Ignite Creation Date:
2025-12-25 @ 2:04 AM
Ignite Modification Date:
2026-07-21 @ 7:14 AM
Study NCT ID:
NCT02526160
Status:
COMPLETED
Last Update Posted:
2024-06-18
First Post:
2015-07-17
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study of KRN23 in Adults With X-linked Hypophosphatemia (XLH)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Canada', 'Denmark']}, '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': '1-888-756-8657', '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': 'From first dose of study drug through the end of study plus 4 weeks (+ 5 days). Mean (SE) duration of exposure to burosumab for all periods combined through EOS II was 771.3 (21.97) days (range: 167 - 957) in the burosumab->burosumab group and 625.7 (19.40) days (range: 165 - 844) in the placebo->burosumab group.', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo (DB Period)', 'description': 'SC injection of placebo Q4W for 24 weeks (double-blind placebo-controlled Treatment Period)', 'otherNumAtRisk': 66, 'deathsNumAtRisk': 66, 'otherNumAffected': 57, 'seriousNumAtRisk': 66, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Placebo -> Burosumab (OL Period)', 'description': 'SC injection of placebo Q4W for 24 weeks (double-blind placebo-controlled Treatment Period), SC injection of burosumab 1 mg/kg Q4W for 24 weeks (open-label Treatment Continuation Period), SC injection of burosumab 1 mg/kg Q4W for 48 weeks (open label Treatment Extension Period I), and SC injection of burosumab 1 mg/kg Q4W up to 53 weeks (open-label Treatment Extension Period II \\[US only\\]).', 'otherNumAtRisk': 66, 'deathsNumAtRisk': 66, 'otherNumAffected': 63, 'seriousNumAtRisk': 66, 'deathsNumAffected': 0, 'seriousNumAffected': 10}, {'id': 'EG002', 'title': 'Burosumab -> Burosumab (Combined DB and OL Period)', 'description': 'SC injection of 1.0 mg/kg burosumab Q4W for 24 weeks (double-blind placebo-controlled Treatment Period), SC injection of burosumab 1 mg/kg Q4W for 24 weeks (open-label Treatment Continuation Period), SC injection of burosumab 1 mg/kg Q4W for 48 weeks (open-label Treatment Extension Period I), and SC injection of burosumab 1 mg/kg Q4W up to 53 weeks (open-label Treatment Extension Period II \\[US only\\]).', 'otherNumAtRisk': 68, 'deathsNumAtRisk': 68, 'otherNumAffected': 68, 'seriousNumAtRisk': 68, 'deathsNumAffected': 1, 'seriousNumAffected': 12}, {'id': 'EG003', 'title': 'Total Burosumab (Combined DB and OL Period)', 'description': 'SC injection of 1.0 mg/kg burosumab at any time during the study.', 'otherNumAtRisk': 134, 'deathsNumAtRisk': 134, 'otherNumAffected': 131, 'seriousNumAtRisk': 134, 'deathsNumAffected': 1, 'seriousNumAffected': 22}], 'otherEvents': [{'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 66, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 68, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 134, 'numAffected': 7}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Hyperparathyroidism Secondary', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 66, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 68, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 134, 'numAffected': 7}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Abdominal Discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 66, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 68, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 134, 'numAffected': 7}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Abdominal Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 66, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 68, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 134, 'numAffected': 8}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Abdominal Pain Upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 66, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 68, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 134, 'numAffected': 9}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 66, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 68, 'numAffected': 10}, {'groupId': 'EG003', 'numAtRisk': 134, 'numAffected': 14}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 66, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 68, 'numAffected': 13}, {'groupId': 'EG003', 'numAtRisk': 134, 'numAffected': 18}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 66, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 68, 'numAffected': 11}, {'groupId': 'EG003', 'numAtRisk': 134, 'numAffected': 16}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Toothache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 66, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 68, 'numAffected': 12}, {'groupId': 'EG003', 'numAtRisk': 134, 'numAffected': 22}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 66, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 68, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 134, 'numAffected': 10}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 66, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 68, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 134, 'numAffected': 6}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 66, 'numAffected': 14}, {'groupId': 'EG002', 'numAtRisk': 68, 'numAffected': 16}, {'groupId': 'EG003', 'numAtRisk': 134, 'numAffected': 30}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Injection Site Erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 66, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 68, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 134, 'numAffected': 12}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Injection Site Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 66, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 68, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 134, 'numAffected': 11}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Injection Site Reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 66, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 68, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 134, 'numAffected': 15}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 66, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 68, 'numAffected': 12}, {'groupId': 'EG003', 'numAtRisk': 134, 'numAffected': 21}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 66, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 68, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 134, 'numAffected': 9}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Seasonal Allergy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 66, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 68, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 134, 'numAffected': 11}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 66, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 68, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 134, 'numAffected': 10}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 66, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 68, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 134, 'numAffected': 6}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 66, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 68, 'numAffected': 9}, {'groupId': 'EG003', 'numAtRisk': 134, 'numAffected': 15}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 66, 'numAffected': 24}, {'groupId': 'EG002', 'numAtRisk': 68, 'numAffected': 28}, {'groupId': 'EG003', 'numAtRisk': 134, 'numAffected': 52}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Oral Herpes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 66, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 68, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 134, 'numAffected': 8}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Pharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 66, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 68, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 134, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Rhinitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 66, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 68, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 134, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 66, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 68, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 134, 'numAffected': 8}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Tooth Abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 66, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 68, 'numAffected': 19}, {'groupId': 'EG003', 'numAtRisk': 134, 'numAffected': 24}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Upper Respiratory Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 66, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 68, 'numAffected': 12}, {'groupId': 'EG003', 'numAtRisk': 134, 'numAffected': 14}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Urinary Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 66, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 68, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 134, 'numAffected': 11}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 66, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 68, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 134, 'numAffected': 9}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 66, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 68, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 134, 'numAffected': 13}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Ligament Sprain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 66, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 68, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 134, 'numAffected': 6}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Procedural Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 66, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 68, 'numAffected': 9}, {'groupId': 'EG003', 'numAtRisk': 134, 'numAffected': 15}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Blood 25-Hydroxycholecalciferol Decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 66, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 68, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 134, 'numAffected': 9}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Blood Glucose Increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 66, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 68, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 134, 'numAffected': 6}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Blood Parathyroid Hormone Increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 66, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 68, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 134, 'numAffected': 6}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Blood Pressure Increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 66, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 68, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 134, 'numAffected': 7}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Lipase Increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 66, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 68, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 134, 'numAffected': 4}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Vitamin D Decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 66, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 68, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 134, 'numAffected': 17}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Decreased Appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 66, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 68, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 134, 'numAffected': 4}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Hyperphosphataemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 66, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 68, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 134, 'numAffected': 5}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Vitamin D Deficiency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 66, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 68, 'numAffected': 15}, {'groupId': 'EG003', 'numAtRisk': 134, 'numAffected': 22}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 66, 'numAffected': 23}, {'groupId': 'EG002', 'numAtRisk': 68, 'numAffected': 27}, {'groupId': 'EG003', 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'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Invasive Ductal Breast Carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 66, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 68, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 134, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Parathyroid Tumour Benign', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 66, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 68, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 134, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Cerebrospinal Fluid Leakage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 66, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 68, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 134, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Cervical Radiculopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 66, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 68, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 134, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 66, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 68, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 134, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Myelopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 66, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 68, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 134, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Neuralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 66, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 68, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 134, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Paraesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 66, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 68, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 134, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Partial Seizures', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 66, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 68, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 134, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Presyncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 66, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 68, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 134, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants Achieving Mean Serum Phosphorus Levels Above the LLN (2.5 mg/dL [0.81 mmol/L]) at the Mid-Point of the Dose Interval, as Averaged Across Dose Cycles Between Baseline and Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo SC Q4W through Week 24'}, {'id': 'OG001', 'title': 'Burosumab', 'description': 'Burosumab 1 mg/kg SC Q4W'}], 'classes': [{'categories': [{'measurements': [{'value': '7.6', 'groupId': 'OG000', 'lowerLimit': '3.3', 'upperLimit': '16.5'}, {'value': '92.6', 'groupId': 'OG001', 'lowerLimit': '83.9', 'upperLimit': '96.8'}]}]}], 'analyses': [{'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'From Cochran-Mantel-Haenszel (CMH) testing for association between achieving mean serum phosphorus levels above lower limit of normal (LLN) and treatment group, adjusting for stratification of Brief Pain Inventory (BPI) Average Pain and region.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline through Week 24', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Primary Analysis Set: all randomized participants who received at least 1 dose of study drug during the Placebo-Controlled Treatment Period.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Week 24 in Brief Pain Inventory (BPI) Question 3 (Q3; Worst Pain in Past 24 Hours) Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo SC Q4W through Week 24'}, {'id': 'OG001', 'title': 'Burosumab', 'description': 'Burosumab 1 mg/kg SC Q4W'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.32', 'spread': '0.222', 'groupId': 'OG000'}, {'value': '-0.79', 'spread': '0.211', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0919', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least squares (LS) mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.46', 'ciLowerLimit': '-1.00', 'ciUpperLimit': '0.08', 'pValueComment': 'Prespecified significance level for test after Hochberg adjustment: 0.05', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.275', 'statisticalMethod': 'GEE model', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, 24 weeks', 'description': 'The BPI evaluates the condition of all pain over the previous 24 hours. Two dimensions are measured: pain severity (worst, least, average, and now) and the impact of pain on functioning (pain interference with general activity, walking, work, mood, enjoyment of life, relations with others, and sleep). Question 3 of the short-form BPI (BPI-Q3) asks subjects to rate their pain at its worst in the last 24 hours on a scale of 0 (no pain) to 10 (pain as bad as you can imagine).\n\nFrom the generalized estimating equation (GEE) model, which includes the change from Baseline for the endpoint of interest as the dependent variable; region, visit, treatment, actual randomization stratification (not included for analysis of BPI Worst Pain), and visit by treatment as fixed factors; and Baseline value for the endpoint of interest as a covariate, with compound symmetry covariance structure.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Primary Analysis Set: all randomized participants who received at least 1 dose of study drug during the Placebo-Controlled Treatment Period.