Ignite Creation Date:
2025-12-24 @ 4:40 PM
Ignite Modification Date:
2025-12-28 @ 8:46 PM
Study NCT ID:
NCT01897766
Status:
COMPLETED
Last Update Posted:
2023-09-25
First Post:
2013-07-09
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Special Investigation Of Genotropin Long Follow-Up For Patients With A Small For Gestational Age "Scoped for Japanese"
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D019382', 'term': 'Human Growth Hormone'}], 'ancestors': [{'id': 'D013006', 'term': 'Growth Hormone'}, {'id': 'D010908', 'term': 'Pituitary Hormones, Anterior'}, {'id': 'D010907', 'term': 'Pituitary Hormones'}, {'id': 'D036361', 'term': 'Peptide Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': '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': 'Approximately 11.58 years', 'description': 'The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both serious and non-serious events during the study.', 'eventGroups': [{'id': 'EG000', 'title': 'Genotropin [Somatropin (Genetical Recombination)]', 'description': 'Participants who received Genotropin treatment in a real world clinic setting as prescribed in clinical practice from July 2005 - February 2017. Data was observed retrospectively.', 'otherNumAtRisk': 482, 'deathsNumAtRisk': 482, 'otherNumAffected': 105, 'seriousNumAtRisk': 482, 'deathsNumAffected': 1, 'seriousNumAffected': 32}], 'otherEvents': [{'term': 'Lymphadenitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 482, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Sinus tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 482, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Arnold-Chiari malformation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 482, 'numAffected': 1}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Spine malformation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 482, 'numAffected': 1}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Hyperthyroidism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 482, 'numAffected': 1}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Hypothyroidism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 482, 'numAffected': 2}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Thyroiditis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 482, 'numAffected': 1}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Conjunctivitis allergic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 482, 'numAffected': 3}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Colitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 482, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 482, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Pigmentation lip', 'stats': [{'groupId': 'EG000', 'numAtRisk': 482, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 482, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Injection site haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 482, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Injection site urticaria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 482, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 482, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Hepatic function abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 482, 'numAffected': 5}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Food allergy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 482, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Seasonal allergy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 482, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Adenoviral upper respiratory infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 482, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Beta haemolytic streptococcal infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 482, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 482, 'numAffected': 17}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Bronchitis viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 482, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Dermatitis infected', 'stats': [{'groupId': 'EG000', 'numAtRisk': 482, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Ear infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 482, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Erythema infectiosum', 'stats': [{'groupId': 'EG000', 'numAtRisk': 482, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Exanthema subitum', 'stats': [{'groupId': 'EG000', 'numAtRisk': 482, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 482, 'numAffected': 12}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'H1N1 influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 482, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Impetigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 482, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 482, 'numAffected': 14}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Molluscum contagiosum', 'stats': [{'groupId': 'EG000', 'numAtRisk': 482, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 482, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Oral herpes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 482, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Otitis externa', 'stats': [{'groupId': 'EG000', 'numAtRisk': 482, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Otitis media', 'stats': [{'groupId': 'EG000', 'numAtRisk': 482, 'numAffected': 7}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Otitis media acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 482, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Parotitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 482, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Pharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 482, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 482, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 482, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Streptococcal infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 482, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Subcutaneous abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 482, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Tonsillitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 482, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Tracheobronchitis mycoplasmal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 482, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Varicella', 'stats': [{'groupId': 'EG000', 'numAtRisk': 482, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 482, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 482, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Meniscus injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 482, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Thermal burn', 'stats': [{'groupId': 'EG000', 'numAtRisk': 482, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 482, 'numAffected': 4}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 482, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Blood alkaline phosphatase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 482, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Blood cholesterol increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 482, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Blood glucose increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 482, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Blood thyroid stimulating hormone decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 482, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Blood thyroid stimulating hormone increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 482, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Blood urea increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 482, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Blood urine present', 'stats': [{'groupId': 'EG000', 'numAtRisk': 482, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Body mass index increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 482, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Glucose urine', 'stats': [{'groupId': 'EG000', 'numAtRisk': 482, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Glycosylated haemoglobin increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 482, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Insulin-like growth factor increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 482, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Protein urine present', 'stats': [{'groupId': 'EG000', 'numAtRisk': 482, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'White blood cell count increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 482, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Glucose tolerance impaired', 'stats': [{'groupId': 'EG000', 'numAtRisk': 482, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Hyperglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 482, 'numAffected': 3}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Hyperinsulinaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 482, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Hypertriglyceridaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 482, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Obesity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 482, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 482, 'numAffected': 4}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Arthropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 482, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 482, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Scoliosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 482, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 482, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Neurofibroma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 482, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Febrile convulsion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 482, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 482, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Orthostatic intolerance', 'stats': [{'groupId': 'EG000', 'numAtRisk': 482, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Seizure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 482, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Attention deficit/hyperactivity disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 482, 'numAffected': 5}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Autism spectrum disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 482, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 482, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Tic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 482, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Orthostatic proteinuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 482, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Proteinuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 482, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Renal glycosuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 482, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Renal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 482, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Asthma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 482, 'numAffected': 11}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 482, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Rhinitis allergic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 482, 'numAffected': 8}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Upper respiratory tract inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 482, 'numAffected': 17}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Asteatosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 482, 'numAffected': 3}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Blister', 'stats': [{'groupId': 'EG000', 'numAtRisk': 482, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Dermal cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 482, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Dermatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 482, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Dermatitis atopic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 482, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Eczema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 482, 'numAffected': 5}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Eczema asteatotic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 482, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 482, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 482, 'numAffected': 3}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Urticaria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 482, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Oral surgery', 'stats': [{'groupId': 'EG000', 'numAtRisk': 482, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 482, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}], 'seriousEvents': [{'term': 'Acute sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 482, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Appendicitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 482, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 482, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Campylobacter gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 482, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 482, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Meningitis bacterial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 482, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Otitis media', 'stats': [{'groupId': 'EG000', 'numAtRisk': 482, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 482, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Bone neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 482, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 482, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Febrile convulsion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 482, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Seizure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 482, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Cardiac disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 482, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': "Kawasaki's disease", 'stats': [{'groupId': 'EG000', 'numAtRisk': 482, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Asthma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 482, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Sleep apnoea syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 482, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Upper respiratory tract inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 482, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Henoch-Schonlein purpura', 'stats': [{'groupId': 'EG000', 'numAtRisk': 482, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Osteochondrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 482, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Scoliosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 482, 'numAffected': 4}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Synovial disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 482, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Cryptorchism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 482, 'numAffected': 1}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Condition aggravated', 'stats': [{'groupId': 'EG000', 'numAtRisk': 482, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Patella fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 482, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Snake bite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 482, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Subdural haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 482, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Adverse Drug Reaction (ADR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '482', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Genotropin [Somatropin (Genetical Recombination)]', 'description': 'Participants who received Genotropin treatment in a real world clinic setting as prescribed in clinical practice from July 2005 - February 2017. Data was observed retrospectively.'