Ignite Creation Date:
2025-12-25 @ 3:20 AM
Ignite Modification Date:
2025-12-26 @ 1:58 AM
Study NCT ID:
NCT01073605
Status:
COMPLETED
Last Update Posted:
2010-11-18
First Post:
2010-02-22
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Genotropin Treatment in Short Prepubertal Children With Intra-Uterine Growth Retardation
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006130', 'term': 'Growth Disorders'}, {'id': 'D005317', 'term': 'Fetal Growth Retardation'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D005315', 'term': 'Fetal Diseases'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}, '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': {'description': 'The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.', 'eventGroups': [{'id': 'EG000', 'title': 'Genotonorm 0.7 (Continuous Treatment)', 'description': 'Subjects received 0.7 international unit (IU)/kilogram (kg)/week (0.03 milligram \\[mg\\]/kg/day) of Genotonorm growth hormone (GH) as a continuous treatment. Treatment was allowed to be taken until final height of the subject had been reached.', 'otherNumAtRisk': 68, 'otherNumAffected': 40, 'seriousNumAtRisk': 68, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Genotonorm 1.4 (Continuous Treatment)', 'description': 'Subjects received 1.4 IU/kg/week (0.06 mg/kg/day) of the growth hormone Genotonorm as a continuous treatment. Treatment was allowed to be taken until final height of the subject had been reached.', 'otherNumAtRisk': 70, 'otherNumAffected': 42, 'seriousNumAtRisk': 70, 'seriousNumAffected': 4}, {'id': 'EG002', 'title': 'Genotonorm 1.4 (Intermittent Treatment)', 'description': 'Subjects received 1.4 IU/kg/week (0.06 mg/kg/day) of the growth hormone Genotonorm as an intermittent treatment. Treatment was allowed to be taken until final height of the subject had been reached.', 'otherNumAtRisk': 68, 'otherNumAffected': 35, 'seriousNumAtRisk': 68, 'seriousNumAffected': 3}], 'otherEvents': [{'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 70, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 68, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 70, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 68, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 70, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 68, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 70, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 68, 'numAffected': 17}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Ear infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 70, 'numAffected': 15}, {'groupId': 'EG002', 'numAtRisk': 68, 'numAffected': 9}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Fungal infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 70, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 68, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 70, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 68, 'numAffected': 11}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 70, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 68, 'numAffected': 7}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 70, 'numAffected': 16}, {'groupId': 'EG002', 'numAtRisk': 68, 'numAffected': 11}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Pharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 70, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 68, 'numAffected': 7}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Rhinitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 70, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 68, 'numAffected': 6}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Tracheitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 70, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 68, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 70, 'numAffected': 19}, {'groupId': 'EG002', 'numAtRisk': 68, 'numAffected': 12}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Varicella', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 70, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 68, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Scoliosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 70, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 68, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Convulsion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 70, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 68, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 70, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 68, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Asthma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 70, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 68, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 70, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 68, 'numAffected': 5}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Eczema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 70, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 68, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Urticaria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 70, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 68, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}], 'seriousEvents': [{'term': 'Tonsillectomy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 70, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 68, 'numAffected': 3}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline in Annual Growth Rate Measured at 2 Years Following Treatment With Genotonorm', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}, {'value': '40', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Genotonorm 0.7 (Continuous Treatment)', 'description': 'Subjects received 0.7 IU/kg/week (0.03 mg/kg/day) of the growth hormone Genotonorm as a continuous treatment. Treatment was allowed to be taken until final height of the subject had been reached.'}, {'id': 'OG001', 'title': 'Genotonorm 1.4 (Continuous Treatment)', 'description': 'Subjects received 1.4 IU/kg/week (0.06 mg/kg/day) of the growth hormone Genotonorm as a continuous treatment. Treatment was allowed to be taken until final height of the subject had been reached.'}, {'id': 'OG002', 'title': 'Genotonorm 1.4 (Intermittent Treatment)', 'description': 'Subjects received 1.4 IU/kg/week (0.06 mg/kg/day) of the growth hormone Genotonorm as an intermittent treatment. Treatment was allowed to be taken until final height of the subject had been reached.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.07', 'spread': '2.21', 'groupId': 'OG000'}, {'value': '3.97', 'spread': '1.72', 'groupId': 'OG001'}, {'value': '2.84', 'spread': '1.71', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.02922', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'pValueComment': 'P-values for the 3 treatment comparisons should be interpreted in line with the Bonferroni stepwise (Holm) testing procedure, to maintain the Type 1 error at p=0.05.', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.74299', 'groupIds': ['OG000', 'OG002'], 'ciNumSides': 'TWO_SIDED', 'pValueComment': 'P-values for the 3 treatment comparisons should be interpreted in line with the Bonferroni stepwise (Holm) testing procedure, to maintain the Type 1 error at p=0.05.', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.00467', 'groupIds': ['OG001', 'OG002'], 'ciNumSides': 'TWO_SIDED', 'pValueComment': 'P-values for the 3 treatment comparisons should be interpreted in line with the Bonferroni stepwise (Holm) testing procedure, to maintain the Type 1 error at p=0.05.', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 2 years', 'description': 'Annual growth rate was expressed as height velocity (centimeter \\[cm\\]/year). This was derived by substracting annual growth rate at Baseline from 2-year value. (Annual growth rate was calculated each year and rescaled to 1 year if the interval between x and x-1 was not 365 days, as long as a subject remains in the study): ANGRYx = (Height Yx - Height Y{x-1}) / {(Date of Yx - Date of Y{x-1}) /365.25}', 'unitOfMeasure': 'cm/year', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All subjects who received at least 1 study dose of Genotonorm were included in the Full Analysis Set (FAS). Number of Participants Analyzed = number of subjects with change in annual growth rate at 2 years.'