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Week 24 in the Western Ontario and McMaster University Osteoarthritis Index (WOMAC) Stiffness Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo SC Q4W through Week 24'}, {'id': 'OG001', 'title': 'Burosumab', 'description': 'Burosumab 1 mg/kg SC Q4W'}], 'classes': [{'categories': [{'measurements': [{'value': '0.46', 'spread': '3.139', 'groupId': 'OG000'}, {'value': '-7.85', 'spread': '3.034', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0106', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-8.31', 'ciLowerLimit': '-14.68', 'ciUpperLimit': '-1.94', 'pValueComment': 'Prespecified significance level for test after Hochberg adjustment: 0.0167', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '3.251', 'statisticalMethod': 'GEE model', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, 24 weeks', 'description': 'The WOMAC is a 24-item participant-reported questionnaire with two domains, Stiffness (2 questions) and Physical Function (17 questions) over the previous 48 hours. The WOMAC is administered in a 5-point Likert-scale format using descriptors of none, mild, moderate, severe, and extreme corresponding to an ordinal scale of 0-4. Higher scores on the WOMAC indicate worse stiffness and functional limitations. Scores are normalized to a 0-100 metric where 0 was the best health state and 100 the worst.\n\nThe GEE estimates are from the GEE model which includes the change from baseline for WOMAC Stiffness as the dependent variable, region, visit, treatment, actual randomization stratification and visit by treatment as fixed factors, and baseline of WOMAC Stiffness as a covariate, with compound symmetry covariance structure.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Primary Analysis Set: all randomized participants who received at least 1 dose of study drug during the Placebo-Controlled Treatment Period.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Week 24 in the WOMAC Physical Function Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo SC Q4W through Week 24'}, {'id': 'OG001', 'title': 'Burosumab', 'description': 'Burosumab 1 mg/kg SC Q4W'}], 'classes': [{'categories': [{'measurements': [{'value': '1.79', 'spread': '2.722', 'groupId': 'OG000'}, {'value': '-3.11', 'spread': '2.553', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0478', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-4.9', 'ciLowerLimit': '-9.76', 'ciUpperLimit': '-0.05', 'pValueComment': 'Prespecified significance level for test after Hochberg adjustment: 0.025', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.479', 'statisticalMethod': 'GEE model', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, 24 weeks', 'description': 'The WOMAC is a 24-item participant-reported questionnaire with two domains, Stiffness (2 questions) and Physical Function (17 questions) over the previous 48 hours. The WOMAC is administered in a 5-point Likert-scale format using descriptors of none, mild, moderate, severe, and extreme corresponding to an ordinal scale of 0-4. Higher scores on the WOMAC indicate worse stiffness and functional limitations. Scores are normalized to a 0-100 metric where 0 was the best health state and 100 the worst.\n\nThe GEE Estimates are from the GEE model which includes the change from baseline for WOMAC Physical Function as the dependent variable, region, visit, treatment, actual randomization stratification and visit by treatment as fixed factors, and baseline of WOMAC Physical Function as a covariate, with compound symmetry covariance structure.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Primary Analysis Set: all randomized participants who received at least 1 dose of study drug during the Placebo-Controlled Treatment Period.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline Over Time in BPI Worst Pain Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Subcutaneous (SC) injection of placebo every 4 weeks (Q4W) for 24 weeks (Double-blind Placebo-controlled Treatment Period), SC injection of burosumab 1 mg/kg Q4W for 24 weeks (Open-label Treatment Continuation Period), SC injection of burosumab 1 mg/kg Q4W for 48 weeks (Open-label Treatment Extension Period I), and SC injection of burosumab 1 mg/kg Q4W up to 53 weeks (Open-label Treatment Extension Period II).'}, {'id': 'OG001', 'title': 'Burosumab 1 mg/kg', 'description': 'SC injection of 1.0 mg/kg burosumab Q4W for 24 weeks (double-blind placebo-controlled Treatment Period), SC injection of burosumab 1 mg/kg Q4W for 24 weeks (open-label Treatment Continuation Period), SC injection of burosumab 1 mg/kg Q4W for 48 weeks (open-label Treatment Extension Period I), and SC injection of burosumab 1 mg/kg Q4W up to 53 weeks (open-label Treatment Extension Period II).'}], 'classes': [{'title': 'Change at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.37', 'spread': '0.216', 'groupId': 'OG000'}, {'value': '-0.62', 'spread': '0.208', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}, {'value': '67', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.31', 'spread': '0.242', 'groupId': 'OG000'}, {'value': '-0.77', 'spread': '0.228', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.25', 'spread': '0.234', 'groupId': 'OG000'}, {'value': '-0.95', 'spread': '0.228', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.49', 'spread': '0.243', 'groupId': 'OG000'}, {'value': '-1.05', 'spread': '0.230', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 72', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.28', 'spread': '0.283', 'groupId': 'OG000'}, {'value': '-1.21', 'spread': '0.316', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 96', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.99', 'spread': '0.265', 'groupId': 'OG000'}, {'value': '-1.48', 'spread': '0.299', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Weeks 12, 24, 36, 48, 72, 96', 'description': 'Change from baseline to post-baseline visits in BPI-Q3 (Worst Pain) score as averaged from daily diary scores recorded over 1 week and the study visit score. The BPI evaluates the condition of all pain over the previous 24 hours. Two dimensions are measured: pain severity (worst, least, average, and now) and the impact of pain on functioning (pain interference with general activity, walking, work, mood, enjoyment of life, relations with others, and sleep). Question 3 of the short-form BPI (BPI-Q3) asks subjects to rate their pain at its worst in the last 24 hours on a scale of 0 (no pain) to 10 (pain as bad as you can imagine).\n\nThe GEE Estimates are from the GEE model which includes the change from baseline for BPI worst pain as the dependent variable, region, visit, treatment and visit by treatment as fixed factors, and baseline of BPI Worst Pain as a covariate, with compound symmetry covariance structure.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Primary Analysis Set: all randomized participants who received at least 1 dose of study drug during the Placebo-Controlled Treatment Period. Participants with an assessment at given time point.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline Over Time in BPI Pain Severity Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Subcutaneous (SC) injection of placebo every 4 weeks (Q4W) for 24 weeks (Double-blind Placebo-controlled Treatment Period), SC injection of burosumab 1 mg/kg Q4W for 24 weeks (Open-label Treatment Continuation Period), SC injection of burosumab 1 mg/kg Q4W for 48 weeks (Open-label Treatment Extension Period I), and SC injection of burosumab 1 mg/kg Q4W up to 53 weeks (Open-label Treatment Extension Period II).'}, {'id': 'OG001', 'title': 'Burosumab 1 mg/kg', 'description': 'SC injection of 1.0 mg/kg burosumab Q4W for 24 weeks (double-blind placebo-controlled Treatment Period), SC injection of burosumab 1 mg/kg Q4W for 24 weeks (open-label Treatment Continuation Period), SC injection of burosumab 1 mg/kg Q4W for 48 weeks (open-label Treatment Extension Period I), and SC injection of burosumab 1 mg/kg Q4W up to 53 weeks (open-label Treatment Extension Period II).'}], 'classes': [{'title': 'Change at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.32', 'spread': '0.166', 'groupId': 'OG000'}, {'value': '-0.43', 'spread': '0.163', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}, {'value': '67', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.10', 'spread': '0.211', 'groupId': 'OG000'}, {'value': '-0.53', 'spread': '0.172', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.97', 'spread': '0.214', 'groupId': 'OG000'}, {'value': '-0.62', 'spread': '0.184', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.13', 'spread': '0.205', 'groupId': 'OG000'}, {'value': '-0.79', 'spread': '0.162', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 72', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.36', 'spread': '0.216', 'groupId': 'OG000'}, {'value': '-1.24', 'spread': '0.231', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 96', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.18', 'spread': '0.195', 'groupId': 'OG000'}, {'value': '-1.42', 'spread': '0.229', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Weeks 12, 24, 36, 48, 72, 96', 'description': 'Change from baseline to post-baseline visits in BPI pain severity score as averaged from daily diary scores recorded over 1 week and the study visit score. The BPI evaluates the condition of all pain over the previous 24 hours. Two dimensions are measured: pain severity (worst, least, average, and now) and the impact of pain on functioning (pain interference with general activity, walking, work, mood, enjoyment of life, relations with others, and sleep). The severity of pain in the last 24 hours is rated on a scale of 0 (no pain) to 10 (pain as bad as you can imagine).\n\nThe GEE Estimates are from the GEE model which includes the change from baseline for each BPI endpoint as the dependent variable, region, visit, treatment, and visit by treatment as fixed factors, and baseline of each BPI endpoint as a covariate, with compound symmetry covariance structure.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Primary Analysis Set: all randomized participants who received at least 1 dose of study drug during the Placebo-Controlled Treatment Period. Participants with an assessment at given time point.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline Over Time in BPI Pain Interference Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Subcutaneous (SC) injection of placebo every 4 weeks (Q4W) for 24 weeks (Double-blind Placebo-controlled Treatment Period), SC injection of burosumab 1 mg/kg Q4W for 24 weeks (Open-label Treatment Continuation Period), SC injection of burosumab 1 mg/kg Q4W for 48 weeks (Open-label Treatment Extension Period I), and SC injection of burosumab 1 mg/kg Q4W up to 53 weeks (Open-label Treatment Extension Period II).'}, {'id': 'OG001', 'title': 'Burosumab 1 mg/kg', 'description': 'SC injection of 1.0 mg/kg burosumab Q4W for 24 weeks (double-blind placebo-controlled Treatment Period), SC injection of burosumab 1 mg/kg Q4W for 24 weeks (open-label Treatment Continuation Period), SC injection of burosumab 1 mg/kg Q4W for 48 weeks (open-label Treatment Extension Period I), and SC injection of burosumab 1 mg/kg Q4W up to 53 weeks (open-label Treatment Extension Period II).'}], 'classes': [{'title': 'Change at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.29', 'spread': '0.215', 'groupId': 'OG000'}, {'value': '-0.51', 'spread': '0.207', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}, {'value': '67', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.28', 'spread': '0.242', 'groupId': 'OG000'}, {'value': '-0.41', 'spread': '0.207', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.30', 'spread': '0.260', 'groupId': 'OG000'}, {'value': '-0.79', 'spread': '0.221', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.28', 'spread': '0.251', 'groupId': 'OG000'}, {'value': '-1.04', 'spread': '0.235', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 72', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.22', 'spread': '0.247', 'groupId': 'OG000'}, {'value': '-1.24', 'spread': '0.263', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 96', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.08', 'spread': '0.260', 'groupId': 'OG000'}, {'value': '-1.43', 'spread': '0.234', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Weeks 12, 24, 36, 48, 72, 96', 'description': 'Change from baseline to post-baseline visits in BPI pain interference score as recorded on the day of the study visit. The BPI evaluates the condition of all pain over the previous 24 hours. Two dimensions are measured: pain severity (worst, least, average, and now) and the impact of pain on functioning (pain interference with general activity, walking, work, mood, enjoyment of life, relations with others, and sleep). Pain interference in the last 24 hours is rated on a scale of 0 (does not interfere) to 10 (completely interferes).\n\nThe GEE Estimates are from the GEE model which includes the change from baseline for each BPI endpoint as the dependent variable, region, visit, treatment, and visit by treatment as fixed factors, and baseline of each BPI endpoint as a covariate, with compound symmetry covariance structure.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Primary Analysis Set: all randomized participants who received at least 1 dose of study drug during the Placebo-Controlled Treatment Period. Participants with an assessment at given time point.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline Over Time in WOMAC Stiffness Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Subcutaneous (SC) injection of placebo every 4 weeks (Q4W) for 24 weeks (Double-blind Placebo-controlled Treatment Period), SC injection of burosumab 1 mg/kg Q4W for 24 weeks (Open-label Treatment Continuation Period), SC injection of burosumab 1 mg/kg Q4W for 48 weeks (Open-label Treatment Extension Period I), and SC injection of burosumab 1 mg/kg Q4W up to 53 weeks (Open-label Treatment Extension Period II).'}, {'id': 'OG001', 'title': 'Burosumab 1 mg/kg', 'description': 'SC injection of 1.0 mg/kg burosumab Q4W for 24 weeks (double-blind placebo-controlled Treatment Period), SC injection of burosumab 1 mg/kg Q4W for 24 weeks (open-label Treatment Continuation Period), SC injection of burosumab 1 mg/kg Q4W for 48 weeks (open-label Treatment Extension Period I), and SC injection of burosumab 1 mg/kg Q4W up to 53 weeks (open-label Treatment Extension Period II).'}], 'classes': [{'title': 'Change at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.24', 'spread': '2.929', 'groupId': 'OG000'}, {'value': '-7.86', 'spread': '3.622', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}, {'value': '67', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.20', 'spread': '3.289', 'groupId': 'OG000'}, {'value': '-8.01', 'spread': '2.968', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-13.50', 'spread': '3.422', 'groupId': 'OG000'}, {'value': '-12.58', 'spread': '3.411', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-15.83', 'spread': '3.488', 'groupId': 'OG000'}, {'value': '-16.63', 'spread': '3.302', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 72', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-18.02', 'spread': '3.613', 'groupId': 'OG000'}, {'value': '-15.47', 'spread': '3.111', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 96', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-17.67', 'spread': '3.737', 'groupId': 'OG000'}, {'value': '-15.32', 'spread': '3.577', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 120', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-19.23', 'spread': '3.404', 'groupId': 'OG000'}, {'value': '-20.57', 'spread': '3.371', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 144', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-30.64', 'spread': '4.407', 'groupId': 'OG000'}, {'value': '-25.88', 'spread': '4.501', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Weeks 12, 24, 36, 48, 72, 96, 120, 144', 'description': 'The WOMAC is a 24-item participant-reported questionnaire with two domains, Stiffness (2 questions) and Physical Function (17 questions) over the previous 48 hours. The WOMAC is administered in a 5-point Likert-scale format using descriptors of none, mild, moderate, severe, and extreme corresponding to an ordinal scale of 0-4. Higher scores on the WOMAC indicate worse stiffness and functional limitations. Scores are normalized to a 0-100 metric where 0 was the best health state and 100 the worst.\n\nThe GEE Estimates are from the GEE model which includes the change from baseline for WOMAC Stiffness as the dependent variable, region, visit, treatment, actual randomization stratification and visit by treatment as fixed factors, and baseline of WOMAC Stiffness as a covariate, with compound symmetry covariance structure.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Primary Analysis Set: all randomized participants who received at least 1 dose of study drug during the Placebo-Controlled Treatment Period. Participants with an assessment at given time point.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline Over Time in WOMAC Physical Function Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Subcutaneous (SC) injection of placebo every 4 weeks (Q4W) for 24 weeks (Double-blind Placebo-controlled Treatment Period), SC injection of burosumab 1 mg/kg Q4W for 24 weeks (Open-label Treatment Continuation Period), SC injection of burosumab 1 mg/kg Q4W for 48 weeks (Open-label Treatment Extension Period I), and SC injection of burosumab 1 mg/kg Q4W up to 53 weeks (Open-label Treatment Extension Period II).'}, {'id': 'OG001', 'title': 'Burosumab 1 mg/kg', 'description': 'SC injection of 1.0 mg/kg burosumab Q4W for 24 weeks (double-blind placebo-controlled Treatment Period), SC injection of burosumab 1 mg/kg Q4W for 24 weeks (open-label Treatment Continuation Period), SC injection of burosumab 1 mg/kg Q4W for 48 weeks (open-label Treatment Extension Period I), and SC injection of burosumab 1 mg/kg Q4W up to 53 weeks (open-label Treatment Extension Period II).'