult Onset Growth Hormone Deficiency (GHD)', 'description': 'Participants were diagnosed with GHD before 2013, were previously treated with Genotropin and were followed in KIMS®. Participants continued to be diagnosed with GHD as per current medical standards, who aged greater than or equal to (\\>=) 18 years, received Genotropin treatment in a real world clinic setting as prescribed in clinical practice and were followed up/observed for long-term Genotropin therapy treatment outcomes in this study. KIMS® (Pfizer international metabolic database), have data for long-term safety and treatment outcomes of adult participants treated with Genotropin in a real-world clinical setting between 1994 and 2012.'}, {'id': 'OG001', 'title': 'Naive Adult Onset GHD', 'description': 'Participants who were newly diagnosed with GHD as per current medical standards, aged \\>=18 years, received Genotropin treatment in a real world clinic setting as prescribed in clinical practice and were followed up/observed for long-term Genotropin therapy treatment outcomes in this study.'}, {'id': 'OG002', 'title': 'Childhood Onset Growth Hormone Deficiency (CO-GHD)', 'description': 'Participants were diagnosed with CO-GHD before 2013. Participants aged \\>=18 years and continued to be diagnosed with GHD as per current medical standards, received Genotropin treatment in a real world clinic setting as prescribed in clinical practice and were followed up/observed for long-term Genotropin therapy treatment outcomes in this study.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '169', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '50', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '69.3', 'spread': '9.42', 'groupId': 'OG000'}, {'value': '68.7', 'spread': '10.66', 'groupId': 'OG001'}, {'value': '69.7', 'spread': '8.28', 'groupId': 'OG002'}]}]}, {'title': 'Year 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '137', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '41', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '70.2', 'spread': '11.22', 'groupId': 'OG000'}, {'value': '70.7', 'spread': '13.39', 'groupId': 'OG001'}, {'value': '74.1', 'spread': '10.79', 'groupId': 'OG002'}]}]}, {'title': 'Year 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '129', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '33', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '69.8', 'spread': '10.41', 'groupId': 'OG000'}, {'value': '70.5', 'spread': '14.46', 'groupId': 'OG001'}, {'value': '71.3', 'spread': '11.05', 'groupId': 'OG002'}]}]}, {'title': 'Year 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '84', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '35', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '71.5', 'spread': '9.90', 'groupId': 'OG000'}, {'value': '69.8', 'spread': '10.59', 'groupId': 'OG001'}, {'value': '69.0', 'spread': '11.08', 'groupId': 'OG002'}]}]}, {'title': 'Year 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '68.3', 'spread': '9.15', 'groupId': 'OG000'}, {'value': '64.3', 'spread': '15.34', 'groupId': 'OG001'}, {'value': '69.4', 'spread': '11.68', 'groupId': 'OG002'}]}]}, {'title': 'Year 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '68.5', 'spread': '10.92', 'groupId': 'OG000'}, {'value': '70.0', 'spread': 'NA', 'comment': 'Standard deviation was not estimable because only 1 participant was analyzed.', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Year 1, 2, 3, 4, 5', 'description': 'Heart rate was measured in supine position.', 'unitOfMeasure': 'beats per minute (bpm)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS was analyzed. Here, "Number analyzed" = participants who were evaluable at specified time points for each arm, respectively.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Heart Rate of Participants at Years 1, 2, 3, 4 and 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '246', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}, {'value': '87', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'KIMS Adult Onset Growth Hormone Deficiency (GHD)', 'description': 'Participants were diagnosed with GHD before 2013, were previously treated with Genotropin and were followed in KIMS®. Participants continued to be diagnosed with GHD as per current medical standards, who aged greater than or equal to (\\>=) 18 years, received Genotropin treatment in a real world clinic setting as prescribed in clinical practice and were followed up/observed for long-term Genotropin therapy treatment outcomes in this study. KIMS® (Pfizer international metabolic database), have data for long-term safety and treatment outcomes of adult participants treated with Genotropin in a real-world clinical setting between 1994 and 2012.'