}], 'classes': [{'title': 'ADR', 'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000'}]}]}, {'title': 'SADR', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Approximately 11.58 years', 'description': 'An adverse drug reaction (ADR) was any untoward medical occurrence attributed to Genotropin in a participant who received Genotropin. A serious ADR (SADR) was an ADR resulting in any of the following out comes or deemed significant for any other reason: death; life-threatening experience (immediate risk of dying); initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly. Relatedness to Genotropin was assessed by the physician.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety analysis set comprised of participants who satisfied the inclusion criteria and had received Genotropin.'}, {'type': 'PRIMARY', 'title': 'Change in Height Velocity Standard Deviation (SD) Score for Chronological Age From Baseline At Year 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '324', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Genotropin [Somatropin (Genetical Recombination)]', 'description': 'Participants who received Genotropin treatment in a real world clinic setting as prescribed in clinical practice from July 2005 - February 2017. Data was observed retrospectively.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.1', 'spread': '3.06', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Year 1', 'description': "Change in height Velocity SD score from baseline was calculated. Height Velocity SD score = (Height - Standard height for chronological age of gender) / SD. An SD score indicates how far a participant's score deviates from the mean of the reference population; an SD score higher than the mean gives a positive SD score whereas an SD score lower than the mean gives a negative SD score. SD score indicates how similar participant was to reference population.", 'unitOfMeasure': 'SD score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The efficacy analysis set comprised of participants in the safety analysis set who had effectiveness evaluation at least once. Here "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.'}, {'type': 'PRIMARY', 'title': 'Change in Height Velocity Standard Deviation (SD) Score for Chronological Age From Baseline at Year 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '243', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Genotropin [Somatropin (Genetical Recombination)]', 'description': 'Participants who received Genotropin treatment in a real world clinic setting as prescribed in clinical practice from July 2005 - February 2017. Data was observed retrospectively.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.0', 'spread': '2.92', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Year 2', 'description': "Change in height Velocity SD score from baseline was calculated. Height Velocity SD score = (Height - Standard height for chronological age of gender) / SD. An SD score indicates how far a participant's score deviates from the mean of the reference population; an SD score higher than the mean gives a positive SD score whereas an SD score lower than the mean gives a negative SD score. SD score indicates how similar participant was to reference population.", 'unitOfMeasure': 'SD score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The efficacy analysis set comprised of participants in the safety analysis set who had effectiveness evaluation at least once. Here "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.'}, {'type': 'PRIMARY', 'title': 'Change in Height Velocity Standard Deviation (SD) Score for Chronological Age From Baseline at Year 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '169', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Genotropin [Somatropin (Genetical Recombination)]', 'description': 'Participants who received Genotropin treatment in a real world clinic setting as prescribed in clinical practice from July 2005 - February 2017. Data was observed retrospectively.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.5', 'spread': '2.53', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Year 3', 'description': "Change in height Velocity SD score from baseline was calculated. Height Velocity SD score = (Height - Standard height for chronological age of gender) / SD. An SD score indicates how far a participant's score deviates from the mean of the reference population; an SD score higher than the mean gives a positive SD score whereas an SD score lower than the mean gives a negative SD score. SD score indicates how similar participant was to reference population.", 'unitOfMeasure': 'SD score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The efficacy analysis set comprised of participants in the safety analysis set who had effectiveness evaluation at least once. Here "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.'}, {'type': 'PRIMARY', 'title': 'Change in Height Velocity Standard Deviation (SD) Score for Chronological Age From Baseline at Year 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '146', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Genotropin [Somatropin (Genetical Recombination)]', 'description': 'Participants who received Genotropin treatment in a real world clinic setting as prescribed in clinical practice from July 2005 - February 2017. Data was observed retrospectively.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.6', 'spread': '2.81', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Year 4', 'description': "Change in height Velocity SD score from baseline was calculated. Height Velocity SD score = (Height - Standard height for chronological age of gender) / SD. An SD score indicates how far a participant's score deviates from the mean of the reference population; an SD score higher than the mean gives a positive SD score whereas an SD score lower than the mean gives a negative SD score. SD score indicates how similar participant was to reference population.", 'unitOfMeasure': 'SD score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The efficacy analysis set comprised of participants in the safety analysis set who had effectiveness evaluation at least once. Here "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.'}, {'type': 'PRIMARY', 'title': 'Change in Height Velocity Standard Deviation (SD) Score for Chronological Age From Baseline at Year 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '137', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Genotropin [Somatropin (Genetical Recombination)]', 'description': 'Participants who received Genotropin treatment in a real world clinic setting as prescribed in clinical practice from July 2005 - February 2017. Data was observed retrospectively.