}], 'classes': [{'title': 'Change at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.40', 'spread': '2.418', 'groupId': 'OG000'}, {'value': '-3.96', 'spread': '1.787', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.14', 'spread': '2.531', 'groupId': 'OG000'}, {'value': '-3.45', 'spread': '2.193', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-5.47', 'spread': '2.694', 'groupId': 'OG000'}, {'value': '-7.14', 'spread': '2.133', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-7.15', 'spread': '2.801', 'groupId': 'OG000'}, {'value': '-8.42', 'spread': '2.057', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 72', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-8.68', 'spread': '2.835', 'groupId': 'OG000'}, {'value': '-8.66', 'spread': '2.523', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 96', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-8.41', 'spread': '2.752', 'groupId': 'OG000'}, {'value': '-9.02', 'spread': '2.270', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 120', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-11.93', 'spread': '2.685', 'groupId': 'OG000'}, {'value': '-11.98', 'spread': '2.291', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 144', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-19.49', 'spread': '3.892', 'groupId': 'OG000'}, {'value': '-17.67', 'spread': '4.061', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Weeks 12, 24, 36, 48, 72, 96, 120, 144', 'description': 'The WOMAC is a 24-item participant-reported questionnaire with two domains, Stiffness (2 questions) and Physical Function (17 questions) over the previous 48 hours. The WOMAC is administered in a 5-point Likert-scale format using descriptors of none, mild, moderate, severe, and extreme corresponding to an ordinal scale of 0-4. Higher scores on the WOMAC indicate worse stiffness and functional limitations. Scores are normalized to a 0-100 metric where 0 was the best health state and 100 the worst.\n\nThe GEE Estimates are from the GEE model which includes the change from baseline for WOMAC Stiffness as the dependent variable, region, visit, treatment, actual randomization stratification and visit by treatment as fixed factors, and baseline of WOMAC Stiffness as a covariate, with compound symmetry covariance structure.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Primary Analysis Set: all randomized participants who received at least 1 dose of study drug during the Placebo-Controlled Treatment Period. Participants with an assessment at given time point.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline Over Time in BFI Worst Fatigue Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Subcutaneous (SC) injection of placebo every 4 weeks (Q4W) for 24 weeks (Double-blind Placebo-controlled Treatment Period), SC injection of burosumab 1 mg/kg Q4W for 24 weeks (Open-label Treatment Continuation Period), SC injection of burosumab 1 mg/kg Q4W for 48 weeks (Open-label Treatment Extension Period I), and SC injection of burosumab 1 mg/kg Q4W up to 53 weeks (Open-label Treatment Extension Period II).'}, {'id': 'OG001', 'title': 'Burosumab 1 mg/kg', 'description': 'SC injection of 1.0 mg/kg burosumab Q4W for 24 weeks (double-blind placebo-controlled Treatment Period), SC injection of burosumab 1 mg/kg Q4W for 24 weeks (open-label Treatment Continuation Period), SC injection of burosumab 1 mg/kg Q4W for 48 weeks (open-label Treatment Extension Period I), and SC injection of burosumab 1 mg/kg Q4W up to 53 weeks (open-label Treatment Extension Period II).'}], 'classes': [{'title': 'Change at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.53', 'spread': '0.266', 'groupId': 'OG000'}, {'value': '-0.44', 'spread': '0.261', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}, {'value': '67', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.45', 'spread': '0.298', 'groupId': 'OG000'}, {'value': '-0.65', 'spread': '0.280', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.23', 'spread': '0.305', 'groupId': 'OG000'}, {'value': '-0.90', 'spread': '0.271', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.21', 'spread': '0.317', 'groupId': 'OG000'}, {'value': '-0.99', 'spread': '0.295', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 72', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.79', 'spread': '0.352', 'groupId': 'OG000'}, {'value': '-0.58', 'spread': '0.309', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 96', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.82', 'spread': '0.362', 'groupId': 'OG000'}, {'value': '-0.75', 'spread': '0.306', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Weeks 12, 24, 36, 48, 72, 96', 'description': 'Change from baseline to post-baseline visits in Brief Fatigue Inventory Question 3 (Worst Fatigue in Past 24 Hours; BFI-Q3) as averaged from daily diary scores recorded over 1 week and the study visit score. The BFI is a self-reported questionnaire consisting of 9 items related to fatigue rated on a 0 to 10 numerical scale with a recall period of 24 hours. Two dimensions are measured: fatigue severity and the interference of fatigue on daily life (activity, mood, walking ability, work, relations with others, and enjoyment of life). Participants are asked to rate their worst fatigue over the past 24 hours from 0 (no fatigue) to 10 (as bad a you can imagine).\n\nThe GEE Estimates are from the GEE model which includes the change from baseline for each BFI endpoint as the dependent variable, region, visit, treatment, actual randomization stratification and visit by treatment as fixed factors, and baseline of each BFI endpoint as a covariate, with compound symmetry covariance structure.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Primary Analysis Set: all randomized participants who received at least 1 dose of study drug during the Placebo-Controlled Treatment Period. Participants with an assessment at given time point.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline Over Time in BFI Global Fatigue Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'SC injection of placebo Q4W for 24 weeks (Double-blind Placebo-controlled Treatment Period), SC injection of burosumab 1 mg/kg Q4W for 24 weeks (Open-label Treatment Continuation Period), SC injection of burosumab 1 mg/kg Q4W for 48 weeks (Open-label Treatment Extension Period I), and SC injection of burosumab 1 mg/kg Q4W up to 53 weeks (Open-label Treatment Extension Period II).'}, {'id': 'OG001', 'title': 'Burosumab 1 mg/kg', 'description': 'SC injection of 1.0 mg/kg burosumab Q4W for 24 weeks (double-blind placebo-controlled Treatment Period), SC injection of burosumab 1 mg/kg Q4W for 24 weeks (open-label Treatment Continuation Period), SC injection of burosumab 1 mg/kg Q4W for 48 weeks (open-label Treatment Extension Period I), and SC injection of burosumab 1 mg/kg Q4W up to 53 weeks (open-label Treatment Extension Period II).'}], 'classes': [{'title': 'Change at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.14', 'spread': '0.262', 'groupId': 'OG000'}, {'value': '-0.18', 'spread': '0.261', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}, {'value': '67', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.08', 'spread': '0.292', 'groupId': 'OG000'}, {'value': '0.05', 'spread': '0.261', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.69', 'spread': '0.315', 'groupId': 'OG000'}, {'value': '-0.54', 'spread': '0.283', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.75', 'spread': '0.303', 'groupId': 'OG000'}, {'value': '-0.45', 'spread': '0.275', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 72', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.72', 'spread': '0.304', 'groupId': 'OG000'}, {'value': '-0.78', 'spread': '0.266', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 96', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.86', 'spread': '0.291', 'groupId': 'OG000'}, {'value': '-0.80', 'spread': '0.285', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Weeks 12, 24, 36, 48, 72, 96', 'description': 'Change from baseline to post-baseline visits in BFI global fatigue score, calculated by averaging all 9 BFI items as recorded on the day of the study visit. The BFI is a self-reported questionnaire consisting of 9 items related to fatigue that are rated on a numerical scale with a recall period of 24 hours. Two dimensions are measured: fatigue severity and the interference of fatigue on daily life (activity, mood, walking ability, work, relations with others, and enjoyment of life). BFI Global Fatigue score was calculated by averaging all 9 items on the BFI. Global scores range from 0 to 10, with higher score indicating worse fatigue severity and interference.\n\nThe GEE Estimates are from the GEE model which includes the change from baseline for each BFI endpoint as the dependent variable, region, visit, treatment, actual randomization stratification and visit by treatment as fixed factors, and baseline of each BFI endpoint as a covariate, with compound symmetry covariance structure.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Primary Analysis Set: all randomized participants who received at least 1 dose of study drug during the Placebo-Controlled Treatment Period. Participants with an assessment at given time point.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline Over Time in Biochemical Marker of Bone Remodeling Procollagen Type 1 N-Propeptide (P1NP)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}, {'value': '67', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'SC injection of placebo Q4W for 24 weeks (Double-blind Placebo-controlled Treatment Period), SC injection of burosumab 1 mg/kg Q4W for 24 weeks (Open-label Treatment Continuation Period), SC injection of burosumab 1 mg/kg Q4W for 48 weeks (Open-label Treatment Extension Period I), and SC injection of burosumab 1 mg/kg Q4W up to 53 weeks (Open-label Treatment Extension Period II).'}, {'id': 'OG001', 'title': 'Burosumab 1 mg/kg', 'description': 'SC injection of 1.0 mg/kg burosumab Q4W for 24 weeks (double-blind placebo-controlled Treatment Period), SC injection of burosumab 1 mg/kg Q4W for 24 weeks (open-label Treatment Continuation Period), SC injection of burosumab 1 mg/kg Q4W for 48 weeks (open-label Treatment Extension Period I), and SC injection of burosumab 1 mg/kg Q4W up to 53 weeks (open-label Treatment Extension Period II).'}], 'classes': [{'title': 'Change at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}, {'value': '67', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.86', 'spread': '5.958', 'groupId': 'OG000'}, {'value': '96.22', 'spread': '14.264', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.95', 'spread': '6.423', 'groupId': 'OG000'}, {'value': '63.50', 'spread': '7.239', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '100.00', 'spread': '10.562', 'groupId': 'OG000'}, {'value': '49.71', 'spread': '6.786', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '85.12', 'spread': '11.037', 'groupId': 'OG000'}, {'value': '40.07', 'spread': '7.292', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 72', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '48.98', 'spread': '7.286', 'groupId': 'OG000'}, {'value': '18.04', 'spread': '9.186', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 96', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '22.98', 'spread': '7.075', 'groupId': 'OG000'}, {'value': '12.48', 'spread': '8.661', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Weeks 12, 24, 36, 48, 72, 96', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Primary Analysis Set: all randomized participants who received at least 1 dose of study drug during the Placebo-Controlled Treatment Period. Participants with an assessment at given time point.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline Over Time in Biochemical Marker of Bone Remodeling P1NP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}, {'value': '67', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'SC injection of placebo Q4W for 24 weeks (Double-blind Placebo-controlled Treatment Period), SC injection of burosumab 1 mg/kg Q4W for 24 weeks (Open-label Treatment Continuation Period), SC injection of burosumab 1 mg/kg Q4W for 48 weeks (Open-label Treatment Extension Period I), and SC injection of burosumab 1 mg/kg Q4W up to 53 weeks (Open-label Treatment Extension Period II).'}, {'id': 'OG001', 'title': 'Burosumab 1 mg/kg', 'description': 'SC injection of 1.0 mg/kg burosumab Q4W for 24 weeks (double-blind placebo-controlled Treatment Period), SC injection of burosumab 1 mg/kg Q4W for 24 weeks (open-label Treatment Continuation Period), SC injection of burosumab 1 mg/kg Q4W for 48 weeks (open-label Treatment Extension Period I), and SC injection of burosumab 1 mg/kg Q4W up to 53 weeks (open-label Treatment Extension Period II).'}], 'classes': [{'title': 'Change at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}, {'value': '67', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.30', 'spread': '6.318', 'groupId': 'OG000'}, {'value': '91.78', 'spread': '10.787', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7.83', 'spread': '7.076', 'groupId': 'OG000'}, {'value': '72.43', 'spread': '8.519', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '116.39', 'spread': '9.726', 'groupId': 'OG000'}, {'value': '63.58', 'spread': '8.562', 'groupId': 'OG001'}]}]}, {'title': 'Change a Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '99.10', 'spread': '11.442', 'groupId': 'OG000'}, {'value': '56.51', 'spread': '8.771', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 72', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '72.56', 'spread': '10.055', 'groupId': 'OG000'}, {'value': '38.82', 'spread': '10.225', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 96', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '41.62', 'spread': '8.163', 'groupId': 'OG000'}, {'value': '31.04', 'spread': '8.126', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Weeks 12, 24, 36, 48, 72, 96', 'unitOfMeasure': 'percentage change', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Primary Analysis Set: all randomized participants who received at least 1 dose of study drug during the Placebo-Controlled Treatment Period. Participants with an assessment at given time point.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline Over Time in Biochemical Marker of Bone Remodeling Carboxy-Terminal Cross-Linked Telopeptide of Type I Collagen (CTx)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}, {'value': '67', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'SC injection of placebo Q4W for 24 weeks (Double-blind Placebo-controlled Treatment Period), SC injection of burosumab 1 mg/kg Q4W for 24 weeks (Open-label Treatment Continuation Period), SC injection of burosumab 1 mg/kg Q4W for 48 weeks (Open-label Treatment Extension Period I), and SC injection of burosumab 1 mg/kg Q4W up to 53 weeks (Open-label Treatment Extension Period II).'}, {'id': 'OG001', 'title': 'Burosumab 1 mg/kg', 'description': 'SC injection of 1.0 mg/kg burosumab Q4W for 24 weeks (double-blind placebo-controlled Treatment Period), SC injection of burosumab 1 mg/kg Q4W for 24 weeks (open-label Treatment Continuation Period), SC injection of burosumab 1 mg/kg Q4W for 48 weeks (open-label Treatment Extension Period I), and SC injection of burosumab 1 mg/kg Q4W up to 53 weeks (open-label Treatment Extension Period II).'}], 'classes': [{'title': 'Change at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}, {'value': '67', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '26.96', 'spread': '35.689', 'groupId': 'OG000'}, {'value': '322.09', 'spread': '56.924', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-4.20', 'spread': '34.835', 'groupId': 'OG000'}, {'value': '184.56', 'spread': '39.213', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '350.89', 'spread': '53.131', 'groupId': 'OG000'}, {'value': '193.50', 'spread': '39.461', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '310.67', 'spread': '45.003', 'groupId': 'OG000'}, {'value': '138.61', 'spread': '37.886', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 72', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '178.03', 'spread': '42.702', 'groupId': 'OG000'}, {'value': '51.59', 'spread': '42.863', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 96', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '79.04', 'spread': '45.622', 'groupId': 'OG000'}, {'value': '10.84', 'spread': '40.761', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Weeks 12, 24, 36, 48, 72, 96', 'description': 'The GEE Estimates are from the GEE model which includes the change from baseline for CTx as the dependent variable, region, visit, treatment, actual randomization stratification and visit by treatment as fixed factors, and baseline of CTx as a covariate, with compound symmetry covariance structure.', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Primary Analysis Set: all randomized participants who received at least 1 dose of study drug during the Placebo-Controlled Treatment Period. Participants with an assessment at given time point.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline Over Time in Biochemical Marker of Bone Remodeling CTx', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}, {'value': '67', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'SC injection of placebo Q4W for 24 weeks (Double-blind Placebo-controlled Treatment Period), SC injection of burosumab 1 mg/kg Q4W for 24 weeks (Open-label Treatment Continuation Period), SC injection of burosumab 1 mg/kg Q4W for 48 weeks (Open-label Treatment Extension Period I), and SC injection of burosumab 1 mg/kg Q4W up to 53 weeks (Open-label Treatment Extension Period II).'}, {'id': 'OG001', 'title': 'Burosumab 1 mg/kg', 'description': 'SC injection of 1.0 mg/kg burosumab Q4W for 24 weeks (double-blind placebo-controlled Treatment Period), SC injection of burosumab 1 mg/kg Q4W for 24 weeks (open-label Treatment Continuation Period), SC injection of burosumab 1 mg/kg Q4W for 48 weeks (open-label Treatment Extension Period I), and SC injection of burosumab 1 mg/kg Q4W up to 53 weeks (open-label Treatment Extension Period II).'