}, {'id': 'OG001', 'title': 'Naive Adult Onset GHD', 'description': 'Participants who were newly diagnosed with GHD as per current medical standards, aged \\>=18 years, received Genotropin treatment in a real world clinic setting as prescribed in clinical practice and were followed up/observed for long-term Genotropin therapy treatment outcomes in this study.'}, {'id': 'OG002', 'title': 'Childhood Onset Growth Hormone Deficiency (CO-GHD)', 'description': 'Participants were diagnosed with CO-GHD before 2013. Participants aged \\>=18 years and continued to be diagnosed with GHD as per current medical standards, received Genotropin treatment in a real world clinic setting as prescribed in clinical practice and were followed up/observed for long-term Genotropin therapy treatment outcomes in this study.'}], 'classes': [{'title': 'Change at Year 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '113', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.4', 'spread': '11.62', 'groupId': 'OG000'}, {'value': '-1.4', 'spread': '12.66', 'groupId': 'OG001'}, {'value': '4.7', 'spread': '12.06', 'groupId': 'OG002'}]}]}, {'title': 'Change at Year 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.7', 'spread': '10.57', 'groupId': 'OG000'}, {'value': '1.8', 'spread': '14.88', 'groupId': 'OG001'}, {'value': '3.4', 'spread': '11.47', 'groupId': 'OG002'}]}]}, {'title': 'Change at Year 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.1', 'spread': '13.24', 'groupId': 'OG000'}, {'value': '1.5', 'spread': '13.94', 'groupId': 'OG001'}, {'value': '1.6', 'spread': '15.11', 'groupId': 'OG002'}]}]}, {'title': 'Change at Year 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.3', 'spread': '8.97', 'groupId': 'OG000'}, {'value': '1.0', 'spread': '16.31', 'groupId': 'OG001'}, {'value': '0.7', 'spread': '9.76', 'groupId': 'OG002'}]}]}, {'title': 'Change at Year 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '3.7', 'spread': '13.49', 'groupId': 'OG000'}, {'value': '0', 'spread': 'NA', 'comment': 'Standard deviation was not estimable because only 1 participant was analyzed.', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Year 1, 2, 3, 4, 5', 'description': 'Heart rate was measured in supine position.', 'unitOfMeasure': 'bpm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS was analyzed. Here, "Number analyzed" = participants who were evaluable at specified time points for each arm, respectively.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Body Composition Assessments at Baseline, Years 1, 2, 3 and 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '246', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}, {'value': '87', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'KIMS Adult Onset Growth Hormone Deficiency (GHD)', 'description': 'Participants were diagnosed with GHD before 2013, were previously treated with Genotropin and were followed in KIMS®. Participants continued to be diagnosed with GHD as per current medical standards, who aged greater than or equal to (\\>=) 18 years, received Genotropin treatment in a real world clinic setting as prescribed in clinical practice and were followed up/observed for long-term Genotropin therapy treatment outcomes in this study. KIMS® (Pfizer international metabolic database), have data for long-term safety and treatment outcomes of adult participants treated with Genotropin in a real-world clinical setting between 1994 and 2012.'}, {'id': 'OG001', 'title': 'Naive Adult Onset GHD', 'description': 'Participants who were newly diagnosed with GHD as per current medical standards, aged \\>=18 years, received Genotropin treatment in a real world clinic setting as prescribed in clinical practice and were followed up/observed for long-term Genotropin therapy treatment outcomes in this study.'}, {'id': 'OG002', 'title': 'Childhood Onset Growth Hormone Deficiency (CO-GHD)', 'description': 'Participants were diagnosed with CO-GHD before 2013. Participants aged \\>=18 years and continued to be diagnosed with GHD as per current medical standards, received Genotropin treatment in a real world clinic setting as prescribed in clinical practice and were followed up/observed for long-term Genotropin therapy treatment outcomes in this study.