}, {'type': 'SECONDARY', 'title': 'Annual Growth Rate Standard Deviation Score (SDS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}, {'value': '43', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Genotonorm 0.7 (Continuous Treatment)', 'description': 'Subjects received 0.7 IU/kg/week (0.03 mg/kg/day) of the growth hormone Genotonorm as a continuous treatment. Treatment was allowed to be taken until final height of the subject had been reached.'}, {'id': 'OG001', 'title': 'Genotonorm 1.4 (Continuous Treatment)', 'description': 'Subjects received 1.4 IU/kg/week (0.06 mg/kg/day) of the growth hormone Genotonorm as a continuous treatment. Treatment was allowed to be taken until final height of the subject had been reached.'}, {'id': 'OG002', 'title': 'Genotonorm 1.4 (Intermittent Treatment)', 'description': 'Subjects received 1.4 IU/kg/week (0.06 mg/kg/day) of the growth hormone Genotonorm as an intermittent treatment. Treatment was allowed to be taken until final height of the subject had been reached.'}], 'classes': [{'title': 'Baseline (n=50, 42, 43)', 'categories': [{'measurements': [{'value': '-2.72', 'spread': '1.83', 'groupId': 'OG000'}, {'value': '-2.58', 'spread': '1.39', 'groupId': 'OG001'}, {'value': '-2.75', 'spread': '1.73', 'groupId': 'OG002'}]}]}, {'title': '1 year (n=57, 55, 59)', 'categories': [{'measurements': [{'value': '2.14', 'spread': '1.52', 'groupId': 'OG000'}, {'value': '3.97', 'spread': '2.26', 'groupId': 'OG001'}, {'value': '1.71', 'spread': '1.51', 'groupId': 'OG002'}]}]}, {'title': '2 years (n=53, 49, 56)', 'categories': [{'measurements': [{'value': '0.77', 'spread': '1.57', 'groupId': 'OG000'}, {'value': '2.00', 'spread': '1.73', 'groupId': 'OG001'}, {'value': '0.67', 'spread': '1.22', 'groupId': 'OG002'}]}]}, {'title': '3 years (n=39, 34, 41)', 'categories': [{'measurements': [{'value': '0.36', 'spread': '1.14', 'groupId': 'OG000'}, {'value': '1.35', 'spread': '1.78', 'groupId': 'OG001'}, {'value': '0.31', 'spread': '1.12', 'groupId': 'OG002'}]}]}, {'title': '4 years (n=21, 18, 27)', 'categories': [{'measurements': [{'value': '0.13', 'spread': '1.55', 'groupId': 'OG000'}, {'value': '0.61', 'spread': '1.20', 'groupId': 'OG001'}, {'value': '0.34', 'spread': '1.20', 'groupId': 'OG002'}]}]}, {'title': '5 years (n=12, 10, 20)', 'categories': [{'measurements': [{'value': '0.18', 'spread': '1.24', 'groupId': 'OG000'}, {'value': '0.09', 'spread': '0.88', 'groupId': 'OG001'}, {'value': '-0.02', 'spread': '1.46', 'groupId': 'OG002'}]}]}, {'title': '6 years (n=11, 7, 19)', 'categories': [{'measurements': [{'value': '0.90', 'spread': '1.92', 'groupId': 'OG000'}, {'value': '0.59', 'spread': '1.61', 'groupId': 'OG001'}, {'value': '0.05', 'spread': '1.20', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 1 to 6 years', 'description': 'Calculated using Sempe reference means and standard deviations for growth rate according to age and sex. Standardization was performed for chronological age.', 'unitOfMeasure': 'SDS', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS. Number of Participants Analyzed = number of subjects with evaluable data at Baseline. n = number of subjects with evaluable data at each time point. Data beyond 6 years are not reported due to the low proportion of subjects followed up beyond 6 years.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Annual Growth Rate SDS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}, {'value': '42', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Genotonorm 0.7 (Continuous Treatment)', 'description': 'Subjects received 0.7 IU/kg/week (0.03 mg/kg/day) of the growth hormone Genotonorm as a continuous treatment. Treatment was allowed to be taken until final height of the subject had been reached.'}, {'id': 'OG001', 'title': 'Genotonorm 1.4 (Continuous Treatment)', 'description': 'Subjects received 1.4 IU/kg/week (0.06 mg/kg/day) of the growth hormone Genotonorm as a continuous treatment. Treatment was allowed to be taken until final height of the subject had been reached.'}, {'id': 'OG002', 'title': 'Genotonorm 1.4 (Intermittent Treatment)', 'description': 'Subjects received 1.4 IU/kg/week (0.06 mg/kg/day) of the growth hormone Genotonorm as an intermittent treatment. Treatment was allowed to be taken until final height of the subject had been reached.'}], 'classes': [{'title': '1 year (n=49, 42, 42)', 'categories': [{'measurements': [{'value': '4.81', 'spread': '2.27', 'groupId': 'OG000'}, {'value': '6.56', 'spread': '2.55', 'groupId': 'OG001'}, {'value': '4.37', 'spread': '2.16', 'groupId': 'OG002'}]}]}, {'title': '2 years (n=47, 37, 40)', 'categories': [{'measurements': [{'value': '3.51', 'spread': '2.50', 'groupId': 'OG000'}, {'value': '4.53', 'spread': '1.89', 'groupId': 'OG001'}, {'value': '3.37', 'spread': '2.33', 'groupId': 'OG002'}]}]}, {'title': '3 years (n=34, 25, 32)', 'categories': [{'measurements': [{'value': '3.31', 'spread': '2.06', 'groupId': 'OG000'}, {'value': '3.80', 'spread': '2.20', 'groupId': 'OG001'}, {'value': '3.17', 'spread': '1.86', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.00125', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'pValueComment': 'P-values for the 3 treatment comparisons should be interpreted in line with the Bonferroni stepwise (Holm) testing procedure, to maintain the Type 1 error at p=0.05.', 'groupDescription': '1 year', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.25995', 'groupIds': ['OG000', 'OG002'], 'ciNumSides': 'TWO_SIDED', 'pValueComment': 'P-values for the 3 treatment comparisons should be interpreted in line with the Bonferroni stepwise (Holm) testing procedure, to maintain the Type 1 error at p=0.05.', 'groupDescription': '1 year', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.00008', 'groupIds': ['OG001', 'OG002'], 'ciNumSides': 'TWO_SIDED', 'pValueComment': 'P-values for the 3 treatment comparisons should be interpreted in line with the Bonferroni stepwise (Holm) testing procedure, to maintain the Type 1 error at p=0.05.', 'groupDescription': '1 year', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.03273', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'pValueComment': 'P-values for the 3 treatment comparisons should be interpreted in line with the Bonferroni stepwise (Holm) testing procedure, to maintain the Type 1 error at p=0.05.', 'groupDescription': '2 years', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.68581', 'groupIds': ['OG000', 'OG002'], 'ciNumSides': 'TWO_SIDED', 'pValueComment': 'P-values for the 3 treatment comparisons should be interpreted in line with the Bonferroni stepwise (Holm) testing procedure, to maintain the Type 1 error at p=0.05.', 'groupDescription': '2 years', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.00530', 'groupIds': ['OG001', 'OG002'], 'ciNumSides': 'TWO_SIDED', 'pValueComment': 'P-values for the 3 treatment comparisons should be interpreted in line with the Bonferroni stepwise (Holm) testing procedure, to maintain the Type 1 error at p=0.05.', 'groupDescription': '2 years', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.57556', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'pValueComment': 'P-values for the 3 treatment comparisons should be interpreted in line with the Bonferroni stepwise (Holm) testing procedure, to maintain the Type 1 error at p=0.05.', 'groupDescription': '3 years', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.63956', 'groupIds': ['OG000', 'OG002'], 'ciNumSides': 'TWO_SIDED', 'pValueComment': 'P-values for the 3 treatment comparisons should be interpreted in line with the Bonferroni stepwise (Holm) testing procedure, to maintain the Type 1 error at p=0.05.', 'groupDescription': '3 years', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.16421', 'groupIds': ['OG001', 'OG002'], 'ciNumSides': 'TWO_SIDED', 'pValueComment': 'P-values for the 3 treatment comparisons should be interpreted in line with the Bonferroni stepwise (Holm) testing procedure, to maintain the Type 1 error at p=0.05.', 'groupDescription': '3 years', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 1 to 3 years', 'description': 'Calculated corresponding to the gender and chronological age by substracting annual growth rate SDS at Baseline from annual growth rate SDS at each year.', 'unitOfMeasure': 'SDS', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS. Number of Participants Analyzed = number of subjects with evaluable data at 1 year. n = number of subjects with evaluable data at each time point.'}, {'type': 'SECONDARY', 'title': 'Height (cm)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}, {'value': '60', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Genotonorm 0.7 (Continuous Treatment)', 'description': 'Subjects received 0.7 IU/kg/week (0.03 mg/kg/day) of the growth hormone Genotonorm as a continuous treatment. Treatment was allowed to be taken until final height of the subject had been reached.'}, {'id': 'OG001', 'title': 'Genotonorm 1.4 (Continuous Treatment)', 'description': 'Subjects received 1.4 IU/kg/week (0.06 mg/kg/day) of the growth hormone Genotonorm as a continuous treatment. Treatment was allowed to be taken until final height of the subject had been reached.'}, {'id': 'OG002', 'title': 'Genotonorm 1.4 (Intermittent Treatment)', 'description': 'Subjects received 1.4 IU/kg/week (0.06 mg/kg/day) of the growth hormone Genotonorm as an intermittent treatment. Treatment was allowed to be taken until final height of the subject had been reached.'}], 'classes': [{'title': 'Baseline (n=58, 56, 60)', 'categories': [{'measurements': [{'value': '105.22', 'spread': '15.04', 'groupId': 'OG000'}, {'value': '107.06', 'spread': '12.29', 'groupId': 'OG001'}, {'value': '106.44', 'spread': '12.04', 'groupId': 'OG002'}]}]}, {'title': '1 year (n=57, 55, 59)', 'categories': [{'measurements': [{'value': '113.38', 'spread': '15.09', 'groupId': 'OG000'}, {'value': '116.31', 'spread': '12.24', 'groupId': 'OG001'}, {'value': '113.71', 'spread': '12.01', 'groupId': 'OG002'}]}]}, {'title': '2 years (n=53, 49, 56)', 'categories': [{'measurements': [{'value': '119.67', 'spread': '15.18', 'groupId': 'OG000'}, {'value': '124.11', 'spread': '13.02', 'groupId': 'OG001'}, {'value': '120.64', 'spread': '12.34', 'groupId': 'OG002'}]}]}, {'title': '3 years (n=39, 34, 41)', 'categories': [{'measurements': [{'value': '123.92', 'spread': '15.08', 'groupId': 'OG000'}, {'value': '131.75', 'spread': '13.76', 'groupId': 'OG001'}, {'value': '125.39', 'spread': '12.52', 'groupId': 'OG002'}]}]}, {'title': '4 years (n=21, 18, 27)', 'categories': [{'measurements': [{'value': '124.67', 'spread': '13.14', 'groupId': 'OG000'}, {'value': '132.30', 'spread': '13.23', 'groupId': 'OG001'}, {'value': '127.59', 'spread': '11.51', 'groupId': 'OG002'}]}]}, {'title': '5 years (n=12, 10, 21)', 'categories': [{'measurements': [{'value': '126.73', 'spread': '10.01', 'groupId': 'OG000'}, {'value': '131.01', 'spread': '9.26', 'groupId': 'OG001'}, {'value': '129.98', 'spread': '9.93', 'groupId': 'OG002'}]}]}, {'title': '6 years (n=11, 7, 20)', 'categories': [{'measurements': [{'value': '133.29', 'spread': '10.46', 'groupId': 'OG000'}, {'value': '138.84', 'spread': '8.69', 'groupId': 'OG001'}, {'value': '135.45', 'spread': '10.10', 'groupId': 'OG002'}]}]}, {'title': 'Final height (n=17, 12, 22)', 'categories': [{'measurements': [{'value': '146.86', 'spread': '11.26', 'groupId': 'OG000'}, {'value': '151.98', 'spread': '6.52', 'groupId': 'OG001'}, {'value': '149.13', 'spread': '9.07', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 1 to 6 years, final height', 'description': 'Performed by use of a wallmounted device (eg, Harpenden Stadiometer). Each subject was measured 3 times and the mean of these measurements was recorded as the present height. Final Height: Children are defined as reaching their final height when annual Growth Rate is less than 2 cm in the previous year and bone age is equal to or greater than 17 years in boys and equal to or greater than 15 years in girls.', 'unitOfMeasure': 'cm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS. Number of Participants Analyzed = number of subjects with evaluable data at Baseline. n = number of subjects with evaluable data at each time point. Data beyond 6 years are not reported due to the low proportion of subjects followed up beyond 6 years.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Height (cm)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}, {'value': '60', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Genotonorm 0.7 (Continuous Treatment)', 'description': 'Subjects received 0.7 IU/kg/week (0.03 mg/kg/day) of the growth hormone Genotonorm as a continuous treatment. Treatment was allowed to be taken until final height of the subject had been reached.'}, {'id': 'OG001', 'title': 'Genotonorm 1.4 (Continuous Treatment)', 'description': 'Subjects received 1.4 IU/kg/week (0.06 mg/kg/day) of the growth hormone Genotonorm as a continuous treatment. Treatment was allowed to be taken until final height of the subject had been reached.'}, {'id': 'OG002', 'title': 'Genotonorm 1.4 (Intermittent Treatment)', 'description': 'Subjects received 1.4 IU/kg/week (0.06 mg/kg/day) of the growth hormone Genotonorm as an intermittent treatment. Treatment was allowed to be taken until final height of the subject had been reached.'}], 'classes': [{'title': '1 year (n=57, 55, 59)', 'categories': [{'measurements': [{'value': '8.21', 'spread': '1.38', 'groupId': 'OG000'}, {'value': '9.21', 'spread': '1.45', 'groupId': 'OG001'}, {'value': '7.33', 'spread': '1.32', 'groupId': 'OG002'}]}]}, {'title': '2 years (n=53, 49, 56)', 'categories': [{'measurements': [{'value': '14.77', 'spread': '2.45', 'groupId': 'OG000'}, {'value': '17.01', 'spread': '2.21', 'groupId': 'OG001'}, {'value': '13.92', 'spread': '2.03', 'groupId': 'OG002'}]}]}, {'title': '3 years (n=39, 34, 41)', 'categories': [{'measurements': [{'value': '20.62', 'spread': '3.00', 'groupId': 'OG000'}, {'value': '24.49', 'spread': '3.04', 'groupId': 'OG001'}, {'value': '20.14', 'spread': '2.78', 'groupId': 'OG002'}]}]}, {'title': '4 years (n=21, 18, 27)', 'categories': [{'measurements': [{'value': '26.36', 'spread': '4.37', 'groupId': 'OG000'}, {'value': '30.77', 'spread': '3.43', 'groupId': 'OG001'}, {'value': '25.83', 'spread': '3.26', 'groupId': 'OG002'}]}]}, {'title': '5 years (n=12, 10, 21)', 'categories': [{'measurements': [{'value': '32.23', 'spread': '5.92', 'groupId': 'OG000'}, {'value': '35.70', 'spread': '4.27', 'groupId': 'OG001'}, {'value': '32.16', 'spread': '3.81', 'groupId': 'OG002'}]}]}, {'title': '6 years (n=11, 7, 20)', 'categories': [{'measurements': [{'value': '38.20', 'spread': '6.66', 'groupId': 'OG000'}, {'value': '44.03', 'spread': '3.09', 'groupId': 'OG001'}, {'value': '38.01', 'spread': '4.82', 'groupId': 'OG002'}]}]}, {'title': 'Final height (n=17, 12, 22)', 'categories': [{'measurements': [{'value': '45.39', 'spread': '13.08', 'groupId': 'OG000'}, {'value': '45.30', 'spread': '13.72', 'groupId': 'OG001'}, {'value': '40.93', 'spread': '9.22', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 1 to 6 years, final height', 'description': 'Calculated by substracting height at Baseline from height at each year. Final Height: Children are defined as reaching their final height when annual Growth Rate is less than 2 cm in the previous year and bone age is equal to or greater than 17 years in boys and equal to or greater than 15 years in girls.', 'unitOfMeasure': 'cm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS. Number of Participants Analyzed = number of subjects with evaluable data at Baseline. n = number of subjects with evaluable data at Baseline and each time point. Data beyond 6 years are not reported due to the low proportion of subjects followed up beyond 6 years.'