}], 'classes': [{'title': 'Change at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}, {'value': '67', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9.64', 'spread': '5.671', 'groupId': 'OG000'}, {'value': '45.40', 'spread': '7.267', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.75', 'spread': '5.280', 'groupId': 'OG000'}, {'value': '32.48', 'spread': '6.414', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '61.31', 'spread': '10.653', 'groupId': 'OG000'}, {'value': '34.07', 'spread': '6.250', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '50.35', 'spread': '6.464', 'groupId': 'OG000'}, {'value': '28.33', 'spread': '5.354', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 72', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '34.78', 'spread': '7.007', 'groupId': 'OG000'}, {'value': '17.09', 'spread': '5.957', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 96', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '27.38', 'spread': '7.783', 'groupId': 'OG000'}, {'value': '13.47', 'spread': '5.952', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Weeks 12, 24, 36, 48, 72, 96', 'description': 'The GEE Estimates are from the GEE model which includes the percent change from baseline for CTx as the dependent variable, region, visit, treatment, actual randomization stratification and visit by treatment as fixed factors, and baseline of CTx as a covariate, with compound symmetry covariance structure.', 'unitOfMeasure': 'percentage change', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Primary Analysis Set: all randomized participants who received at least 1 dose of study drug during the Placebo-Controlled Treatment Period. Participants with an assessment at given time point.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline Over Time in Biochemical Marker of Bone Remodeling Bone-Specific Alkaline Phosphatase (BALP)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'SC injection of placebo Q4W for 24 weeks (Double-blind Placebo-controlled Treatment Period), SC injection of burosumab 1 mg/kg Q4W for 24 weeks (Open-label Treatment Continuation Period), SC injection of burosumab 1 mg/kg Q4W for 48 weeks (Open-label Treatment Extension Period I), and SC injection of burosumab 1 mg/kg Q4W up to 53 weeks (Open-label Treatment Extension Period II).'}, {'id': 'OG001', 'title': 'Burosumab 1 mg/kg', 'description': 'SC injection of 1.0 mg/kg burosumab Q4W for 24 weeks (double-blind placebo-controlled Treatment Period), SC injection of burosumab 1 mg/kg Q4W for 24 weeks (open-label Treatment Continuation Period), SC injection of burosumab 1 mg/kg Q4W for 48 weeks (open-label Treatment Extension Period I), and SC injection of burosumab 1 mg/kg Q4W up to 53 weeks (open-label Treatment Extension Period II).'}], 'classes': [{'title': 'Change at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-2.11', 'spread': '1.529', 'groupId': 'OG000'}, {'value': '6.52', 'spread': '2.832', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.03', 'spread': '1.801', 'groupId': 'OG000'}, {'value': '5.70', 'spread': '2.038', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '10.42', 'spread': '2.017', 'groupId': 'OG000'}, {'value': '4.46', 'spread': '1.607', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6.69', 'spread': '1.929', 'groupId': 'OG000'}, {'value': '0.23', 'spread': '1.830', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 72', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.92', 'spread': '1.779', 'groupId': 'OG000'}, {'value': '-3.39', 'spread': '1.739', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 96', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-2.49', 'spread': '1.887', 'groupId': 'OG000'}, {'value': '-2.76', 'spread': '1.640', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Weeks 12, 24, 36, 48, 72, 96', 'description': 'The GEE Estimates are from the GEE model which includes the change from baseline for BALP as the dependent variable, region, visit, treatment, actual randomization stratification and visit by treatment as fixed factors, and baseline of BALP as a covariate, with compound symmetry covariance structure.', 'unitOfMeasure': 'μg/L', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Primary Analysis Set: all randomized participants who received at least 1 dose of study drug during the Placebo-Controlled Treatment Period. Participants with an assessment at given time point.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline Over Time in Biochemical Marker of Bone Remodeling BALP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'SC injection of placebo Q4W for 24 weeks (Double-blind Placebo-controlled Treatment Period), SC injection of burosumab 1 mg/kg Q4W for 24 weeks (Open-label Treatment Continuation Period), SC injection of burosumab 1 mg/kg Q4W for 48 weeks (Open-label Treatment Extension Period I), and SC injection of burosumab 1 mg/kg Q4W up to 53 weeks (Open-label Treatment Extension Period II).'}, {'id': 'OG001', 'title': 'Burosumab 1 mg/kg', 'description': 'SC injection of 1.0 mg/kg burosumab Q4W for 24 weeks (double-blind placebo-controlled Treatment Period), SC injection of burosumab 1 mg/kg Q4W for 24 weeks (open-label Treatment Continuation Period), SC injection of burosumab 1 mg/kg Q4W for 48 weeks (open-label Treatment Extension Period I), and SC injection of burosumab 1 mg/kg Q4W up to 53 weeks (open-label Treatment Extension Period II).'}], 'classes': [{'title': 'Change at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7.85', 'spread': '9.867', 'groupId': 'OG000'}, {'value': '30.29', 'spread': '13.476', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '27.56', 'spread': '10.339', 'groupId': 'OG000'}, {'value': '39.13', 'spread': '10.902', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '64.41', 'spread': '11.669', 'groupId': 'OG000'}, {'value': '43.13', 'spread': '11.473', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '50.65', 'spread': '11.317', 'groupId': 'OG000'}, {'value': '23.46', 'spread': '10.041', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 72', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '19.79', 'spread': '11.755', 'groupId': 'OG000'}, {'value': '14.40', 'spread': '11.618', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 96', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '16.46', 'spread': '11.027', 'groupId': 'OG000'}, {'value': '21.21', 'spread': '9.688', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Weeks 12, 24, 36, 48, 72, 96', 'description': 'The GEE Estimates are from the GEE model which includes the percent change from baseline for BALP as the dependent variable, region, visit, treatment, actual randomization stratification and visit by treatment as fixed factors, and baseline of Bone ALP as a covariate, with compound symmetry covariance structure.', 'unitOfMeasure': 'percentage change', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Primary Analysis Set: all randomized participants who received at least 1 dose of study drug during the Placebo-Controlled Treatment Period. Participants with an assessment at given time point.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline Over Time in Serum Phosphorus', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'SC injection of placebo Q4W for 24 weeks (Double-blind Placebo-controlled Treatment Period), SC injection of burosumab 1 mg/kg Q4W for 24 weeks (Open-label Treatment Continuation Period), SC injection of burosumab 1 mg/kg Q4W for 48 weeks (Open-label Treatment Extension Period I), and SC injection of burosumab 1 mg/kg Q4W up to 53 weeks (Open-label Treatment Extension Period II).'}, {'id': 'OG001', 'title': 'Burosumab 1 mg/kg', 'description': 'SC injection of 1.0 mg/kg burosumab Q4W for 24 weeks (double-blind placebo-controlled Treatment Period), SC injection of burosumab 1 mg/kg Q4W for 24 weeks (open-label Treatment Continuation Period), SC injection of burosumab 1 mg/kg Q4W for 48 weeks (open-label Treatment Extension Period I), and SC injection of burosumab 1 mg/kg Q4W up to 53 weeks (open-label Treatment Extension Period II).'}], 'classes': [{'title': 'Change at Week 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.01', 'spread': '0.024', 'groupId': 'OG000'}, {'value': '0.44', 'spread': '0.031', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.03', 'spread': '0.023', 'groupId': 'OG000'}, {'value': '0.43', 'spread': '0.032', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}, {'value': '67', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.03', 'spread': '0.022', 'groupId': 'OG000'}, {'value': '0.27', 'spread': '0.034', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.00', 'spread': '0.023', 'groupId': 'OG000'}, {'value': '0.45', 'spread': '0.036', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.01', 'spread': '0.022', 'groupId': 'OG000'}, {'value': '0.37', 'spread': '0.033', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.01', 'spread': '0.023', 'groupId': 'OG000'}, {'value': '0.17', 'spread': '0.032', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.02', 'spread': '0.022', 'groupId': 'OG000'}, {'value': '0.32', 'spread': '0.032', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.02', 'spread': '0.023', 'groupId': 'OG000'}, {'value': '0.32', 'spread': '0.031', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 20', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.01', 'spread': '0.023', 'groupId': 'OG000'}, {'value': '0.18', 'spread': '0.028', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 21', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.00', 'spread': '0.024', 'groupId': 'OG000'}, {'value': '0.31', 'spread': '0.033', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 22', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.02', 'spread': '0.022', 'groupId': 'OG000'}, {'value': '0.25', 'spread': '0.033', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.00', 'spread': '0.023', 'groupId': 'OG000'}, {'value': '0.13', 'spread': '0.028', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 26', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.47', 'spread': '0.035', 'groupId': 'OG000'}, {'value': '0.31', 'spread': '0.032', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}, {'value': '67', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.28', 'spread': '0.028', 'groupId': 'OG000'}, {'value': '0.18', 'spread': '0.028', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 34', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.36', 'spread': '0.029', 'groupId': 'OG000'}, {'value': '0.28', 'spread': '0.031', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.17', 'spread': '0.026', 'groupId': 'OG000'}, {'value': '0.13', 'spread': '0.027', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 46', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.31', 'spread': '0.026', 'groupId': 'OG000'}, {'value': '0.27', 'spread': '0.030', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.13', 'spread': '0.027', 'groupId': 'OG000'}, {'value': '0.11', 'spread': '0.027', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 60', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.14', 'spread': '0.028', 'groupId': 'OG000'}, {'value': '0.11', 'spread': '0.028', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 70', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.30', 'spread': '0.029', 'groupId': 'OG000'}, {'value': '0.30', 'spread': '0.030', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 72', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.13', 'spread': '0.025', 'groupId': 'OG000'}, {'value': '0.11', 'spread': '0.027', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 84', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.12', 'spread': '0.025', 'groupId': 'OG000'}, {'value': '0.14', 'spread': '0.027', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 94', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.25', 'spread': '0.029', 'groupId': 'OG000'}, {'value': '0.30', 'spread': '0.029', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 96', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.07', 'spread': '0.026', 'groupId': 'OG000'}, {'value': '0.13', 'spread': '0.025', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 108', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.11', 'spread': '0.028', 'groupId': 'OG000'}, {'value': '0.13', 'spread': '0.031', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 120', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.09', 'spread': '0.027', 'groupId': 'OG000'}, {'value': '0.13', 'spread': '0.033', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 132', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.12', 'spread': '0.033', 'groupId': 'OG000'}, {'value': '0.15', 'spread': '0.036', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 144', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.05', 'spread': '0.064', 'groupId': 'OG000'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Weeks 1, 2, 4, 6, 10, 12, 14, 18, 20, 21, 22, 24, 26, 28, 34, 36, 46, 48, 60, 70, 72, 84, 94, 96, 108, 120, 132, 144', 'description': 'The GEE Estimates are from the GEE model which includes the change from baseline for serum phosphorus as the dependent variable, region, visit, treatment, actual randomization stratification and visit by treatment as fixed factors, and baseline of serum phosphorus as a covariate, with compound symmetry covariance structure.', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Primary Analysis Set: all randomized participants who received at least 1 dose of study drug during the Placebo-Controlled Treatment Period. Participants with an assessment at given time point.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline Over Time in Serum Phosphorus', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'SC injection of placebo Q4W for 24 weeks (Double-blind Placebo-controlled Treatment Period), SC injection of burosumab 1 mg/kg Q4W for 24 weeks (Open-label Treatment Continuation Period), SC injection of burosumab 1 mg/kg Q4W for 48 weeks (Open-label Treatment Extension Period I), and SC injection of burosumab 1 mg/kg Q4W up to 53 weeks (Open-label Treatment Extension Period II).'}, {'id': 'OG001', 'title': 'Burosumab 1 mg/kg', 'description': 'SC injection of 1.0 mg/kg burosumab Q4W for 24 weeks (double-blind placebo-controlled Treatment Period), SC injection of burosumab 1 mg/kg Q4W for 24 weeks (open-label Treatment Continuation Period), SC injection of burosumab 1 mg/kg Q4W for 48 weeks (open-label Treatment Extension Period I), and SC injection of burosumab 1 mg/kg Q4W up to 53 weeks (open-label Treatment Extension Period II).'}], 'classes': [{'title': 'Change at Week 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.11', 'spread': '3.936', 'groupId': 'OG000'}, {'value': '69.24', 'spread': '4.762', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-5.91', 'spread': '3.969', 'groupId': 'OG000'}, {'value': '69.39', 'spread': '4.881', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}, {'value': '67', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-4.84', 'spread': '3.792', 'groupId': 'OG000'}, {'value': '42.89', 'spread': '5.325', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.41', 'spread': '3.951', 'groupId': 'OG000'}, {'value': '72.96', 'spread': '5.944', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.40', 'spread': '3.680', 'groupId': 'OG000'}, {'value': '59.96', 'spread': '5.356', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-2.14', 'spread': '3.798', 'groupId': 'OG000'}, {'value': '29.50', 'spread': '5.087', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.58', 'spread': '3.691', 'groupId': 'OG000'}, {'value': '52.14', 'spread': '5.194', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.93', 'spread': '3.857', 'groupId': 'OG000'}, {'value': '53.22', 'spread': '5.106', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 20', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.81', 'spread': '3.759', 'groupId': 'OG000'}, {'value': '31.28', 'spread': '4.472', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 21', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.21', 'spread': '4.011', 'groupId': 'OG000'}, {'value': '50.59', 'spread': '5.123', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 22', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-3.42', 'spread': '3.709', 'groupId': 'OG000'}, {'value': '40.98', 'spread': '5.196', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.61', 'spread': '3.802', 'groupId': 'OG000'}, {'value': '22.01', 'spread': '4.523', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 26', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '78.30', 'spread': '5.993', 'groupId': 'OG000'}, {'value': '51.51', 'spread': '5.204', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}, {'value': '67', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '46.07', 'spread': '4.766', 'groupId': 'OG000'}, {'value': '31.32', 'spread': '4.415', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 34', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '59.18', 'spread': '4.959', 'groupId': 'OG000'}, {'value': '45.83', 'spread': '4.871', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '28.03', 'spread': '4.424', 'groupId': 'OG000'}, {'value': '22.34', 'spread': '4.256', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 46', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '51.49', 'spread': '4.380', 'groupId': 'OG000'}, {'value': '45.39', 'spread': '5.018', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '21.58', 'spread': '4.365', 'groupId': 'OG000'}, {'value': '19.12', 'spread': '4.190', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 60', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '22.90', 'spread': '4.338', 'groupId': 'OG000'}, {'value': '19.60', 'spread': '4.436', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 70', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '50.22', 'spread': '4.916', 'groupId': 'OG000'}, {'value': '47.81', 'spread': '4.768', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 72', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '21.59', 'spread': '4.155', 'groupId': 'OG000'}, {'value': '19.45', 'spread': '4.344', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 84', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '21.47', 'spread': '4.089', 'groupId': 'OG000'}, {'value': '23.58', 'spread': '4.200', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 94', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '43.67', 'spread': '4.834', 'groupId': 'OG000'}, {'value': '49.36', 'spread': '4.501', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 96', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '12.97', 'spread': '4.216', 'groupId': 'OG000'}, {'value': '21.65', 'spread': '3.854', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 108', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '19.21', 'spread': '4.665', 'groupId': 'OG000'}, {'value': '23.39', 'spread': '4.749', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 120', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '15.13', 'spread': '4.365', 'groupId': 'OG000'}, {'value': '21.50', 'spread': '5.268', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 132', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '20.43', 'spread': '5.362', 'groupId': 'OG000'}, {'value': '25.34', 'spread': '5.847', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 144', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.49', 'spread': '12.212', 'groupId': 'OG000'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Weeks 1, 2, 4, 6, 10, 12, 14, 18, 20, 21, 22, 24, 26, 28, 34, 36, 46, 48, 60, 70, 72, 84, 94, 96, 108, 120, 132, 144', 'description': 'The GEE Estimates are from the GEE model which includes the percent change from baseline for serum phosphorus as the dependent variable, region, visit, treatment, actual randomization stratification and visit by treatment as fixed factors, and baseline of serum phosphorus as a covariate, with compound symmetry covariance structure.', 'unitOfMeasure': 'percentage change', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Primary Analysis Set: all randomized participants who received at least 1 dose of study drug during the Placebo-Controlled Treatment Period. Participants with an assessment at given time point.