Ignite Creation Date:
2025-12-25 @ 3:21 AM
Ignite Modification Date:
2026-01-09 @ 2:55 PM
Study NCT ID:
NCT02915705
Status:
COMPLETED
Last Update Posted:
2024-08-29
First Post:
2016-05-23
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Efficacy and Safety of Burosumab Versus Oral Phosphate and Active Vitamin D Treatment in Pediatric Patients With XLH
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Denmark', 'Germany', 'Ireland', 'Italy', 'Spain']}, 'conditionBrowseModule': {'meshes': [{'id': 'D053098', 'term': 'Familial Hypophosphatemic Rickets'}], 'ancestors': [{'id': 'D063730', 'term': 'Rickets, Hypophosphatemic'}, {'id': 'D012279', 'term': 'Rickets'}, {'id': 'D001851', 'term': 'Bone Diseases, Metabolic'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D007015', 'term': 'Hypophosphatemia, Familial'}, {'id': 'D015499', 'term': 'Renal Tubular Transport, Inborn Errors'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D008664', 'term': 'Metal Metabolism, Inborn Errors'}, {'id': 'D008661', 'term': 'Metabolism, Inborn Errors'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D002128', 'term': 'Calcium Metabolism Disorders'}, {'id': 'D017674', 'term': 'Hypophosphatemia'}, {'id': 'D010760', 'term': 'Phosphorus Metabolism Disorders'}, {'id': 'D014808', 'term': 'Vitamin D Deficiency'}, {'id': 'D001361', 'term': 'Avitaminosis'}, {'id': 'D003677', 'term': 'Deficiency Diseases'}, {'id': 'D044342', 'term': 'Malnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000601956', 'term': 'burosumab'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'medinfo@ultragenyx.com', 'phone': '1-888-756-8567', 'title': 'Medical Information', 'organization': 'Ultragenyx Pharmaceutical Inc'}, 'certainAgreement': {'otherDetails': 'The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Up to Week 64 in the Treatment Period and up to Week 140 in the Long Term Extension Period, plus up to 12 weeks ±1 week after the last dose of study drug.', 'eventGroups': [{'id': 'EG000', 'title': 'Oral Phosphate/Active Vitamin D (Treatment Period)', 'description': 'Multiple daily doses of oral phosphate and one or more daily doses of active vitamin D therapy, titrated and individualized by the investigator based on published recommendations during the Treatment Period (up to Week 64).', 'otherNumAtRisk': 32, 'deathsNumAtRisk': 32, 'otherNumAffected': 23, 'seriousNumAtRisk': 32, 'deathsNumAffected': 0, 'seriousNumAffected': 3}, {'id': 'EG001', 'title': 'Burosumab (Treatment Period)', 'description': 'Burosumab 0.8 mg/kg starting dose, administered Q2W by SC injection during the Treatment Period (up to Week 64).', 'otherNumAtRisk': 29, 'deathsNumAtRisk': 29, 'otherNumAffected': 21, 'seriousNumAtRisk': 29, 'deathsNumAffected': 0, 'seriousNumAffected': 3}, {'id': 'EG002', 'title': 'Oral Phosphate/Active Vitamin D->Burosumab (Extension Period)', 'description': 'Multiple daily doses of oral phosphate and one or more daily doses of active vitamin D therapy, titrated and individualized by the investigator based on published recommendations during the Treatment Period (up to Week 64). During the Treatment Extension Period (Week 64 to Week 140), participants crossed over to receive a starting dose of SC burosumab 0.8 mg/kg Q2W. Participants in Japan and Korea did not enter the Treatment Extension Period.', 'otherNumAtRisk': 26, 'deathsNumAtRisk': 26, 'otherNumAffected': 9, 'seriousNumAtRisk': 26, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Burosumab->Burosumab (Treatment Period and Extension Period)', 'description': 'Burosumab 0.8 mg/kg starting dose, administered Q2W by SC injection during the Treatment Period (up to Week 64). During the Treatment Extension Period (Week 64 to Week 140), participants continued to receive a starting dose of SC burosumab 0.8 mg/kg Q2W. Participants in Japan and Korea did not enter the Treatment Extension Period.', 'otherNumAtRisk': 29, 'deathsNumAtRisk': 29, 'otherNumAffected': 25, 'seriousNumAtRisk': 29, 'deathsNumAffected': 0, 'seriousNumAffected': 4}, {'id': 'EG004', 'title': 'Total Burosumab (Treatment Period and Extension Period)', 'description': 'Burosumab 0.8 mg/kg starting dose, administered Q2W by SC injection at any time during the study.', 'otherNumAtRisk': 55, 'deathsNumAtRisk': 55, 'otherNumAffected': 34, 'seriousNumAtRisk': 55, 'deathsNumAffected': 0, 'seriousNumAffected': 4}], 'otherEvents': [{'term': 'Tooth Hypoplasia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 29, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 55, 'numAffected': 2}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Ear Discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 29, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 55, 'numAffected': 2}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Ear Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 29, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 55, 'numAffected': 6}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Abdominal Discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 29, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 55, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Abdominal Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 29, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 55, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Abdominal Pain Upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 29, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 55, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 29, 'numAffected': 5}, {'groupId': 'EG004', 'numAtRisk': 55, 'numAffected': 7}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Dental Caries', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 29, 'numAffected': 10}, {'groupId': 'EG004', 'numAtRisk': 55, 'numAffected': 10}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 29, 'numAffected': 7}, {'groupId': 'EG004', 'numAtRisk': 55, 'numAffected': 8}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Haematochezia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 29, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 55, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 29, 'numAffected': 5}, {'groupId': 'EG004', 'numAtRisk': 55, 'numAffected': 7}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Teething', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 29, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 55, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Tooth Loss', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 29, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 55, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Toothache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 29, 'numAffected': 5}, {'groupId': 'EG004', 'numAtRisk': 55, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 29, 'numAffected': 14}, {'groupId': 'EG004', 'numAtRisk': 55, 'numAffected': 19}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 29, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 55, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Injection Site Bruising', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 29, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 55, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Injection Site Erosion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 29, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 55, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Injection Site Erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 29, 'numAffected': 9}, {'groupId': 'EG004', 'numAtRisk': 55, 'numAffected': 15}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Injection Site Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 29, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 55, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Injection Site Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 29, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 55, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Injection Site Reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 29, 'numAffected': 8}, {'groupId': 'EG004', 'numAtRisk': 55, 'numAffected': 10}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Injection Site Swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 29, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 55, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Injection Site Urticaria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 29, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 55, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 29, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 55, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 16}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 29, 'numAffected': 17}, {'groupId': 'EG004', 'numAtRisk': 55, 'numAffected': 24}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Hypersensitivity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 29, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 55, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Seasonal Allergy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 29, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 55, 'numAffected': 5}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Ear Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 29, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 55, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 29, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 55, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Gastroenteritis Viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 29, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 55, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 29, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 55, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 29, 'numAffected': 15}, {'groupId': 'EG004', 'numAtRisk': 55, 'numAffected': 21}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Otitis Externa', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 29, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 55, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Otitis Media', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 29, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 55, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Pharyngitis Streptococcal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 29, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 55, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 29, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 55, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Rhinitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 29, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 55, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Tooth Abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 29, 'numAffected': 9}, {'groupId': 'EG004', 'numAtRisk': 55, 'numAffected': 11}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Upper Respiratory Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 29, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 55, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Varicella', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 29, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 55, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Viral Upper Respiratory Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 29, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 55, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 29, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 55, 'numAffected': 4}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 29, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 55, 'numAffected': 3}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Procedural Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 29, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 55, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Vitamin D Decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 29, 'numAffected': 6}, {'groupId': 'EG004', 'numAtRisk': 55, 'numAffected': 7}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Decreased Appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 29, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 55, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Vitamin D Deficiency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 29, 'numAffected': 5}, {'groupId': 'EG004', 'numAtRisk': 55, 'numAffected': 5}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 29, 'numAffected': 13}, {'groupId': 'EG004', 'numAtRisk': 55, 'numAffected': 16}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Back Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 29, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 55, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Pain In Extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 29, 'numAffected': 11}, {'groupId': 'EG004', 'numAtRisk': 55, 'numAffected': 14}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 29, 'numAffected': 10}, {'groupId': 'EG004', 'numAtRisk': 55, 'numAffected': 13}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Migraine', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 29, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 55, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Attention Deficit/Hyperactivity Disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 29, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 55, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Dysuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 29, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 55, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Asthma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 29, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 55, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 15}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 29, 'numAffected': 15}, {'groupId': 'EG004', 'numAtRisk': 55, 'numAffected': 19}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Nasal Congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 29, 'numAffected': 7}, {'groupId': 'EG004', 'numAtRisk': 55, 'numAffected': 8}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Oropharyngeal Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 29, 'numAffected': 6}, {'groupId': 'EG004', 'numAtRisk': 55, 'numAffected': 9}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Rhinitis Allergic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 29, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 55, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Rhinorrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 29, 'numAffected': 8}, {'groupId': 'EG004', 'numAtRisk': 55, 'numAffected': 11}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Wheezing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 29, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 55, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 29, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 55, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 29, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 55, 'numAffected': 4}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Skin Lesion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 29, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 55, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Swelling Face', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 29, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 55, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}], 'seriousEvents': [{'term': 'Craniosynostosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 29, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 55, 'numAffected': 1}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Papilloedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 29, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 55, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Viral Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 29, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 55, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Knee Deformity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 29, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 55, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Migraine', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 29, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 55, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Haematuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 29, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 55, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Radiographic Global Impression of Change (RGI-C) Global Score at Week 40', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Active Control', 'description': 'Multiple daily doses of oral phosphate and one or more daily doses of active vitamin D therapy, titrated and individualized by the investigator based on published recommendations during the Treatment Period (up to Week 64). During the Treatment Extension Period (Week 64 to Week 140), participants crossed over to receive a starting dose of SC burosumab 0.8 mg/kg Q2W. Participants in Japan and Korea did not enter the Treatment Extension Period.'}, {'id': 'OG001', 'title': 'Burosumab', 'description': 'Burosumab 0.8 mg/kg starting dose, administered Q2W by SC injection during the Treatment Period (up to Week 64). During the Treatment Extension Period (Week 64 to Week 140), participants continued to receive a starting dose of SC burosumab 0.8 mg/kg Q2W. Participants in Japan and Korea did not enter the Treatment Extension Period.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.77', 'spread': '0.107', 'groupId': 'OG000'}, {'value': '1.92', 'spread': '0.110', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.14', 'ciLowerLimit': '0.83', 'ciUpperLimit': '1.45', 'groupDescription': 'Least squares (LS) mean, standard error (SE), confidence interval (CI), and 2-sided p value per ANCOVA model, which included RGI-C as the dependent variable, treatment group and baseline age stratification factor as independent variables and baseline RSS score as a continuous covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Week 40', 'description': 'Changes in the severity of rickets and bowing were assessed using a disease specific qualitative RGI-C scoring system. The RGI-C is a 7-point ordinal scale with possible values: +3 = very much better (complete or near complete healing of rickets), +2 = much better (substantial healing of rickets), +1 = minimally better (i.e., minimal healing of rickets), 0 = unchanged, -1 = minimally worse (minimal worsening of rickets), -2 = much worse (moderate worsening of rickets), -3 = very much worse (severe worsening of rickets).', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set: all randomized participants who received at least one dose of assigned medication and had at least one post-baseline assessment.