}, {'type': 'SECONDARY', 'title': 'Height (SDS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}, {'value': '60', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Genotonorm 0.7 (Continuous Treatment)', 'description': 'Subjects received 0.7 IU/kg/week (0.03 mg/kg/day) of the growth hormone Genotonorm as a continuous treatment. Treatment was allowed to be taken until final height of the subject had been reached.'}, {'id': 'OG001', 'title': 'Genotonorm 1.4 (Continuous Treatment)', 'description': 'Subjects received 1.4 IU/kg/week (0.06 mg/kg/day) of the growth hormone Genotonorm as a continuous treatment. Treatment was allowed to be taken until final height of the subject had been reached.'}, {'id': 'OG002', 'title': 'Genotonorm 1.4 (Intermittent Treatment)', 'description': 'Subjects received 1.4 IU/kg/week (0.06 mg/kg/day) of the growth hormone Genotonorm as an intermittent treatment. Treatment was allowed to be taken until final height of the subject had been reached.'}], 'classes': [{'title': 'Baseline (n=58, 56, 60)', 'categories': [{'measurements': [{'value': '-3.16', 'spread': '0.52', 'groupId': 'OG000'}, {'value': '-3.07', 'spread': '0.46', 'groupId': 'OG001'}, {'value': '-3.21', 'spread': '0.65', 'groupId': 'OG002'}]}]}, {'title': '1 year (n=57, 55, 59)', 'categories': [{'measurements': [{'value': '-2.49', 'spread': '0.54', 'groupId': 'OG000'}, {'value': '-2.17', 'spread': '0.50', 'groupId': 'OG001'}, {'value': '-2.68', 'spread': '0.69', 'groupId': 'OG002'}]}]}, {'title': '2 years (n=53, 49, 56)', 'categories': [{'measurements': [{'value': '-2.21', 'spread': '0.66', 'groupId': 'OG000'}, {'value': '-1.68', 'spread': '0.52', 'groupId': 'OG001'}, {'value': '-2.38', 'spread': '0.75', 'groupId': 'OG002'}]}]}, {'title': '3 years (n=39, 34, 41)', 'categories': [{'measurements': [{'value': '-2.17', 'spread': '0.70', 'groupId': 'OG000'}, {'value': '-1.38', 'spread': '0.57', 'groupId': 'OG001'}, {'value': '-2.24', 'spread': '0.90', 'groupId': 'OG002'}]}]}, {'title': '4 years (n=21, 18, 27)', 'categories': [{'measurements': [{'value': '-2.16', 'spread': '1.03', 'groupId': 'OG000'}, {'value': '-1.16', 'spread': '0.73', 'groupId': 'OG001'}, {'value': '-2.09', 'spread': '0.96', 'groupId': 'OG002'}]}]}, {'title': '5 years (n=12, 10, 21)', 'categories': [{'measurements': [{'value': '-1.95', 'spread': '1.26', 'groupId': 'OG000'}, {'value': '-1.15', 'spread': '0.83', 'groupId': 'OG001'}, {'value': '-1.96', 'spread': '1.10', 'groupId': 'OG002'}]}]}, {'title': '6 years (n=11, 7, 19)', 'categories': [{'measurements': [{'value': '-1.80', 'spread': '1.28', 'groupId': 'OG000'}, {'value': '-0.67', 'spread': '0.66', 'groupId': 'OG001'}, {'value': '-1.93', 'spread': '1.18', 'groupId': 'OG002'}]}]}, {'title': 'Final height (n=14, 9, 18)', 'categories': [{'measurements': [{'value': '-2.06', 'spread': '0.76', 'groupId': 'OG000'}, {'value': '-1.97', 'spread': '0.95', 'groupId': 'OG001'}, {'value': '-2.29', 'spread': '1.35', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 1 to 6 years, final height', 'description': 'Calculated using Sempe reference means and standard deviations for height. Final Height: Children are defined as reaching their final height when annual Growth Rate is less than 2 cm in the previous year and bone age is equal to or greater than 17 years in boys and equal to or greater than 15 years in girls.', 'unitOfMeasure': 'SDS', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS. Number of Participants Analyzed = number of subjects with evaluable data at Baseline. n = number of subjects with evaluable data at each time point. Data beyond 6 years are not reported due to the low proportion of subjects followed up beyond 6 years.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Height (SDS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}, {'value': '60', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Genotonorm 0.7 (Continuous Treatment)', 'description': 'Subjects received 0.7 IU/kg/week (0.03 mg/kg/day) of the growth hormone Genotonorm as a continuous treatment. Treatment was allowed to be taken until final height of the subject had been reached.'}, {'id': 'OG001', 'title': 'Genotonorm 1.4 (Continuous Treatment)', 'description': 'Subjects received 1.4 IU/kg/week (0.06 mg/kg/day) of the growth hormone Genotonorm as a continuous treatment. Treatment was allowed to be taken until final height of the subject had been reached.'}, {'id': 'OG002', 'title': 'Genotonorm 1.4 (Intermittent Treatment)', 'description': 'Subjects received 1.4 IU/kg/week (0.06 mg/kg/day) of the growth hormone Genotonorm as an intermittent treatment. Treatment was allowed to be taken until final height of the subject had been reached.'}], 'classes': [{'title': '1 year (n=57, 55, 59)', 'categories': [{'measurements': [{'value': '0.67', 'spread': '0.28', 'groupId': 'OG000'}, {'value': '0.88', 'spread': '0.30', 'groupId': 'OG001'}, {'value': '0.53', 'spread': '0.28', 'groupId': 'OG002'}]}]}, {'title': '2 years (n=53, 49, 56)', 'categories': [{'measurements': [{'value': '0.94', 'spread': '0.45', 'groupId': 'OG000'}, {'value': '1.40', 'spread': '0.43', 'groupId': 'OG001'}, {'value': '0.84', 'spread': '0.37', 'groupId': 'OG002'}]}]}, {'title': '3 years (n=39, 34, 41)', 'categories': [{'measurements': [{'value': '1.06', 'spread': '0.54', 'groupId': 'OG000'}, {'value': '1.70', 'spread': '0.54', 'groupId': 'OG001'}, {'value': '0.99', 'spread': '0.51', 'groupId': 'OG002'}]}]}, {'title': '4 years (n=21, 18, 27)', 'categories': [{'measurements': [{'value': '1.20', 'spread': '0.81', 'groupId': 'OG000'}, {'value': '1.98', 'spread': '0.69', 'groupId': 'OG001'}, {'value': '1.21', 'spread': '0.54', 'groupId': 'OG002'}]}]}, {'title': '5 years (n=12, 10, 21)', 'categories': [{'measurements': [{'value': '1.37', 'spread': '1.12', 'groupId': 'OG000'}, {'value': '2.03', 'spread': '0.87', 'groupId': 'OG001'}, {'value': '1.46', 'spread': '0.69', 'groupId': 'OG002'}]}]}, {'title': '6 years (n=11, 7, 19)', 'categories': [{'measurements': [{'value': '1.54', 'spread': '1.12', 'groupId': 'OG000'}, {'value': '2.60', 'spread': '0.66', 'groupId': 'OG001'}, {'value': '1.54', 'spread': '0.86', 'groupId': 'OG002'}]}]}, {'title': 'Final height (n=14, 9, 18)', 'categories': [{'measurements': [{'value': '1.00', 'spread': '0.53', 'groupId': 'OG000'}, {'value': '0.97', 'spread': '0.95', 'groupId': 'OG001'}, {'value': '0.86', 'spread': '1.16', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.0001', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'pValueComment': 'P-values for the 3 treatment comparisons should be interpreted in line with the Bonferroni