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline Over Time in Serum 1,25(OH)2D', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'SC injection of placebo Q4W for 24 weeks (Double-blind Placebo-controlled Treatment Period), SC injection of burosumab 1 mg/kg Q4W for 24 weeks (Open-label Treatment Continuation Period), SC injection of burosumab 1 mg/kg Q4W for 48 weeks (Open-label Treatment Extension Period I), and SC injection of burosumab 1 mg/kg Q4W up to 53 weeks (Open-label Treatment Extension Period II).'}, {'id': 'OG001', 'title': 'Burosumab 1 mg/kg', 'description': 'SC injection of 1.0 mg/kg burosumab Q4W for 24 weeks (double-blind placebo-controlled Treatment Period), SC injection of burosumab 1 mg/kg Q4W for 24 weeks (open-label Treatment Continuation Period), SC injection of burosumab 1 mg/kg Q4W for 48 weeks (open-label Treatment Extension Period I), and SC injection of burosumab 1 mg/kg Q4W up to 53 weeks (open-label Treatment Extension Period II).'}], 'classes': [{'title': 'Change at Week 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.04', 'spread': '2.251', 'groupId': 'OG000'}, {'value': '87.23', 'spread': '5.500', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.40', 'spread': '2.113', 'groupId': 'OG000'}, {'value': '58.20', 'spread': '3.931', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.61', 'spread': '2.300', 'groupId': 'OG000'}, {'value': '20.55', 'spread': '2.828', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 20', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.88', 'spread': '2.163', 'groupId': 'OG000'}, {'value': '8.11', 'spread': '2.294', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 21', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.09', 'spread': '2.177', 'groupId': 'OG000'}, {'value': '33.95', 'spread': '3.019', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 22', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.45', 'spread': '2.289', 'groupId': 'OG000'}, {'value': '26.10', 'spread': '2.952', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 46', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '25.23', 'spread': '2.576', 'groupId': 'OG000'}, {'value': '23.08', 'spread': '3.243', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '10.50', 'spread': '2.418', 'groupId': 'OG000'}, {'value': '7.24', 'spread': '2.449', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 60', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9.29', 'spread': '2.336', 'groupId': 'OG000'}, {'value': '5.69', 'spread': '2.583', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 70', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '24.20', 'spread': '2.529', 'groupId': 'OG000'}, {'value': '18.82', 'spread': '2.486', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 72', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7.12', 'spread': '2.424', 'groupId': 'OG000'}, {'value': '5.52', 'spread': '2.607', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 84', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.13', 'spread': '2.388', 'groupId': 'OG000'}, {'value': '1.16', 'spread': '2.549', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 94', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '18.96', 'spread': '2.655', 'groupId': 'OG000'}, {'value': '15.26', 'spread': '2.502', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 96', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.43', 'spread': '2.348', 'groupId': 'OG000'}, {'value': '1.95', 'spread': '2.356', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 108', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.76', 'spread': '2.349', 'groupId': 'OG000'}, {'value': '4.29', 'spread': '2.672', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 120', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.64', 'spread': '2.496', 'groupId': 'OG000'}, {'value': '5.37', 'spread': '2.935', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 132', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.08', 'spread': '3.142', 'groupId': 'OG000'}, {'value': '8.05', 'spread': '4.227', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 144', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.38', 'spread': '4.677', 'groupId': 'OG000'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Weeks 1, 2, 4, 20, 21, 22, 46, 48, 60, 70, 72, 84, 94, 96, 108, 120, 132, 144', 'description': 'The GEE Estimates are from the GEE model which includes the change from baseline for 1,25(OH)2D as the dependent variable, region, visit, treatment, actual randomization stratification and visit by treatment as fixed factors, and baseline of 1, 25 (OH)2 D as a covariate, with compound symmetry covariance structure.', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Primary Analysis Set: all randomized participants who received at least 1 dose of study drug during the Placebo-Controlled Treatment Period. Participants with an assessment at given time point.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline Over Time in Serum 1,25(OH)2D', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'SC injection of placebo Q4W for 24 weeks (Double-blind Placebo-controlled Treatment Period), SC injection of burosumab 1 mg/kg Q4W for 24 weeks (Open-label Treatment Continuation Period), SC injection of burosumab 1 mg/kg Q4W for 48 weeks (Open-label Treatment Extension Period I), and SC injection of burosumab 1 mg/kg Q4W up to 53 weeks (Open-label Treatment Extension Period II).'}, {'id': 'OG001', 'title': 'Burosumab 1 mg/kg', 'description': 'SC injection of 1.0 mg/kg burosumab Q4W for 24 weeks (double-blind placebo-controlled Treatment Period), SC injection of burosumab 1 mg/kg Q4W for 24 weeks (open-label Treatment Continuation Period), SC injection of burosumab 1 mg/kg Q4W for 48 weeks (open-label Treatment Extension Period I), and SC injection of burosumab 1 mg/kg Q4W up to 53 weeks (open-label Treatment Extension Period II).'}], 'classes': [{'title': 'Change at Week 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '10.45', 'spread': '13.041', 'groupId': 'OG000'}, {'value': '310.72', 'spread': '23.225', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '10.53', 'spread': '12.760', 'groupId': 'OG000'}, {'value': '207.90', 'spread': '16.728', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '16.07', 'spread': '12.810', 'groupId': 'OG000'}, {'value': '76.22', 'spread': '12.147', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 20', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '21.36', 'spread': '12.424', 'groupId': 'OG000'}, {'value': '41.08', 'spread': '11.943', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 21', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '21.51', 'spread': '12.825', 'groupId': 'OG000'}, {'value': '131.76', 'spread': '14.862', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 22', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '21.07', 'spread': '12.725', 'groupId': 'OG000'}, {'value': '102.81', 'spread': '14.619', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 46', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '130.29', 'spread': '22.718', 'groupId': 'OG000'}, {'value': '96.63', 'spread': '16.909', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '70.09', 'spread': '17.114', 'groupId': 'OG000'}, {'value': '34.47', 'spread': '12.903', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 60', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '65.46', 'spread': '13.083', 'groupId': 'OG000'}, {'value': '32.32', 'spread': '12.230', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 70', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '123.58', 'spread': '17.315', 'groupId': 'OG000'}, {'value': '82.03', 'spread': '12.604', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 72', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '58.45', 'spread': '13.957', 'groupId': 'OG000'}, {'value': '31.14', 'spread': '13.070', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 84', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '55.67', 'spread': '15.323', 'groupId': 'OG000'}, {'value': '18.83', 'spread': '12.801', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 94', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '111.25', 'spread': '21.970', 'groupId': 'OG000'}, {'value': '71.30', 'spread': '12.280', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 96', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '50.17', 'spread': '18.857', 'groupId': 'OG000'}, {'value': '22.15', 'spread': '10.487', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 108', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '44.78', 'spread': '14.219', 'groupId': 'OG000'}, {'value': '29.16', 'spread': '13.326', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 120', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '58.37', 'spread': '19.621', 'groupId': 'OG000'}, {'value': '36.09', 'spread': '13.089', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 132', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '67.59', 'spread': '35.770', 'groupId': 'OG000'}, {'value': '42.55', 'spread': '15.925', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 144', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '22.65', 'spread': '19.297', 'groupId': 'OG000'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Weeks 1, 2, 4, 20, 21, 22, 46, 48, 60, 70, 72, 84, 94, 96, 108, 120, 132, 144', 'description': 'The GEE Estimates are from the GEE model which includes the percent change from baseline for 1,25(OH)2D as the dependent variable, region, visit, treatment, actual randomization stratification and visit by treatment as fixed factors, and baseline of 1, 25 (OH)2 D as a covariate, with compound symmetry covariance structure.', 'unitOfMeasure': 'percentage change', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Primary Analysis Set: all randomized participants who received at least 1 dose of study drug during the Placebo-Controlled Treatment Period. Participants with an assessment at given time point.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline Over Time in 24-Hour Urinary Phosphorus', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}, {'value': '67', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'SC injection of placebo Q4W for 24 weeks (Double-blind Placebo-controlled Treatment Period), SC injection of burosumab 1 mg/kg Q4W for 24 weeks (Open-label Treatment Continuation Period), SC injection of burosumab 1 mg/kg Q4W for 48 weeks (Open-label Treatment Extension Period I), and SC injection of burosumab 1 mg/kg Q4W up to 53 weeks (Open-label Treatment Extension Period II).'}, {'id': 'OG001', 'title': 'Burosumab 1 mg/kg', 'description': 'SC injection of 1.0 mg/kg burosumab Q4W for 24 weeks (double-blind placebo-controlled Treatment Period), SC injection of burosumab 1 mg/kg Q4W for 24 weeks (open-label Treatment Continuation Period), SC injection of burosumab 1 mg/kg Q4W for 48 weeks (open-label Treatment Extension Period I), and SC injection of burosumab 1 mg/kg Q4W up to 53 weeks (open-label Treatment Extension Period II).'}], 'classes': [{'title': 'Change at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.06', 'spread': '0.052', 'groupId': 'OG000'}, {'value': '0.05', 'spread': '0.046', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}, {'value': '67', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.07', 'spread': '0.065', 'groupId': 'OG000'}, {'value': '0.05', 'spread': '0.046', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.04', 'spread': '0.054', 'groupId': 'OG000'}, {'value': '0.07', 'spread': '0.045', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.07', 'spread': '0.060', 'groupId': 'OG000'}, {'value': '0.13', 'spread': '0.067', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 72', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.08', 'spread': '0.065', 'groupId': 'OG000'}, {'value': '0.05', 'spread': '0.052', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 96', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.10', 'spread': '0.075', 'groupId': 'OG000'}, {'value': '0.10', 'spread': '0.054', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 12, 24, 36, 48, 72, 96', 'description': 'The GEE Estimates are from the GEE model which includes the change from baseline for 24-Hour urinary phosphorus as the dependent variable, region, visit, treatment, actual randomization stratification and visit by treatment as fixed factors, and baseline of urinary phosphorus as a covariate, with compound symmetry covariance structure.', 'unitOfMeasure': 'g/24 hour', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Primary Analysis Set: all randomized participants who received at least 1 dose of study drug during the Placebo-Controlled Treatment Period. Participants with an assessment at given time point.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline Over Time in 24-Hour Urinary Phosphorus', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}, {'value': '67', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'SC injection of placebo Q4W for 24 weeks (Double-blind Placebo-controlled Treatment Period), SC injection of burosumab 1 mg/kg Q4W for 24 weeks (Open-label Treatment Continuation Period), SC injection of burosumab 1 mg/kg Q4W for 48 weeks (Open-label Treatment Extension Period I), and SC injection of burosumab 1 mg/kg Q4W up to 53 weeks (Open-label Treatment Extension Period II).'}, {'id': 'OG001', 'title': 'Burosumab 1 mg/kg', 'description': 'SC injection of 1.0 mg/kg burosumab Q4W for 24 weeks (double-blind placebo-controlled Treatment Period), SC injection of burosumab 1 mg/kg Q4W for 24 weeks (open-label Treatment Continuation Period), SC injection of burosumab 1 mg/kg Q4W for 48 weeks (open-label Treatment Extension Period I), and SC injection of burosumab 1 mg/kg Q4W up to 53 weeks (open-label Treatment Extension Period II).'}], 'classes': [{'title': 'Change at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '21.91', 'spread': '11.844', 'groupId': 'OG000'}, {'value': '21.40', 'spread': '11.453', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}, {'value': '67', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '28.45', 'spread': '15.518', 'groupId': 'OG000'}, {'value': '20.35', 'spread': '11.567', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '18.19', 'spread': '11.784', 'groupId': 'OG000'}, {'value': '28.31', 'spread': '12.173', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '27.32', 'spread': '14.328', 'groupId': 'OG000'}, {'value': '37.50', 'spread': '14.687', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 72', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '29.53', 'spread': '14.485', 'groupId': 'OG000'}, {'value': '25.80', 'spread': '15.476', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 96', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '31.17', 'spread': '17.248', 'groupId': 'OG000'}, {'value': '30.64', 'spread': '10.420', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 12, 24, 36, 48, 72, 96', 'description': 'The GEE Estimates are from the GEE model which includes the percent change from baseline for 24-hour urinary phosphorus as the dependent variable, region, visit, treatment, actual randomization stratification and visit by treatment as fixed factors, and baseline of urinary phosphorus as a covariate, with compound symmetry covariance structure.', 'unitOfMeasure': 'percentage change', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Primary Analysis Set: all randomized participants who received at least 1 dose of study drug during the Placebo-Controlled Treatment Period. Participants with an assessment at given time point.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline Over Time in Ratio of Renal Tubular Maximum Reabsorption Rate of Phosphate to Glomerular Filtration Rate (TmP/GFR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'SC injection of placebo Q4W for 24 weeks (Double-blind Placebo-controlled Treatment Period), SC injection of burosumab 1 mg/kg Q4W for 24 weeks (Open-label Treatment Continuation Period), SC injection of burosumab 1 mg/kg Q4W for 48 weeks (Open-label Treatment Extension Period I), and SC injection of burosumab 1 mg/kg Q4W up to 53 weeks (Open-label Treatment Extension Period II).'