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With a Mean RGI-C Global Score ≥ +2.0 (Responders) at Week 40', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Active Control', 'description': 'Multiple daily doses of oral phosphate and one or more daily doses of active vitamin D therapy, titrated and individualized by the investigator based on published recommendations during the Treatment Period (up to Week 64). During the Treatment Extension Period (Week 64 to Week 140), participants crossed over to receive a starting dose of SC burosumab 0.8 mg/kg Q2W. Participants in Japan and Korea did not enter the Treatment Extension Period.'}, {'id': 'OG001', 'title': 'Burosumab', 'description': 'Burosumab 0.8 mg/kg starting dose, administered Q2W by SC injection during the Treatment Period (up to Week 64). During the Treatment Extension Period (Week 64 to Week 140), participants continued to receive a starting dose of SC burosumab 0.8 mg/kg Q2W. Participants in Japan and Korea did not enter the Treatment Extension Period.'}], 'classes': [{'categories': [{'measurements': [{'value': '6.3', 'groupId': 'OG000'}, {'value': '72.4', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '39.1', 'ciLowerLimit': '7.2', 'ciUpperLimit': '211.7', 'pValueComment': 'Odds ratio, CI, and 2-sided p-value were per logistic regression model, which included treatment group and baseline age stratification factor as independent variables and baseline RSS score as a continuous covariate.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Week 40', 'description': 'RGI-C responders are defined as participants with a mean RGI-C global score \\>= +2.0. The RGI-C is a 7-point ordinal scale with possible values: +3 = very much better (complete or near complete healing of rickets), +2 = much better (substantial healing of rickets), +1 = minimally better (i.e., minimal healing of rickets), 0 = unchanged, -1 = minimally worse (minimal worsening of rickets), -2 = much worse (moderate worsening of rickets), -3 = very much worse (severe worsening of rickets).', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set: all randomized participants who received at least one dose of assigned medication and had at least one post-baseline assessment.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With a Mean RGI-C Global Score ≥ +2.0 (Responders) at Week 64', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Active Control', 'description': 'Multiple daily doses of oral phosphate and one or more daily doses of active vitamin D therapy, titrated and individualized by the investigator based on published recommendations during the Treatment Period (up to Week 64). During the Treatment Extension Period (Week 64 to Week 140), participants crossed over to receive a starting dose of SC burosumab 0.8 mg/kg Q2W. Participants in Japan and Korea did not enter the Treatment Extension Period.'}, {'id': 'OG001', 'title': 'Burosumab', 'description': 'Burosumab 0.8 mg/kg starting dose, administered Q2W by SC injection during the Treatment Period (up to Week 64). During the Treatment Extension Period (Week 64 to Week 140), participants continued to receive a starting dose of SC burosumab 0.8 mg/kg Q2W. Participants in Japan and Korea did not enter the Treatment Extension Period.'}], 'classes': [{'categories': [{'measurements': [{'value': '18.8', 'groupId': 'OG000'}, {'value': '86.2', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0002', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '34.1', 'ciLowerLimit': '5.6', 'ciUpperLimit': '206.3', 'pValueComment': 'Odds ratio, CI, and 2-sided p-value were per generalized linear mixed model, which includes treatment, visit, treatment by visit interaction and baseline age stratification factor as factors, baseline RSS total score as a continuous covariate.', 'statisticalMethod': 'generalized linear mixed model', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Week 64', 'description': 'RGI-C responders are defined as participants with a mean RGI-C global score \\>= +2.0. The RGI-C is a 7-point ordinal scale with possible values: +3 = very much better (complete or near complete healing of rickets), +2 = much better (substantial healing of rickets), +1 = minimally better (i.e., minimal healing of rickets), 0 = unchanged, -1 = minimally worse (minimal worsening of rickets), -2 = much worse (moderate worsening of rickets), -3 = very much worse (severe worsening of rickets).', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set: all randomized participants who received at least one dose of assigned medication and had at least one post-baseline assessment.'}, {'type': 'SECONDARY', 'title': 'RGI-C Global Score at Week 64', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Active Control', 'description': 'Multiple daily doses of oral phosphate and one or more daily doses of active vitamin D therapy, titrated and individualized by the investigator based on published recommendations during the Treatment Period (up to Week 64). During the Treatment Extension Period (Week 64 to Week 140), participants crossed over to receive a starting dose of SC burosumab 0.8 mg/kg Q2W. Participants in Japan and Korea did not enter the Treatment Extension Period.'}, {'id': 'OG001', 'title': 'Burosumab', 'description': 'Burosumab 0.8 mg/kg starting dose, administered Q2W by SC injection during the Treatment Period (up to Week 64). During the Treatment Extension Period (Week 64 to Week 140), participants continued to receive a starting dose of SC burosumab 0.8 mg/kg Q2W. Participants in Japan and Korea did not enter the Treatment Extension Period.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.03', 'spread': '0.136', 'groupId': 'OG000'}, {'value': '2.06', 'spread': '0.072', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'difference in LS means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.02', 'ciLowerLimit': '0.72', 'ciUpperLimit': '1.33', 'groupDescription': 'Per generalized estimating equation (GEE) model, which included RGI-C as the dependent variable, treatment, visit, treatment by visit interaction and baseline age stratification factor as factors, baseline RSS score as a continuous covariate, with exchangeable covariate structure.', 'statisticalMethod': 'GEE model', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Week 64', 'description': 'Changes in the severity of rickets and bowing were assessed using a disease specific qualitative RGI-C scoring system. The RGI-C is a 7-point ordinal scale with possible values: +3 = very much better (complete or near complete healing of rickets), +2 = much better (substantial healing of rickets), +1 = minimally better (i.e., minimal healing of rickets), 0 = unchanged, -1 = minimally worse (minimal worsening of rickets), -2 = much worse (moderate worsening of rickets), -3 = very much worse (severe worsening of rickets).', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set: all randomized participants who received at least one dose of assigned medication and had at least one post-baseline assessment.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in RSS Total Score at Week 40', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Active Control', 'description': 'Multiple daily doses of oral phosphate and one or more daily doses of active vitamin D therapy, titrated and individualized by the investigator based on published recommendations during the Treatment Period (up to Week 64). During the Treatment Extension Period (Week 64 to Week 140), participants crossed over to receive a starting dose of SC burosumab 0.8 mg/kg Q2W. Participants in Japan and Korea did not enter the Treatment Extension Period.'}, {'id': 'OG001', 'title': 'Burosumab', 'description': 'Burosumab 0.8 mg/kg starting dose, administered Q2W by SC injection during the Treatment Period (up to Week 64). During the Treatment Extension Period (Week 64 to Week 140), participants continued to receive a starting dose of SC burosumab 0.8 mg/kg Q2W. Participants in Japan and Korea did not enter the Treatment Extension Period.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.71', 'spread': '0.138', 'groupId': 'OG000'}, {'value': '-2.04', 'spread': '0.145', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.34', 'ciLowerLimit': '-1.74', 'ciUpperLimit': '-0.94', 'pValueComment': 'LS mean, SE, CI, and 2-sided p value per ANCOVA model, which included treatment group and baseline age stratification factor as independent variables and baseline RSS score as a continuous covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 40', 'description': 'The RSS system is a 10-point radiographic scoring method that was developed to assess the severity of nutritional rickets in the wrists and knees based on the degree of metaphyseal fraying, cupping, lucency, separation, and the proportion of the growth plate affected. Scores are assigned for the unilateral wrist and knee X-rays deemed by the rater to be the more severe of the bilateral images. The maximum total score on the RSS is 10 points and the minimum score is 0, with a total possible score of 4 points for the wrists and 6 points for the knees (the total score is the sum of the wrist and knee score). Higher scores indicate greater rickets severity.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set: all randomized participants who received at least one dose of assigned medication and had at least one post-baseline RSS Total Score assessment.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in RSS Total Score at Week 64', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Active Control', 'description': 'Multiple daily doses of oral phosphate and one or more daily doses of active vitamin D therapy, titrated and individualized by the investigator based on published recommendations during the Treatment Period (up to Week 64). During the Treatment Extension Period (Week 64 to Week 140), participants crossed over to receive a starting dose of SC burosumab 0.8 mg/kg Q2W. Participants in Japan and Korea did not enter the Treatment Extension Period.'}, {'id': 'OG001', 'title': 'Burosumab', 'description': 'Burosumab 0.8 mg/kg starting dose, administered Q2W by SC injection during the Treatment Period (up to Week 64). During the Treatment Extension Period (Week 64 to Week 140), participants continued to receive a starting dose of SC burosumab 0.8 mg/kg Q2W. Participants in Japan and Korea did not enter the Treatment Extension Period.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.01', 'spread': '0.151', 'groupId': 'OG000'}, {'value': '-2.23', 'spread': '0.117', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'difference in LS means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.21', 'ciLowerLimit': '-1.59', 'ciUpperLimit': '-0.83', 'pValueComment': 'LS mean, SE, CI, and 2-sided p value per GEE model, which included treatment, visit, treatment by visit interaction and baseline age stratification factor as factors, baseline RSS score as a continuous covariate.', 'statisticalMethod': 'GEE model', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 64', 'description': 'The RSS system is a 10-point radiographic scoring method that was developed to assess the severity of nutritional rickets in the wrists and knees based on the degree of metaphyseal fraying, cupping, and the proportion of the growth plate affected. Scores are assigned for the unilateral wrist and knee X-rays deemed by the rater to be the more severe of the bilateral images. The maximum total score on the RSS is 10 points and the minimum score is 0, with a total possible score of 4 points for the wrists and 6 points for the knees. Higher scores indicate greater rickets severity.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set: all randomized participants who received at least one dose of assigned medication and had at least one post-baseline RSS Total Score assessment.'}, {'type': 'SECONDARY', 'title': 'RGI-C Long Leg Score at Week 40', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Active Control', 'description': 'Multiple daily doses of oral phosphate and one or more daily doses of active vitamin D therapy, titrated and individualized by the investigator based on published recommendations during the Treatment Period (up to Week 64). During the Treatment Extension Period (Week 64 to Week 140), participants crossed over to receive a starting dose of SC burosumab 0.8 mg/kg Q2W. Participants in Japan and Korea did not enter the Treatment Extension Period.'}, {'id': 'OG001', 'title': 'Burosumab', 'description': 'Burosumab 0.8 mg/kg starting dose, administered Q2W by SC injection during the Treatment Period (up to Week 64). During the Treatment Extension Period (Week 64 to Week 140), participants continued to receive a starting dose of SC burosumab 0.8 mg/kg Q2W. Participants in Japan and Korea did not enter the Treatment Extension Period.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.22', 'spread': '0.080', 'groupId': 'OG000'}, {'value': '0.62', 'spread': '0.153', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0162', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.40', 'ciLowerLimit': '0.07', 'ciUpperLimit': '0.72', 'pValueComment': 'LS mean, SE, CI, and 2-sided p value per GEE model, which included treatment, visit, treatment by visit interaction, and baseline age stratification factor as factors; and baseline RSS score as a continuous covariate.', 'statisticalMethod': 'GEE model', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Week 40', 'description': 'Changes in the severity of lower extremity skeletal abnormalities, including genu varum and genu valgus, were assessed using a disease specific qualitative RGI-C scoring system. The RGI-C is a 7-point ordinal scale with possible values: +3 = very much better (complete or near complete healing), +2 = much better (substantial healing), +1 = minimally better (i.e., minimal healing), 0 = unchanged, -1 = minimally worse (minimal worsening), -2 = much worse (moderate worsening), -3 = very much worse (severe worsening).', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set: all randomized participants who received at least one dose of assigned medication and had at least one post-baseline assessment.'}, {'type': 'SECONDARY', 'title': 'RGI-C Long Leg Score at Week 64', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Active Control', 'description': 'Multiple daily doses of oral phosphate and one or more daily doses of active vitamin D therapy, titrated and individualized by the investigator based on published recommendations during the Treatment Period (up to Week 64). During the Treatment Extension Period (Week 64 to Week 140), participants crossed over to receive a starting dose of SC burosumab 0.8 mg/kg Q2W. Participants in Japan and Korea did not enter the Treatment Extension Period.'}, {'id': 'OG001', 'title': 'Burosumab', 'description': 'Burosumab 0.8 mg/kg starting dose, administered Q2W by SC injection during the Treatment Period (up to Week 64). During the Treatment Extension Period (Week 64 to Week 140), participants continued to receive a starting dose of SC burosumab 0.8 mg/kg Q2W. Participants in Japan and Korea did not enter the Treatment Extension Period.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.29', 'spread': '0.119', 'groupId': 'OG000'}, {'value': '1.25', 'spread': '0.170', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'difference in LS means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.97', 'ciLowerLimit': '0.57', 'ciUpperLimit': '1.37', 'pValueComment': 'LS mean, SE, CI, and 2-sided p value per GEE model, which included treatment, visit, treatment by visit interaction, and baseline age stratification factor as factors; and baseline RSS score as a continuous covariate.', 'statisticalMethod': 'GEE model', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Week 64', 'description': 'Changes in the severity of lower extremity skeletal abnormalities, including genu varum and genu valgus, were assessed using a disease specific qualitative RGI-C scoring system. The RGI-C is a 7-point ordinal scale with possible values: +3 = very much better (complete or near complete healing), +2 = much better (substantial healing), +1 = minimally better (i.e., minimal healing), 0 = unchanged, -1 = minimally worse (minimal worsening), -2 = much worse (moderate worsening), -3 = very much worse (severe worsening).', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set: all randomized participants who received at least one dose of assigned medication and had at least one post-baseline assessment.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Height-For-Age Z-Scores to Week 40', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Active Control', 'description': 'Multiple daily doses of oral phosphate and one or more daily doses of active vitamin D therapy, titrated and individualized by the investigator based on published recommendations during the Treatment Period (up to Week 64). During the Treatment Extension Period (Week 64 to Week 140), participants crossed over to receive a starting dose of SC burosumab 0.8 mg/kg Q2W. Participants in Japan and Korea did not enter the Treatment Extension Period.'}, {'id': 'OG001', 'title': 'Burosumab', 'description': 'Burosumab 0.8 mg/kg starting dose, administered Q2W by SC injection during the Treatment Period (up to Week 64). During the Treatment Extension Period (Week 64 to Week 140), participants continued to receive a starting dose of SC burosumab 0.8 mg/kg Q2W. Participants in Japan and Korea did not enter the Treatment Extension Period.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.03', 'spread': '0.031', 'groupId': 'OG000'}, {'value': '0.16', 'spread': '0.052', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0408', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.12', 'ciLowerLimit': '0.01', 'ciUpperLimit': '0.24', 'groupDescription': 'LS mean, SE, CI, and 2-sided p value per GEE model, which included change from baseline for recumbent length/standing height Z score as the dependent variable, treatment group, visit, interaction between treatment group by visit and baseline RSS stratification as factors, age and baseline recumbent length/standing height Z score as continuous covariates, with exchangeable covariance structure.', 'statisticalMethod': 'GEE model', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 40', 'description': "Recumbent length/Standing height z scores are measures of height adjusted for a child's age and sex. The Z-score indicates the number of standard deviations away from a reference population (from the Centers for Disease Control \\[CDC\\] growth charts) in the same age range and with the same sex. A Z-score of 0 is equal to the mean with negative numbers indicating values lower than the mean and positive values higher. Higher Z-scores indicate a better outcome.", 'unitOfMeasure': 'Z score', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set: all randomized participants who received at least one dose of assigned medication and had at least one post-baseline assessment. Participants with an assessment at Week 40.