stepwise (Holm) testing procedure, to maintain the Type 1 error at p=0.05.', 'groupDescription': '3 years', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.58324', 'groupIds': ['OG000', 'OG002'], 'ciNumSides': 'TWO_SIDED', 'pValueComment': 'P-values for the 3 treatment comparisons should be interpreted in line with the Bonferroni stepwise (Holm) testing procedure, to maintain the Type 1 error at p=0.05.', 'groupDescription': '3 years', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG001', 'OG002'], 'ciNumSides': 'TWO_SIDED', 'pValueComment': 'P-values for the 3 treatment comparisons should be interpreted in line with the Bonferroni stepwise (Holm) testing procedure, to maintain the Type 1 error at p=0.05.', 'groupDescription': '3 years', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 1 to 6 years, final height', 'description': 'Calculated by substracting height SDS at Baseline from height SDS at each year. Final Height: Children are defined as reaching their final height when annual Growth Rate is less than 2 cm in the previous year and bone age is equal to or greater than 17 years in boys and equal to or greater than 15 years in girls.', 'unitOfMeasure': 'SDS', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS. Number of Participants Analyzed = number of subjects with evaluable data at Baseline. n = number of subjects with evaluable data at Baseline and each time point. Data beyond 6 years are not reported due to the low proportion of subjects followed up beyond 6 years.'}, {'type': 'SECONDARY', 'title': 'Body Mass Index (BMI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}, {'value': '60', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Genotonorm 0.7 (Continuous Treatment)', 'description': 'Subjects received 0.7 IU/kg/week (0.03 mg/kg/day) of the growth hormone Genotonorm as a continuous treatment. Treatment was allowed to be taken until final height of the subject had been reached.'}, {'id': 'OG001', 'title': 'Genotonorm 1.4 (Continuous Treatment)', 'description': 'Subjects received 1.4 IU/kg/week (0.06 mg/kg/day) of the growth hormone Genotonorm as a continuous treatment. Treatment was allowed to be taken until final height of the subject had been reached.'}, {'id': 'OG002', 'title': 'Genotonorm 1.4 (Intermittent Treatment)', 'description': 'Subjects received 1.4 IU/kg/week (0.06 mg/kg/day) of the growth hormone Genotonorm as an intermittent treatment. Treatment was allowed to be taken until final height of the subject had been reached.'}], 'classes': [{'title': 'Baseline (n=58, 56, 60)', 'categories': [{'measurements': [{'value': '14.74', 'spread': '1.48', 'groupId': 'OG000'}, {'value': '15.14', 'spread': '1.76', 'groupId': 'OG001'}, {'value': '14.59', 'spread': '1.51', 'groupId': 'OG002'}]}]}, {'title': '1 year (n=56, 55, 59)', 'categories': [{'measurements': [{'value': '14.82', 'spread': '1.52', 'groupId': 'OG000'}, {'value': '15.44', 'spread': '1.94', 'groupId': 'OG001'}, {'value': '14.87', 'spread': '1.76', 'groupId': 'OG002'}]}]}, {'title': '2 years (n=53, 49, 56)', 'categories': [{'measurements': [{'value': '15.33', 'spread': '1.78', 'groupId': 'OG000'}, {'value': '15.92', 'spread': '2.15', 'groupId': 'OG001'}, {'value': '15.29', 'spread': '2.00', 'groupId': 'OG002'}]}]}, {'title': '3 years (n=39, 34, 41)', 'categories': [{'measurements': [{'value': '15.59', 'spread': '2.02', 'groupId': 'OG000'}, {'value': '16.65', 'spread': '2.92', 'groupId': 'OG001'}, {'value': '15.58', 'spread': '2.11', 'groupId': 'OG002'}]}]}, {'title': '4 years (n=21, 18, 27)', 'categories': [{'measurements': [{'value': '15.32', 'spread': '1.56', 'groupId': 'OG000'}, {'value': '17.03', 'spread': '3.70', 'groupId': 'OG001'}, {'value': '15.80', 'spread': '2.37', 'groupId': 'OG002'}]}]}, {'title': '5 years (n=12, 10, 21)', 'categories': [{'measurements': [{'value': '15.80', 'spread': '1.57', 'groupId': 'OG000'}, {'value': '16.25', 'spread': '1.70', 'groupId': 'OG001'}, {'value': '16.69', 'spread': '3.92', 'groupId': 'OG002'}]}]}, {'title': '6 years (n=11, 7, 20)', 'categories': [{'measurements': [{'value': '16.21', 'spread': '1.46', 'groupId': 'OG000'}, {'value': '16.34', 'spread': '1.80', 'groupId': 'OG001'}, {'value': '17.28', 'spread': '4.21', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 1 to 6 years', 'description': 'BMI was calculated by weight divided by height squared.', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS. Number of Participants Analyzed = number of subjects with evaluable data at Baseline. n = number of subjects with evaluable data at each time point. Data beyond 6 years are not reported due to the low proportion of subjects followed up beyond 6 years.'}, {'type': 'SECONDARY', 'title': 'Weight', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}, {'value': '60', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Genotonorm 0.7 (Continuous Treatment)', 'description': 'Subjects received 0.7 IU/kg/week (0.03 mg/kg/day) of the growth hormone Genotonorm as a continuous treatment. Treatment was allowed to be taken until final height of the subject had been reached.'}, {'id': 'OG001', 'title': 'Genotonorm 1.4 (Continuous Treatment)', 'description': 'Subjects received 1.4 IU/kg/week (0.06 mg/kg/day) of the growth hormone Genotonorm as a continuous treatment. Treatment was allowed to be taken until final height of the subject had been reached.'}, {'id': 'OG002', 'title': 'Genotonorm 1.4 (Intermittent Treatment)', 'description': 'Subjects received 1.4 IU/kg/week (0.06 mg/kg/day) of the growth hormone Genotonorm as an intermittent treatment. Treatment was allowed to be taken until final height of the subject had been reached.'}], 'classes': [{'title': 'Baseline (n=58, 56, 60)', 'categories': [{'measurements': [{'value': '16.77', 'spread': '5.43', 'groupId': 'OG000'}, {'value': '17.70', 'spread': '5.12', 'groupId': 'OG001'}, {'value': '16.79', 'spread': '4.35', 'groupId': 'OG002'}]}]}, {'title': '1 year (n=56, 55, 59)', 'categories': [{'measurements': [{'value': '19.71', 'spread': '6.28', 'groupId': 'OG000'}, {'value': '21.29', 'spread': '6.04', 'groupId': 'OG001'}, {'value': '19.56', 'spread': '5.17', 'groupId': 'OG002'}]}]}, {'title': '2 years (n=53, 49, 56)', 'categories': [{'measurements': [{'value': '22.66', 'spread': '7.62', 'groupId': 'OG000'}, {'value': '25.08', 'spread': '7.43', 'groupId': 'OG001'}, {'value': '22.64', 'spread': '6.05', 'groupId': 'OG002'}]}]}, {'title': '3 years (n=39, 34, 41)', 'categories': [{'measurements': [{'value': '24.77', 'spread': '8.80', 'groupId': 'OG000'}, {'value': '29.61', 'spread': '9.62', 'groupId': 'OG001'}, {'value': '24.98', 'spread': '7.05', 'groupId': 'OG002'}]}]}, {'title': '4 years (n=21, 18, 27)', 'categories': [{'measurements': [{'value': '24.30', 'spread': '7.01', 'groupId': 'OG000'}, {'value': '30.56', 'spread': '10.42', 'groupId': 'OG001'}, {'value': '26.28', 'spread': '7.94', 'groupId': 'OG002'}]}]}, {'title': '5 years (n=12, 10, 21)', 'categories': [{'measurements': [{'value': '25.74', 'spread': '6.22', 'groupId': 'OG000'}, {'value': '28.07', 'spread': '5.22', 'groupId': 'OG001'}, {'value': '28.52', 'spread': '8.96', 'groupId': 'OG002'}]}]}, {'title': '6 years (n=11, 7, 21)', 'categories': [{'measurements': [{'value': '29.13', 'spread': '6.42', 'groupId': 'OG000'}, {'value': '31.94', 'spread': '7.28', 'groupId': 'OG001'}, {'value': '32.30', 'spread': '10.32', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 1 to 6 years', 'unitOfMeasure': 'kg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS. Number of Participants Analyzed = number of subjects with evaluable data at Baseline. n = number of subjects with evaluable data at each time point. Data beyond 6 years are not reported due to the low proportion of subjects followed up beyond 6 years.