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.3', 'spread': '2.74', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Year 5', 'description': "Change in height Velocity SD score from baseline was calculated. Height Velocity SD score = (Height - Standard height for chronological age of gender) / SD. An SD score indicates how far a participant's score deviates from the mean of the reference population; an SD score higher than the mean gives a positive SD score whereas an SD score lower than the mean gives a negative SD score. SD score indicates how similar participant was to reference population.", 'unitOfMeasure': 'SD score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The efficacy analysis set comprised of participants in the safety analysis set who had effectiveness evaluation at least once. Here "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.'}, {'type': 'PRIMARY', 'title': 'Change in Height Velocity Standard Deviation (SD) Score for Chronological Age From Baseline at Year 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Genotropin [Somatropin (Genetical Recombination)]', 'description': 'Participants who received Genotropin treatment in a real world clinic setting as prescribed in clinical practice from July 2005 - February 2017. Data was observed retrospectively.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.4', 'spread': '3.07', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Year 6', 'description': "Change in height Velocity SD score from baseline was calculated. Height Velocity SD score = (Height - Standard height for chronological age of gender) / SD. An SD score indicates how far a participant's score deviates from the mean of the reference population; an SD score higher than the mean gives a positive SD score whereas an SD score lower than the mean gives a negative SD score. SD score indicates how similar participant was to reference population.", 'unitOfMeasure': 'SD score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The efficacy analysis set comprised of participants in the safety analysis set who had effectiveness evaluation at least once. Here "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.'}, {'type': 'PRIMARY', 'title': 'Change in Height Velocity Standard Deviation (SD) Score for Chronological Age From Baseline at Year 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Genotropin [Somatropin (Genetical Recombination)]', 'description': 'Participants who received Genotropin treatment in a real world clinic setting as prescribed in clinical practice from July 2005 - February 2017. Data was observed retrospectively.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.4', 'spread': '3.86', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Year 7', 'description': "Change in height Velocity SD score from baseline was calculated. Height Velocity SD score = (Height - Standard height for chronological age of gender) / SD. An SD score indicates how far a participant's score deviates from the mean of the reference population; an SD score higher than the mean gives a positive SD score whereas an SD score lower than the mean gives a negative SD score. SD score indicates how similar participant was to reference population.", 'unitOfMeasure': 'SD score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The efficacy analysis set comprised of participants in the safety analysis set who had effectiveness evaluation at least once. Here "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.'}, {'type': 'PRIMARY', 'title': 'Change in Height Velocity Standard Deviation (SD) Score for Chronological Age From Baseline at Year 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Genotropin [Somatropin (Genetical Recombination)]', 'description': 'Participants who received Genotropin treatment in a real world clinic setting as prescribed in clinical practice from July 2005 - February 2017. Data was observed retrospectively.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.6', 'spread': 'NA', 'comment': 'Only 1 subject evaluable hence standard deviation could not be estimated.', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Year 10', 'description': "Change in height Velocity SD score from baseline was calculated. Height Velocity SD score = (Height - Standard height for chronological age of gender) / SD. An SD score indicates how far a participant's score deviates from the mean of the reference population; an SD score higher than the mean gives a positive SD score whereas an SD score lower than the mean gives a negative SD score. SD score indicates how similar participant was to reference population.", 'unitOfMeasure': 'SD score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The efficacy analysis set comprised of participants in the safety analysis set who had effectiveness evaluation at least once. Here "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.'}, {'type': 'PRIMARY', 'title': 'Change in Height Standard Deviation (SD) Score for Chronological Age From Baseline at Year 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '388', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Genotropin [Somatropin (Genetical Recombination)]', 'description': 'Participants who received Genotropin treatment in a real world clinic setting as prescribed in clinical practice from July 2005 - February 2017. Data was observed retrospectively.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.6', 'spread': '0.36', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Year 1', 'description': "Change in height SD score from baseline was calculated. Height SD score = (Height - Standard height for chronological age of gender) / SD. An SD score indicates how far a participant's score deviates from the mean of the reference population; an SD score higher than the mean gives a positive SD score whereas an SD score lower than the mean gives a negative SD score. SD score indicates how similar participant was to reference population.", 'unitOfMeasure': 'SD score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The efficacy analysis set comprised of participants in the safety analysis set who had effectiveness evaluation at least once. Here "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.'}, {'type': 'PRIMARY', 'title': 'Change in Height Standard Deviation (SD) Score for Chronological Age From Baseline at Year 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '315', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Genotropin [Somatropin (Genetical Recombination)]', 'description': 'Participants who received Genotropin treatment in a real world clinic setting as prescribed in clinical practice from July 2005 - February 2017. Data was observed retrospectively.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.9', 'spread': '0.49', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Year 2', 'description': "Change in height SD score from baseline was calculated. Height SD score = (Height - Standard height for chronological age of gender) / SD. An SD score indicates how far a participant's score deviates from the mean of the reference population; an SD score higher than the mean gives a positive SD score whereas an SD score lower than the mean gives a negative SD score. SD score indicates how similar participant was to reference population.", 'unitOfMeasure': 'SD score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The efficacy analysis set comprised of participants in the safety analysis set who had effectiveness evaluation at least once. Here "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.'}, {'type': 'PRIMARY', 'title': 'Change in Height Standard Deviation (SD) Score for Chronological Age From Baseline at Year 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '233', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Genotropin [Somatropin (Genetical Recombination)]', 'description': 'Participants who received Genotropin treatment in a real world clinic setting as prescribed in clinical practice from July 2005 - February 2017. Data was observed retrospectively.