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Height-For-Age Z-Scores to Week 64', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Active Control', 'description': 'Multiple daily doses of oral phosphate and one or more daily doses of active vitamin D therapy, titrated and individualized by the investigator based on published recommendations during the Treatment Period (up to Week 64). During the Treatment Extension Period (Week 64 to Week 140), participants crossed over to receive a starting dose of SC burosumab 0.8 mg/kg Q2W. Participants in Japan and Korea did not enter the Treatment Extension Period.'}, {'id': 'OG001', 'title': 'Burosumab', 'description': 'Burosumab 0.8 mg/kg starting dose, administered Q2W by SC injection during the Treatment Period (up to Week 64). During the Treatment Extension Period (Week 64 to Week 140), participants continued to receive a starting dose of SC burosumab 0.8 mg/kg Q2W. Participants in Japan and Korea did not enter the Treatment Extension Period.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.02', 'spread': '0.035', 'groupId': 'OG000'}, {'value': '0.17', 'spread': '0.066', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0490', 'groupIds': ['OG000', 'OG001'], 'paramType': 'difference in LS means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.14', 'ciLowerLimit': '0.00', 'ciUpperLimit': '0.29', 'groupDescription': 'LS mean, SE, CI, and 2-sided p value per GEE model, which included change from baseline for recumbent length/standing height Z score as the dependent variable, treatment group, visit, interaction between treatment group by visit and baseline RSS stratification as factors, age and baseline recumbent length/standing height Z score as continuous covariates, with exchangeable covariance structure.', 'statisticalMethod': 'GEE model', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 64', 'description': "Recumbent length/Standing height z scores are measures of height adjusted for a child's age and sex. The Z-score indicates the number of standard deviations away from a reference population (from the CDC growth charts) in the same age range and with the same sex. A Z-score of 0 is equal to the mean with negative numbers indicating values lower than the mean and positive values higher. Higher Z-scores indicate a better outcome.", 'unitOfMeasure': 'Z score', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set: all randomized participants who received at least one dose of assigned medication and had at least one post-baseline assessment. Participants with an assessment at Week 64.'}, {'type': 'SECONDARY', 'title': 'Change in Growth Velocity Z Score From Baseline to Week 40', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Active Control', 'description': 'Multiple daily doses of oral phosphate and one or more daily doses of active vitamin D therapy, titrated and individualized by the investigator based on published recommendations during the Treatment Period (up to Week 64). During the Treatment Extension Period (Week 64 to Week 140), participants crossed over to receive a starting dose of SC burosumab 0.8 mg/kg Q2W. Participants in Japan and Korea did not enter the Treatment Extension Period.'}, {'id': 'OG001', 'title': 'Burosumab', 'description': 'Burosumab 0.8 mg/kg starting dose, administered Q2W by SC injection during the Treatment Period (up to Week 64). During the Treatment Extension Period (Week 64 to Week 140), participants continued to receive a starting dose of SC burosumab 0.8 mg/kg Q2W. Participants in Japan and Korea did not enter the Treatment Extension Period.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.73', 'spread': '0.339', 'groupId': 'OG000'}, {'value': '1.76', 'spread': '0.337', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0386', 'groupIds': ['OG000', 'OG001'], 'paramType': 'difference in LS means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.02', 'ciLowerLimit': '0.06', 'ciUpperLimit': '1.99', 'groupDescription': 'LS mean, SE, CI, and 2-sided p value per ANCOVA model, which included change from baseline for growth velocity Z score as the dependent variable, treatment group and baseline RSS total score stratification as factors, baseline Z score and age as continuous covariates.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 40', 'description': "A growth velocity Z score was calculated based on Tanner's standard. The Z score indicates the number of standard deviations away from a reference population (from Tanner's standard) in the same age range and with the same sex. The baseline growth velocity was calculated for participants who had data available from within 1.5 years prior to baseline. The Week 64 growth velocity was calculated using data between baseline and Week 64. The mid-point of the age interval was used to locate the closest reference age provided by Tanner's Standard. Children with a mid-point age under 2.25 years were excluded, because younger ages are not available in Tanner's standard. To smoothly transition from recumbent length to standing height, 0·8 cm was subtracted from recumbent length before pooling with standing height. A Z score of 0 is equal to the mean with negative numbers indicating values lower than the mean and positive values higher. Higher Z scores indicate a better outcome.", 'unitOfMeasure': 'Z score', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set: all randomized participants who received at least one dose of assigned medication and had at least one post-baseline assessment. Participants with Baseline growth velocity.'}, {'type': 'SECONDARY', 'title': 'Change in Growth Velocity Z Score From Baseline to Week 64', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Active Control', 'description': 'Multiple daily doses of oral phosphate and one or more daily doses of active vitamin D therapy, titrated and individualized by the investigator based on published recommendations during the Treatment Period (up to Week 64). During the Treatment Extension Period (Week 64 to Week 140), participants crossed over to receive a starting dose of SC burosumab 0.8 mg/kg Q2W. Participants in Japan and Korea did not enter the Treatment Extension Period.'}, {'id': 'OG001', 'title': 'Burosumab', 'description': 'Burosumab 0.8 mg/kg starting dose, administered Q2W by SC injection during the Treatment Period (up to Week 64). During the Treatment Extension Period (Week 64 to Week 140), participants continued to receive a starting dose of SC burosumab 0.8 mg/kg Q2W. Participants in Japan and Korea did not enter the Treatment Extension Period.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.41', 'spread': '0.265', 'groupId': 'OG000'}, {'value': '1.53', 'spread': '0.264', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0047', 'groupIds': ['OG000', 'OG001'], 'paramType': 'difference in LS means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.12', 'ciLowerLimit': '0.37', 'ciUpperLimit': '1.88', 'groupDescription': 'LS mean, SE, CI, and 2-sided p value per ANCOVA model, which included change from baseline for growth velocity Z score as the dependent variable, treatment group and baseline RSS total score stratification as factors, baseline Z score and age as continuous covariates.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 64', 'description': "A growth velocity Z score was calculated based on Tanner's standard. The Z score indicates the number of standard deviations away from a reference population (from Tanner's standard) in the same age range and with the same sex. The baseline growth velocity was calculated for participants who had data available from within 1.5 years prior to baseline. The Week 64 growth velocity was calculated using data between baseline and Week 64. The mid-point of the age interval was used to locate the closest reference age provided by Tanner's Standard. Children with a mid-point age under 2.25 years were excluded, because younger ages are not available in Tanner's standard. To smoothly transition from recumbent length to standing height, 0·8 cm was subtracted from recumbent length before pooling with standing height. A Z score of 0 is equal to the mean with negative numbers indicating values lower than the mean and positive values higher. Higher Z scores indicate a better outcome.", 'unitOfMeasure': 'Z score', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set: all randomized participants who received at least one dose of assigned medication and had at least one post-baseline assessment. Participants with Baseline growth velocity.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline Over Time in Serum Phosphorus Concentration, up to Week 64', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Active Control', 'description': 'Multiple daily doses of oral phosphate and one or more daily doses of active vitamin D therapy, titrated and individualized by the investigator based on published recommendations during the Treatment Period (up to Week 64). During the Treatment Extension Period (Week 64 to Week 140), participants crossed over to receive a starting dose of SC burosumab 0.8 mg/kg Q2W. Participants in Japan and Korea did not enter the Treatment Extension Period.'}, {'id': 'OG001', 'title': 'Burosumab', 'description': 'Burosumab 0.8 mg/kg starting dose, administered Q2W by SC injection during the Treatment Period (up to Week 64). During the Treatment Extension Period (Week 64 to Week 140), participants continued to receive a starting dose of SC burosumab 0.8 mg/kg Q2W. Participants in Japan and Korea did not enter the Treatment Extension Period.'}], 'classes': [{'title': 'Week 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.22', 'spread': '0.072', 'groupId': 'OG000'}, {'value': '1.26', 'spread': '0.094', 'groupId': 'OG001'}]}]}, {'title': 'Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.14', 'spread': '0.098', 'groupId': 'OG001'}]}]}, {'title': 'Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.18', 'spread': '0.061', 'groupId': 'OG000'}, {'value': '1.21', 'spread': '0.102', 'groupId': 'OG001'}]}]}, {'title': 'Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.21', 'spread': '0.064', 'groupId': 'OG000'}, {'value': '0.99', 'spread': '0.074', 'groupId': 'OG001'}]}]}, {'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.01', 'spread': '0.072', 'groupId': 'OG001'}]}]}, {'title': 'Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.24', 'spread': '0.063', 'groupId': 'OG000'}, {'value': '0.87', 'spread': '0.072', 'groupId': 'OG001'}]}]}, {'title': 'Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.27', 'spread': '0.073', 'groupId': 'OG000'}, {'value': '0.78', 'spread': '0.077', 'groupId': 'OG001'}]}]}, {'title': 'Week 32', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.23', 'spread': '0.063', 'groupId': 'OG000'}, {'value': '0.93', 'spread': '0.073', 'groupId': 'OG001'}]}]}, {'title': 'Week 33', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.23', 'spread': '0.106', 'groupId': 'OG001'}]}]}, {'title': 'Week 40', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.20', 'spread': '0.062', 'groupId': 'OG000'}, {'value': '0.92', 'spread': '0.080', 'groupId': 'OG001'}]}]}, {'title': 'Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.30', 'spread': '0.082', 'groupId': 'OG000'}, {'value': '0.91', 'spread': '0.075', 'groupId': 'OG001'}]}]}, {'title': 'Week 64', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.21', 'spread': '0.062', 'groupId': 'OG000'}, {'value': '0.91', 'spread': '0.078', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.04', 'ciLowerLimit': '0.81', 'ciUpperLimit': '1.27', 'estimateComment': 'Difference (Burosumab - Oral Phosphate/Active Vitamin D)', 'groupDescription': 'Week 1', 'statisticalMethod': 'GEE model', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.03', 'ciLowerLimit': '0.79', 'ciUpperLimit': '1.27', 'estimateComment': 'Difference (Burosumab - Oral Phosphate/Active Vitamin D)', 'groupDescription': 'Week 4', 'statisticalMethod': 'GEE model', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.78', 'ciLowerLimit': '0.58', 'ciUpperLimit': '0.97', 'estimateComment': 'Difference (Burosumab - Oral Phosphate/Active Vitamin D)', 'groupDescription': 'Week 8', 'statisticalMethod': 'GEE model', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.63', 'ciLowerLimit': '0.44', 'ciUpperLimit': '0.81', 'estimateComment': 'Difference (Burosumab - Oral Phosphate/Active Vitamin D)', 'groupDescription': 'Week 16', 'statisticalMethod': 'GEE model', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.51', 'ciLowerLimit': '0.30', 'ciUpperLimit': '0.72', 'estimateComment': 'Difference (Burosumab - Oral Phosphate/Active Vitamin D)', 'groupDescription': 'Week 24', 'statisticalMethod': 'GEE model', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.70', 'ciLowerLimit': '0.51', 'ciUpperLimit': '0.89', 'groupDescription': 'Week 32', 'statisticalMethod': 'GEE model', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.71', 'ciLowerLimit': '0.51', 'ciUpperLimit': '0.91', 'estimateComment': 'Difference (burosumab - Oral Phosphate/Active Vitamin D)', 'groupDescription': 'Week 40', 'statisticalMethod': 'GEE model', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.61', 'ciLowerLimit': '0.39', 'ciUpperLimit': '0.82', 'groupDescription': 'Week 52', 'statisticalMethod': 'GEE model', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.69', 'ciLowerLimit': '0.49', 'ciUpperLimit': '0.90', 'groupDescription': 'Week 64', 'statisticalMethod': 'GEE model', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Weeks 1, 2, 4, 8, 12, 16, 24, 32, 33, 40, 52, 64', 'description': 'The GEE model includes change from baseline for serum phosphorous measurement as the dependent variable, treatment group, visit, interaction between treatment group by visit, baseline age and baseline RSS stratification as factors, baseline phosphorous measure as a covariate, with exchangeable covariance structure. The GEE model included data up to Week 64.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacodynamic (PD) Analysis Set: all participants who received at least one dose of study therapy and had evaluable serum data. Participants with data at given time point.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline Over Time in Serum Phosphorus Concentration, Weeks 66-112', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Active Control', 'description': 'Multiple daily doses of oral phosphate and one or more daily doses of active vitamin D therapy, titrated and individualized by the investigator based on published recommendations during the Treatment Period (up to Week 64). During the Treatment Extension Period (Week 64 to Week 140), participants crossed over to receive a starting dose of SC burosumab 0.8 mg/kg Q2W. Participants in Japan and Korea did not enter the Treatment Extension Period.'}, {'id': 'OG001', 'title': 'Burosumab', 'description': 'Burosumab 0.8 mg/kg starting dose, administered Q2W by SC injection during the Treatment Period (up to Week 64). During the Treatment Extension Period (Week 64 to Week 140), participants continued to receive a starting dose of SC burosumab 0.8 mg/kg Q2W. Participants in Japan and Korea did not enter the Treatment Extension Period.'}], 'classes': [{'title': 'Week 66', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.05', 'spread': '0.235', 'groupId': 'OG000'}]}]}, {'title': 'Week 68', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.17', 'spread': '0.472', 'groupId': 'OG000'}, {'value': '1.10', 'spread': 'NA', 'comment': '1 participant analyzed', 'groupId': 'OG001'}]}]}, {'title': 'Week 76', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.90', 'spread': '0.324', 'groupId': 'OG000'}, {'value': '0.92', 'spread': '0.324', 'groupId': 'OG001'}]}]}, {'title': 'Week 88', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.98', 'spread': '0.433', 'groupId': 'OG000'}, {'value': '1.00', 'spread': '0.576', 'groupId': 'OG001'}]}]}, {'title': 'Week 100', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.99', 'spread': '0.445', 'groupId': 'OG000'}, {'value': '1.00', 'spread': '0.424', 'groupId': 'OG001'}]}]}, {'title': 'Week 112', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.26', 'spread': '0.508', 'groupId': 'OG000'}, {'value': '1.10', 'spread': '0.283', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Weeks 66, 68, 76, 88, 100, 112', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PD Analysis Set: all participants who received at least one dose of study therapy and had evaluable serum data. Participants with an assessment at given time point.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Mean Post-Baseline Serum Phosphorus Level to Week 64', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Active Control', 'description': 'Multiple daily doses of oral phosphate and one or more daily doses of active vitamin D therapy, titrated and individualized by the investigator based on published recommendations during the Treatment Period (up to Week 64). During the Treatment Extension Period (Week 64 to Week 140), participants crossed over to receive a starting dose of SC burosumab 0.8 mg/kg Q2W. Participants in Japan and Korea did not enter the Treatment Extension Period.'}, {'id': 'OG001', 'title': 'Burosumab', 'description': 'Burosumab 0.8 mg/kg starting dose, administered Q2W by SC injection during the Treatment Period (up to Week 64). During the Treatment Extension Period (Week 64 to Week 140), participants continued to receive a starting dose of SC burosumab 0.8 mg/kg Q2W. Participants in Japan and Korea did not enter the Treatment Extension Period.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.24', 'spread': '0.058', 'groupId': 'OG000'}, {'value': '0.98', 'spread': '0.061', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'difference in LS means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.74', 'ciLowerLimit': '0.58', 'ciUpperLimit': '0.91', 'estimateComment': 'Difference (KRN23 - Oral Phosphate/Active Vitamin D)', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Weeks 1, 4, 8, 16, 24, 32, 40, 52, 64', 'description': 'The ANCOVA model includes change in serum phosphorus from baseline to mean post-baseline as the dependent variable, treatment group, baseline age and baseline RSS stratification as factors, baseline phosphorous measure as a covariate.