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '246', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}, {'value': '87', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '48.78', 'groupId': 'OG000'}, {'value': '47.37', 'groupId': 'OG001'}, {'value': '58.62', 'groupId': 'OG002'}]}]}, {'title': 'Year 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '246', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}, {'value': '87', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '31.30', 'groupId': 'OG000'}, {'value': '5.26', 'groupId': 'OG001'}, {'value': '31.03', 'groupId': 'OG002'}]}]}, {'title': 'Year 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '246', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}, {'value': '87', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '33.33', 'groupId': 'OG000'}, {'value': '21.05', 'groupId': 'OG001'}, {'value': '34.48', 'groupId': 'OG002'}]}]}, {'title': 'Year 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '246', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}, {'value': '87', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '15.85', 'groupId': 'OG000'}, {'value': '21.05', 'groupId': 'OG001'}, {'value': '20.69', 'groupId': 'OG002'}]}]}, {'title': 'Year 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '246', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '87', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2.03', 'groupId': 'OG000'}, {'value': '5.75', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Year 1, 2, 3, 4', 'description': 'Body composition included parameters fat mass and muscle mass.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS was analyzed. Here, "Number analyzed" = participants who were evaluable at specified time points for each arm, respectively.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Computed Tomography (CT) or Magnetic Resonance Imaging (MRI) Investigation at Baseline, Years 1, 2, 3, 4 and 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '246', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}, {'value': '87', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'KIMS Adult Onset Growth Hormone Deficiency (GHD)', 'description': 'Participants were diagnosed with GHD before 2013, were previously treated with Genotropin and were followed in KIMS®. Participants continued to be diagnosed with GHD as per current medical standards, who aged greater than or equal to (\\>=) 18 years, received Genotropin treatment in a real world clinic setting as prescribed in clinical practice and were followed up/observed for long-term Genotropin therapy treatment outcomes in this study. KIMS® (Pfizer international metabolic database), have data for long-term safety and treatment outcomes of adult participants treated with Genotropin in a real-world clinical setting between 1994 and 2012.'}, {'id': 'OG001', 'title': 'Naive Adult Onset GHD', 'description': 'Participants who were newly diagnosed with GHD as per current medical standards, aged \\>=18 years, received Genotropin treatment in a real world clinic setting as prescribed in clinical practice and were followed up/observed for long-term Genotropin therapy treatment outcomes in this study.'}, {'id': 'OG002', 'title': 'Childhood Onset Growth Hormone Deficiency (CO-GHD)', 'description': 'Participants were diagnosed with CO-GHD before 2013. Participants aged \\>=18 years and continued to be diagnosed with GHD as per current medical standards, received Genotropin treatment in a real world clinic setting as prescribed in clinical practice and were followed up/observed for long-term Genotropin therapy treatment outcomes in this study.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '246', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}, {'value': '87', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '32.93', 'groupId': 'OG000'}, {'value': '42.11', 'groupId': 'OG001'}, {'value': '18.39', 'groupId': 'OG002'}]}]}, {'title': 'Year 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '246', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}, {'value': '87', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '14.63', 'groupId': 'OG000'}, {'value': '23.68', 'groupId': 'OG001'}, {'value': '6.9', 'groupId': 'OG002'}]}]}, {'title': 'Year 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '246', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}, {'value': '87', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '15.04', 'groupId': 'OG000'}, {'value': '13.16', 'groupId': 'OG001'}, {'value': '3.45', 'groupId': 'OG002'}]}]}, {'title': 'Year 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '246', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}, {'value': '87', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '11.38', 'groupId': 'OG000'}, {'value': '7.89', 'groupId': 'OG001'}, {'value': '5.75', 'groupId': 'OG002'}]}]}, {'title': 'Year 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '246', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}, {'value': '87', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '4.88', 'groupId': 'OG000'}, {'value': '5.26', 'groupId': 'OG001'}, {'value': '4.6', 'groupId': 'OG002'}]}]}, {'title': 'Year 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '246', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '87', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.63', 'groupId': 'OG000'}, {'value': '1.15', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Year 1, 2, 3, 4, 5', 'description': 'CT is a diagnostic imaging test used to create detailed images of internal organs, bones, soft tissue and blood vessels. MRI investigation uses strong magnetic field and radio waves to create detailed images of the organs and tissues within the body.