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.1', 'spread': '0.51', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Year 3', 'description': "Change in height SD score from baseline was calculated. Height SD score = (Height - Standard height for chronological age of gender) / SD. An SD score indicates how far a participant's score deviates from the mean of the reference population; an SD score higher than the mean gives a positive SD score whereas an SD score lower than the mean gives a negative SD score. SD score indicates how similar participant was to reference population.", 'unitOfMeasure': 'SD score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The efficacy analysis set comprised of participants in the safety analysis set who had effectiveness evaluation at least once. Here "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.'}, {'type': 'PRIMARY', 'title': 'Change in Height Standard Deviation (SD) Score for Chronological Age From Baseline at Year 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '223', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Genotropin [Somatropin (Genetical Recombination)]', 'description': 'Participants who received Genotropin treatment in a real world clinic setting as prescribed in clinical practice from July 2005 - February 2017. Data was observed retrospectively.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.3', 'spread': '0.63', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Year 4', 'description': "Change in height SD score from baseline was calculated. Height SD score = (Height - Standard height for chronological age of gender) / SD. An SD score indicates how far a participant's score deviates from the mean of the reference population; an SD score higher than the mean gives a positive SD score whereas an SD score lower than the mean gives a negative SD score. SD score indicates how similar participant was to reference population.", 'unitOfMeasure': 'SD score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The efficacy analysis set comprised of participants in the safety analysis set who had effectiveness evaluation at least once. Here "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.'}, {'type': 'PRIMARY', 'title': 'Change in Height Standard Deviation (SD) Score for Chronological Age From Baseline at Year 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '205', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Genotropin [Somatropin (Genetical Recombination)]', 'description': 'Participants who received Genotropin treatment in a real world clinic setting as prescribed in clinical practice from July 2005 - February 2017. Data was observed retrospectively.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.3', 'spread': '0.71', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Year 5', 'description': "Change in height SD score from baseline was calculated. Height SD score = (Height - Standard height for chronological age of gender) / SD. An SD score indicates how far a participant's score deviates from the mean of the reference population; an SD score higher than the mean gives a positive SD score whereas an SD score lower than the mean gives a negative SD score. SD score indicates how similar participant was to reference population.", 'unitOfMeasure': 'SD score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The efficacy analysis set comprised of participants in the safety analysis set who had effectiveness evaluation at least once. Here "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.'}, {'type': 'PRIMARY', 'title': 'Change in Height Standard Deviation (SD) Score for Chronological Age From Baseline at Year 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '136', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Genotropin [Somatropin (Genetical Recombination)]', 'description': 'Participants who received Genotropin treatment in a real world clinic setting as prescribed in clinical practice from July 2005 - February 2017. Data was observed retrospectively.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.4', 'spread': '0.81', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Year 6', 'description': "Change in height SD score from baseline was calculated. Height SD score = (Height - Standard height for chronological age of gender) / SD. An SD score indicates how far a participant's score deviates from the mean of the reference population; an SD score higher than the mean gives a positive SD score whereas an SD score lower than the mean gives a negative SD score. SD score indicates how similar participant was to reference population.", 'unitOfMeasure': 'SD score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The efficacy analysis set comprised of participants in the safety analysis set who had effectiveness evaluation at least once. Here "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.'}, {'type': 'PRIMARY', 'title': 'Change in Height Standard Deviation (SD) Score for Chronological Age From Baseline at Year 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Genotropin [Somatropin (Genetical Recombination)]', 'description': 'Participants who received Genotropin treatment in a real world clinic setting as prescribed in clinical practice from July 2005 - February 2017. Data was observed retrospectively.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.4', 'spread': '0.87', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Year 7', 'description': "Change in height SD score from baseline was calculated. Height SD score = (Height - Standard height for chronological age of gender) / SD. An SD score indicates how far a participant's score deviates from the mean of the reference population; an SD score higher than the mean gives a positive SD score whereas an SD score lower than the mean gives a negative SD score. SD score indicates how similar participant was to reference population.", 'unitOfMeasure': 'SD score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The efficacy analysis set comprised of participants in the safety analysis set who had effectiveness evaluation at least once. Here "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.'}, {'type': 'PRIMARY', 'title': 'Change in Height Standard Deviation (SD) Score for Chronological Age From Baseline at Year 9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Genotropin [Somatropin (Genetical Recombination)]', 'description': 'Participants who received Genotropin treatment in a real world clinic setting as prescribed in clinical practice from July 2005 - February 2017. Data was observed retrospectively.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.1', 'spread': 'NA', 'comment': 'Only 1 subject evaluable hence standard deviation could not be estimated.', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Year 9', 'description': "Change in height SD score from baseline was calculated. Height SD score = (Height - Standard height for chronological age of gender) / SD. An SD score indicates how far a participant's score deviates from the mean of the reference population; an SD score higher than the mean gives a positive SD score whereas an SD score lower than the mean gives a negative SD score. SD score indicates how similar participant was to reference population.", 'unitOfMeasure': 'SD score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The efficacy analysis set comprised of participants in the safety analysis set who had effectiveness evaluation at least once. Here "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.'}, {'type': 'PRIMARY', 'title': 'Change in Height Standard Deviation (SD) Score for Chronological Age From Baseline at Year 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Genotropin [Somatropin (Genetical Recombination)]', 'description': 'Participants who received Genotropin treatment in a real world clinic setting as prescribed in clinical practice from July 2005 - February 2017. Data was observed retrospectively.