}, {'id': 'OG001', 'title': 'Burosumab 1 mg/kg', 'description': 'SC injection of 1.0 mg/kg burosumab Q4W for 24 weeks (double-blind placebo-controlled Treatment Period), SC injection of burosumab 1 mg/kg Q4W for 24 weeks (open-label Treatment Continuation Period), SC injection of burosumab 1 mg/kg Q4W for 48 weeks (open-label Treatment Extension Period I), and SC injection of burosumab 1 mg/kg Q4W up to 53 weeks (open-label Treatment Extension Period II).'}], 'classes': [{'title': 'Change at Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.02', 'spread': '0.072', 'groupId': 'OG000'}, {'value': '1.60', 'spread': '0.121', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.03', 'spread': '0.070', 'groupId': 'OG000'}, {'value': '0.91', 'spread': '0.117', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.11', 'spread': '0.082', 'groupId': 'OG000'}, {'value': '0.70', 'spread': '0.107', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 22', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.02', 'spread': '0.069', 'groupId': 'OG000'}, {'value': '1.01', 'spread': '0.123', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.07', 'spread': '0.071', 'groupId': 'OG000'}, {'value': '0.51', 'spread': '0.093', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.55', 'spread': '0.087', 'groupId': 'OG000'}, {'value': '0.48', 'spread': '0.091', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 60', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.57', 'spread': '0.097', 'groupId': 'OG000'}, {'value': '0.43', 'spread': '0.086', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 72', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.55', 'spread': '0.086', 'groupId': 'OG000'}, {'value': '0.43', 'spread': '0.091', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 84', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.49', 'spread': '0.078', 'groupId': 'OG000'}, {'value': '0.42', 'spread': '0.092', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 96', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.29', 'spread': '0.086', 'groupId': 'OG000'}, {'value': '0.46', 'spread': '0.084', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Weeks 2, 4, 12, 22, 24, 48, 60, 72, 84, 96', 'description': 'The GEE Estimates are from the GEE model which includes the change from baseline for TmP/GFR as the dependent variable, region, visit, treatment, actual randomization stratification and visit by treatment as fixed factors, and baseline of TmP/GFR as a covariate, with compound symmetry covariance structure.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Primary Analysis Set: all randomized participants who received at least 1 dose of study drug during the Placebo-Controlled Treatment Period. Participants with an assessment at given time point.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline Over Time in TmP/GFR', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'SC injection of placebo Q4W for 24 weeks (Double-blind Placebo-controlled Treatment Period), SC injection of burosumab 1 mg/kg Q4W for 24 weeks (Open-label Treatment Continuation Period), SC injection of burosumab 1 mg/kg Q4W for 48 weeks (Open-label Treatment Extension Period I), and SC injection of burosumab 1 mg/kg Q4W up to 53 weeks (Open-label Treatment Extension Period II).'}, {'id': 'OG001', 'title': 'Burosumab 1 mg/kg', 'description': 'SC injection of 1.0 mg/kg burosumab Q4W for 24 weeks (double-blind placebo-controlled Treatment Period), SC injection of burosumab 1 mg/kg Q4W for 24 weeks (open-label Treatment Continuation Period), SC injection of burosumab 1 mg/kg Q4W for 48 weeks (open-label Treatment Extension Period I), and SC injection of burosumab 1 mg/kg Q4W up to 53 weeks (open-label Treatment Extension Period II).'}], 'classes': [{'title': 'Change at Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-2.15', 'spread': '4.515', 'groupId': 'OG000'}, {'value': '100.10', 'spread': '7.222', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-2.73', 'spread': '4.416', 'groupId': 'OG000'}, {'value': '56.53', 'spread': '6.816', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6.28', 'spread': '4.900', 'groupId': 'OG000'}, {'value': '43.65', 'spread': '6.206', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 22', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.38', 'spread': '4.252', 'groupId': 'OG000'}, {'value': '62.38', 'spread': '7.144', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.63', 'spread': '4.460', 'groupId': 'OG000'}, {'value': '33.02', 'spread': '5.464', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '35.52', 'spread': '5.390', 'groupId': 'OG000'}, {'value': '31.02', 'spread': '5.489', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 60', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '37.13', 'spread': '5.855', 'groupId': 'OG000'}, {'value': '27.49', 'spread': '5.002', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 72', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '35.89', 'spread': '5.492', 'groupId': 'OG000'}, {'value': '28.98', 'spread': '5.513', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 84', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '33.15', 'spread': '4.924', 'groupId': 'OG000'}, {'value': '27.69', 'spread': '5.527', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 96', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '19.95', 'spread': '5.417', 'groupId': 'OG000'}, {'value': '29.67', 'spread': '4.759', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Weeks 2, 4, 12, 22, 24, 48, 60, 72, 84, 96', 'description': 'The GEE Estimates are from the GEE model which includes the percent change from baseline for TmP/GFR as the dependent variable, region, visit, treatment, actual randomization stratification and visit by treatment as fixed factors, and baseline of TmP/GFR as a covariate, with compound symmetry covariance structure.', 'unitOfMeasure': 'percentage change', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Primary Analysis Set: all randomized participants who received at least 1 dose of study drug during the Placebo-Controlled Treatment Period. Participants with an assessment at given time point.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline Over Time in Tubular Reabsorption of Phosphate (TRP)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}, {'value': '67', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'SC injection of placebo Q4W for 24 weeks (Double-blind Placebo-controlled Treatment Period), SC injection of burosumab 1 mg/kg Q4W for 24 weeks (Open-label Treatment Continuation Period), SC injection of burosumab 1 mg/kg Q4W for 48 weeks (Open-label Treatment Extension Period I), and SC injection of burosumab 1 mg/kg Q4W up to 53 weeks (Open-label Treatment Extension Period II).'}, {'id': 'OG001', 'title': 'Burosumab 1 mg/kg', 'description': 'SC injection of 1.0 mg/kg burosumab Q4W for 24 weeks (double-blind placebo-controlled Treatment Period), SC injection of burosumab 1 mg/kg Q4W for 24 weeks (open-label Treatment Continuation Period), SC injection of burosumab 1 mg/kg Q4W for 48 weeks (open-label Treatment Extension Period I), and SC injection of burosumab 1 mg/kg Q4W up to 53 weeks (open-label Treatment Extension Period II).'}], 'classes': [{'title': 'Change at Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.02', 'spread': '0.013', 'groupId': 'OG000'}, {'value': '0.07', 'spread': '0.008', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.03', 'spread': '0.012', 'groupId': 'OG000'}, {'value': '0.03', 'spread': '0.009', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.00', 'spread': '0.010', 'groupId': 'OG000'}, {'value': '0.04', 'spread': '0.008', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 22', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.01', 'spread': '0.009', 'groupId': 'OG000'}, {'value': '0.05', 'spread': '0.011', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}, {'value': '67', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.02', 'spread': '0.012', 'groupId': 'OG000'}, {'value': '0.03', 'spread': '0.009', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.02', 'spread': '0.012', 'groupId': 'OG000'}, {'value': '0.03', 'spread': '0.009', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 60', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.03', 'spread': '0.009', 'groupId': 'OG000'}, {'value': '0.02', 'spread': '0.009', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 72', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.02', 'spread': '0.011', 'groupId': 'OG000'}, {'value': '0.02', 'spread': '0.011', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 84', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.02', 'spread': '0.010', 'groupId': 'OG000'}, {'value': '0.01', 'spread': '0.012', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 96', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.01', 'spread': '0.014', 'groupId': 'OG000'}, {'value': '0.03', 'spread': '0.009', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Weeks 2, 4, 12, 22, 24, 48, 60, 72, 84, 96', 'description': 'The GEE Estimates are from the GEE model which includes the change from baseline for TRP as the dependent variable, region, visit, treatment, actual randomization stratification and visit by treatment as fixed factors, and baseline of TRP as a covariate, with compound symmetry covariance structure.', 'unitOfMeasure': 'fraction of phosphate reabsorbed', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Primary Analysis Set: all randomized participants who received at least 1 dose of study drug during the Placebo-Controlled Treatment Period. Participants with an assessment at given time point.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline Over Time in TRP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}, {'value': '67', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'SC injection of placebo Q4W for 24 weeks (Double-blind Placebo-controlled Treatment Period), SC injection of burosumab 1 mg/kg Q4W for 24 weeks (Open-label Treatment Continuation Period), SC injection of burosumab 1 mg/kg Q4W for 48 weeks (Open-label Treatment Extension Period I), and SC injection of burosumab 1 mg/kg Q4W up to 53 weeks (Open-label Treatment Extension Period II).'}, {'id': 'OG001', 'title': 'Burosumab 1 mg/kg', 'description': 'SC injection of 1.0 mg/kg burosumab Q4W for 24 weeks (double-blind placebo-controlled Treatment Period), SC injection of burosumab 1 mg/kg Q4W for 24 weeks (open-label Treatment Continuation Period), SC injection of burosumab 1 mg/kg Q4W for 48 weeks (open-label Treatment Extension Period I), and SC injection of burosumab 1 mg/kg Q4W up to 53 weeks (open-label Treatment Extension Period II).'}], 'classes': [{'title': 'Change at Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-2.00', 'spread': '1.530', 'groupId': 'OG000'}, {'value': '9.81', 'spread': '1.111', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-3.75', 'spread': '1.486', 'groupId': 'OG000'}, {'value': '4.86', 'spread': '1.114', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.56', 'spread': '1.261', 'groupId': 'OG000'}, {'value': '5.45', 'spread': '1.079', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 22', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.01', 'spread': '1.163', 'groupId': 'OG000'}, {'value': '7.03', 'spread': '1.451', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}, {'value': '67', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.56', 'spread': '1.579', 'groupId': 'OG000'}, {'value': '4.21', 'spread': '1.141', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.95', 'spread': '1.547', 'groupId': 'OG000'}, {'value': '4.70', 'spread': '1.183', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 60', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.99', 'spread': '1.096', 'groupId': 'OG000'}, {'value': '3.00', 'spread': '1.123', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 72', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.90', 'spread': '1.427', 'groupId': 'OG000'}, {'value': '3.24', 'spread': '1.414', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 84', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.78', 'spread': '1.276', 'groupId': 'OG000'}, {'value': '1.97', 'spread': '1.516', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 96', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.09', 'spread': '1.582', 'groupId': 'OG000'}, {'value': '4.44', 'spread': '1.116', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Weeks 2, 4, 12, 22, 24, 48, 60, 72, 84, 96', 'description': 'The GEE Estimates are from the GEE model which includes the percent change from baseline for TRP as the dependent variable, region, visit, treatment, actual randomization stratification and visit by treatment as fixed factors, and baseline of TRP as a covariate, with compound symmetry covariance structure.', 'unitOfMeasure': 'percentage change', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Primary Analysis Set: all randomized participants who received at least 1 dose of study drug during the Placebo-Controlled Treatment Period. Participants with an assessment at given time point.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Achieving Mean Serum Phosphorus Levels Above the LLN (2.5 mg/dL [0.81 mmol/L]) at the End of the Dosing Cycle, as Averaged Across Dose Cycles Between Baseline and Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo SC Q4W through Week 24'}, {'id': 'OG001', 'title': 'Burosumab', 'description': 'Burosumab 1 mg/kg SC Q4W'}], 'classes': [{'categories': [{'measurements': [{'value': '6.1', 'groupId': 'OG000', 'lowerLimit': '2.4', 'upperLimit': '14.6'}, {'value': '67.6', 'groupId': 'OG001', 'lowerLimit': '55.8', 'upperLimit': '77.6'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline through Week 24', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Primary Analysis Set: all randomized participants who received at least 1 dose of study drug during the Placebo-Controlled Treatment Period.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Serum Phosphorus at Each Mid-Point of Dosing Cycle, as Averaged Across Dose Cycles Between Baseline and Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo SC Q4W through Week 24'}, {'id': 'OG001', 'title': 'Burosumab', 'description': 'Burosumab 1 mg/kg SC Q4W'}], 'classes': [{'categories': [{'measurements': [{'value': '0.16', 'spread': '0.272', 'groupId': 'OG000'}, {'value': '1.21', 'spread': '0.513', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline through Week 24', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Primary Analysis Set: all randomized participants who received at least 1 dose of study drug during the Placebo-Controlled Treatment Period.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in Serum Phosphorus at Each Mid-Point of Dosing Cycle, as Averaged Across Dose Cycles Between Baseline and Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo SC Q4W through Week 24'}, {'id': 'OG001', 'title': 'Burosumab', 'description': 'Burosumab 1 mg/kg SC Q4W'}], 'classes': [{'categories': [{'measurements': [{'value': '9.85', 'spread': '15.292', 'groupId': 'OG000'}, {'value': '61.44', 'spread': '28.961', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline through Week 24', 'unitOfMeasure': 'percentage change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Primary Analysis Set: all randomized participants who received at least 1 dose of study drug during the Placebo-Controlled Treatment Period.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Serum Phosphorus at Each End of Dosing Cycle, as Averaged Across Dose Cycles Between Baseline and Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo SC Q4W through Week 24'}, {'id': 'OG001', 'title': 'Burosumab', 'description': 'Burosumab 1 mg/kg SC Q4W'}], 'classes': [{'categories': [{'measurements': [{'value': '0.13', 'spread': '0.265', 'groupId': 'OG000'}, {'value': '0.69', 'spread': '0.392', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline through Week 24', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Primary Analysis Set: all randomized participants who received at least 1 dose of study drug during the Placebo-Controlled Treatment Period.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in Serum Phosphorus at Each End of Dosing Cycle, as Averaged Across Dose Cycles Between Baseline and Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo SC Q4W through Week 24'}, {'id': 'OG001', 'title': 'Burosumab', 'description': 'Burosumab 1 mg/kg SC Q4W'}], 'classes': [{'categories': [{'measurements': [{'value': '7.83', 'spread': '14.755', 'groupId': 'OG000'}, {'value': '35.18', 'spread': '20.731', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline through Week 24', 'unitOfMeasure': 'percentage change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Primary Analysis Set: all randomized participants who received at least 1 dose of study drug during the Placebo-Controlled Treatment Period.'}, {'type': 'SECONDARY', 'title': 'Time-Adjusted Area Under the Curve (AUC) of Serum Phosphorus Between Baseline and Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo SC Q4W through Week 24'}, {'id': 'OG001', 'title': 'Burosumab', 'description': 'Burosumab 1 mg/kg SC Q4W'}], 'classes': [{'categories': [{'measurements': [{'value': '2.08', 'spread': '0.292', 'groupId': 'OG000'}, {'value': '3.08', 'spread': '0.477', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline through Week 24', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Primary Analysis Set: all randomized participants who received at least 1 dose of study drug during the Placebo-Controlled Treatment Period.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo', 'description': 'Subcutaneous (SC) injection of placebo every 4 weeks (Q4W) for 24 weeks (Double-blind Placebo-controlled Treatment Period), SC injection of burosumab 1 mg/kg Q4W for 24 weeks (Open-label Treatment Continuation Period), SC injection of burosumab 1 mg/kg Q4W for 48 weeks (Open-label Treatment Extension Period I), and SC injection of burosumab 1 mg/kg Q4W up to 53 weeks (Open-label Treatment Extension Period II).'