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Bone Age', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}, {'value': '61', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Genotonorm 0.7 (Continuous Treatment)', 'description': 'Subjects received 0.7 IU/kg/week (0.03 mg/kg/day) of the growth hormone Genotonorm as a continuous treatment. Treatment was allowed to be taken until final height of the subject had been reached.'}, {'id': 'OG001', 'title': 'Genotonorm 1.4 (Continuous Treatment)', 'description': 'Subjects received 1.4 IU/kg/week (0.06 mg/kg/day) of the growth hormone Genotonorm as a continuous treatment. Treatment was allowed to be taken until final height of the subject had been reached.'}, {'id': 'OG002', 'title': 'Genotonorm 1.4 (Intermittent Treatment)', 'description': 'Subjects received 1.4 IU/kg/week (0.06 mg/kg/day) of the growth hormone Genotonorm as an intermittent treatment. Treatment was allowed to be taken until final height of the subject had been reached.'}], 'classes': [{'title': '1 year (n=53, 60, 56)', 'categories': [{'measurements': [{'value': '1.17', 'spread': '0.51', 'groupId': 'OG000'}, {'value': '1.27', 'spread': '0.72', 'groupId': 'OG001'}, {'value': '1.25', 'spread': '0.54', 'groupId': 'OG002'}]}]}, {'title': '2 years (n=52, 51, 49)', 'categories': [{'measurements': [{'value': '2.40', 'spread': '0.90', 'groupId': 'OG000'}, {'value': '2.50', 'spread': '1.08', 'groupId': 'OG001'}, {'value': '2.58', 'spread': '0.97', 'groupId': 'OG002'}]}]}, {'title': '3 years (n=41, 39, 35)', 'categories': [{'measurements': [{'value': '3.53', 'spread': '1.22', 'groupId': 'OG000'}, {'value': '4.06', 'spread': '1.05', 'groupId': 'OG001'}, {'value': '3.67', 'spread': '0.97', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 1 to 3 years', 'description': 'Bone age was determined by the Greulich-Pyle method. Calculated by substracting bone age at Baseline from bone age at each year', 'unitOfMeasure': 'Years', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population = all subjects who received at least 1 study dose of GH. Number of Participants Analyzed = number of subjects with evaluable data at Baseline. n = number of subjects with evaluable data at Baseline and each time point.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Bone Age/Change From Baseline in Chronological Age Ratio', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}, {'value': '56', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Genotonorm 0.7 (Continuous Treatment)', 'description': 'Subjects received 0.7 IU/kg/week (0.03 mg/kg/day) of the growth hormone Genotonorm as a continuous treatment. Treatment was allowed to be taken until final height of the subject had been reached.'}, {'id': 'OG001', 'title': 'Genotonorm 1.4 (Continuous Treatment)', 'description': 'Subjects received 1.4 IU/kg/week (0.06 mg/kg/day) of the growth hormone Genotonorm as a continuous treatment. Treatment was allowed to be taken until final height of the subject had been reached.'}, {'id': 'OG002', 'title': 'Genotonorm 1.4 (Intermittent Treatment)', 'description': 'Subjects received 1.4 IU/kg/week (0.06 mg/kg/day) of the growth hormone Genotonorm as an intermittent treatment. Treatment was allowed to be taken until final height of the subject had been reached.'}], 'classes': [{'title': '1 year (n=53, 60, 56)', 'categories': [{'measurements': [{'value': '0.96', 'spread': '0.41', 'groupId': 'OG000'}, {'value': '1.07', 'spread': '0.62', 'groupId': 'OG001'}, {'value': '1.06', 'spread': '0.45', 'groupId': 'OG002'}]}]}, {'title': '2 years (n=51, 51, 49)', 'categories': [{'measurements': [{'value': '1.06', 'spread': '0.41', 'groupId': 'OG000'}, {'value': '1.14', 'spread': '0.50', 'groupId': 'OG001'}, {'value': '1.18', 'spread': '0.44', 'groupId': 'OG002'}]}]}, {'title': '3 years (n=35, 37, 35)', 'categories': [{'measurements': [{'value': '1.09', 'spread': '0.39', 'groupId': 'OG000'}, {'value': '1.26', 'spread': '0.32', 'groupId': 'OG001'}, {'value': '1.14', 'spread': '0.29', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 to 3 years', 'description': 'Bone age was determined by the Greulich-Pyle method. Chronological Age (years) was calculated as: (Date minus Date of Birth) divided by 365.25. Chronological Age used was the age at the date that the corresponding Bone Age X-ray was performed. Ratio was calculated by change from Baseline in bone age divided by change from Baseline in chronological age.', 'unitOfMeasure': 'ratio', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population = all subjects who received at least 1 study dose of GH. Number of Participants Analyzed = number of subjects with evaluable data at 1 year. n = number of subjects with evaluable data at each time point.'}, {'type': 'SECONDARY', 'title': 'Chronological Age at Onset of Puberty', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '45', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Genotonorm 0.7 (Continuous Treatment)', 'description': 'Subjects received 0.7 IU/kg/week (0.03 mg/kg/day) of the growth hormone Genotonorm as a continuous treatment. Treatment was allowed to be taken until final height of the subject had been reached.'}, {'id': 'OG001', 'title': 'Genotonorm 1.4 (Continuous Treatment)', 'description': 'Subjects received 1.4 IU/kg/week (0.06 mg/kg/day) of the growth hormone Genotonorm as a continuous treatment. Treatment was allowed to be taken until final height of the subject had been reached.'}, {'id': 'OG002', 'title': 'Genotonorm 1.4 (Intermittent Treatment)', 'description': 'Subjects received 1.4 IU/kg/week (0.06 mg/kg/day) of the growth hormone Genotonorm as an intermittent treatment. Treatment was allowed to be taken until final height of the subject had been reached.'}], 'classes': [{'categories': [{'measurements': [{'value': '11.88', 'spread': '2.22', 'groupId': 'OG000'}, {'value': '11.12', 'spread': '1.74', 'groupId': 'OG001'}, {'value': '11.58', 'spread': '1.42', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.0681', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.67', 'ciLowerLimit': '-0.05', 'ciUpperLimit': '1.39', 'pValueComment': 'There is no adjustment for multiplicity of treatment comparisons.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The Analysis of Covariance took into account the patient covariates age and gender.', 'testedNonInferiority': False}, {'pValue': '0.8971', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.05', 'ciLowerLimit': '-0.65', 'ciUpperLimit': '0.74', 'pValueComment': 'There is no adjustment for multiplicity of treatment comparisons.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The Analysis of Covariance took into account the patient covariates age and gender.', 'testedNonInferiority': False}, {'pValue': '0.0583', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.63', 'ciLowerLimit': '-1.27', 'ciUpperLimit': '0.02', 'pValueComment': 'There is no adjustment for multiplicity of treatment comparisons.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The Analysis of Covariance took into account the patient covariates age and gender.', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Onset of puberty', 'description': 'Chronological age (years) at first study visit with onset of puberty = (Date of study visit minus Date of Birth) divided by 365.25.', 'unitOfMeasure': 'Years', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population. Number of participants analyzed = number of subjects who started puberty by the end of the study.