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS was analyzed. Here, "Number analyzed" = participants who were evaluable at specified time points for each arm, respectively.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Any Change From Baseline in Hormone Abnormalities at Years 1, 2, 3, and 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '246', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}, {'value': '87', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'KIMS Adult Onset Growth Hormone Deficiency (GHD)', 'description': 'Participants were diagnosed with GHD before 2013, were previously treated with Genotropin and were followed in KIMS®. Participants continued to be diagnosed with GHD as per current medical standards, who aged greater than or equal to (\\>=) 18 years, received Genotropin treatment in a real world clinic setting as prescribed in clinical practice and were followed up/observed for long-term Genotropin therapy treatment outcomes in this study. KIMS® (Pfizer international metabolic database), have data for long-term safety and treatment outcomes of adult participants treated with Genotropin in a real-world clinical setting between 1994 and 2012.'}, {'id': 'OG001', 'title': 'Naive Adult Onset GHD', 'description': 'Participants who were newly diagnosed with GHD as per current medical standards, aged \\>=18 years, received Genotropin treatment in a real world clinic setting as prescribed in clinical practice and were followed up/observed for long-term Genotropin therapy treatment outcomes in this study.'}, {'id': 'OG002', 'title': 'Childhood Onset Growth Hormone Deficiency (CO-GHD)', 'description': 'Participants were diagnosed with CO-GHD before 2013. Participants aged \\>=18 years and continued to be diagnosed with GHD as per current medical standards, received Genotropin treatment in a real world clinic setting as prescribed in clinical practice and were followed up/observed for long-term Genotropin therapy treatment outcomes in this study.'}], 'classes': [{'title': 'Year 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '246', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}, {'value': '87', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2.03', 'groupId': 'OG000'}, {'value': '2.63', 'groupId': 'OG001'}, {'value': '1.15', 'groupId': 'OG002'}]}]}, {'title': 'Year 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '246', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '87', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.63', 'groupId': 'OG000'}, {'value': '1.15', 'groupId': 'OG002'}]}]}, {'title': 'Year 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '246', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}, {'value': '87', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.63', 'groupId': 'OG000'}, {'value': '2.63', 'groupId': 'OG001'}, {'value': '1.15', 'groupId': 'OG002'}]}]}, {'title': 'Year 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '246', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.41', 'groupId': 'OG000'}, {'value': '2.63', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Year 1, 2, 3, 4', 'description': 'Hormones that were evaluated were thyroid stimulating hormone, adrenocorticotropic hormone, luteinizing hormone, follicle-stimulating hormone, antidiuretic hormone and prolactin hormone. Abnormalities were judged by the investigator.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS was analyzed. Here, "Number analyzed" = participants who were evaluable at specified time points for each arm, respectively.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Any Concomitant Medication at Baseline and During Follow-up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '247', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}, {'value': '88', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'KIMS Adult Onset Growth Hormone Deficiency (GHD)', 'description': 'Participants were diagnosed with GHD before 2013, were previously treated with Genotropin and were followed in KIMS®. 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KIMS® (Pfizer international metabolic database), have data for long-term safety and treatment outcomes of adult participants treated with Genotropin in a real-world clinical setting between 1994 and 2012.'}, {'id': 'OG001', 'title': 'Naive Adult Onset GHD', 'description': 'Participants who were newly diagnosed with GHD as per current medical standards, aged \\>=18 years, received Genotropin treatment in a real world clinic setting as prescribed in clinical practice and were followed up/observed for long-term Genotropin therapy treatment outcomes in this study.'