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'PD Analysis Set: all participants who received at least one dose of study therapy and had evaluable serum data.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Mean Post-Baseline Serum Phosphorus Level to Week 140 (During Treatment With Burosumab)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Active Control', 'description': 'Multiple daily doses of oral phosphate and one or more daily doses of active vitamin D therapy, titrated and individualized by the investigator based on published recommendations during the Treatment Period (up to Week 64). During the Treatment Extension Period (Week 64 to Week 140), participants crossed over to receive a starting dose of SC burosumab 0.8 mg/kg Q2W. Participants in Japan and Korea did not enter the Treatment Extension Period.'}, {'id': 'OG001', 'title': 'Burosumab', 'description': 'Burosumab 0.8 mg/kg starting dose, administered Q2W by SC injection during the Treatment Period (up to Week 64). During the Treatment Extension Period (Week 64 to Week 140), participants continued to receive a starting dose of SC burosumab 0.8 mg/kg Q2W. Participants in Japan and Korea did not enter the Treatment Extension Period.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.05', 'spread': '0.310', 'groupId': 'OG000'}, {'value': '0.93', 'spread': '0.336', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Burosumab arm: Baseline, Week 1, 4, 8, 16, 24, 32, 40, 52, 64, 66, 68, 76, 88, 100, 112, 124, 140; Active Control arm: Baseline, Week 68, 76, 88, 100, 112, 124, 140', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PD Analysis Set: all participants who received at least one dose of study therapy and had evaluable serum data.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Reaching the Normal Range of Serum Phosphorus Concentration (3.2 - 6.1 mg/dL)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Active Control', 'description': 'Multiple daily doses of oral phosphate and one or more daily doses of active vitamin D therapy, titrated and individualized by the investigator based on published recommendations during the Treatment Period (up to Week 64). During the Treatment Extension Period (Week 64 to Week 140), participants crossed over to receive a starting dose of SC burosumab 0.8 mg/kg Q2W. Participants in Japan and Korea did not enter the Treatment Extension Period.'}, {'id': 'OG001', 'title': 'Burosumab', 'description': 'Burosumab 0.8 mg/kg starting dose, administered Q2W by SC injection during the Treatment Period (up to Week 64). During the Treatment Extension Period (Week 64 to Week 140), participants continued to receive a starting dose of SC burosumab 0.8 mg/kg Q2W. Participants in Japan and Korea did not enter the Treatment Extension Period.'}], 'classes': [{'categories': [{'measurements': [{'value': '75.0', 'groupId': 'OG000'}, {'value': '96.6', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Burosumab arm: Baseline, up to Week 140; Active Control arm: Baseline, Week 68 up to Week 140', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'PD Analysis Set: all participants who received at least one dose of study therapy and had evaluable serum data.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline Over Time in 1,25-Dihydroxyvitamin D, up to Week 64', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Active Control', 'description': 'Multiple daily doses of oral phosphate and one or more daily doses of active vitamin D therapy, titrated and individualized by the investigator based on published recommendations during the Treatment Period (up to Week 64). During the Treatment Extension Period (Week 64 to Week 140), participants crossed over to receive a starting dose of SC burosumab 0.8 mg/kg Q2W. Participants in Japan and Korea did not enter the Treatment Extension Period.'}, {'id': 'OG001', 'title': 'Burosumab', 'description': 'Burosumab 0.8 mg/kg starting dose, administered Q2W by SC injection during the Treatment Period (up to Week 64). During the Treatment Extension Period (Week 64 to Week 140), participants continued to receive a starting dose of SC burosumab 0.8 mg/kg Q2W. Participants in Japan and Korea did not enter the Treatment Extension Period.'}], 'classes': [{'title': 'Week 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '19.81', 'spread': '2.758', 'groupId': 'OG000'}, {'value': '68.09', 'spread': '5.251', 'groupId': 'OG001'}]}]}, {'title': 'Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '31.78', 'spread': '5.130', 'groupId': 'OG001'}]}]}, {'title': 'Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '12.77', 'spread': '2.998', 'groupId': 'OG000'}, {'value': '33.86', 'spread': '3.561', 'groupId': 'OG001'}]}]}, {'title': 'Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '15.10', 'spread': '2.528', 'groupId': 'OG000'}, {'value': '30.85', 'spread': '3.830', 'groupId': 'OG001'}]}]}, {'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '33.43', 'spread': '3.176', 'groupId': 'OG001'}]}]}, {'title': 'Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '19.41', 'spread': '3.757', 'groupId': 'OG000'}, {'value': '32.38', 'spread': '3.032', 'groupId': 'OG001'}]}]}, {'title': 'Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '17.46', 'spread': '2.905', 'groupId': 'OG000'}, {'value': '28.35', 'spread': '3.113', 'groupId': 'OG001'}]}]}, {'title': 'Week 32', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '17.25', 'spread': '3.156', 'groupId': 'OG000'}, {'value': '23.49', 'spread': '2.439', 'groupId': 'OG001'}]}]}, {'title': 'Week 33', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '31.50', 'spread': '3.423', 'groupId': 'OG001'}]}]}, {'title': 'Week 40', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '18.42', 'spread': '3.594', 'groupId': 'OG000'}, {'value': '29.63', 'spread': '3.721', 'groupId': 'OG001'}]}]}, {'title': 'Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '8.74', 'spread': '3.866', 'groupId': 'OG000'}, {'value': '13.75', 'spread': '2.862', 'groupId': 'OG001'}]}]}, {'title': 'Week 64', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.19', 'spread': '2.785', 'groupId': 'OG000'}, {'value': '9.89', 'spread': '2.235', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '48.27', 'ciLowerLimit': '36.53', 'ciUpperLimit': '60.02', 'estimateComment': 'Difference (Burosumab - Oral Phosphate/Active Vitamin D)', 'groupDescription': 'Week 1', 'statisticalMethod': 'GEE model', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '21.09', 'ciLowerLimit': '12.01', 'ciUpperLimit': '30.16', 'estimateComment': 'Difference (Burosumab - Oral Phosphate/Active Vitamin D)', 'groupDescription': 'Week 4', 'statisticalMethod': 'GEE model', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0010', 'groupIds': ['OG000', 'OG001'], 'paramType': 'difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '15.75', 'ciLowerLimit': '6.35', 'ciUpperLimit': '25.15', 'estimateComment': 'Difference (Burosumab - Oral Phosphate/Active Vitamin D)', 'groupDescription': 'Week 8', 'statisticalMethod': 'GEE model', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0078', 'groupIds': ['OG000', 'OG001'], 'paramType': 'difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '12.97', 'ciLowerLimit': '3.41', 'ciUpperLimit': '22.53', 'estimateComment': 'Difference (Burosumab - Oral Phosphate/Active Vitamin D)', 'groupDescription': 'Week 16', 'statisticalMethod': 'GEE model', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0101', 'groupIds': ['OG000', 'OG001'], 'paramType': 'difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '10.89', 'ciLowerLimit': '2.59', 'ciUpperLimit': '19.19', 'estimateComment': 'Difference (Burosumab - Oral Phosphate/Active Vitamin D)', 'groupDescription': 'Week 24', 'statisticalMethod': 'GEE model', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.1165', 'groupIds': ['OG000', 'OG001'], 'paramType': 'difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '6.23', 'ciLowerLimit': '-1.55', 'ciUpperLimit': '14.02', 'estimateComment': 'Difference (Burosumab - Oral Phosphate/Active Vitamin D)', 'groupDescription': 'Week 32', 'statisticalMethod': 'GEE model', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0317', 'groupIds': ['OG000', 'OG001'], 'paramType': 'difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '11.21', 'ciLowerLimit': '0.98', 'ciUpperLimit': '21.44', 'estimateComment': 'Difference (Burosumab - Oral Phosphate/Active Vitamin D)', 'groupDescription': 'Week 40', 'statisticalMethod': 'GEE model', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.3044', 'groupIds': ['OG000', 'OG001'], 'paramType': 'difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '5.01', 'ciLowerLimit': '-4.55', 'ciUpperLimit': '14.56', 'estimateComment': 'Difference (Burosumab - Oral Phosphate/Active Vitamin D)', 'groupDescription': 'Week 52', 'statisticalMethod': 'GEE model', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0145', 'groupIds': ['OG000', 'OG001'], 'paramType': 'difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '8.70', 'ciLowerLimit': '1.72', 'ciUpperLimit': '15.68', 'estimateComment': 'Difference (Burosumab - Oral Phosphate/Active Vitamin D', 'groupDescription': 'Week 64', 'statisticalMethod': 'GEE model', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Weeks 1, 2, 4, 8, 12, 16, 24, 32, 33, 40, 52, 64', 'description': 'The GEE model includes change from baseline for 1, 25-Dihydroxyvitamin D measurement as the dependent variable, treatment group, visit, interaction between treatment group by visit, baseline age and baseline RSS stratification as factors, baseline 1, 25-Dihydroxyvitamin D measure as a covariate, with exchangeable covariance structure. The GEE model included data up to Week 64.', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'PD Analysis Set: all participants who received at least one dose of study therapy and had evaluable serum data. Participants with an assessment at given time point.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline Over Time in 1,25-Dihydroxyvitamin D, Weeks 68 to 112', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Active Control', 'description': 'Multiple daily doses of oral phosphate and one or more daily doses of active vitamin D therapy, titrated and individualized by the investigator based on published recommendations during the Treatment Period (up to Week 64). During the Treatment Extension Period (Week 64 to Week 140), participants crossed over to receive a starting dose of SC burosumab 0.8 mg/kg Q2W. Participants in Japan and Korea did not enter the Treatment Extension Period.'}, {'id': 'OG001', 'title': 'Burosumab', 'description': 'Burosumab 0.8 mg/kg starting dose, administered Q2W by SC injection during the Treatment Period (up to Week 64). During the Treatment Extension Period (Week 64 to Week 140), participants continued to receive a starting dose of SC burosumab 0.8 mg/kg Q2W. Participants in Japan and Korea did not enter the Treatment Extension Period.'}], 'classes': [{'title': 'Week 68', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '22.12', 'spread': '23.950', 'groupId': 'OG000'}, {'value': '-9.80', 'spread': 'NA', 'comment': '1 participant analyzed', 'groupId': 'OG001'}]}]}, {'title': 'Week 76', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '19.05', 'spread': '22.612', 'groupId': 'OG000'}, {'value': '12.80', 'spread': '20.093', 'groupId': 'OG001'}]}]}, {'title': 'Week 88', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '24.58', 'spread': '17.787', 'groupId': 'OG000'}, {'value': '11.76', 'spread': '22.874', 'groupId': 'OG001'}]}]}, {'title': 'Week 100', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '33.57', 'spread': '16.591', 'groupId': 'OG000'}, {'value': '13.25', 'spread': '1.061', 'groupId': 'OG001'}]}]}, {'title': 'Week 112', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '29.94', 'spread': '15.402', 'groupId': 'OG000'}, {'value': '31.05', 'spread': '33.729', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Weeks 68, 76, 88, 100, 112', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PD Analysis Set: all participants who received at least one dose of study therapy and had evaluable serum data. Participants with an assessment at given time point.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline Over Time in TmP/GFR, up to Week 64', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Active Control', 'description': 'Multiple daily doses of oral phosphate and one or more daily doses of active vitamin D therapy, titrated and individualized by the investigator based on published recommendations during the Treatment Period (up to Week 64). During the Treatment Extension Period (Week 64 to Week 140), participants crossed over to receive a starting dose of SC burosumab 0.8 mg/kg Q2W. Participants in Japan and Korea did not enter the Treatment Extension Period.'}, {'id': 'OG001', 'title': 'Burosumab', 'description': 'Burosumab 0.8 mg/kg starting dose, administered Q2W by SC injection during the Treatment Period (up to Week 64). During the Treatment Extension Period (Week 64 to Week 140), participants continued to receive a starting dose of SC burosumab 0.8 mg/kg Q2W. Participants in Japan and Korea did not enter the Treatment Extension Period.'}], 'classes': [{'title': 'Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.17', 'spread': '0.065', 'groupId': 'OG000'}, {'value': '1.48', 'spread': '0.173', 'groupId': 'OG001'}]}]}, {'title': 'Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.20', 'spread': '0.057', 'groupId': 'OG000'}, {'value': '1.22', 'spread': '0.101', 'groupId': 'OG001'}]}]}, {'title': 'Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.15', 'spread': '0.085', 'groupId': 'OG000'}, {'value': '1.00', 'spread': '0.139', 'groupId': 'OG001'}]}]}, {'title': 'Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.12', 'spread': '0.072', 'groupId': 'OG000'}, {'value': '0.99', 'spread': '0.134', 'groupId': 'OG001'}]}]}, {'title': 'Week 32', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.10', 'spread': '0.062', 'groupId': 'OG000'}, {'value': '1.14', 'spread': '0.115', 'groupId': 'OG001'}]}]}, {'title': 'Week 40', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.15', 'spread': '0.053', 'groupId': 'OG000'}, {'value': '1.20', 'spread': '0.113', 'groupId': 'OG001'}]}]}, {'title': 'Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.12', 'spread': '0.069', 'groupId': 'OG000'}, {'value': '1.13', 'spread': '0.124', 'groupId': 'OG001'}]}]}, {'title': 'Week 64', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.09', 'spread': '0.070', 'groupId': 'OG000'}, {'value': '1.16', 'spread': '0.127', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.65', 'ciLowerLimit': '1.28', 'ciUpperLimit': '2.02', 'estimateComment': 'Difference (Burosumab - Oral Phosphate/Active Vitamin D)', 'groupDescription': 'Week 4', 'statisticalMethod': 'GEE model', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.42', 'ciLowerLimit': '1.19', 'ciUpperLimit': '1.64', 'estimateComment': 'Difference (Burosumab - Oral Phosphate/Active Vitamin D)', 'groupDescription': 'Week 8', 'statisticalMethod': 'GEE model', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.16', 'ciLowerLimit': '0.84', 'ciUpperLimit': '1.48', 'groupDescription': 'Week 16', 'statisticalMethod': 'GEE model', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.11', 'ciLowerLimit': '0.80', 'ciUpperLimit': '1.41', 'estimateComment': 'Difference (Burosumab - Oral Phosphate/Active Vitamin D)', 'groupDescription': 'Week 24', 'statisticalMethod': 'GEE model', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.24', 'ciLowerLimit': '0.98', 'ciUpperLimit': '1.51', 'groupDescription': 'Week 32', 'statisticalMethod': 'GEE model', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.35', 'ciLowerLimit': '1.10', 'ciUpperLimit': '1.60', 'estimateComment': 'Difference (Burosumab - Oral Phosphate/Active Vitamin D)', 'groupDescription': 'Week 40', 'statisticalMethod': 'GEE model', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.26', 'ciLowerLimit': '0.97', 'ciUpperLimit': '1.54', 'estimateComment': 'Difference (Burosumab - Oral Phosphate/Active Vitamin D)', 'groupDescription': 'Week 52', 'statisticalMethod': 'GEE model', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.25', 'ciLowerLimit': '0.96', 'ciUpperLimit': '1.54', 'estimateComment': 'Difference (Burosumab - Oral Phosphate/Active Vitamin D)', 'groupDescription': 'Week 64', 'statisticalMethod': 'GEE model', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Weeks 4, 8, 16, 24, 32, 40, 52, 64', 'description': 'Serum phosphorus and TRP measurements were used in the calculation of TmP/GFR.\n\nThe GEE model includes change from baseline for TmP/GFR measurement as the dependent variable, treatment group, visit, interaction between treatment group by visit, baseline age and baseline RSS stratification as factors, baseline TmP/GFR measure as a covariate, with exchangeable covariance structure. The GEE model included data up to Week 64.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'PD Analysis Set: all participants who received at least one dose of study therapy and had evaluable serum data. Participants with an assessment at given time point.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline Over Time in TmP/GFR, Week 68 to 112', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Active Control', 'description': 'Multiple daily doses of oral phosphate and one or more daily doses of active vitamin D therapy, titrated and individualized by the investigator based on published recommendations during the Treatment Period (up to Week 64). During the Treatment Extension Period (Week 64 to Week 140), participants crossed over to receive a starting dose of SC burosumab 0.8 mg/kg Q2W. Participants in Japan and Korea did not enter the Treatment Extension Period.'}, {'id': 'OG001', 'title': 'Burosumab', 'description': 'Burosumab 0.8 mg/kg starting dose, administered Q2W by SC injection during the Treatment Period (up to Week 64). During the Treatment Extension Period (Week 64 to Week 140), participants continued to receive a starting dose of SC burosumab 0.8 mg/kg Q2W. Participants in Japan and Korea did not enter the Treatment Extension Period.'