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.8', 'spread': 'NA', 'comment': 'Only 1 subject evaluable hence standard deviation could not be estimated.', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Year 10', 'description': "Change in height SD score from baseline was calculated. Height SD score = (Height - Standard height for chronological age of gender) / SD. An SD score indicates how far a participant's score deviates from the mean of the reference population; an SD score higher than the mean gives a positive SD score whereas an SD score lower than the mean gives a negative SD score. SD score indicates how similar participant was to reference population.", 'unitOfMeasure': 'SD score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The efficacy analysis set comprised of participants in the safety analysis set who had effectiveness evaluation at least once. Here "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Height Standard Deviation (SD) Score at Puberty and at Near Final Height in Participants Who Reached Near Final Height', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Genotropin [Somatropin (Genetical Recombination)]', 'description': 'Participants who received Genotropin treatment in a real world clinic setting as prescribed in clinical practice from July 2005 - February 2017. Data was observed retrospectively.'}], 'classes': [{'title': 'At baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-3.1', 'spread': '0.77', 'groupId': 'OG000'}]}]}, {'title': 'At puberty', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.8', 'spread': '0.86', 'groupId': 'OG000'}]}]}, {'title': 'At near final height', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.5', 'spread': '1.16', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, At Puberty, At Near Final Height within the span of approximately maximum of 11.58 years', 'description': "Height SD score = (Height - Standard height for chronological age of gender) / SD. An SD score indicates how far a participant's score deviates from the mean of the reference population; an SD score higher than the mean gives a positive SD score whereas an SD score lower than the mean gives a negative SD score. SD score indicates how similar participant was to reference population. Near final height was defined as the height at one of the following conditions: the annual height velocity became less than 2 cm/year after reaching the maximum height in puberty, bone age reached 17 years old and older for male and 15 years old and older for female, or the reason for discontinuation was that subject reached the near final height or had epiphyseal closure.", 'unitOfMeasure': 'SD score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The efficacy analysis set comprised of participants in the safety analysis set who had effectiveness evaluation at least once. Among the efficacy analysis set, the participants who reached near final height was analyzed.'}, {'type': 'SECONDARY', 'title': 'Change in Height Standard Deviation (SD) Score at Puberty and at Near Final Height in Participants Who Reached Near Final Height From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Genotropin [Somatropin (Genetical Recombination)]', 'description': 'Participants who received Genotropin treatment in a real world clinic setting as prescribed in clinical practice from July 2005 - February 2017. Data was observed retrospectively.'}], 'classes': [{'title': 'Change at At puberty', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.3', 'spread': '0.36', 'groupId': 'OG000'}]}]}, {'title': 'Change At near final height', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.6', 'spread': '0.74', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, At Puberty, At Near Final Height within the span of approximately maximum of 11.58 years', 'description': "Change in height SD score from baseline was calculated. Height SD score = (Height - Standard height for chronological age of gender) / SD. An SD score indicates how far a participant's score deviates from the mean of the reference population; an SD score higher than the mean gives a positive SD score whereas an SD score lower than the mean gives a negative SD score. SD score indicates how similar participant was to reference population. Near final height was defined as the height at one of the following conditions: the annual height velocity became less than 2 cm/year after reaching the maximum height in puberty, bone age reached 17 years old and older for male and 15 years old and older for female, or the reason for discontinuation was that subject reached the near final height or had epiphyseal closure.", 'unitOfMeasure': 'SD score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The efficacy analysis set comprised of participants in the safety analysis set who had effectiveness evaluation at least once. Among the efficacy analysis set, the participants who reached near final height was analyzed.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Genotropin [Somatropin (Genetical Recombination)]', 'description': 'Participants who received Genotropin treatment in a real world clinic setting as prescribed in clinical practice from July 2005 - February 2017. Data was observed retrospectively.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '482'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '482'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'It is a retrospective study. Data was collected for participants from July 2005 - February 2017(approximately over 11 years 6 months).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '482', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Genotropin [Somatropin (Genetical Recombination)]', 'description': 'Participants who received Genotropin treatment in a real world clinic setting as prescribed in clinical practice from July 2005 - February 2017. Data was observed retrospectively.'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': '<5 years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '482', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '220', 'groupId': 'BG000'}]}]}, {'title': '≥5 and <7 years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '482', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '95', 'groupId': 'BG000'}]}]}, {'title': '≥7 years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '482', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '167', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}, {'title': 'Sex/Gender, Customized', 'classes': [{'title': 'Male', 'denoms': [{'units': 'Participants', 'counts': [{'value': '482', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '240', 'groupId': 'BG000'}]}]}, {'title': 'Female', 'denoms': [{'units': 'Participants', 'counts': [{'value': '482', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '242', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}], 'populationDescription': 'Participants enrolled in this study.