}, {'id': 'OG002', 'title': 'Childhood Onset Growth Hormone Deficiency (CO-GHD)', 'description': 'Participants were diagnosed with CO-GHD before 2013. Participants aged \\>=18 years and continued to be diagnosed with GHD as per current medical standards, received Genotropin treatment in a real world clinic setting as prescribed in clinical practice and were followed up/observed for long-term Genotropin therapy treatment outcomes in this study.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '83.0', 'groupId': 'OG000'}, {'value': '69.0', 'groupId': 'OG001'}, {'value': '83.0', 'groupId': 'OG002'}]}]}, {'title': 'During follow-up', 'categories': [{'measurements': [{'value': '92.3', 'groupId': 'OG000'}, {'value': '73.8', 'groupId': 'OG001'}, {'value': '88.6', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Follow-up (during 28 days after last dose of Genotropin treatment)', 'description': 'Percentage of participants taking any medications other than Genotropin (concomitant medication) are reported.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who were enrolled in the study.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'KIMS Adult Onset Growth Hormone Deficiency (GHD)', 'description': 'Participants were diagnosed with GHD before 2013, were previously treated with Genotropin and were followed in KIMS®. Participants continued to be diagnosed with GHD as per current medical standards, who aged greater than or equal to (\\>=) 18 years, received Genotropin treatment in a real world clinic setting as prescribed in clinical practice and were followed up/observed for long-term Genotropin therapy treatment outcomes in this study. 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Participants aged \\>=18 years and continued to be diagnosed with GHD as per current medical standards, received Genotropin treatment in a real world clinic setting as prescribed in clinical practice and were followed up/observed for long-term Genotropin therapy treatment outcomes in this study.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '247'}, {'groupId': 'FG001', 'numSubjects': '42'}, {'groupId': 'FG002', 'numSubjects': '88'}]}, {'type': 'Treated', 'achievements': [{'groupId': 'FG000', 'numSubjects': '246'}, {'groupId': 'FG001', 'numSubjects': '41'}, {'groupId': 'FG002', 'numSubjects': '87'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '160'}, {'groupId': 'FG001', 'numSubjects': '24'}, {'groupId': 'FG002', 'numSubjects': '61'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '87'}, {'groupId': 'FG001', 'numSubjects': '18'}, {'groupId': 'FG002', 'numSubjects': '27'}]}], 'dropWithdraws': [{'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '3'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Switched to other growth hormone brand', 'reasons': [{'groupId': 'FG000', 'numSubjects': '53'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '23'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '247', 'groupId': 'BG000'}, {'value': '42', 'groupId': 'BG001'}, {'value': '88', 'groupId': 'BG002'}, {'value': '377', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'KIMS Adult Onset Growth Hormone Deficiency (GHD)', 'description': 'Participants were diagnosed with GHD before 2013, were previously treated with Genotropin and were followed in KIMS®. Participants continued to be diagnosed with GHD as per current medical standards, who aged greater than or equal to (\\>=) 18 years, received Genotropin treatment in a real world clinic setting as prescribed in clinical practice and were followed up/observed for long-term Genotropin therapy treatment outcomes in this study. KIMS® (Pfizer international metabolic database), have data for long-term safety and treatment outcomes of adult participants treated with Genotropin in a real-world clinical setting between 1994 and 2012.'}, {'id': 'BG001', 'title': 'Naive Adult Onset GHD', 'description': 'Participants who were newly diagnosed with GHD as per current medical standards, aged \\>=18 years, received Genotropin treatment in a real world clinic setting as prescribed in clinical practice and were followed up/observed for long-term Genotropin therapy treatment outcomes in this study.'}, {'id': 'BG002', 'title': 'Childhood Onset Growth Hormone Deficiency (CO-GHD)', 'description': 'Participants were diagnosed with CO-GHD before 2013. Participants aged \\>=18 years and continued to be diagnosed with GHD as per current medical standards, received Genotropin treatment in a real world clinic setting as prescribed in clinical practice and were followed up/observed for long-term Genotropin therapy treatment outcomes in this study.