}, {'id': 'FG001', 'title': 'Burosumab 1 mg/kg', 'description': 'SC injection of 1.0 mg/kg burosumab Q4W for 24 weeks (double-blind placebo-controlled Treatment Period), SC injection of burosumab 1 mg/kg Q4W for 24 weeks (open-label Treatment Continuation Period), SC injection of burosumab 1 mg/kg Q4W for 48 weeks (open-label Treatment Extension Period I), and SC injection of burosumab 1 mg/kg Q4W up to 53 weeks (open-label Treatment Extension Period II).'}], 'periods': [{'title': 'Double-Blind (Placebo-Controlled) Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '66'}, {'groupId': 'FG001', 'numSubjects': '68'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '66'}, {'groupId': 'FG001', 'numSubjects': '67'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}, {'title': 'Open-label Treatment Continuation Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '66'}, {'groupId': 'FG001', 'numSubjects': '67'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '63'}, {'groupId': 'FG001', 'numSubjects': '63'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '4'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Other, Not Specified', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}]}]}, {'title': 'Open-Label Treatment Extension Period I', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '63'}, {'groupId': 'FG001', 'numSubjects': '63'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '60'}, {'groupId': 'FG001', 'numSubjects': '59'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '4'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Other, Not Specified', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}, {'title': 'Open-Label Treatment Extension Period II', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '52'}, {'groupId': 'FG001', 'numSubjects': '49'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '51'}, {'groupId': 'FG001', 'numSubjects': '49'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Other, Not Specified', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'BG000'}, {'value': '68', 'groupId': 'BG001'}, {'value': '134', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo', 'description': 'Placebo SC Q4W through Week 24'}, {'id': 'BG001', 'title': 'Burosumab', 'description': 'Burosumab 1 mg/kg SC Q4W'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'BG000'}, {'value': '68', 'groupId': 'BG001'}, {'value': '134', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '38.65', 'spread': '12.756', 'groupId': 'BG000'}, {'value': '41.29', 'spread': '11.582', 'groupId': 'BG001'}, {'value': '39.99', 'spread': '12.201', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'BG000'}, {'value': '68', 'groupId': 'BG001'}, {'value': '134', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '43', 'groupId': 'BG000'}, {'value': '44', 'groupId': 'BG001'}, {'value': '87', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '47', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'BG000'}, {'value': '68', 'groupId': 'BG001'}, {'value': '134', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '61', 'groupId': 'BG000'}, {'value': '61', 'groupId': 'BG001'}, {'value': '122', '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': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'BG000'}, {'value': '68', 'groupId': 'BG001'}, {'value': '134', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Asian', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '53', 'groupId': 'BG000'}, {'value': '55', 'groupId': 'BG001'}, {'value': '108', 'groupId': 'BG002'}]}, {'title': 'Other, Not Specified', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Brief Pain Inventory (BPI) Worst Pain Score', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'BG000'}, {'value': '68', 'groupId': 'BG001'}, {'value': '134', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '6.54', 'spread': '1.433', 'groupId': 'BG000'}, {'value': '6.81', 'spread': '1.308', 'groupId': 'BG001'}, {'value': '6.68', 'spread': '1.372', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'The BPI evaluates the condition of all pain over the previous 24 hours. Question 3 of the short-form BPI (BPI-Q3) asks participants to rate their pain at its worst in the last 24 hours on a scale of 0 (no pain) to 10 (pain as bad as you can imagine). The baseline BPI Worst Pain is defined as the mean of the BPI Worst Pain for 8 days including the 7 days of diary scores prior to baseline visit and the baseline visit score.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'BPI Pain Severity Score', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'BG000'}, {'value': '68', 'groupId': 'BG001'}, {'value': '134', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '4.92', 'spread': '1.547', 'groupId': 'BG000'}, {'value': '5.18', 'spread': '1.531', 'groupId': 'BG001'}, {'value': '5.05', 'spread': '1.539', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'The BPI evaluates the condition of all pain over the previous 24 hours. Two dimensions are measured: pain severity (worst, least, average, and now) and the impact of pain on functioning (pain interference with general activity, walking, work, mood, enjoyment of life, relations with others, and sleep). The severity of pain in the last 24 hours is rated on a scale of 0 (no pain) to 10 (pain as bad as you can imagine).', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'BPI Pain Interference Score', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'BG000'}, {'value': '68', 'groupId': 'BG001'}, {'value': '134', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '4.76', 'spread': '2.174', 'groupId': 'BG000'}, {'value': '5.23', 'spread': '2.237', 'groupId': 'BG001'}, {'value': '5.00', 'spread': '2.210', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'The BPI evaluates the condition of all pain over the previous 24 hours. Two dimensions are measured: pain severity (worst, least, average, and now) and the impact of pain on functioning (pain interference with general activity, walking, work, mood, enjoyment of life, relations with others, and sleep). Pain interference in the last 24 hours is rated on a scale of 0 (does not interfere) to 10 (completely interferes).', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Score', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'BG000'}, {'value': '68', 'groupId': 'BG001'}, {'value': '134', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '61.36', 'spread': '20.770', 'groupId': 'BG000'}, {'value': '64.71', 'spread': '20.253', 'groupId': 'BG001'}, {'value': '63.06', 'spread': '20.500', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'The WOMAC is a 24-item participant-reported questionnaire with two domains, Stiffness (2 questions) and Physical Function (17 questions) over the previous 48 hours. The WOMAC is administered in a 5-point Likert-scale format using descriptors of none, mild, moderate, severe, and extreme corresponding to an ordinal scale of 0-4. Higher scores on the WOMAC indicate worse stiffness and functional limitations. Scores are normalized to a 0-100 metric where 0 was the best health state and 100 the worst.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'WOMAC Physical Function Score', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'BG000'}, {'value': '68', 'groupId': 'BG001'}, {'value': '134', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '43.89', 'spread': '19.938', 'groupId': 'BG000'}, {'value': '50.79', 'spread': '19.660', 'groupId': 'BG001'}, {'value': '47.40', 'spread': '20.024', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'The WOMAC is a 24-item participant-reported questionnaire with two domains, Stiffness (2 questions) and Physical Function (17 questions) over the previous 48 hours. The WOMAC is administered in a 5-point Likert-scale format using descriptors of none, mild, moderate, severe, and extreme corresponding to an ordinal scale of 0-4. Higher scores on the WOMAC indicate worse stiffness and functional limitations. Scores are normalized to a 0-100 metric where 0 was the best health state and 100 the worst.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Brief Fatigue Inventory (BFI) Worst Fatigue Score', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'BG000'}, {'value': '68', 'groupId': 'BG001'}, {'value': '134', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '6.74', 'spread': '1.526', 'groupId': 'BG000'}, {'value': '6.94', 'spread': '1.657', 'groupId': 'BG001'}, {'value': '6.84', 'spread': '1.591', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'The BFI is a self-reported questionnaire consisting of 9 items related to fatigue rated on a 0 to 10 numerical scale with a recall period of 24 hours. Two dimensions are measured: fatigue severity and the interference of fatigue on daily life (activity, mood, walking ability, work, relations with others, and enjoyment of life). Participants are asked to rate their worst fatigue over the past 24 hours from 0 (no fatigue) to 10 (as bad a you can imagine).', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'BFI Global Fatigue Score', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'BG000'}, {'value': '68', 'groupId': 'BG001'}, {'value': '134', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '4.86', 'spread': '1.932', 'groupId': 'BG000'}, {'value': '5.37', 'spread': '2.044', 'groupId': 'BG001'}, {'value': '5.12', 'spread': '1.999', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'The BFI is a self-reported questionnaire consisting of 9 items related to fatigue that are rated on a numerical scale with a recall period of 24 hours. Two dimensions are measured: fatigue severity and the interference of fatigue on daily life (activity, mood, walking ability, work, relations with others, and enjoyment of life). BFI Global Fatigue score was calculated by averaging all 9 items on the BFI. Global scores range from 0 to 10, with higher score indicating worse fatigue severity and interference.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Serum Procollagen Type 1 N- Propeptide (P1NP)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'BG000'}, {'value': '67', 'groupId': 'BG001'}, {'value': '133', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '87.6', 'spread': '53.41', 'groupId': 'BG000'}, {'value': '87.5', 'spread': '53.60', 'groupId': 'BG001'}, {'value': '87.6', 'spread': '53.30', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'participants with a baseline assessment'}, {'title': 'Serum Carboxy-Terminal Cross-Linked Telopeptide of Type I Collagen (CTx)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'BG000'}, {'value': '67', 'groupId': 'BG001'}, {'value': '133', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '719.2', 'spread': '419.24', 'groupId': 'BG000'}, {'value': '718.4', 'spread': '413.71', 'groupId': 'BG001'}, {'value': '718.8', 'spread': '414.89', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'participants with a baseline assessment'}, {'title': 'Serum Bone-Specific Alkaline Phosphatase (BALP)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'BG000'}, {'value': '66', 'groupId': 'BG001'}, {'value': '132', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '24.6', 'spread': '17.30', 'groupId': 'BG000'}, {'value': '25.1', 'spread': '21.55', 'groupId': 'BG001'}, {'value': '24.9', 'spread': '19.47', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'μg/L', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'participants with a baseline assessment'}, {'title': 'Serum Phosphorus', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'BG000'}, {'value': '68', 'groupId': 'BG001'}, {'value': '134', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0.617', 'spread': '0.1001', 'groupId': 'BG000'}, {'value': '0.653', 'spread': '0.1072', 'groupId': 'BG001'}, {'value': '0.635', 'spread': '0.1050', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Serum 1, 25 (OH)2 D', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'BG000'}, {'value': '66', 'groupId': 'BG001'}, {'value': '130', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '33.5', 'spread': '15.61', 'groupId': 'BG000'}, {'value': '32.4', 'spread': '12.96', 'groupId': 'BG001'}, {'value': '33.0', 'spread': '14.28', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'participants with a baseline assessment'}, {'title': '24-Hour Urinary Phosphorus', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'BG000'}, {'value': '68', 'groupId': 'BG001'}, {'value': '133', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0.81', 'spread': '0.262', 'groupId': 'BG000'}, {'value': '0.72', 'spread': '0.241', 'groupId': 'BG001'}, {'value': '0.77', 'spread': '0.255', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'g/24 hour', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'participants with a baseline assessment'}, {'title': 'Ratio of Renal Tubular Maximum Reabsorption Rate of Phosphate to Glomerular Filtration Rate(TmP/GFR)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'BG000'}, {'value': '66', 'groupId': 'BG001'}, {'value': '130', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '1.598', 'spread': '0.3693', 'groupId': 'BG000'}, {'value': '1.678', 'spread': '0.4004', 'groupId': 'BG001'}, {'value': '1.639', 'spread': '0.3860', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'participants with a baseline assessment'}, {'title': 'Tubular Reabsorption of Phosphate (TRP)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'BG000'}, {'value': '67', 'groupId': 'BG001'}, {'value': '131', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0.812', 'spread': '0.0842', 'groupId': 'BG000'}, {'value': '0.807', 'spread': '0.0832', 'groupId': 'BG001'}, {'value': '0.810', 'spread': '0.0834', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'fraction of phosphate reabsorbed', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'participants with a baseline assessment'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 134}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-10-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'nctId': 'NCT03775187', 'statusForNctId': 'AVAILABLE', 'hasExpandedAccess': True}, 'statusVerifiedDate': '2024-06', 'dispFirstSubmitDate': '2017-12-21', 'completionDateStruct': {'date': '2018-12-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-06-14', 'studyFirstSubmitDate': '2015-07-17', 'dispFirstSubmitQcDate': '2018-02-13', 'resultsFirstSubmitDate': '2020-12-17', 'studyFirstSubmitQcDate': '2015-08-14', 'dispFirstPostDateStruct': {'date': '2018-02-15', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2024-06-18', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-01-15', 'studyFirstPostDateStruct': {'date': '2015-08-18', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2021-02-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-12-22', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants Achieving Mean Serum Phosphorus Levels Above the LLN (2.5 mg/dL [0.81 mmol/L]) at the Mid-Point of the Dose Interval, as Averaged Across Dose Cycles Between Baseline and Week 24', 'timeFrame': 'Baseline through Week 24'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline to Week 24 in Brief Pain Inventory (BPI) Question 3 (Q3; Worst Pain in Past 24 Hours) Score', 'timeFrame': 'Baseline, 24 weeks', 'description': 'The BPI evaluates the condition of all pain over the previous 24 hours. Two dimensions are measured: pain severity (worst, least, average, and now) and the impact of pain on functioning (pain interference with general activity, walking, work, mood, enjoyment of life, relations with others, and sleep). Question 3 of the short-form BPI (BPI-Q3) asks subjects to rate their pain at its worst in the last 24 hours on a scale of 0 (no pain) to 10 (pain as bad as you can imagine).\n\nFrom the generalized estimating equation (GEE) model, which includes the change from Baseline for the endpoint of interest as the dependent variable; region, visit, treatment, actual randomization stratification (not included for analysis of BPI Worst Pain), and visit by treatment as fixed factors; and Baseline value for the endpoint of interest as a covariate, with compound symmetry covariance structure.'}, {'measure': 'Change From Baseline to Week 24 in the Western Ontario and McMaster University Osteoarthritis Index (WOMAC) Stiffness Score', 'timeFrame': 'Baseline, 24 weeks', 'description': 'The WOMAC is a 24-item participant-reported questionnaire with two domains, Stiffness (2 questions) and Physical Function (17 questions) over the previous 48 hours. The WOMAC is administered in a 5-point Likert-scale format using descriptors of none, mild, moderate, severe, and extreme corresponding to an ordinal scale of 0-4. Higher scores on the WOMAC indicate worse stiffness and functional limitations. Scores are normalized to a 0-100 metric where 0 was the best health state and 100 the worst.\n\nThe GEE estimates are from the GEE model which includes the change from baseline for WOMAC Stiffness as the dependent variable, region, visit, treatment, actual randomization stratification and visit by treatment as fixed factors, and baseline of WOMAC Stiffness as a covariate, with compound symmetry covariance structure.'}, {'measure': 'Change From Baseline to Week 24 in the WOMAC Physical Function Score', 'timeFrame': 'Baseline, 24 weeks', 'description': 'The WOMAC is a 24-item participant-reported questionnaire with two domains, Stiffness (2 questions) and Physical Function (17 questions) over the previous 48 hours. The WOMAC is administered in a 5-point Likert-scale format using descriptors of none, mild, moderate, severe, and extreme corresponding to an ordinal scale of 0-4. Higher scores on the WOMAC indicate worse stiffness and functional limitations. Scores are normalized to a 0-100 metric where 0 was the best health state and 100 the worst.\n\nThe GEE Estimates are from the GEE model which includes the change from baseline for WOMAC Physical Function as the dependent variable, region, visit, treatment, actual randomization stratification and visit by treatment as fixed factors, and baseline of WOMAC Physical Function as a covariate, with compound symmetry covariance structure.'