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2013-07-02', 'size': 356583, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2018-02-26T10:52', 'hasProtocol': True}, {'date': '2016-10-27', 'size': 1823018, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2018-02-26T10:52', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 482}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-09-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-08', 'completionDateStruct': {'date': '2017-06-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-08-31', 'studyFirstSubmitDate': '2013-07-09', 'resultsFirstSubmitDate': '2018-02-26', 'studyFirstSubmitQcDate': '2013-07-09', 'lastUpdatePostDateStruct': {'date': '2023-09-25', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-01-29', 'studyFirstPostDateStruct': {'date': '2013-07-12', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-02-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-02-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Adverse Drug Reaction (ADR)', 'timeFrame': 'Approximately 11.58 years', 'description': 'An adverse drug reaction (ADR) was any untoward medical occurrence attributed to Genotropin in a participant who received Genotropin. A serious ADR (SADR) was an ADR resulting in any of the following out comes or deemed significant for any other reason: death; life-threatening experience (immediate risk of dying); initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly. Relatedness to Genotropin was assessed by the physician.'}, {'measure': 'Change in Height Velocity Standard Deviation (SD) Score for Chronological Age From Baseline At Year 1', 'timeFrame': 'Baseline, Year 1', 'description': "Change in height Velocity SD score from baseline was calculated. Height Velocity SD score = (Height - Standard height for chronological age of gender) / SD. An SD score indicates how far a participant's score deviates from the mean of the reference population; an SD score higher than the mean gives a positive SD score whereas an SD score lower than the mean gives a negative SD score. SD score indicates how similar participant was to reference population."}, {'measure': 'Change in Height Velocity Standard Deviation (SD) Score for Chronological Age From Baseline at Year 2', 'timeFrame': 'Baseline, Year 2', 'description': "Change in height Velocity SD score from baseline was calculated. Height Velocity SD score = (Height - Standard height for chronological age of gender) / SD. An SD score indicates how far a participant's score deviates from the mean of the reference population; an SD score higher than the mean gives a positive SD score whereas an SD score lower than the mean gives a negative SD score. SD score indicates how similar participant was to reference population."}, {'measure': 'Change in Height Velocity Standard Deviation (SD) Score for Chronological Age From Baseline at Year 3', 'timeFrame': 'Baseline, Year 3', 'description': "Change in height Velocity SD score from baseline was calculated. Height Velocity SD score = (Height - Standard height for chronological age of gender) / SD. An SD score indicates how far a participant's score deviates from the mean of the reference population; an SD score higher than the mean gives a positive SD score whereas an SD score lower than the mean gives a negative SD score. SD score indicates how similar participant was to reference population."}, {'measure': 'Change in Height Velocity Standard Deviation (SD) Score for Chronological Age From Baseline at Year 4', 'timeFrame': 'Baseline, Year 4', 'description': "Change in height Velocity SD score from baseline was calculated. Height Velocity SD score = (Height - Standard height for chronological age of gender) / SD. An SD score indicates how far a participant's score deviates from the mean of the reference population; an SD score higher than the mean gives a positive SD score whereas an SD score lower than the mean gives a negative SD score. SD score indicates how similar participant was to reference population."}, {'measure': 'Change in Height Velocity Standard Deviation (SD) Score for Chronological Age From Baseline at Year 5', 'timeFrame': 'Baseline, Year 5', 'description': "Change in height Velocity SD score from baseline was calculated. Height Velocity SD score = (Height - Standard height for chronological age of gender) / SD. An SD score indicates how far a participant's score deviates from the mean of the reference population; an SD score higher than the mean gives a positive SD score whereas an SD score lower than the mean gives a negative SD score. SD score indicates how similar participant was to reference population."}, {'measure': 'Change in Height Velocity Standard Deviation (SD) Score for Chronological Age From Baseline at Year 6', 'timeFrame': 'Baseline, Year 6', 'description': "Change in height Velocity SD score from baseline was calculated. Height Velocity SD score = (Height - Standard height for chronological age of gender) / SD. An SD score indicates how far a participant's score deviates from the mean of the reference population; an SD score higher than the mean gives a positive SD score whereas an SD score lower than the mean gives a negative SD score. SD score indicates how similar participant was to reference population."}, {'measure': 'Change in Height Velocity Standard Deviation (SD) Score for Chronological Age From Baseline at Year 7', 'timeFrame': 'Baseline, Year 7', 'description': "Change in height Velocity SD score from baseline was calculated. Height Velocity SD score = (Height - Standard height for chronological age of gender) / SD. An SD score indicates how far a participant's score deviates from the mean of the reference population; an SD score higher than the mean gives a positive SD score whereas an SD score lower than the mean gives a negative SD score. SD score indicates how similar participant was to reference population."}, {'measure': 'Change in Height Velocity Standard Deviation (SD) Score for Chronological Age From Baseline at Year 10', 'timeFrame': 'Baseline, Year 10', 'description': "Change in height Velocity SD score from baseline was calculated. Height Velocity SD score = (Height - Standard height for chronological age of gender) / SD. An SD score indicates how far a participant's score deviates from the mean of the reference population; an SD score higher than the mean gives a positive SD score whereas an SD score lower than the mean gives a negative SD score. SD score indicates how similar participant was to reference population."}, {'measure': 'Change in Height Standard Deviation (SD) Score for Chronological Age From Baseline at Year 1', 'timeFrame': 'Baseline, Year 1', 'description': "Change in height SD score from baseline was calculated. Height SD score = (Height - Standard height for chronological age of gender) / SD. An SD score indicates how far a participant's score deviates from the mean of the reference population; an SD score higher than the mean gives a positive SD score whereas an SD score lower than the mean gives a negative SD score. SD score indicates how similar participant was to reference population."}, {'measure': 'Change in Height Standard Deviation (SD) Score for Chronological Age From Baseline at Year 2', 'timeFrame': 'Baseline, Year 2', 'description': "Change in height SD score from baseline was calculated. Height SD score = (Height - Standard height for chronological age of gender) / SD. An SD score indicates how far a participant's score deviates from the mean of the reference population; an SD score higher than the mean gives a positive SD score whereas an SD score lower than the mean gives a negative SD score. SD score indicates how similar participant was to reference population."}, {'measure': 'Change in Height Standard Deviation (SD) Score for Chronological Age From Baseline at Year 3', 'timeFrame': 'Baseline, Year 3', 'description': "Change in height SD score from baseline was calculated. Height SD score = (Height - Standard height for chronological age of gender) / SD. An SD score indicates how far a participant's score deviates from the mean of the reference population; an SD score higher than the mean gives a positive SD score whereas an SD score lower than the mean gives a negative SD score. SD score indicates how similar participant was to reference population."