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '247', 'groupId': 'BG000'}, {'value': '42', 'groupId': 'BG001'}, {'value': '88', 'groupId': 'BG002'}, {'value': '377', 'groupId': 'BG003'}]}], 'categories': [{'title': '0 to less than or equal to (<=) 18 Years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Greater than (>) 18 to less than (<) 65 Years', 'measurements': [{'value': '138', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '83', 'groupId': 'BG002'}, {'value': '259', 'groupId': 'BG003'}]}, {'title': '>=65 Years', 'measurements': [{'value': '100', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '106', 'groupId': 'BG003'}]}, {'title': 'Unknown', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '12', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '247', 'groupId': 'BG000'}, {'value': '42', 'groupId': 'BG001'}, {'value': '88', 'groupId': 'BG002'}, {'value': '377', 'groupId': 'BG003'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '120', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '42', 'groupId': 'BG002'}, {'value': '184', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '127', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '46', 'groupId': 'BG002'}, {'value': '193', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}], 'populationDescription': 'All participants who were enrolled in the study.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2015-10-23', 'size': 9862904, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2019-10-29T13:09', 'hasProtocol': True}, {'date': '2019-06-14', 'size': 595679, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2019-10-29T14:29', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 377}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-11-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-10', 'completionDateStruct': {'date': '2018-10-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-10-29', 'studyFirstSubmitDate': '2013-06-18', 'resultsFirstSubmitDate': '2019-10-29', 'studyFirstSubmitQcDate': '2013-09-09', 'lastUpdatePostDateStruct': {'date': '2019-11-20', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-10-29', 'studyFirstPostDateStruct': {'date': '2013-09-23', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-11-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-10-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants Classified According to Insulin-like Growth Factor (IGF-I) Assessments', 'timeFrame': 'Up to 5 years (after baseline visit)', 'description': "IGF-I along with growth hormone helps promote normal bone and tissue growth and development. Categories for assessment for participant's post-baseline IGF-I values: (1) IGF-I LLN = if any of assessments of IGF-I post-baseline visit was lower than lower limit of normal (LLN); (2) IGF-I ULN = If any of assessments of IGF-I post-baseline visit was greater than upper level of normal (ULN); (3) IGF-I unknown = no IGF-I reported; (4) Within reference range = IGF-I levels within normal range. Following is normal reference range of IGF-I in nanogram per milliliter. 18 Years of age (Y): Male =162-541, Female =170-640; 19 Y: Male =138-442, Female =147-527; 20 Y: Male =122-384,Female =132-457; 21-25 Y=116-341; 26-30 Y=117-321; 31-35 Y=113-297; 36-40 Y=106-277; 41-45 Y =98-261; 46-50 Y=91-246; 51-55 Y=84-233; 56-60 Y=78-220; 61-65 Y=72-207; 66-70 Y=67-195; 71-75 Y=62-184; 76-80 Y=57-172; \\>80 Y=53-162. There was no differentiation for male and female in normal range of IGF-I after 20 years of age."}], 'secondaryOutcomes': [{'measure': 'Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)', 'timeFrame': 'Baseline up to 5 years', 'description': 'An AE was any untoward medical occurrence in a participant who received Genotropin without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. A treatment emergent AE was defined as an event that emerged during the treatment period that was absent before treatment, or worsened during the treatment period relative to the pretreatment state. AEs included both serious and non-serious AEs.'}, {'measure': 'Number of Treatment Related Adverse Events', 'timeFrame': 'Baseline up to 5 years', 'description': 'Treatment-related AEs refer to AEs that have a causal relationship with the treatment or usage. If there was any relationship between AE and Genotropin treatment,that was judged by investigator.'}, {'measure': 'Number of Adverse Events Leading to Withdrawal of Genotropin Treatment', 'timeFrame': 'Baseline up to 5 years', 'description': 'An AE is any untoward medical occurrence in a participant administered a medicinal product that need not necessarily have a causal relationship with the product treatment or usage. An SAE is any untoward medical occurrence in a participant administered a medicinal or nutritional product at any dose that resulted to death, life-threatening, hospitalization or prolongation of hospitalization, persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions); and congenital anomaly/birth defect.'