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects Reaching Puberty', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}, {'value': '68', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Genotonorm 0.7 (Continuous Treatment)', 'description': 'Subjects received 0.7 IU/kg/week (0.03 mg/kg/day) of the growth hormone Genotonorm as a continuous treatment. Treatment was allowed to be taken until final height of the subject had been reached.'}, {'id': 'OG001', 'title': 'Genotonorm 1.4 (Continuous Treatment)', 'description': 'Subjects received 1.4 IU/kg/week (0.06 mg/kg/day) of the growth hormone Genotonorm as a continuous treatment. Treatment was allowed to be taken until final height of the subject had been reached.'}, {'id': 'OG002', 'title': 'Genotonorm 1.4 (Intermittent Treatment)', 'description': 'Subjects received 1.4 IU/kg/week (0.06 mg/kg/day) of the growth hormone Genotonorm as an intermittent treatment. Treatment was allowed to be taken until final height of the subject had been reached.'}], 'classes': [{'title': 'Baseline (Female, Not Started)', 'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}, {'value': '39', 'groupId': 'OG002'}]}]}, {'title': 'Baseline (Male, Not Started)', 'categories': [{'measurements': [{'value': '43', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}]}]}, {'title': '1 year (Female, Not Started)', 'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}]}]}, {'title': '1 year (Female, Started)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': '1 year (Male, Not Started)', 'categories': [{'measurements': [{'value': '36', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '27', 'groupId': 'OG002'}]}]}, {'title': '1 year (Male, Started)', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': '2 years (Female, Not Started)', 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '31', 'groupId': 'OG002'}]}]}, {'title': '2 years (Female, Started)', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}]}, {'title': '2 years (Male, Not Started)', 'categories': [{'measurements': [{'value': '31', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}]}]}, {'title': '2 years (Male, Started)', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}]}, {'title': '3 years (Female, Not Started)', 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}]}]}, {'title': '3 years (Female, Started)', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}]}]}, {'title': '3 years (Male, Not Started)', 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}]}, {'title': '3 years (Male, Started)', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}]}, {'title': '4 years (Female, Not Started)', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}]}]}, {'title': '4 years (Female, Started)', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}]}, {'title': '4 years (Male, Not Started)', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}]}, {'title': '4 years (Male, Started)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}, {'title': '5 years (Female, Not Started)', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}]}, {'title': '5 years (Female, Started)', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}]}]}, {'title': '5 years (Male, Not Started)', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}]}, {'title': '5 years (Male, Started)', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': '6 years (Female, Not Started)', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}, {'title': '6 years (Female, Started)', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}]}]}, {'title': '6 years (Male, Not Started)', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': '6 years (Male, Started)', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, 1 to 6 years', 'description': 'The defined criteria for reaching puberty were: boy=if right or left testes volume ≥4 ml; girl=if breast development ≥2. Tanner Adolescent Pubertal Staging Questionnaire documents the stage of development of secondary sexual characteristics rated in 5 stages: stage 1 (no development) to 5 (adult-like development in quantity and size). Onset of puberty was defined as the visit where the data recorded first met the above criteria for starting puberty.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population. Number of Participants Analyzed = number of subjects with evaluable data at Baseline. Data beyond 6 years are not reported due to the low proportion of subjects followed up beyond 6 years. Started = started puberty; Not Started = not started puberty yet as per Tanner scale.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Genotonorm 0.7 (Continuous Treatment)', 'description': 'Subjects received 0.7 international unit (IU)/kilogram (kg)/week (0.03 milligram \\[mg\\]/kg/day) of Genotonorm growth hormone (GH) as a continuous treatment. Treatment was allowed to be taken until final height of the subject had been reached.'}, {'id': 'FG001', 'title': 'Genotonorm 1.4 (Continuous Treatment)', 'description': 'Subjects received 1.4 IU/kg/week (0.06 mg/kg/day) of the growth hormone Genotonorm as a continuous treatment. Treatment was allowed to be taken until final height of the subject had been reached.'}, {'id': 'FG002', 'title': 'Genotonorm 1.4 (Intermittent Treatment)', 'description': 'Subjects received 1.4 IU/kg/week (0.06 mg/kg/day) of the growth hormone Genotonorm as an intermittent treatment. Treatment was allowed to be taken until final height of the subject had been reached.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '68'}, {'groupId': 'FG001', 'numSubjects': '71'}, {'groupId': 'FG002', 'numSubjects': '69'}]}, {'type': 'Received Treatment', 'achievements': [{'groupId': 'FG000', 'numSubjects': '68'}, {'groupId': 'FG001', 'numSubjects': '70'}, {'groupId': 'FG002', 'numSubjects': '68'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': 'Corresponds to follow-up until final height', 'groupId': 'FG000', 'numSubjects': '6'}, {'comment': 'Corresponds to follow-up until final height', 'groupId': 'FG001', 'numSubjects': '4'}, {'comment': 'Corresponds to follow-up until final height', 'groupId': 'FG002', 'numSubjects': '8'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '62'}, {'groupId': 'FG001', 'numSubjects': '67'}, {'groupId': 'FG002', 'numSubjects': '61'}]}], 'dropWithdraws': [{'type': 'Ongoing at Cutoff Date', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '9'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '25'}, {'groupId': 'FG001', 'numSubjects': '21'}, {'groupId': 'FG002', 'numSubjects': '29'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '31'}, {'groupId': 'FG001', 'numSubjects': '39'}, {'groupId': 'FG002', 'numSubjects': '22'}]}, {'type': 'Randomized But Not Treated', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'BG000'}, {'value': '70', 'groupId': 'BG001'}, {'value': '68', 'groupId': 'BG002'}, {'value': '206', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Genotonorm 0.7 (Continuous Treatment)', 'description': 'Subjects received 0.7 IU/kg/week (0.03 mg/kg/day) of the growth hormone Genotonorm as a continuous treatment. Treatment was allowed to be taken until final height of the subject had been reached.'}, {'id': 'BG001', 'title': 'Genotonorm 1.4 (Continuous Treatment)', 'description': 'Subjects received 1.4 IU/kg/week (0.06 mg/kg/day) of the growth hormone Genotonorm as a continuous treatment. Treatment was allowed to be taken until final height of the subject had been reached.'}, {'id': 'BG002', 'title': 'Genotonorm 1.4 (Intermittent Treatment)', 'description': 'Subjects received 1.4 IU/kg/week (0.06 mg/kg/day) of the growth hormone Genotonorm as an intermittent treatment. Treatment was allowed to be taken until final height of the subject had been reached.