}], 'classes': [{'title': 'Week 68', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.61', 'spread': '0.705', 'groupId': 'OG000'}, {'value': '1.65', 'spread': 'NA', 'comment': '1 participant analyzed', 'groupId': 'OG001'}]}]}, {'title': 'Week 76', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.18', 'spread': '0.758', 'groupId': 'OG000'}, {'value': '0.59', 'spread': '0.429', 'groupId': 'OG001'}]}]}, {'title': 'Week 88', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.33', 'spread': '0.480', 'groupId': 'OG000'}, {'value': '0.95', 'spread': '0.620', 'groupId': 'OG001'}]}]}, {'title': 'Week 112', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.56', 'spread': '0.233', 'groupId': 'OG000'}, {'value': '1.32', 'spread': '0.233', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Weeks 68, 76, 88, 112', 'description': 'Serum phosphorus and TRP measurements were used in the calculation of TmP/GFR.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PD Analysis Set: all participants who received at least one dose of study therapy and had evaluable serum data. Participants with data at given time point.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline Over Time in Serum ALP, up to Week 64', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Active Control', 'description': 'Multiple daily doses of oral phosphate and one or more daily doses of active vitamin D therapy, titrated and individualized by the investigator based on published recommendations during the Treatment Period (up to Week 64). During the Treatment Extension Period (Week 64 to Week 140), participants crossed over to receive a starting dose of SC burosumab 0.8 mg/kg Q2W. Participants in Japan and Korea did not enter the Treatment Extension Period.'}, {'id': 'OG001', 'title': 'Burosumab', 'description': 'Burosumab 0.8 mg/kg starting dose, administered Q2W by SC injection during the Treatment Period (up to Week 64). During the Treatment Extension Period (Week 64 to Week 140), participants continued to receive a starting dose of SC burosumab 0.8 mg/kg Q2W. Participants in Japan and Korea did not enter the Treatment Extension Period.'}], 'classes': [{'title': 'Week 16', 'categories': [{'measurements': [{'value': '-5.43', 'spread': '17.885', 'groupId': 'OG000'}, {'value': '-97.97', 'spread': '11.281', 'groupId': 'OG001'}]}]}, {'title': 'Week 24', 'categories': [{'measurements': [{'value': '-22.43', 'spread': '15.074', 'groupId': 'OG000'}, {'value': '-108.00', 'spread': '16.225', 'groupId': 'OG001'}]}]}, {'title': 'Week 40', 'categories': [{'measurements': [{'value': '-34.78', 'spread': '18.132', 'groupId': 'OG000'}, {'value': '-130.72', 'spread': '12.365', 'groupId': 'OG001'}]}]}, {'title': 'Week 52', 'categories': [{'measurements': [{'value': '-50.03', 'spread': '18.641', 'groupId': 'OG000'}, {'value': '-161.31', 'spread': '11.674', 'groupId': 'OG001'}]}]}, {'title': 'Week 64', 'categories': [{'measurements': [{'value': '-28.06', 'spread': '19.980', 'groupId': 'OG000'}, {'value': '-174.62', 'spread': '13.427', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-92.53', 'ciLowerLimit': '-131.40', 'ciUpperLimit': '-53.66', 'estimateComment': 'Difference (Burosumab - Oral Phosphate/Active Vitamin D)', 'groupDescription': 'Week 16', 'statisticalMethod': 'GEE model', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-85.57', 'ciLowerLimit': '-126.37', 'ciUpperLimit': '-44.76', 'estimateComment': 'Difference (Burosumab - Oral Phosphate/Active Vitamin D)', 'groupDescription': 'Week 24', 'statisticalMethod': 'GEE model', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-95.95', 'ciLowerLimit': '-136.05', 'ciUpperLimit': '-55.84', 'estimateComment': 'Difference (Burosumab - Oral Phosphate/Active Vitamin D)', 'groupDescription': 'Week 40', 'statisticalMethod': 'GEE model', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-111.28', 'ciLowerLimit': '-152.08', 'ciUpperLimit': '-70.49', 'estimateComment': 'Difference (Burosumab - Oral Phosphate/Active Vitamin D)', 'groupDescription': 'Week 52', 'statisticalMethod': 'GEE model', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-146.56', 'ciLowerLimit': '-191.61', 'ciUpperLimit': '-101.52', 'estimateComment': 'Difference (Burosumab - Oral Phosphate/Active Vitamin D)', 'groupDescription': 'Week 64', 'statisticalMethod': 'GEE model', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Weeks 16, 24, 40, 52, 64', 'description': 'The GEE model includes change from baseline for ALP measurement as the dependent variable, treatment group, visit, interaction between treatment group by visit, baseline age and baseline RSS stratification as factors, baseline ALP measure as a covariate, with exchangeable covariance structure. The GEE model included data up to Week 64.', 'unitOfMeasure': 'U/L', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'PD Analysis Set: all participants who received at least one dose of study therapy and had evaluable serum data.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline Over Time in Serum ALP, Week 68 to 112', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Active Control', 'description': 'Multiple daily doses of oral phosphate and one or more daily doses of active vitamin D therapy, titrated and individualized by the investigator based on published recommendations during the Treatment Period (up to Week 64). During the Treatment Extension Period (Week 64 to Week 140), participants crossed over to receive a starting dose of SC burosumab 0.8 mg/kg Q2W. Participants in Japan and Korea did not enter the Treatment Extension Period.'}, {'id': 'OG001', 'title': 'Burosumab', 'description': 'Burosumab 0.8 mg/kg starting dose, administered Q2W by SC injection during the Treatment Period (up to Week 64). During the Treatment Extension Period (Week 64 to Week 140), participants continued to receive a starting dose of SC burosumab 0.8 mg/kg Q2W. Participants in Japan and Korea did not enter the Treatment Extension Period.'}], 'classes': [{'title': 'Week 68', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-82.73', 'spread': '83.683', 'groupId': 'OG000'}, {'value': '-184.00', 'spread': 'NA', 'comment': '1 participant analyzed', 'groupId': 'OG001'}]}]}, {'title': 'Week 76', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-106.73', 'spread': '73.316', 'groupId': 'OG000'}, {'value': '-166.73', 'spread': '87.700', 'groupId': 'OG001'}]}]}, {'title': 'Week 88', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-146.56', 'spread': '73.120', 'groupId': 'OG000'}, {'value': '-154.55', 'spread': '48.148', 'groupId': 'OG001'}]}]}, {'title': 'Week 100', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-83.14', 'spread': '104.675', 'groupId': 'OG000'}, {'value': '-184.00', 'spread': '48.083', 'groupId': 'OG001'}]}]}, {'title': 'Week 112', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-104.80', 'spread': '80.350', 'groupId': 'OG000'}, {'value': '-172.00', 'spread': '26.870', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Weeks 68, 76, 88, 100, 112', 'unitOfMeasure': 'U/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PD Analysis Set: all participants who received at least one dose of study therapy and had evaluable serum data.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline Over Time in Serum ALP, up to Week 112', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Active Control', 'description': 'Multiple daily doses of oral phosphate and one or more daily doses of active vitamin D therapy, titrated and individualized by the investigator based on published recommendations during the Treatment Period (up to Week 64). During the Treatment Extension Period (Week 64 to Week 140), participants crossed over to receive a starting dose of SC burosumab 0.8 mg/kg Q2W. Participants in Japan and Korea did not enter the Treatment Extension Period.'}, {'id': 'OG001', 'title': 'Burosumab', 'description': 'Burosumab 0.8 mg/kg starting dose, administered Q2W by SC injection during the Treatment Period (up to Week 64). During the Treatment Extension Period (Week 64 to Week 140), participants continued to receive a starting dose of SC burosumab 0.8 mg/kg Q2W. Participants in Japan and Korea did not enter the Treatment Extension Period.'}], 'classes': [{'title': 'Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.41', 'spread': '21.021', 'groupId': 'OG000'}, {'value': '-18.39', 'spread': '10.815', 'groupId': 'OG001'}]}]}, {'title': 'Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-3.21', 'spread': '15.827', 'groupId': 'OG000'}, {'value': '-19.88', 'spread': '17.642', 'groupId': 'OG001'}]}]}, {'title': 'Week 40', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-6.85', 'spread': '16.493', 'groupId': 'OG000'}, {'value': '-24.38', 'spread': '13.498', 'groupId': 'OG001'}]}]}, {'title': 'Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-8.60', 'spread': '19.027', 'groupId': 'OG000'}, {'value': '-30.60', 'spread': '11.852', 'groupId': 'OG001'}]}]}, {'title': 'Week 64', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-4.60', 'spread': '20.711', 'groupId': 'OG000'}, {'value': '-32.78', 'spread': '13.095', 'groupId': 'OG001'}]}]}, {'title': 'Week 68', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-14.66', 'spread': '14.760', 'groupId': 'OG000'}, {'value': '-38.02', 'spread': 'NA', 'comment': '1 participant analyzed', 'groupId': 'OG001'}]}]}, {'title': 'Week 76', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-20.49', 'spread': '13.926', 'groupId': 'OG000'}, {'value': '-31.42', 'spread': '13.422', 'groupId': 'OG001'}]}]}, {'title': 'Week 88', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-28.77', 'spread': '12.201', 'groupId': 'OG000'}, {'value': '-32.02', 'spread': '10.610', 'groupId': 'OG001'}]}]}, {'title': 'Week 100', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-16.06', 'spread': '23.703', 'groupId': 'OG000'}, {'value': '-39.29', 'spread': '11.460', 'groupId': 'OG001'}]}]}, {'title': 'Week 112', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-21.00', 'spread': '15.053', 'groupId': 'OG000'}, {'value': '-36.67', 'spread': '6.868', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Weeks 16, 24, 40, 52, 64, 68, 76, 88, 100, 112', 'description': 'Decreases indicate improvement.', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PD Analysis Set: all participants who received at least one dose of study therapy and had evaluable serum data.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in the PROMIS Pediatric Pain Interference, Physical Function Mobility and Fatigue Domain Scores (For Participants ≥ 5 Years of Age at the Screening Visit) at Week 40', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Active Control', 'description': 'Multiple daily doses of oral phosphate and one or more daily doses of active vitamin D therapy, titrated and individualized by the investigator based on published recommendations during the Treatment Period (up to Week 64). During the Treatment Extension Period (Week 64 to Week 140), participants crossed over to receive a starting dose of SC burosumab 0.8 mg/kg Q2W. Participants in Japan and Korea did not enter the Treatment Extension Period.'}, {'id': 'OG001', 'title': 'Burosumab', 'description': 'Burosumab 0.8 mg/kg starting dose, administered Q2W by SC injection during the Treatment Period (up to Week 64). During the Treatment Extension Period (Week 64 to Week 140), participants continued to receive a starting dose of SC burosumab 0.8 mg/kg Q2W. Participants in Japan and Korea did not enter the Treatment Extension Period.'}], 'classes': [{'title': 'Pain Interference Domain Score', 'categories': [{'measurements': [{'value': '-0.29', 'spread': '1.539', 'groupId': 'OG000'}, {'value': '-5.31', 'spread': '1.705', 'groupId': 'OG001'}]}]}, {'title': 'Physical Function Mobility Domain Score', 'categories': [{'measurements': [{'value': '0.10', 'spread': '0.966', 'groupId': 'OG000'}, {'value': '2.78', 'spread': '1.336', 'groupId': 'OG001'}]}]}, {'title': 'Fatigue Domain Score', 'categories': [{'measurements': [{'value': '-1.05', 'spread': '1.754', 'groupId': 'OG000'}, {'value': '-4.29', 'spread': '1.709', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0212', 'groupIds': ['OG000', 'OG001'], 'paramType': 'difference in LS means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-5.02', 'ciLowerLimit': '-9.29', 'ciUpperLimit': '-0.75', 'groupDescription': 'Pain Interference Domain. 2-sided p value per GEE model, which included change from baseline for the parameter as the dependent variable, treatment group, visit, interaction between treatment group by visit, baseline age and baseline RSS stratification as factors, baseline parameter measure as a covariate, with exchangeable covariance structure.', 'statisticalMethod': 'GEE model', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.1009', 'groupIds': ['OG000', 'OG001'], 'paramType': 'difference in LS means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.68', 'ciLowerLimit': '-0.52', 'ciUpperLimit': '5.89', 'groupDescription': 'Physical Function Mobility Domain. 2-sided p value per GEE model, which included change from baseline for the parameter as the dependent variable, treatment group, visit, interaction between treatment group by visit, baseline age and baseline RSS stratification as factors, baseline parameter measure as a covariate, with exchangeable covariance structure.', 'statisticalMethod': 'GEE model', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.1676', 'groupIds': ['OG000', 'OG001'], 'paramType': 'difference in LS means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-3.25', 'ciLowerLimit': '-7.86', 'ciUpperLimit': '1.37', 'groupDescription': 'Fatigue Domain. 2-sided p value per GEE model, which included change from baseline for the parameter as the dependent variable, treatment group, visit, interaction between treatment group by visit, baseline age and baseline RSS stratification as factors, baseline parameter measure as a covariate, with exchangeable covariance structure.', 'statisticalMethod': 'GEE model', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 40', 'description': 'The PROMIS was developed by the National Institutes of Health and uses domain-specific measures to assess patient well-being (Broderick et al. 2013), (NIH 2015). It uses a T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population. For the Pain Interference Domain, decreases indicate less pain, for the Physical Function Mobility Domain, increases indicate greater mobility and for the Fatigue Domain, decreases indicate less fatigue.', 'unitOfMeasure': 'T-score', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set: all randomized participants who received at least one dose of assigned medication and had at least one post-baseline assessment. Participants with an assessment at Week 40.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in the PROMIS Pediatric Pain Interference, Physical Function Mobility and Fatigue Domain Scores (For Participants ≥ 5 Years of Age at the Screening Visit) at Week 64', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Active Control', 'description': 'Multiple daily doses of oral phosphate and one or more daily doses of active vitamin D therapy, titrated and individualized by the investigator based on published recommendations during the Treatment Period (up to Week 64). During the Treatment Extension Period (Week 64 to Week 140), participants crossed over to receive a starting dose of SC burosumab 0.8 mg/kg Q2W. Participants in Japan and Korea did not enter the Treatment Extension Period.'}, {'id': 'OG001', 'title': 'Burosumab', 'description': 'Burosumab 0.8 mg/kg starting dose, administered Q2W by SC injection during the Treatment Period (up to Week 64). During the Treatment Extension Period (Week 64 to Week 140), participants continued to receive a starting dose of SC burosumab 0.8 mg/kg Q2W. Participants in Japan and Korea did not enter the Treatment Extension Period.'}], 'classes': [{'title': 'Pain Interference Domain Score', 'categories': [{'measurements': [{'value': '-1.29', 'spread': '1.267', 'groupId': 'OG000'}, {'value': '-3.55', 'spread': '1.873', 'groupId': 'OG001'}]}]}, {'title': 'Physical Function Mobility Domain Score', 'categories': [{'measurements': [{'value': '0.92', 'spread': '0.962', 'groupId': 'OG000'}, {'value': '2.82', 'spread': '1.648', 'groupId': 'OG001'}]}]}, {'title': 'Fatigue Domain Score', 'categories': [{'measurements': [{'value': '-2.57', 'spread': '1.547', 'groupId': 'OG000'}, {'value': '-3.65', 'spread': '2.119', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.3091', 'groupIds': ['OG000', 'OG001'], 'paramType': 'difference in LS means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.26', 'ciLowerLimit': '-6.61', 'ciUpperLimit': '2.09', 'groupDescription': 'Pain Interference Domain. 2-sided p value per GEE model, which included change from baseline for the parameter as the dependent variable, treatment group, visit, interaction between treatment group by visit, baseline age and baseline RSS stratification as factors, baseline parameter measure as a covariate, with exchangeable covariance structure.', 'statisticalMethod': 'GEE model', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.3145', 'groupIds': ['OG000', 'OG001'], 'paramType': 'difference in LS means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.90', 'ciLowerLimit': '-1.80', 'ciUpperLimit': '5.59', 'groupDescription': 'Physical Function Mobility Domain. 2-sided p value per GEE model, which included change from baseline for the parameter as the dependent variable, treatment group, visit, interaction between treatment group by visit, baseline age and baseline RSS stratification as factors, baseline parameter measure as a covariate, with exchangeable covariance structure.', 'statisticalMethod': 'GEE model', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.6810', 'groupIds': ['OG000', 'OG001'], 'paramType': 'difference in LS means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.08', 'ciLowerLimit': '-6.21', 'ciUpperLimit': '4.06', 'groupDescription': 'Fatigue Domain. 2-sided p value per GEE model, which included change from baseline for the parameter as the dependent variable, treatment group, visit, interaction between treatment group by visit, baseline age and baseline RSS stratification as factors, baseline parameter measure as a covariate, with exchangeable covariance structure.', 'statisticalMethod': 'GEE model', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 64', 'description': 'The PROMIS was developed by the National Institutes of Health and uses domain-specific measures to assess patient well-being (Broderick et al. 2013), (NIH 2015). It uses a T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population. For the Pain Interference Domain, decreases indicate less pain, for the Physical Function Mobility Domain, increases indicate greater mobility and for the Fatigue Domain, decreases indicate less fatigue.', 'unitOfMeasure': 'T-score', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set: all randomized participants who received at least one dose of assigned medication and had at least one post-baseline assessment. Participants with an assessment at Week 64.