}, {'measure': 'Number of Participants Who Discontinued Study Due to Adverse Events', 'timeFrame': 'Baseline up to 5 years', 'description': 'An AE is any untoward medical occurrence in a participant administered a medicinal product that need not necessarily have a causal relationship with the product treatment or usage. An SAE is any untoward medical occurrence in a participant administered a medicinal or nutritional product at any dose that resulted to death, life-threatening, hospitalization or prolongation of hospitalization, persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions); and congenital anomaly/birth defect. Participants who discontinued study due to AEs were reported.'}, {'measure': 'Weight of Participants at Baseline, Years 1, 2, 3, 4 and 5', 'timeFrame': 'Baseline, Year 1, 2, 3, 4, 5', 'description': 'Weight of participants was measured in kilograms (kg).'}, {'measure': 'Change From Baseline in Weight of Participants at Years 1, 2, 3, 4 and 5', 'timeFrame': 'Baseline, Year 1, 2, 3, 4, 5', 'description': 'Weight of participants was measured in kg.'}, {'measure': 'Height of Participants at Baseline, Years 1, 2, 3, 4 and 5', 'timeFrame': 'Baseline, Year 1, 2, 3, 4, 5', 'description': 'Height of participants was measured in centimeters.'}, {'measure': 'Change From Baseline in Height of Participants at Years 1, 2, 3, 4 and 5', 'timeFrame': 'Baseline, Year 1, 2, 3, 4, 5', 'description': 'Height of participants was measured in centimeters.'}, {'measure': 'Body Mass Index (BMI) of Participants at Baseline, Years 1, 2, 3, 4 and 5', 'timeFrame': 'Baseline, Year 1, 2, 3, 4, 5', 'description': 'BMI was defined as an index for assessing overweight and underweight and was obtained by dividing body weight in kilograms (kg) by height in meters squared (m\\^2).'}, {'measure': 'Change From Baseline in Body Mass Index of Participants at Years 1, 2, 3, 4 and 5', 'timeFrame': 'Baseline, Year 1, 2, 3, 4, 5', 'description': 'BMI was defined as an index for assessing overweight and underweight and was obtained by dividing body weight in kilograms (kg) by height in m\\^2.'}, {'measure': 'Blood Pressure (BP) of Participants at Baseline, Years 1, 2, 3, 4 and 5', 'timeFrame': 'Baseline, Year 1, 2, 3, 4, 5', 'description': 'Measurement of BP included supine systolic blood pressure (SBP) and diastolic blood pressure (DBP).'}, {'measure': 'Change From Baseline in Blood Pressure of Participants at Years 1, 2, 3, 4 and 5', 'timeFrame': 'Baseline, Year 1, 2, 3, 4, 5', 'description': 'Measurement of BP included supine SBP and DBP.'}, {'measure': 'Heart Rate of Participants at Baseline, Years 1, 2, 3, 4 and 5', 'timeFrame': 'Baseline, Year 1, 2, 3, 4, 5', 'description': 'Heart rate was measured in supine position.'}, {'measure': 'Change From Baseline in Heart Rate of Participants at Years 1, 2, 3, 4 and 5', 'timeFrame': 'Baseline, Year 1, 2, 3, 4, 5', 'description': 'Heart rate was measured in supine position.'}, {'measure': 'Percentage of Participants With Body Composition Assessments at Baseline, Years 1, 2, 3 and 4', 'timeFrame': 'Baseline, Year 1, 2, 3, 4', 'description': 'Body composition included parameters fat mass and muscle mass.'}, {'measure': 'Percentage of Participants With Computed Tomography (CT) or Magnetic Resonance Imaging (MRI) Investigation at Baseline, Years 1, 2, 3, 4 and 5', 'timeFrame': 'Baseline, Year 1, 2, 3, 4, 5', 'description': 'CT is a diagnostic imaging test used to create detailed images of internal organs, bones, soft tissue and blood vessels. MRI investigation uses strong magnetic field and radio waves to create detailed images of the organs and tissues within the body.'}, {'measure': 'Percentage of Participants With Any Change From Baseline in Hormone Abnormalities at Years 1, 2, 3, and 4', 'timeFrame': 'Baseline, Year 1, 2, 3, 4', 'description': 'Hormones that were evaluated were thyroid stimulating hormone, adrenocorticotropic hormone, luteinizing hormone, follicle-stimulating hormone, antidiuretic hormone and prolactin hormone. Abnormalities were judged by the investigator.'}, {'measure': 'Percentage of Participants With Any Concomitant Medication at Baseline and During Follow-up', 'timeFrame': 'Baseline, Follow-up (during 28 days after last dose of Genotropin treatment)', 'description': 'Percentage of participants taking any medications other than Genotropin (concomitant medication) are reported.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Growth Hormone Deficiency']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A6281313&StudyName=A%20Prospective%20Non-Interventional%20Study%20Protocol%20With%20Primary%20Data%20Collection%20-%20%20Assessment%20Of%20The%20Long%20Term%20Treatment%20Outcomes%20Of%20Genotr', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess the long term treatment outcomes of Growth Hormone treatment in patients who are prescribed and treated with Genotropin. Also, plan to determine the relationships between clinical status, dosage schedule and response to Genotropin treatment.