}, {'measure': 'Change in Height Standard Deviation (SD) Score for Chronological Age From Baseline at Year 4', 'timeFrame': 'Baseline, Year 4', 'description': "Change in height SD score from baseline was calculated. Height SD score = (Height - Standard height for chronological age of gender) / SD. An SD score indicates how far a participant's score deviates from the mean of the reference population; an SD score higher than the mean gives a positive SD score whereas an SD score lower than the mean gives a negative SD score. SD score indicates how similar participant was to reference population."}, {'measure': 'Change in Height Standard Deviation (SD) Score for Chronological Age From Baseline at Year 5', 'timeFrame': 'Baseline, Year 5', 'description': "Change in height SD score from baseline was calculated. Height SD score = (Height - Standard height for chronological age of gender) / SD. An SD score indicates how far a participant's score deviates from the mean of the reference population; an SD score higher than the mean gives a positive SD score whereas an SD score lower than the mean gives a negative SD score. SD score indicates how similar participant was to reference population."}, {'measure': 'Change in Height Standard Deviation (SD) Score for Chronological Age From Baseline at Year 6', 'timeFrame': 'Baseline, Year 6', 'description': "Change in height SD score from baseline was calculated. Height SD score = (Height - Standard height for chronological age of gender) / SD. An SD score indicates how far a participant's score deviates from the mean of the reference population; an SD score higher than the mean gives a positive SD score whereas an SD score lower than the mean gives a negative SD score. SD score indicates how similar participant was to reference population."}, {'measure': 'Change in Height Standard Deviation (SD) Score for Chronological Age From Baseline at Year 7', 'timeFrame': 'Baseline, Year 7', 'description': "Change in height SD score from baseline was calculated. Height SD score = (Height - Standard height for chronological age of gender) / SD. An SD score indicates how far a participant's score deviates from the mean of the reference population; an SD score higher than the mean gives a positive SD score whereas an SD score lower than the mean gives a negative SD score. SD score indicates how similar participant was to reference population."}, {'measure': 'Change in Height Standard Deviation (SD) Score for Chronological Age From Baseline at Year 9', 'timeFrame': 'Baseline, Year 9', 'description': "Change in height SD score from baseline was calculated. Height SD score = (Height - Standard height for chronological age of gender) / SD. An SD score indicates how far a participant's score deviates from the mean of the reference population; an SD score higher than the mean gives a positive SD score whereas an SD score lower than the mean gives a negative SD score. SD score indicates how similar participant was to reference population."}, {'measure': 'Change in Height Standard Deviation (SD) Score for Chronological Age From Baseline at Year 10', 'timeFrame': 'Baseline, Year 10', 'description': "Change in height SD score from baseline was calculated. Height SD score = (Height - Standard height for chronological age of gender) / SD. An SD score indicates how far a participant's score deviates from the mean of the reference population; an SD score higher than the mean gives a positive SD score whereas an SD score lower than the mean gives a negative SD score. SD score indicates how similar participant was to reference population."}], 'secondaryOutcomes': [{'measure': 'Height Standard Deviation (SD) Score at Puberty and at Near Final Height in Participants Who Reached Near Final Height', 'timeFrame': 'Baseline, At Puberty, At Near Final Height within the span of approximately maximum of 11.58 years', 'description': "Height SD score = (Height - Standard height for chronological age of gender) / SD. An SD score indicates how far a participant's score deviates from the mean of the reference population; an SD score higher than the mean gives a positive SD score whereas an SD score lower than the mean gives a negative SD score. SD score indicates how similar participant was to reference population. Near final height was defined as the height at one of the following conditions: the annual height velocity became less than 2 cm/year after reaching the maximum height in puberty, bone age reached 17 years old and older for male and 15 years old and older for female, or the reason for discontinuation was that subject reached the near final height or had epiphyseal closure."}, {'measure': 'Change in Height Standard Deviation (SD) Score at Puberty and at Near Final Height in Participants Who Reached Near Final Height From Baseline', 'timeFrame': 'Baseline, At Puberty, At Near Final Height within the span of approximately maximum of 11.58 years', 'description': "Change in height SD score from baseline was calculated. Height SD score = (Height - Standard height for chronological age of gender) / SD. An SD score indicates how far a participant's score deviates from the mean of the reference population; an SD score higher than the mean gives a positive SD score whereas an SD score lower than the mean gives a negative SD score. SD score indicates how similar participant was to reference population. Near final height was defined as the height at one of the following conditions: the annual height velocity became less than 2 cm/year after reaching the maximum height in puberty, bone age reached 17 years old and older for male and 15 years old and older for female, or the reason for discontinuation was that subject reached the near final height or had epiphyseal closure."}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Genotropin', 'Somatropin', 'Long Term Follow-Up', 'Special Investigation', 'Small for Gestational Age', 'SGA'], 'conditions': ['Small for Gestational Age (SGA)']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A6281314&StudyName=Special%20Investigation%20Of%20Genotropin%20Long%20Follow-Up%20For%20Patients%20With%20A%20Small%20For%20Gestational%20Age%20%28SGA%29', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'The objective of this surveillance is to collect Safety and Effectiveness information for Long term Use of Somatropin for Patients with a Small for Gestational Age (SGA).', 'detailedDescription': 'All the patients whom an investigator prescribes Genotropin should be registered consecutively until the number of subjects reaches target number in order to extract patients enrolled into the investigation at random.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '20 Years', 'minimumAge': '2 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': '* A patients who is diagnosed for SGA. (SGA is defined as birth weight and/or length at least 2 standard deviations (SDs) below the mean for gestational age (\\<or=-2 SD)).\n* A patient who is SGA and older than 3 years.\n* A patient who has persistent short stature (i.e., remaining at least 2.5 SD below the mean for chronologic age).', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* A patient who was administered Somatropin (Genotropin).\n\nExclusion Criteria:\n\n* N/A.'}, 'identificationModule': {'nctId': 'NCT01897766', 'briefTitle': 'Special Investigation Of Genotropin Long Follow-Up For Patients With A Small For Gestational Age "Scoped for Japanese"', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'AN INVESTIGATION INTENDED TO EVALUATE THE LONG-TERM EFFICACY AND SAFETY OF GENOTROPIN IN CHILDREN WITH SGA DWARFISM WITHOUT EPIPHYSEAL CLOSURE. (RETROSPECTIVE STUDY)', 'orgStudyIdInfo': {'id': 'A6281314'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Somatropin', 'description': 'Patients administered Somatropin.', 'interventionNames': ['Drug: Somatropin']}], 'interventions': [{'name': 'Somatropin', 'type': 'DRUG', 'otherNames': ['Genotropin'], 'description': '0.23 mg to 0.48 mg/kg/week', 'armGroupLabels': ['Somatropin']}]}, 'contactsLocationsModule': {'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'}}}}