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in the FPS-R (For Participants ≥ 5 Years of Age at the Screening Visit) at Week 40', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Active Control', 'description': 'Multiple daily doses of oral phosphate and one or more daily doses of active vitamin D therapy, titrated and individualized by the investigator based on published recommendations during the Treatment Period (up to Week 64). During the Treatment Extension Period (Week 64 to Week 140), participants crossed over to receive a starting dose of SC burosumab 0.8 mg/kg Q2W. Participants in Japan and Korea did not enter the Treatment Extension Period.'}, {'id': 'OG001', 'title': 'Burosumab', 'description': 'Burosumab 0.8 mg/kg starting dose, administered Q2W by SC injection during the Treatment Period (up to Week 64). During the Treatment Extension Period (Week 64 to Week 140), participants continued to receive a starting dose of SC burosumab 0.8 mg/kg Q2W. Participants in Japan and Korea did not enter the Treatment Extension Period.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.02', 'spread': '0.323', 'groupId': 'OG000'}, {'value': '0.03', 'spread': '0.323', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.9862', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in LS Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.01', 'ciLowerLimit': '-0.79', 'ciUpperLimit': '0.80', 'groupDescription': 'GEE model includes change from baseline for FPS-R as the dependent variable, treatment group, visit, interaction between treatment group by visit and baseline RSS stratification as factors, baseline FPS-R as a covariate, with exchangeable covariance structure. The LS Mean, SE, 95% CI and 2-sided p-value are from the GEE model.', 'statisticalMethod': 'GEE model', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 40', 'description': 'The FPS-R is a dimensionless 10 point Likert scale used to assess self-reported pain intensity on a scale from 0 (no pain) to 10 (most pain you can imagine). Greater pain scores are indicative of more severe pain.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set: all randomized participants who received at least one dose of assigned medication and had at least one post-baseline assessment. Participants with an assessment at Week 40.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in the FPS-R (For Participants ≥ 5 Years of Age at the Screening Visit) at Week 64', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Active Control', 'description': 'Multiple daily doses of oral phosphate and one or more daily doses of active vitamin D therapy, titrated and individualized by the investigator based on published recommendations during the Treatment Period (up to Week 64). During the Treatment Extension Period (Week 64 to Week 140), participants crossed over to receive a starting dose of SC burosumab 0.8 mg/kg Q2W. Participants in Japan and Korea did not enter the Treatment Extension Period.'}, {'id': 'OG001', 'title': 'Burosumab', 'description': 'Burosumab 0.8 mg/kg starting dose, administered Q2W by SC injection during the Treatment Period (up to Week 64). During the Treatment Extension Period (Week 64 to Week 140), participants continued to receive a starting dose of SC burosumab 0.8 mg/kg Q2W. Participants in Japan and Korea did not enter the Treatment Extension Period.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.04', 'spread': '0.270', 'groupId': 'OG000'}, {'value': '-0.01', 'spread': '0.234', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.8786', 'groupIds': ['OG000', 'OG001'], 'paramType': 'difference in LS means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.05', 'ciLowerLimit': '-0.58', 'ciUpperLimit': '0.68', 'groupDescription': 'GEE model includes change from baseline for FPS-R as the dependent variable, treatment group, visit, interaction between treatment group by visit and baseline RSS stratification as factors, baseline FPS-R as a covariate, with exchangeable covariance structure. The LS Mean, SE, 95% CI and 2-sided p-value are from the GEE model.', 'statisticalMethod': 'GEE model', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 64', 'description': 'The FPS-R is a dimensionless 10 point Likert scale used to assess self-reported pain intensity on a scale from 0 (no pain) to 10 (most pain you can imagine). Greater pain scores are indicative of more severe pain.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set: all randomized participants who received at least one dose of assigned medication and had at least one post-baseline assessment. Participants with an assessment at Week 64.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in the 6MWT Total Distance at Week 40', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Active Control', 'description': 'Multiple daily doses of oral phosphate and one or more daily doses of active vitamin D therapy, titrated and individualized by the investigator based on published recommendations during the Treatment Period (up to Week 64). During the Treatment Extension Period (Week 64 to Week 140), participants crossed over to receive a starting dose of SC burosumab 0.8 mg/kg Q2W. Participants in Japan and Korea did not enter the Treatment Extension Period.'}, {'id': 'OG001', 'title': 'Burosumab', 'description': 'Burosumab 0.8 mg/kg starting dose, administered Q2W by SC injection during the Treatment Period (up to Week 64). During the Treatment Extension Period (Week 64 to Week 140), participants continued to receive a starting dose of SC burosumab 0.8 mg/kg Q2W. Participants in Japan and Korea did not enter the Treatment Extension Period.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.65', 'spread': '14.060', 'groupId': 'OG000'}, {'value': '47.10', 'spread': '15.768', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0514', 'groupIds': ['OG000', 'OG001'], 'paramType': 'difference in LS means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '43.46', 'ciLowerLimit': '-0.26', 'ciUpperLimit': '87.17', 'groupDescription': '2-sided p value per GEE model, which included change from baseline for the parameter as the dependent variable, treatment group, visit, interaction between treatment group by visit, baseline age and baseline RSS stratification as factors, baseline parameter measure as a covariate, with exchangeable covariance structure.', 'statisticalMethod': 'GEE model', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 40', 'description': 'The total distance walked (meters) in a 6-minute period was measured in participants ≥ 5 years of age at the Screening Visit who were able to complete the test.', 'unitOfMeasure': 'meters', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set: all randomized participants who received at least one dose of assigned medication and had at least one post-baseline assessment. Participants with an assessment at Week 40 in subjects ≥ 5 years who were able to complete the test.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in the 6MWT Total Distance at Week 64', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Active Control', 'description': 'Multiple daily doses of oral phosphate and one or more daily doses of active vitamin D therapy, titrated and individualized by the investigator based on published recommendations during the Treatment Period (up to Week 64). During the Treatment Extension Period (Week 64 to Week 140), participants crossed over to receive a starting dose of SC burosumab 0.8 mg/kg Q2W. Participants in Japan and Korea did not enter the Treatment Extension Period.'}, {'id': 'OG001', 'title': 'Burosumab', 'description': 'Burosumab 0.8 mg/kg starting dose, administered Q2W by SC injection during the Treatment Period (up to Week 64). During the Treatment Extension Period (Week 64 to Week 140), participants continued to receive a starting dose of SC burosumab 0.8 mg/kg Q2W. Participants in Japan and Korea did not enter the Treatment Extension Period.'}], 'classes': [{'categories': [{'measurements': [{'value': '29.28', 'spread': '16.834', 'groupId': 'OG000'}, {'value': '74.83', 'spread': '12.513', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0399', 'groupIds': ['OG000', 'OG001'], 'paramType': 'difference in LS means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '45.55', 'ciLowerLimit': '2.09', 'ciUpperLimit': '89.02', 'groupDescription': '2-sided p value per GEE model, which included change from baseline for the parameter as the dependent variable, treatment group, visit, interaction between treatment group by visit, baseline age and baseline RSS stratification as factors, baseline parameter measure as a covariate, with exchangeable covariance structure.', 'statisticalMethod': 'GEE model', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 64', 'description': 'The total distance walked (meters) in a 6-minute period was measured in participants ≥ 5 years of age at the Screening Visit who were able to complete the test.', 'unitOfMeasure': 'meters', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set: all randomized participants who received at least one dose of assigned medication and had at least one post-baseline assessment. Participants with an assessment at Week 64.'}, {'type': 'SECONDARY', 'title': 'Percent of Predicted Normal in the 6MWT Total Distance at Week 40', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Active Control', 'description': 'Multiple daily doses of oral phosphate and one or more daily doses of active vitamin D therapy, titrated and individualized by the investigator based on published recommendations during the Treatment Period (up to Week 64). During the Treatment Extension Period (Week 64 to Week 140), participants crossed over to receive a starting dose of SC burosumab 0.8 mg/kg Q2W. Participants in Japan and Korea did not enter the Treatment Extension Period.'}, {'id': 'OG001', 'title': 'Burosumab', 'description': 'Burosumab 0.8 mg/kg starting dose, administered Q2W by SC injection during the Treatment Period (up to Week 64). During the Treatment Extension Period (Week 64 to Week 140), participants continued to receive a starting dose of SC burosumab 0.8 mg/kg Q2W. Participants in Japan and Korea did not enter the Treatment Extension Period.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.14', 'spread': '2.224', 'groupId': 'OG000'}, {'value': '5.59', 'spread': '2.633', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0633', 'groupIds': ['OG000', 'OG001'], 'paramType': 'difference in LS means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '6.72', 'ciLowerLimit': '-0.37', 'ciUpperLimit': '13.82', 'groupDescription': '2-sided p value per GEE model, which included change from baseline for the parameter as the dependent variable, treatment group, visit, interaction between treatment group by visit, baseline age and baseline RSS stratification as factors, baseline parameter measure as a covariate, with exchangeable covariance structure.', 'statisticalMethod': 'GEE model', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 40', 'description': 'The total distance walked (meters) in a 6-minute period was measured in participants ≥ 5 years of age at the Screening Visit who were able to complete the test, and the percent predicted distance based on normative data for age and gender was estimated.', 'unitOfMeasure': 'percent of predicted meters', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set: all randomized participants who received at least one dose of assigned medication and had at least one post-baseline assessment. Participants with an assessment at Week 40.'}, {'type': 'SECONDARY', 'title': 'Percent of Predicted Normal in the 6MWT Total Distance at Week 64', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Active Control', 'description': 'Multiple daily doses of oral phosphate and one or more daily doses of active vitamin D therapy, titrated and individualized by the investigator based on published recommendations during the Treatment Period (up to Week 64). During the Treatment Extension Period (Week 64 to Week 140), participants crossed over to receive a starting dose of SC burosumab 0.8 mg/kg Q2W. Participants in Japan and Korea did not enter the Treatment Extension Period.'}, {'id': 'OG001', 'title': 'Burosumab', 'description': 'Burosumab 0.8 mg/kg starting dose, administered Q2W by SC injection during the Treatment Period (up to Week 64). During the Treatment Extension Period (Week 64 to Week 140), participants continued to receive a starting dose of SC burosumab 0.8 mg/kg Q2W. Participants in Japan and Korea did not enter the Treatment Extension Period.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.88', 'spread': '2.789', 'groupId': 'OG000'}, {'value': '9.15', 'spread': '2.056', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0496', 'groupIds': ['OG000', 'OG001'], 'paramType': 'difference in LS means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '7.27', 'ciLowerLimit': '0.01', 'ciUpperLimit': '14.52', 'groupDescription': '2-sided p value per GEE model, which included change from baseline for the parameter as the dependent variable, treatment group, visit, interaction between treatment group by visit, baseline age and baseline RSS stratification as factors, baseline parameter measure as a covariate, with exchangeable covariance structure.', 'statisticalMethod': 'GEE model', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 64', 'description': 'The total distance walked (meters) in a 6-minute period was measured in participants ≥ 5 years of age at the Screening Visit who were able to complete the test, and the percent predicted distance based on normative data for age and gender was estimated.', 'unitOfMeasure': 'percent of predicted meters', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set: all randomized participants who received at least one dose of assigned medication and had at least one post-baseline assessment. Participants with an assessment at Week 64.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Active Control', 'description': 'Multiple daily doses of oral phosphate and one or more daily doses of active vitamin D therapy, titrated and individualized by the investigator based on published recommendations during the Treatment Period (up to Week 64). During the Treatment Extension Period (Week 64 to Week 140), participants crossed over to receive a starting dose of SC burosumab 0.8 mg/kg Q2W. Participants in Japan and Korea did not enter the Treatment Extension Period.'}, {'id': 'FG001', 'title': 'Burosumab', 'description': 'Burosumab 0.8 mg/kg starting dose, administered Q2W by SC injection during the Treatment Period (up to Week 64). During the Treatment Extension Period (Week 64 to Week 140), participants continued to receive a starting dose of SC burosumab 0.8 mg/kg Q2W. Participants in Japan and Korea did not enter the Treatment Extension Period.'}], 'periods': [{'title': 'Treatment Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '32'}, {'groupId': 'FG001', 'numSubjects': '29'}]}, {'type': 'Completed Week 40', 'achievements': [{'groupId': 'FG000', 'numSubjects': '32'}, {'groupId': 'FG001', 'numSubjects': '29'}]}, {'type': 'Completed Week 64', 'achievements': [{'groupId': 'FG000', 'numSubjects': '32'}, {'groupId': 'FG001', 'numSubjects': '29'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '32'}, {'groupId': 'FG001', 'numSubjects': '29'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Long Term Extension Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': '6 participants did not enter the extension period', 'groupId': 'FG000', 'numSubjects': '26'}, {'comment': '4 participants did not enter the extension period', 'groupId': 'FG001', 'numSubjects': '25'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '26'}, {'groupId': 'FG001', 'numSubjects': '25'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'Eligible participants discontinued oral phosphate and active vitamin D therapy for 7 days prior to randomization. Participants were then randomized 1:1 to receive either open label burosumab administered by subcutaneous (SC) injection every 2 weeks (Q2W) or phosphate and active vitamin D therapy administered orally daily for a total of 64 weeks.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '61', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Active Control', 'description': 'Multiple daily doses of oral phosphate and one or more daily doses of active vitamin D therapy, titrated and individualized by the investigator based on published recommendations during the Treatment Period (up to Week 64). During the Treatment Extension Period (Week 64 to Week 140), participants crossed over to receive a starting dose of SC burosumab 0.8 mg/kg Q2W. Participants in Japan and Korea did not enter the Treatment Extension Period.'}, {'id': 'BG001', 'title': 'Burosumab', 'description': 'Burosumab 0.8 mg/kg starting dose, administered Q2W by SC injection during the Treatment Period (up to Week 64). During the Treatment Extension Period (Week 64 to Week 140), participants continued to receive a starting dose of SC burosumab 0.8 mg/kg Q2W. Participants in Japan and Korea did not enter the Treatment Extension Period.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '61', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '6.50', 'spread': '3.250', 'groupId': 'BG000'}, {'value': '6.01', 'spread': '3.408', 'groupId': 'BG001'}, {'value': '6.27', 'spread': '3.307', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'age at first dose', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '61', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '34', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '61', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '29', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '55', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Asian', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '61', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}]}, {'title': 'White', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '61', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}]}]}, {'title': 'Other (Not Specified)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '61', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Rickets Severity Score (RSS) Total Score', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '61', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '3.19', 'spread': '1.141', 'groupId': 'BG000'}, {'value': '3.17', 'spread': '0.975', 'groupId': 'BG001'}, {'value': '3.18', 'spread': '1.057', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'The RSS system is a 10-point radiographic scoring method. Scores are assigned for the unilateral wrist and knee X-rays deemed by the rater to be the more severe of the bilateral images. The maximum total score on the RSS is 10 points and the minimum score is 0, with a total possible score of 4 points for the wrists and 6 points for the knees (the total score is the sum of the wrist and knee score). Higher scores indicate greater rickets severity.