\n\nThis study will also contribute to our knowledge of adult Growth Hormone Deficiency, including transition period in Childhood Onset Growth Hormone Deficiency and its treatment.', 'detailedDescription': 'Patients within inclusion criteria are asked to participate in the study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients wiht Growth Hormone Deficiency', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patients of 18 years of age and above and fulfilling one of the three alternatives a-c below;\n\n 1. Newly diagnosed with GHD according to the current medical standard.\n 2. Diagnosed with GHD before 2013 and previously treated with Genotropin and followed in KIMS®.\n 3. Transition patients diagnosed with CO-GHD before 2013.\n* Prescribed Genotropin at the time of inclusion.\n* Evidence of a personally signed and dated informed consent document indicating that the patient (or a legally acceptable representative) has been informed of all pertinent aspects of the study.\n\nExclusion Criteria:\n\n* Patients who participate in any concurrent clinical interventional trial where a non-authorized or authorized study medication is used, during their participation in Swedish KIMS® Xtended. Concurrent studies which do not include any study interventional items (whether medications or devices) are allowed.'}, 'identificationModule': {'nctId': 'NCT01947894', 'briefTitle': 'A Prospective Non-Interventional Study Protocol With Primary Data Collection - Assessment Of The Long Term Treatment Outcomes Of Genotropin Treatment In Growth Hormone Deficiency (GHD) Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'SWEGHO - A PROSPECTIVE NON INTERVENTIONAL STUDY PROTOCOL WITH PRIMARY DATA COLLECTION - ASSESSMENT OF THE LONG TERM TREATMENT OUTCOMES OF GENOTROPIN TREATMENT IN GHD PATIENTS IN SWEDEN', 'orgStudyIdInfo': {'id': 'A6281313'}, 'secondaryIdInfos': [{'id': 'SWEGHO', 'type': 'OTHER', 'domain': 'Alias Study Number'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Adult Growth Hormone deficient Patients', 'description': 'Patients with GHD on Genotropin® replacement therapy.', 'interventionNames': ['Other: Non Interventional Study']}], 'interventions': [{'name': 'Non Interventional Study', 'type': 'OTHER', 'description': 'Non Interventional Study', 'armGroupLabels': ['Adult Growth Hormone deficient Patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '541 85', 'city': 'Skövde', 'state': 'Skaraborg', 'country': 'Sweden', 'facility': 'Vastra Gotalands Regionen', 'geoPoint': {'lat': 58.39118, 'lon': 13.84506}}, {'zip': '791 82', 'city': 'Falun', 'country': 'Sweden', 'facility': 'Landstinget Dalarna', 'geoPoint': {'lat': 60.60357, 'lon': 15.62597}}, {'zip': '413 45', 'city': 'Gothenburg', 'country': 'Sweden', 'facility': 'Sahlgrenska University hospital', 'geoPoint': {'lat': 57.70716, 'lon': 11.96679}}, {'zip': '291 85', 'city': 'Kristianstad', 'country': 'Sweden', 'facility': 'Central Hospital/ Department of Medicine', 'geoPoint': {'lat': 56.03129, 'lon': 14.15242}}, {'zip': '581 85', 'city': 'Linköping', 'country': 'Sweden', 'facility': 'Universitetssjukhuset, EM-kliniken', 'geoPoint': {'lat': 58.41086, 'lon': 15.62157}}, {'zip': '341 82', 'city': 'Ljungby', 'country': 'Sweden', 'facility': 'Ljungby Lasarettet', 'geoPoint': {'lat': 56.83324, 'lon': 13.94082}}, {'zip': '205 02', 'city': 'Malmo', 'country': 'Sweden', 'facility': 'University Hospital SUS', 'geoPoint': {'lat': 55.60587, 'lon': 13.00073}}, {'zip': '118 83', 'city': 'Stockholm', 'country': 'Sweden', 'facility': 'Landstinget i Stockholms Lan', 'geoPoint': {'lat': 59.32938, 'lon': 18.06871}}, {'zip': '171 76', 'city': 'Stockholm', 'country': 'Sweden', 'facility': 'Karolinska Universitetssjukhuset, Kliniken for Endokrinologi', 'geoPoint': {'lat': 59.32938, 'lon': 18.06871}}, {'zip': '751 85', 'city': 'Uppsala', 'country': 'Sweden', 'facility': 'Akademiska sjukhuset / Medicincentrum, Diabetes- och Endokrinsektionen', 'geoPoint': {'lat': 59.85882, 'lon': 17.63889}}, {'zip': '351 85', 'city': 'Vaxjo', 'country': 'Sweden', 'facility': 'Medicinkliniken, Centrallasarettet Vaxjo', 'geoPoint': {'lat': 56.87767, 'lon': 14.80906}}, {'zip': '331 85', 'city': 'Värnamo', 'country': 'Sweden', 'facility': 'Landstinget i Jonkopings Lan', 'geoPoint': {'lat': 57.18604, 'lon': 14.04001}}], 'overallOfficials': [{'name': 'Pfizer CT.gov Call Center', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Pfizer'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': "Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\\_trials/trial\\_data\\_and\\_results/data\\_requests."}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pfizer', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}