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': '< 4 years', 'categories': [{'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '29', 'groupId': 'BG003'}]}]}, {'title': '4 - 8 years', 'categories': [{'measurements': [{'value': '29', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}, {'value': '90', 'groupId': 'BG003'}]}]}, {'title': '8 - 12 years', 'categories': [{'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}, {'value': '86', 'groupId': 'BG003'}]}]}, {'title': '>= 12 years', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '39', 'groupId': 'BG002'}, {'value': '95', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '43', 'groupId': 'BG000'}, {'value': '39', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}, {'value': '111', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 208}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1993-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-02', 'completionDateStruct': {'date': '2009-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-11-08', 'studyFirstSubmitDate': '2010-02-22', 'resultsFirstSubmitDate': '2010-05-06', 'studyFirstSubmitQcDate': '2010-02-22', 'lastUpdatePostDateStruct': {'date': '2010-11-18', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2010-08-04', 'studyFirstPostDateStruct': {'date': '2010-02-23', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2010-08-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline in Annual Growth Rate Measured at 2 Years Following Treatment With Genotonorm', 'timeFrame': 'Baseline, 2 years', 'description': 'Annual growth rate was expressed as height velocity (centimeter \\[cm\\]/year). This was derived by substracting annual growth rate at Baseline from 2-year value. (Annual growth rate was calculated each year and rescaled to 1 year if the interval between x and x-1 was not 365 days, as long as a subject remains in the study): ANGRYx = (Height Yx - Height Y{x-1}) / {(Date of Yx - Date of Y{x-1}) /365.25}'}], 'secondaryOutcomes': [{'measure': 'Annual Growth Rate Standard Deviation Score (SDS)', 'timeFrame': 'Baseline, 1 to 6 years', 'description': 'Calculated using Sempe reference means and standard deviations for growth rate according to age and sex. Standardization was performed for chronological age.'}, {'measure': 'Change From Baseline in Annual Growth Rate SDS', 'timeFrame': 'Baseline, 1 to 3 years', 'description': 'Calculated corresponding to the gender and chronological age by substracting annual growth rate SDS at Baseline from annual growth rate SDS at each year.'}, {'measure': 'Height (cm)', 'timeFrame': 'Baseline, 1 to 6 years, final height', 'description': 'Performed by use of a wallmounted device (eg, Harpenden Stadiometer). Each subject was measured 3 times and the mean of these measurements was recorded as the present height. Final Height: Children are defined as reaching their final height when annual Growth Rate is less than 2 cm in the previous year and bone age is equal to or greater than 17 years in boys and equal to or greater than 15 years in girls.'}, {'measure': 'Change From Baseline in Height (cm)', 'timeFrame': 'Baseline, 1 to 6 years, final height', 'description': 'Calculated by substracting height at Baseline from height at each year. Final Height: Children are defined as reaching their final height when annual Growth Rate is less than 2 cm in the previous year and bone age is equal to or greater than 17 years in boys and equal to or greater than 15 years in girls.'}, {'measure': 'Height (SDS)', 'timeFrame': 'Baseline, 1 to 6 years, final height', 'description': 'Calculated using Sempe reference means and standard deviations for height. Final Height: Children are defined as reaching their final height when annual Growth Rate is less than 2 cm in the previous year and bone age is equal to or greater than 17 years in boys and equal to or greater than 15 years in girls.'}, {'measure': 'Change From Baseline in Height (SDS)', 'timeFrame': 'Baseline, 1 to 6 years, final height', 'description': 'Calculated by substracting height SDS at Baseline from height SDS at each year. Final Height: Children are defined as reaching their final height when annual Growth Rate is less than 2 cm in the previous year and bone age is equal to or greater than 17 years in boys and equal to or greater than 15 years in girls.'}, {'measure': 'Body Mass Index (BMI)', 'timeFrame': 'Baseline, 1 to 6 years', 'description': 'BMI was calculated by weight divided by height squared.'}, {'measure': 'Weight', 'timeFrame': 'Baseline, 1 to 6 years'}, {'measure': 'Change From Baseline in Bone Age', 'timeFrame': 'Baseline, 1 to 3 years', 'description': 'Bone age was determined by the Greulich-Pyle method. Calculated by substracting bone age at Baseline from bone age at each year'}, {'measure': 'Change From Baseline in Bone Age/Change From Baseline in Chronological Age Ratio', 'timeFrame': '1 to 3 years', 'description': 'Bone age was determined by the Greulich-Pyle method. Chronological Age (years) was calculated as: (Date minus Date of Birth) divided by 365.25. Chronological Age used was the age at the date that the corresponding Bone Age X-ray was performed. Ratio was calculated by change from Baseline in bone age divided by change from Baseline in chronological age.'}, {'measure': 'Chronological Age at Onset of Puberty', 'timeFrame': 'Onset of puberty', 'description': 'Chronological age (years) at first study visit with onset of puberty = (Date of study visit minus Date of Birth) divided by 365.25.'}, {'measure': 'Number of Subjects Reaching Puberty', 'timeFrame': 'Baseline, 1 to 6 years', 'description': 'The defined criteria for reaching puberty were: boy=if right or left testes volume ≥4 ml; girl=if breast development ≥2. Tanner Adolescent Pubertal Staging Questionnaire documents the stage of development of secondary sexual characteristics rated in 5 stages: stage 1 (no development) to 5 (adult-like development in quantity and size). Onset of puberty was defined as the visit where the data recorded first met the above criteria for starting puberty.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Short height', 'intra-uterine growth retardation', 'Genotonorm', 'continuous treatment', 'intermittent treatment'], 'conditions': ['Growth Disorders', 'Intrauterine Growth Retardation']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=93-8122-001&StudyName=Genotropin%20Treatment%20in%20Short%20Prepubertal%20Children%20with%20Intra-Uterine%20Growth%20Retardation', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'To evaluate the effect of continuous and intermittent administration of Genotonorm on stature in short prepubertal children with intra-uterine growth retardation'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '3 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Chronological age (CA) between 3 and 10 for girls\n* Chronological age between 3 and 12 for boys\n* Height for CA below - 2 SD\n* Birth length for CA below -2SD\n\nExclusion Criteria:\n\n* Endocrine disease except well-substituted hypothyroidism\n* Sever chronic disease\n* Skeletal dysplasia\n* Known chromosomal aberration\n* Ongoing treatment with steroids\n* Known intrauterine infection'}, 'identificationModule': {'nctId': 'NCT01073605', 'briefTitle': 'Genotropin Treatment in Short Prepubertal Children With Intra-Uterine Growth Retardation', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'A Two Years Multicentre Study of Genotropin Treatment of Short Prepubertal Children With Intra-Uterine Growth Retardation', 'orgStudyIdInfo': {'id': '93-8122-001'}, 'secondaryIdInfos': [{'id': 'A6281186, CTN 93-8122-001'}]}, 'armsInterventionsModule': 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