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Height-For-Age Z-Score', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '-2.05', 'spread': '0.868', 'groupId': 'BG000'}, {'value': '-2.32', 'spread': '1.167', 'groupId': 'BG001'}, {'value': '-2.17', 'spread': '1.018', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': "Recumbent length/Standing height z scores are measures of height adjusted for a child's age and sex. The Z-score indicates the number of standard deviations away from a reference population (from the Centers for Disease Control \\[CDC\\] growth charts) in the same age range and with the same sex. A Z-score of 0 is equal to the mean with negative numbers indicating values lower than the mean and positive values higher. Higher Z-scores indicate a better outcome.", 'unitOfMeasure': 'Z score', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': '1 participant in the burosumab group did not have a baseline measurement'}, {'title': 'Growth Velocity Z Score From Pre-Treatment', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '44', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '-2.14', 'spread': '5.571', 'groupId': 'BG000'}, {'value': '-1.37', 'spread': '1.334', 'groupId': 'BG001'}, {'value': '-1.75', 'spread': '4.022', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': "The Z score indicates the number of standard deviations away from a reference population (from Tanner's standard) in the same age range and with the same sex. The baseline growth velocity was calculated for participants who had data available from within 1.5 years prior to baseline. Children with a mid-point age under 2.25 years were excluded, because younger ages are not available in Tanner's standard. A Z score of 0 is equal to the mean with negative numbers indicating values lower than the mean and positive values higher. Higher Z scores indicate a better outcome.", 'unitOfMeasure': 'Z score', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'participants with a baseline measurement'}, {'title': 'Serum Phosphorus', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '61', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '2.30', 'spread': '0.257', 'groupId': 'BG000'}, {'value': '2.42', 'spread': '0.244', 'groupId': 'BG001'}, {'value': '2.36', 'spread': '0.256', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Serum 1,25(OH)D', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '58', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '40.18', 'spread': '14.886', 'groupId': 'BG000'}, {'value': '46.00', 'spread': '20.060', 'groupId': 'BG001'}, {'value': '42.99', 'spread': '17.663', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'participants with a baseline measurement'}, {'title': 'Ratio of Renal Tubular Maximum Reabsorption Rate of Phosphate to Glomerular Filtration Rate(TmP/GFR)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '54', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '2.008', 'spread': '0.3300', 'groupId': 'BG000'}, {'value': '2.193', 'spread': '0.3733', 'groupId': 'BG001'}, {'value': '2.091', 'spread': '0.3587', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Data for urinary phosphorus and tubular reabsorption of phosphate (TRP) were used in the calculation of TmP/GFR.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'participants with a baseline measurement'}, {'title': 'Serum Alkaline Phosphatase (ALP) Concentration', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '61', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '523.44', 'spread': '154.419', 'groupId': 'BG000'}, {'value': '510.76', 'spread': '124.903', 'groupId': 'BG001'}, {'value': '517.4', 'spread': '140.15', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'U/L', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Patient-Reported Outcomes Measurement Information System (PROMIS) Pediatric Pain Interference Domain', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '49.9', 'spread': '12.05', 'groupId': 'BG000'}, {'value': '53.1', 'spread': '10.95', 'groupId': 'BG001'}, {'value': '51.3', 'spread': '11.54', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'The PROMIS was developed by the National Institutes of Health and uses domain-specific measures to assess patient well-being (Broderick et al. 2013), (NIH 2015). It uses a T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population. For the Pain Interference Domain, decreases indicate less pain.', 'unitOfMeasure': 'T-score', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'participants with a baseline assessment'}, {'title': 'PROMIS Physical Function Mobility Domain', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '45.5', 'spread': '9.86', 'groupId': 'BG000'}, {'value': '45.2', 'spread': '9.05', 'groupId': 'BG001'}, {'value': '45.3', 'spread': '9.39', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'The PROMIS was developed by the National Institutes of Health and uses domain-specific measures to assess patient well-being (Broderick et al. 2013), (NIH 2015). It uses a T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population. For the Physical Function Mobility Domain, increases indicate greater mobility.', 'unitOfMeasure': 'T-score', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'participants with a baseline assessment'}, {'title': 'PROMIS Fatigue Domain', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '47.0', 'spread': '13.70', 'groupId': 'BG000'}, {'value': '48.8', 'spread': '9.60', 'groupId': 'BG001'}, {'value': '47.8', 'spread': '11.98', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'The PROMIS was developed by the National Institutes of Health and uses domain-specific measures to assess patient well-being (Broderick et al. 2013), (NIH 2015). It uses a T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population. For the Fatigue Domain, decreases indicate less fatigue.', 'unitOfMeasure': 'T-score', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'participants with a baseline assessment'}, {'title': 'Faces Pain Scale-Revised (FPS-R)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0.7', 'spread': '1.17', 'groupId': 'BG000'}, {'value': '0.4', 'spread': '1.12', 'groupId': 'BG001'}, {'value': '0.6', 'spread': '1.14', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'The FPS-R is a dimensionless 10 point Likert scale used to assess self-reported pain intensity on a scale from 0 (no pain) to 10 (most pain you can imagine). Greater pain scores are indicative of more severe pain.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'participants with a baseline assessment'}, {'title': 'Six Minute Walk Test (6MWT) Total Distance', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '450.50', 'spread': '106.432', 'groupId': 'BG000'}, {'value': '365.93', 'spread': '118.083', 'groupId': 'BG001'}, {'value': '414.26', 'spread': '117.790', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'The total distance walked (meters) in a 6-minute period was measured, and the percent predicted distance based on normative data for age and gender was estimated.', 'unitOfMeasure': 'meters', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'participants with a baseline measurement'}, {'title': 'Percent of Predicted Normal in the 6MWT Total Distance', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '76.20', 'spread': '14.838', 'groupId': 'BG000'}, {'value': '62.13', 'spread': '18.629', 'groupId': 'BG001'}, {'value': '70.17', 'spread': '17.771', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'The total distance walked (meters) in a 6-minute period was measured, and the percent predicted distance based on normative data for age and gender was estimated.', 'unitOfMeasure': 'perecent of predicted meters', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'participants with a baseline measurement'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-11-03', 'size': 5426652, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2019-02-27T15:12', 'hasProtocol': True}, {'date': '2018-01-02', 'size': 3291763, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2019-02-27T15:14', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 61}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-09-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'nctId': 'NCT03775187', 'statusForNctId': 'AVAILABLE', 'hasExpandedAccess': True}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2019-07-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-08-06', 'studyFirstSubmitDate': '2016-05-23', 'resultsFirstSubmitDate': '2019-02-28', 'studyFirstSubmitQcDate': '2016-09-22', 'lastUpdatePostDateStruct': {'date': '2024-08-29', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-03-20', 'studyFirstPostDateStruct': {'date': '2016-09-27', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-04-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-02-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Radiographic Global Impression of Change (RGI-C) Global Score at Week 40', 'timeFrame': 'Week 40', 'description': 'Changes in the severity of rickets and bowing were assessed using a disease specific qualitative RGI-C scoring system. The RGI-C is a 7-point ordinal scale with possible values: +3 = very much better (complete or near complete healing of rickets), +2 = much better (substantial healing of rickets), +1 = minimally better (i.e., minimal healing of rickets), 0 = unchanged, -1 = minimally worse (minimal worsening of rickets), -2 = much worse (moderate worsening of rickets), -3 = very much worse (severe worsening of rickets).'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants With a Mean RGI-C Global Score ≥ +2.0 (Responders) at Week 40', 'timeFrame': 'Week 40', 'description': 'RGI-C responders are defined as participants with a mean RGI-C global score \\>= +2.0. The RGI-C is a 7-point ordinal scale with possible values: +3 = very much better (complete or near complete healing of rickets), +2 = much better (substantial healing of rickets), +1 = minimally better (i.e., minimal healing of rickets), 0 = unchanged, -1 = minimally worse (minimal worsening of rickets), -2 = much worse (moderate worsening of rickets), -3 = very much worse (severe worsening of rickets).'}, {'measure': 'Percentage of Participants With a Mean RGI-C Global Score ≥ +2.0 (Responders) at Week 64', 'timeFrame': 'Week 64', 'description': 'RGI-C responders are defined as participants with a mean RGI-C global score \\>= +2.0. The RGI-C is a 7-point ordinal scale with possible values: +3 = very much better (complete or near complete healing of rickets), +2 = much better (substantial healing of rickets), +1 = minimally better (i.e., minimal healing of rickets), 0 = unchanged, -1 = minimally worse (minimal worsening of rickets), -2 = much worse (moderate worsening of rickets), -3 = very much worse (severe worsening of rickets).'}, {'measure': 'RGI-C Global Score at Week 64', 'timeFrame': 'Week 64', 'description': 'Changes in the severity of rickets and bowing were assessed using a disease specific qualitative RGI-C scoring system. The RGI-C is a 7-point ordinal scale with possible values: +3 = very much better (complete or near complete healing of rickets), +2 = much better (substantial healing of rickets), +1 = minimally better (i.e., minimal healing of rickets), 0 = unchanged, -1 = minimally worse (minimal worsening of rickets), -2 = much worse (moderate worsening of rickets), -3 = very much worse (severe worsening of rickets).'}, {'measure': 'Change From Baseline in RSS Total Score at Week 40', 'timeFrame': 'Baseline, Week 40', 'description': 'The RSS system is a 10-point radiographic scoring method that was developed to assess the severity of nutritional rickets in the wrists and knees based on the degree of metaphyseal fraying, cupping, lucency, separation, and the proportion of the growth plate affected. Scores are assigned for the unilateral wrist and knee X-rays deemed by the rater to be the more severe of the bilateral images. The maximum total score on the RSS is 10 points and the minimum score is 0, with a total possible score of 4 points for the wrists and 6 points for the knees (the total score is the sum of the wrist and knee score). Higher scores indicate greater rickets severity.'}, {'measure': 'Change From Baseline in RSS Total Score at Week 64', 'timeFrame': 'Baseline, Week 64', 'description': 'The RSS system is a 10-point radiographic scoring method that was developed to assess the severity of nutritional rickets in the wrists and knees based on the degree of metaphyseal fraying, cupping, and the proportion of the growth plate affected. Scores are assigned for the unilateral wrist and knee X-rays deemed by the rater to be the more severe of the bilateral images. The maximum total score on the RSS is 10 points and the minimum score is 0, with a total possible score of 4 points for the wrists and 6 points for the knees. Higher scores indicate greater rickets severity.'}, {'measure': 'RGI-C Long Leg Score at Week 40', 'timeFrame': 'Week 40', 'description': 'Changes in the severity of lower extremity skeletal abnormalities, including genu varum and genu valgus, were assessed using a disease specific qualitative RGI-C scoring system. The RGI-C is a 7-point ordinal scale with possible values: +3 = very much better (complete or near complete healing), +2 = much better (substantial healing), +1 = minimally better (i.e., minimal healing), 0 = unchanged, -1 = minimally worse (minimal worsening), -2 = much worse (moderate worsening), -3 = very much worse (severe worsening).'}, {'measure': 'RGI-C Long Leg Score at Week 64', 'timeFrame': 'Week 64', 'description': 'Changes in the severity of lower extremity skeletal abnormalities, including genu varum and genu valgus, were assessed using a disease specific qualitative RGI-C scoring system. The RGI-C is a 7-point ordinal scale with possible values: +3 = very much better (complete or near complete healing), +2 = much better (substantial healing), +1 = minimally better (i.e., minimal healing), 0 = unchanged, -1 = minimally worse (minimal worsening), -2 = much worse (moderate worsening), -3 = very much worse (severe worsening).'}, {'measure': 'Change From Baseline in Height-For-Age Z-Scores to Week 40', 'timeFrame': 'Baseline, Week 40', 'description': "Recumbent length/Standing height z scores are measures of height adjusted for a child's age and sex. The Z-score indicates the number of standard deviations away from a reference population (from the Centers for Disease Control \\[CDC\\] growth charts) in the same age range and with the same sex. A Z-score of 0 is equal to the mean with negative numbers indicating values lower than the mean and positive values higher. Higher Z-scores indicate a better outcome."}, {'measure': 'Change From Baseline in Height-For-Age Z-Scores to Week 64', 'timeFrame': 'Baseline, Week 64', 'description': "Recumbent length/Standing height z scores are measures of height adjusted for a child's age and sex. The Z-score indicates the number of standard deviations away from a reference population (from the CDC growth charts) in the same age range and with the same sex. A Z-score of 0 is equal to the mean with negative numbers indicating values lower than the mean and positive values higher. Higher Z-scores indicate a better outcome."}, {'measure': 'Change in Growth Velocity Z Score From Baseline to Week 40', 'timeFrame': 'Baseline, Week 40', 'description': "A growth velocity Z score was calculated based on Tanner's standard. The Z score indicates the number of standard deviations away from a reference population (from Tanner's standard) in the same age range and with the same sex. The baseline growth velocity was calculated for participants who had data available from within 1.5 years prior to baseline. The Week 64 growth velocity was calculated using data between baseline and Week 64. The mid-point of the age interval was used to locate the closest reference age provided by Tanner's Standard. Children with a mid-point age under 2.25 years were excluded, because younger ages are not available in Tanner's standard. To smoothly transition from recumbent length to standing height, 0·8 cm was subtracted from recumbent length before pooling with standing height. A Z score of 0 is equal to the mean with negative numbers indicating values lower than the mean and positive values higher. Higher Z scores indicate a better outcome."}, {'measure': 'Change in Growth Velocity Z Score From Baseline to Week 64', 'timeFrame': 'Baseline, Week 64', 'description': "A growth velocity Z score was calculated based on Tanner's standard. The Z score indicates the number of standard deviations away from a reference population (from Tanner's standard) in the same age range and with the same sex. The baseline growth velocity was calculated for participants who had data available from within 1.5 years prior to baseline. The Week 64 growth velocity was calculated using data between baseline and Week 64. The mid-point of the age interval was used to locate the closest reference age provided by Tanner's Standard. Children with a mid-point age under 2.25 years were excluded, because younger ages are not available in Tanner's standard. To smoothly transition from recumbent length to standing height, 0·8 cm was subtracted from recumbent length before pooling with standing height. A Z score of 0 is equal to the mean with negative numbers indicating values lower than the mean and positive values higher. Higher Z scores indicate a better outcome."}, {'measure': 'Change From Baseline Over Time in Serum Phosphorus Concentration, up to Week 64', 'timeFrame': 'Baseline, Weeks 1, 2, 4, 8, 12, 16, 24, 32, 33, 40, 52, 64', 'description': 'The GEE model includes change from baseline for serum phosphorous measurement as the dependent variable, treatment group, visit, interaction between treatment group by visit, baseline age and baseline RSS stratification as factors, baseline phosphorous measure as a covariate, with exchangeable covariance structure. The GEE model included data up to Week 64.'}, {'measure': 'Change From Baseline Over Time in Serum Phosphorus Concentration, Weeks 66-112', 'timeFrame': 'Baseline, Weeks 66, 68, 76, 88, 100, 112'}, {'measure': 'Change From Baseline in Mean Post-Baseline Serum Phosphorus Level to Week 64', 'timeFrame': 'Baseline, Weeks 1, 4, 8, 16, 24, 32, 40, 52, 64', 'description': 'The ANCOVA model includes change in serum phosphorus from baseline to mean post-baseline as the dependent variable, treatment group, baseline age and baseline RSS stratification as factors, baseline phosphorous measure as a covariate.'}, {'measure': 'Change From Baseline in Mean Post-Baseline Serum Phosphorus Level to Week 140 (During Treatment With Burosumab)', 'timeFrame': 'Burosumab arm: Baseline, Week 1, 4, 8, 16, 24, 32, 40, 52, 64, 66, 68, 76, 88, 100, 112, 124, 140; Active Control arm: Baseline, Week 68, 76, 88, 100, 112, 124, 140'}, {'measure': 'Percentage of Participants Reaching the Normal Range of Serum Phosphorus Concentration (3.2 - 6.1 mg/dL)', 'timeFrame': 'Burosumab arm: Baseline, up to Week 140; Active Control arm: Baseline, Week 68 up to Week 140'}, {'measure': 'Change From Baseline Over Time in 1,25-Dihydroxyvitamin D, up to Week 64', 'timeFrame': 'Baseline, Weeks 1, 2, 4, 8, 12, 16, 24, 32, 33, 40, 52, 64', 'description': 'The GEE model includes change from baseline for 1, 25-Dihydroxyvitamin D measurement as the dependent variable, treatment group, visit, interaction between treatment group by visit, baseline age and baseline RSS stratification as factors, baseline 1, 25-Dihydroxyvitamin D measure as a covariate, with exchangeable covariance structure. The GEE model included data up to Week 64.'}, {'measure': 'Change From Baseline Over Time in 1,25-Dihydroxyvitamin D, Weeks 68 to 112', 'timeFrame': 'Baseline, Weeks 68, 76, 88, 100, 112'}, {'measure': 'Change From Baseline Over Time in TmP/GFR, up to Week 64', 'timeFrame': 'Baseline, Weeks 4, 8, 16, 24, 32, 40, 52, 64', 'description': 'Serum phosphorus and TRP measurements were used in the calculation of TmP/GFR.\n\nThe GEE model includes change from baseline for TmP/GFR measurement as the dependent variable, treatment group, visit, interaction between treatment group by visit, baseline age and baseline RSS stratification as factors, baseline TmP/GFR measure as a covariate, with exchangeable covariance structure. The GEE model included data up to Week 64.'}, {'measure': 'Change From Baseline Over Time in TmP/GFR, Week 68 to 112', 'timeFrame': 'Baseline, Weeks 68, 76, 88, 112', 'description': 'Serum phosphorus and TRP measurements were used in the calculation of TmP/GFR.'}, {'measure': 'Change From Baseline Over Time in Serum ALP, up to Week 64', 'timeFrame': 'Baseline, Weeks 16, 24, 40, 52, 64', 'description': 'The GEE model includes change from baseline for ALP measurement as the dependent variable, treatment group, visit, interaction between treatment group by visit, baseline age and baseline RSS stratification as factors, baseline ALP measure as a covariate, with exchangeable covariance structure. The GEE model included data up to Week 64.'}, {'measure': 'Change From Baseline Over Time in Serum ALP, Week 68 to 112', 'timeFrame': 'Baseline, Weeks 68, 76, 88, 100, 112'}, {'measure': 'Percent Change From Baseline Over Time in Serum ALP, up to Week 112', 'timeFrame': 'Baseline, Weeks 16, 24, 40, 52, 64, 68, 76, 88, 100, 112', 'description': 'Decreases indicate improvement.'}, {'measure': 'Change From Baseline in the PROMIS Pediatric Pain Interference, Physical Function Mobility and Fatigue Domain Scores (For Participants ≥ 5 Years of Age at the Screening Visit) at Week 40', 'timeFrame': 'Baseline, Week 40', 'description': 'The PROMIS was developed by the National Institutes of Health and uses domain-specific measures to assess patient well-being (Broderick et al. 2013), (NIH 2015). It uses a T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population. For the Pain Interference Domain, decreases indicate less pain, for the Physical Function Mobility Domain, increases indicate greater mobility and for the Fatigue Domain, decreases indicate less fatigue.'}, {'measure': 'Change From Baseline in the PROMIS Pediatric Pain Interference, Physical Function Mobility and Fatigue Domain Scores (For Participants ≥ 5 Years of Age at the Screening Visit) at Week 64', 'timeFrame': 'Baseline, Week 64', 'description': 'The PROMIS was developed by the National Institutes of Health and uses domain-specific measures to assess patient well-being (Broderick et al. 2013), (NIH 2015). It uses a T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population. For the Pain Interference Domain, decreases indicate less pain, for the Physical Function Mobility Domain, increases indicate greater mobility and for the Fatigue Domain, decreases indicate less fatigue.'}, {'measure': 'Change From Baseline in the FPS-R (For Participants ≥ 5 Years of Age at the Screening Visit) at Week 40', 'timeFrame': 'Baseline, Week 40', 'description': 'The FPS-R is a dimensionless 10 point Likert scale used to assess self-reported pain intensity on a scale from 0 (no pain) to 10 (most pain you can imagine). Greater pain scores are indicative of more severe pain.'}, {'measure': 'Change From Baseline in the FPS-R (For Participants ≥ 5 Years of Age at the Screening Visit) at Week 64', 'timeFrame': 'Baseline, Week 64', 'description': 'The FPS-R is a dimensionless 10 point Likert scale used to assess self-reported pain intensity on a scale from 0 (no pain) to 10 (most pain you can imagine). Greater pain scores are indicative of more severe pain.'}, {'measure': 'Change From Baseline in the 6MWT Total Distance at Week 40', 'timeFrame': 'Baseline, Week 40', 'description': 'The total distance walked (meters) in a 6-minute period was measured in participants ≥ 5 years of age at the Screening Visit who were able to complete the test.'}, {'measure': 'Change From Baseline in the 6MWT Total Distance at Week 64', 'timeFrame': 'Baseline, Week 64', 'description': 'The total distance walked (meters) in a 6-minute period was measured in participants ≥ 5 years of age at the Screening Visit who were able to complete the test.'}, {'measure': 'Percent of Predicted Normal in the 6MWT Total Distance at Week 40', 'timeFrame': 'Baseline, Week 40', 'description': 'The total distance walked (meters) in a 6-minute period was measured in participants ≥ 5 years of age at the Screening Visit who were able to complete the test, and the percent predicted distance based on normative data for age and gender was estimated.'}, {'measure': 'Percent of Predicted Normal in the 6MWT Total Distance at Week 64', 'timeFrame': 'Baseline, Week 64', 'description': 'The total distance walked (meters) in a 6-minute period was measured in participants ≥ 5 years of age at the Screening Visit who were able to complete the test, and the percent predicted distance based on normative data for age and gender was estimated.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['X-Linked Hypophosphatemia']}, 'referencesModule': {'references': [{'pmid': '37084401', 'type': 'DERIVED', 'citation': 'Imel EA, Glorieux FH, Whyte MP, Portale AA, Munns CF, Nilsson O, Simmons JH, Padidela R, Namba N, Cheong HI, Pitukcheewanont P, Sochett E, Hogler W, Muroya K, Tanaka H, Gottesman GS, Biggin A, Perwad F, Chen A, Roberts MS, Ward LM. Burosumab vs Phosphate/Active Vitamin D in Pediatric X-Linked Hypophosphatemia: A Subgroup Analysis by Dose Level. J Clin Endocrinol Metab. 2023 Oct 18;108(11):2990-2998. doi: 10.1210/clinem/dgad230.'}, {'pmid': '35533340', 'type': 'DERIVED', 'citation': 'Ward LM, Glorieux FH, Whyte MP, Munns CF, Portale AA, Hogler W, Simmons JH, Gottesman GS, Padidela R, Namba N, Cheong HI, Nilsson O, Mao M, Chen A, Skrinar A, Roberts MS, Imel EA. Effect of Burosumab Compared With Conventional Therapy on Younger vs Older Children With X-linked Hypophosphatemia. J Clin Endocrinol Metab. 2022 Jul 14;107(8):e3241-e3253. doi: 10.1210/clinem/dgac296.'}, {'pmid': '33484279', 'type': 'DERIVED', 'citation': 'Padidela R, Whyte MP, Glorieux FH, Munns CF, Ward LM, Nilsson O, Portale AA, Simmons JH, Namba N, Cheong HI, Pitukcheewanont P, Sochett E, Hogler W, Muroya K, Tanaka H, Gottesman GS, Biggin A, Perwad F, Williams A, Nixon A, Sun W, Chen A, Skrinar A, Imel EA. Patient-Reported Outcomes from a Randomized, Active-Controlled, Open-Label, Phase 3 Trial of Burosumab Versus Conventional Therapy in Children with X-Linked Hypophosphatemia. Calcif Tissue Int. 2021 May;108(5):622-633. doi: 10.1007/s00223-020-00797-x. Epub 2021 Jan 23.'}, {'pmid': '32721016', 'type': 'DERIVED', 'citation': 'Mao M, Carpenter TO, Whyte MP, Skrinar A, Chen CY, San Martin J, Rogol AD. Growth Curves for Children with X-linked Hypophosphatemia. J Clin Endocrinol Metab. 2020 Oct 1;105(10):3243-9. doi: 10.1210/clinem/dgaa495.'}, {'pmid': '31104833', 'type': 'DERIVED', 'citation': 'Imel EA, Glorieux FH, Whyte MP, Munns CF, Ward LM, Nilsson O, Simmons JH, Padidela R, Namba N, Cheong HI, Pitukcheewanont P, Sochett E, Hogler W, Muroya K, Tanaka H, Gottesman GS, Biggin A, Perwad F, Mao M, Chen CY, Skrinar A, San Martin J, Portale AA. Burosumab versus conventional therapy in children with X-linked hypophosphataemia: a randomised, active-controlled, open-label, phase 3 trial. Lancet. 2019 Jun 15;393(10189):2416-2427. doi: 10.1016/S0140-6736(19)30654-3. Epub 2019 May 16.'}]}, 'descriptionModule': {'briefSummary': 'The primary objective of this study is to evaluate the effect of KRN23 (burosumab) therapy in improving rickets in children with XLH compared with active control (oral phosphate/active vitamin D).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '1 Year', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Male or female, aged 1 to ≤12 years with radiographic evidence of rickets as determined by central readers\n2. Phosphate-regulating endopeptidase homolog, X-linked (PHEX) mutation or variant of uncertain significance in either the patient or in a directly related family member with appropriate X-linked inheritance\n3. Biochemical findings associated with XLH: serum phosphorus \\<3.0 mg/dL (\\<0.97 mmol/L)\n4. Serum creatinine below the age-adjusted upper limit of normal\n5. Serum 25(OH)D above the lower limit of normal (≥16 ng/mL) at the Screening Visit\n6. Have received both oral phosphate and active vitamin D therapy for ≥ 12 consecutive months (for children ≥3 years of age) or ≥ 6 consecutive months (for children \\<3 years of age) 7 days prior to the Randomization Visit\n7. Willing to provide access to prior medical records for the collection of historical growth and radiographic data and disease history\n8. Provide written or verbal assent (as appropriate for the subject and region) and written informed consent by a legally authorized representative after the nature of the study has been explained, and prior to any research-related procedures.\n9. Must, in the opinion of the investigator, be willing and able to complete all aspects of the study, adhere to the study visit schedule and comply with the assessments\n10. Females who have reached menarche must have a negative pregnancy test at Screening and undergo additional pregnancy testing during the study. Female subjects of childbearing potential must be willing to use a highly effective method of contraception for the duration of the study plus 12 weeks after stopping the study drug. Sexually active male subjects with female partners of childbearing potential must consent to use a condom with spermicide or a highly effective method of contraception for the duration of the study plus 12 weeks after stopping the study drug\n\nExclusion Criteria:\n\n1. Tanner stage 4 or higher in any of the following: genitals, breast, or pubic hair, based on physical examination\n2. Height percentile \\> 50th based on country-specific norms\n3. Use of aluminum hydroxide antacids (eg, Maalox® and Mylanta®), systemic corticosteroids, acetazolamide, and thiazides within 7 days prior to the Screening Visit\n4. Current or prior use of leuprorelin (eg, Lupron®, Viadur®, Eligard®), triptorelin (TRELSTAR®), goserelin (Zoladex®), or other drugs known to delay puberty\n5. Use of growth hormone therapy within 12 months before the Screening Visit\n6. Presence of nephrocalcinosis on renal ultrasound grade 4\n7. Planned orthopedic surgery, including osteotomy or implantation or removal of staples, 8 plates, or any other hardware, within the first 40 weeks of the study\n8. Hypocalcemia or hypercalcemia, defined as serum calcium levels outside the age-adjusted normal limits\n9. Evidence of hyperparathyroidism (parathyroid hormone \\[PTH\\] levels 2.5X upper limit of normal \\[ULN\\])\n10. Use of medication to suppress PTH (eg, cinacalcet, calcimimetics) within 2 months prior to the Screening Visit\n11. Presence or history of any condition that, in the view of the investigator, places the subject at high risk of poor treatment compliance or of not completing the study.\n12. Presence of a concurrent disease or condition that would interfere with study participation or affect safety\n13. History of recurrent infection or predisposition to infection, or of known immunodeficiency\n14. Use of a therapeutic monoclonal antibody within 90 days prior to the Screening Visit or history of allergic or anaphylactic reactions to any monoclonal antibody\n15. Presence or history of any hypersensitivity to KRN23 excipients that, in the judgment of the investigator, places the subject at increased risk for adverse effects\n16. Use of any investigational product or investigational medical device within 30 days prior to screening, or requirement for any investigational agent prior to completion of all scheduled study assessments. OR, in Japan, use of any investigational product or investigational medical device within 4 months prior to screening, or requirement for any investigational agent prior to completion of all scheduled study assessments'}, 'identificationModule': {'nctId': 'NCT02915705', 'briefTitle': 'Efficacy and Safety of Burosumab Versus Oral Phosphate and Active Vitamin D Treatment in Pediatric Patients With XLH', 'organization': {'class': 'INDUSTRY', 'fullName': 'Kyowa Kirin Co., Ltd.'}, 'officialTitle': 'A Randomized, Open-Label, Phase 3 Study to Assess the Efficacy and Safety of KRN23 Versus Oral Phosphate and Active Vitamin D Treatment in Pediatric Patients With X Linked Hypophosphatemia (XLH)', 'orgStudyIdInfo': {'id': 'UX023-CL301'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Burosumab', 'description': 'Burosumab 0.8 mg/kg starting dose, administered Q2W by SC injection during the Treatment Period (up to Week 64). During the Treatment Extension Period (Week 64 to Week 140), participants continued to receive a starting dose of SC burosumab 0.8 mg/kg Q2W. Participants in Japan and Korea did not enter the Treatment Extension Period.', 'interventionNames': ['Biological: burosumab']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Active Control', 'description': 'Multiple daily doses of oral phosphate and one or more daily doses of active vitamin D therapy, titrated and individualized by the investigator based on published recommendations during the Treatment Period (up to Week 64). During the Treatment Extension Period (Week 64 to Week 140), participants crossed over to receive a starting dose of SC burosumab 0.8 mg/kg Q2W. Participants in Japan and Korea did not enter the Treatment Extension Period.', 'interventionNames': ['Biological: burosumab', 'Drug: Oral Phosphate Supplement', 'Drug: active vitamin D']}], 'interventions': [{'name': 'burosumab', 'type': 'BIOLOGICAL', 'otherNames': ['KRN23', 'Crysvita ®', 'UX023'], 'description': 'solution for subcutaneous (SC) injection', 'armGroupLabels': ['Active Control', 'Burosumab']}, {'name': 'Oral Phosphate Supplement', 'type': 'DRUG', 'description': 'oral tablet; oral solution; oral powder', 'armGroupLabels': ['Active Control']}, {'name': 'active vitamin D', 'type': 'DRUG', 'description': 'tablet, oral solution', 'armGroupLabels': ['Active Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90027', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': "Children's Hospital Los Angeles", 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '94158', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'UCSF', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '46202', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Indiana University School of Medicine', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Shriners Hospital For Children', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '37232', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': "Vanderbilt Children's Hospital", 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '2145', 'city': 'Westmead', 'state': 'New South Wales', 'country': 'Australia', 'facility': "The Children's Hospital at Westmead", 'geoPoint': {'lat': -33.80383, 'lon': 150.98768}}, {'zip': 'K1H 8L1', 'city': 'Ottawa', 'state': 'Ontario', 'country': 'Canada', 'facility': "Children's Hospital of Eastern Ontario (CHEO) Research Institute", 'geoPoint': {'lat': 45.41117, 'lon': -75.69812}}, {'zip': 'M5G 1X8', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'The Hospital for Sick Children', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': 'H4A 0A9', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Shriners Hospital for Children - Canada', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'zip': '232-8555', 'city': 'Yokohama', 'state': 'Kanagawa', 'country': 'Japan', 'facility': "Kanagawa Children's Medical Center", 'geoPoint': {'lat': 35.43333, 'lon': 139.65}}, {'zip': '700-0013', 'city': 'Okayama', 'country': 'Japan', 'facility': 'Okayama Saiseikai General Hospital', 'geoPoint': {'lat': 34.65, 'lon': 133.93333}}, {'zip': '553-0003', 'city': 'Osaka', 'country': 'Japan', 'facility': 'Japan Community Healthcare Organization Osaka Hospital', 'geoPoint': {'lat': 34.69379, 'lon': 135.50107}}, {'zip': '03080', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Seoul National University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '17176', 'city': 'Stockholm', 'country': 'Sweden', 'facility': 'Karolinska Institutet and University Hospital', 'geoPoint': {'lat': 59.32938, 'lon': 18.06871}}, {'zip': 'B4 6NH', 'city': 'Birmingham', 'country': 'United Kingdom', 'facility': "Birmingham Children's Hospital", 'geoPoint': {'lat': 52.48142, 'lon': -1.89983}}, {'zip': 'M13 9WL', 'city': 'Manchester', 'country': 'United Kingdom', 'facility': "Royal Manchester Children's Hospital - University of Manchester", 'geoPoint': {'lat': 53.48095, 'lon': -2.23743}}], 'overallOfficials': [{'name': 'Medical Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Ultragenyx Pharmaceutical Inc'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kyowa Kirin, Inc.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Kyowa Kirin Co., Ltd.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}