}, {'measure': 'Change From Baseline Over Time in BPI Worst Pain Score', 'timeFrame': 'Baseline, Weeks 12, 24, 36, 48, 72, 96', 'description': 'Change from baseline to post-baseline visits in BPI-Q3 (Worst Pain) score as averaged from daily diary scores recorded over 1 week and the study visit score. The BPI evaluates the condition of all pain over the previous 24 hours. Two dimensions are measured: pain severity (worst, least, average, and now) and the impact of pain on functioning (pain interference with general activity, walking, work, mood, enjoyment of life, relations with others, and sleep). Question 3 of the short-form BPI (BPI-Q3) asks subjects to rate their pain at its worst in the last 24 hours on a scale of 0 (no pain) to 10 (pain as bad as you can imagine).\n\nThe GEE Estimates are from the GEE model which includes the change from baseline for BPI worst pain as the dependent variable, region, visit, treatment and visit by treatment as fixed factors, and baseline of BPI Worst Pain as a covariate, with compound symmetry covariance structure.'}, {'measure': 'Change From Baseline Over Time in BPI Pain Severity Score', 'timeFrame': 'Baseline, Weeks 12, 24, 36, 48, 72, 96', 'description': 'Change from baseline to post-baseline visits in BPI pain severity score as averaged from daily diary scores recorded over 1 week and the study visit score. The BPI evaluates the condition of all pain over the previous 24 hours. Two dimensions are measured: pain severity (worst, least, average, and now) and the impact of pain on functioning (pain interference with general activity, walking, work, mood, enjoyment of life, relations with others, and sleep). The severity of pain in the last 24 hours is rated on a scale of 0 (no pain) to 10 (pain as bad as you can imagine).\n\nThe GEE Estimates are from the GEE model which includes the change from baseline for each BPI endpoint as the dependent variable, region, visit, treatment, and visit by treatment as fixed factors, and baseline of each BPI endpoint as a covariate, with compound symmetry covariance structure.'}, {'measure': 'Change From Baseline Over Time in BPI Pain Interference Score', 'timeFrame': 'Baseline, Weeks 12, 24, 36, 48, 72, 96', 'description': 'Change from baseline to post-baseline visits in BPI pain interference score as recorded on the day of the study visit. The BPI evaluates the condition of all pain over the previous 24 hours. Two dimensions are measured: pain severity (worst, least, average, and now) and the impact of pain on functioning (pain interference with general activity, walking, work, mood, enjoyment of life, relations with others, and sleep). Pain interference in the last 24 hours is rated on a scale of 0 (does not interfere) to 10 (completely interferes).\n\nThe GEE Estimates are from the GEE model which includes the change from baseline for each BPI endpoint as the dependent variable, region, visit, treatment, and visit by treatment as fixed factors, and baseline of each BPI endpoint as a covariate, with compound symmetry covariance structure.'}, {'measure': 'Change From Baseline Over Time in WOMAC Stiffness Score', 'timeFrame': 'Baseline, Weeks 12, 24, 36, 48, 72, 96, 120, 144', 'description': 'The WOMAC is a 24-item participant-reported questionnaire with two domains, Stiffness (2 questions) and Physical Function (17 questions) over the previous 48 hours. The WOMAC is administered in a 5-point Likert-scale format using descriptors of none, mild, moderate, severe, and extreme corresponding to an ordinal scale of 0-4. Higher scores on the WOMAC indicate worse stiffness and functional limitations. Scores are normalized to a 0-100 metric where 0 was the best health state and 100 the worst.\n\nThe GEE Estimates are from the GEE model which includes the change from baseline for WOMAC Stiffness as the dependent variable, region, visit, treatment, actual randomization stratification and visit by treatment as fixed factors, and baseline of WOMAC Stiffness as a covariate, with compound symmetry covariance structure.'}, {'measure': 'Change From Baseline Over Time in WOMAC Physical Function Score', 'timeFrame': 'Baseline, Weeks 12, 24, 36, 48, 72, 96, 120, 144', 'description': 'The WOMAC is a 24-item participant-reported questionnaire with two domains, Stiffness (2 questions) and Physical Function (17 questions) over the previous 48 hours. The WOMAC is administered in a 5-point Likert-scale format using descriptors of none, mild, moderate, severe, and extreme corresponding to an ordinal scale of 0-4. Higher scores on the WOMAC indicate worse stiffness and functional limitations. Scores are normalized to a 0-100 metric where 0 was the best health state and 100 the worst.\n\nThe GEE Estimates are from the GEE model which includes the change from baseline for WOMAC Stiffness as the dependent variable, region, visit, treatment, actual randomization stratification and visit by treatment as fixed factors, and baseline of WOMAC Stiffness as a covariate, with compound symmetry covariance structure.'}, {'measure': 'Change From Baseline Over Time in BFI Worst Fatigue Score', 'timeFrame': 'Baseline, Weeks 12, 24, 36, 48, 72, 96', 'description': 'Change from baseline to post-baseline visits in Brief Fatigue Inventory Question 3 (Worst Fatigue in Past 24 Hours; BFI-Q3) as averaged from daily diary scores recorded over 1 week and the study visit score. The BFI is a self-reported questionnaire consisting of 9 items related to fatigue rated on a 0 to 10 numerical scale with a recall period of 24 hours. Two dimensions are measured: fatigue severity and the interference of fatigue on daily life (activity, mood, walking ability, work, relations with others, and enjoyment of life). Participants are asked to rate their worst fatigue over the past 24 hours from 0 (no fatigue) to 10 (as bad a you can imagine).\n\nThe GEE Estimates are from the GEE model which includes the change from baseline for each BFI endpoint as the dependent variable, region, visit, treatment, actual randomization stratification and visit by treatment as fixed factors, and baseline of each BFI endpoint as a covariate, with compound symmetry covariance structure.'}, {'measure': 'Change From Baseline Over Time in BFI Global Fatigue Score', 'timeFrame': 'Baseline, Weeks 12, 24, 36, 48, 72, 96', 'description': 'Change from baseline to post-baseline visits in BFI global fatigue score, calculated by averaging all 9 BFI items as recorded on the day of the study visit. The BFI is a self-reported questionnaire consisting of 9 items related to fatigue that are rated on a numerical scale with a recall period of 24 hours. Two dimensions are measured: fatigue severity and the interference of fatigue on daily life (activity, mood, walking ability, work, relations with others, and enjoyment of life). BFI Global Fatigue score was calculated by averaging all 9 items on the BFI. Global scores range from 0 to 10, with higher score indicating worse fatigue severity and interference.\n\nThe GEE Estimates are from the GEE model which includes the change from baseline for each BFI endpoint as the dependent variable, region, visit, treatment, actual randomization stratification and visit by treatment as fixed factors, and baseline of each BFI endpoint as a covariate, with compound symmetry covariance structure.'}, {'measure': 'Change From Baseline Over Time in Biochemical Marker of Bone Remodeling Procollagen Type 1 N-Propeptide (P1NP)', 'timeFrame': 'Baseline, Weeks 12, 24, 36, 48, 72, 96'}, {'measure': 'Percent Change From Baseline Over Time in Biochemical Marker of Bone Remodeling P1NP', 'timeFrame': 'Baseline, Weeks 12, 24, 36, 48, 72, 96'}, {'measure': 'Change From Baseline Over Time in Biochemical Marker of Bone Remodeling Carboxy-Terminal Cross-Linked Telopeptide of Type I Collagen (CTx)', 'timeFrame': 'Baseline, Weeks 12, 24, 36, 48, 72, 96', 'description': 'The GEE Estimates are from the GEE model which includes the change from baseline for CTx as the dependent variable, region, visit, treatment, actual randomization stratification and visit by treatment as fixed factors, and baseline of CTx as a covariate, with compound symmetry covariance structure.'}, {'measure': 'Percent Change From Baseline Over Time in Biochemical Marker of Bone Remodeling CTx', 'timeFrame': 'Baseline, Weeks 12, 24, 36, 48, 72, 96', 'description': 'The GEE Estimates are from the GEE model which includes the percent change from baseline for CTx as the dependent variable, region, visit, treatment, actual randomization stratification and visit by treatment as fixed factors, and baseline of CTx as a covariate, with compound symmetry covariance structure.'}, {'measure': 'Change From Baseline Over Time in Biochemical Marker of Bone Remodeling Bone-Specific Alkaline Phosphatase (BALP)', 'timeFrame': 'Baseline, Weeks 12, 24, 36, 48, 72, 96', 'description': 'The GEE Estimates are from the GEE model which includes the change from baseline for BALP as the dependent variable, region, visit, treatment, actual randomization stratification and visit by treatment as fixed factors, and baseline of BALP as a covariate, with compound symmetry covariance structure.'}, {'measure': 'Percent Change From Baseline Over Time in Biochemical Marker of Bone Remodeling BALP', 'timeFrame': 'Baseline, Weeks 12, 24, 36, 48, 72, 96', 'description': 'The GEE Estimates are from the GEE model which includes the percent change from baseline for BALP as the dependent variable, region, visit, treatment, actual randomization stratification and visit by treatment as fixed factors, and baseline of Bone ALP as a covariate, with compound symmetry covariance structure.'}, {'measure': 'Change From Baseline Over Time in Serum Phosphorus', 'timeFrame': 'Baseline, Weeks 1, 2, 4, 6, 10, 12, 14, 18, 20, 21, 22, 24, 26, 28, 34, 36, 46, 48, 60, 70, 72, 84, 94, 96, 108, 120, 132, 144', 'description': 'The GEE Estimates are from the GEE model which includes the change from baseline for serum phosphorus as the dependent variable, region, visit, treatment, actual randomization stratification and visit by treatment as fixed factors, and baseline of serum phosphorus as a covariate, with compound symmetry covariance structure.'}, {'measure': 'Percent Change From Baseline Over Time in Serum Phosphorus', 'timeFrame': 'Baseline, Weeks 1, 2, 4, 6, 10, 12, 14, 18, 20, 21, 22, 24, 26, 28, 34, 36, 46, 48, 60, 70, 72, 84, 94, 96, 108, 120, 132, 144', 'description': 'The GEE Estimates are from the GEE model which includes the percent change from baseline for serum phosphorus as the dependent variable, region, visit, treatment, actual randomization stratification and visit by treatment as fixed factors, and baseline of serum phosphorus as a covariate, with compound symmetry covariance structure.'}, {'measure': 'Change From Baseline Over Time in Serum 1,25(OH)2D', 'timeFrame': 'Baseline, Weeks 1, 2, 4, 20, 21, 22, 46, 48, 60, 70, 72, 84, 94, 96, 108, 120, 132, 144', 'description': 'The GEE Estimates are from the GEE model which includes the change from baseline for 1,25(OH)2D as the dependent variable, region, visit, treatment, actual randomization stratification and visit by treatment as fixed factors, and baseline of 1, 25 (OH)2 D as a covariate, with compound symmetry covariance structure.'}, {'measure': 'Percent Change From Baseline Over Time in Serum 1,25(OH)2D', 'timeFrame': 'Baseline, Weeks 1, 2, 4, 20, 21, 22, 46, 48, 60, 70, 72, 84, 94, 96, 108, 120, 132, 144', 'description': 'The GEE Estimates are from the GEE model which includes the percent change from baseline for 1,25(OH)2D as the dependent variable, region, visit, treatment, actual randomization stratification and visit by treatment as fixed factors, and baseline of 1, 25 (OH)2 D as a covariate, with compound symmetry covariance structure.'}, {'measure': 'Change From Baseline Over Time in 24-Hour Urinary Phosphorus', 'timeFrame': 'Baseline, Week 12, 24, 36, 48, 72, 96', 'description': 'The GEE Estimates are from the GEE model which includes the change from baseline for 24-Hour urinary phosphorus as the dependent variable, region, visit, treatment, actual randomization stratification and visit by treatment as fixed factors, and baseline of urinary phosphorus as a covariate, with compound symmetry covariance structure.'}, {'measure': 'Percent Change From Baseline Over Time in 24-Hour Urinary Phosphorus', 'timeFrame': 'Baseline, Week 12, 24, 36, 48, 72, 96', 'description': 'The GEE Estimates are from the GEE model which includes the percent change from baseline for 24-hour urinary phosphorus as the dependent variable, region, visit, treatment, actual randomization stratification and visit by treatment as fixed factors, and baseline of urinary phosphorus as a covariate, with compound symmetry covariance structure.'}, {'measure': 'Change From Baseline Over Time in Ratio of Renal Tubular Maximum Reabsorption Rate of Phosphate to Glomerular Filtration Rate (TmP/GFR)', 'timeFrame': 'Baseline, Weeks 2, 4, 12, 22, 24, 48, 60, 72, 84, 96', 'description': 'The GEE Estimates are from the GEE model which includes the change from baseline for TmP/GFR as the dependent variable, region, visit, treatment, actual randomization stratification and visit by treatment as fixed factors, and baseline of TmP/GFR as a covariate, with compound symmetry covariance structure.'}, {'measure': 'Percent Change From Baseline Over Time in TmP/GFR', 'timeFrame': 'Baseline, Weeks 2, 4, 12, 22, 24, 48, 60, 72, 84, 96', 'description': 'The GEE Estimates are from the GEE model which includes the percent change from baseline for TmP/GFR as the dependent variable, region, visit, treatment, actual randomization stratification and visit by treatment as fixed factors, and baseline of TmP/GFR as a covariate, with compound symmetry covariance structure.'}, {'measure': 'Change From Baseline Over Time in Tubular Reabsorption of Phosphate (TRP)', 'timeFrame': 'Baseline, Weeks 2, 4, 12, 22, 24, 48, 60, 72, 84, 96', 'description': 'The GEE Estimates are from the GEE model which includes the change from baseline for TRP as the dependent variable, region, visit, treatment, actual randomization stratification and visit by treatment as fixed factors, and baseline of TRP as a covariate, with compound symmetry covariance structure.'}, {'measure': 'Percent Change From Baseline Over Time in TRP', 'timeFrame': 'Baseline, Weeks 2, 4, 12, 22, 24, 48, 60, 72, 84, 96', 'description': 'The GEE Estimates are from the GEE model which includes the percent change from baseline for TRP as the dependent variable, region, visit, treatment, actual randomization stratification and visit by treatment as fixed factors, and baseline of TRP as a covariate, with compound symmetry covariance structure.'}, {'measure': 'Percentage of Participants Achieving Mean Serum Phosphorus Levels Above the LLN (2.5 mg/dL [0.81 mmol/L]) at the End of the Dosing Cycle, as Averaged Across Dose Cycles Between Baseline and Week 24', 'timeFrame': 'Baseline through Week 24'}, {'measure': 'Change From Baseline in Serum Phosphorus at Each Mid-Point of Dosing Cycle, as Averaged Across Dose Cycles Between Baseline and Week 24', 'timeFrame': 'Baseline through Week 24'}, {'measure': 'Percent Change From Baseline in Serum Phosphorus at Each Mid-Point of Dosing Cycle, as Averaged Across Dose Cycles Between Baseline and Week 24', 'timeFrame': 'Baseline through Week 24'}, {'measure': 'Change From Baseline in Serum Phosphorus at Each End of Dosing Cycle, as Averaged Across Dose Cycles Between Baseline and Week 24', 'timeFrame': 'Baseline through Week 24'}, {'measure': 'Percent Change From Baseline in Serum Phosphorus at Each End of Dosing Cycle, as Averaged Across Dose Cycles Between Baseline and Week 24', 'timeFrame': 'Baseline through Week 24'}, {'measure': 'Time-Adjusted Area Under the Curve (AUC) of Serum Phosphorus Between Baseline and Week 24', 'timeFrame': 'Baseline through Week 24'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['KRN23', 'Fibroblast growth factor 23 (FGF23)', 'XLH', 'X-linked hypophosphatemia', 'burosumab', 'Crysvita'], 'conditions': ['X-linked Hypophosphatemia']}, 'referencesModule': {'references': [{'pmid': '29947083', 'type': 'RESULT', 'citation': 'Insogna KL, Briot K, Imel EA, Kamenicky P, Ruppe MD, Portale AA, Weber T, Pitukcheewanont P, Cheong HI, Jan de Beur S, Imanishi Y, Ito N, Lachmann RH, Tanaka H, Perwad F, Zhang L, Chen CY, Theodore-Oklota C, Mealiffe M, San Martin J, Carpenter TO; AXLES 1 Investigators. A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Trial Evaluating the Efficacy of Burosumab, an Anti-FGF23 Antibody, in Adults With X-Linked Hypophosphatemia: Week 24 Primary Analysis. J Bone Miner Res. 2018 Aug;33(8):1383-1393. doi: 10.1002/jbmr.3475. Epub 2018 Jun 26.'}, {'pmid': '31165191', 'type': 'RESULT', 'citation': 'Portale AA, Carpenter TO, Brandi ML, Briot K, Cheong HI, Cohen-Solal M, Crowley R, Jan De Beur S, Eastell R, Imanishi Y, Imel EA, Ing S, Ito N, Javaid M, Kamenicky P, Keen R, Kubota T, Lachmann R, Perwad F, Pitukcheewanont P, Ralston SH, Takeuchi Y, Tanaka H, Weber TJ, Yoo HW, Zhang L, Theodore-Oklota C, Mealiffe M, San Martin J, Insogna K. Continued Beneficial Effects of Burosumab in Adults with X-Linked Hypophosphatemia: Results from a 24-Week Treatment Continuation Period After a 24-Week Double-Blind Placebo-Controlled Period. Calcif Tissue Int. 2019 Sep;105(3):271-284. doi: 10.1007/s00223-019-00568-3. Epub 2019 Jun 4.'}, {'pmid': '36854566', 'type': 'DERIVED', 'citation': 'Kamenicky P, Briot K, Brandi ML, Cohen-Solal M, Crowley RK, Keen R, Kolta S, Lachmann RH, Lecoq AL, Ralston SH, Walsh JS, Rylands AJ, Williams A, Sun W, Nixon A, Nixon M, Javaid MK. Benefit of burosumab in adults with X-linked hypophosphataemia (XLH) is maintained with long-term treatment. RMD Open. 2023 Feb;9(1):e002676. doi: 10.1136/rmdopen-2022-002676.'}, {'pmid': '35927518', 'type': 'DERIVED', 'citation': 'Brandi ML, Jan de Beur S, Briot K, Carpenter T, Cheong HI, Cohen-Solal M, Crowley RK, Eastell R, Imanishi Y, Imel EA, Ing SW, Insogna K, Ito N, Javaid K, Kamenicky P, Keen R, Kubota T, Lachmann RH, Perwad F, Pitukcheewanont P, Portale A, Ralston SH, Tanaka H, Weber TJ, Yoo HW, Sun W, Williams A, Nixon A, Takeuchi Y. Efficacy of Burosumab in Adults with X-linked Hypophosphatemia (XLH): A Post Hoc Subgroup Analysis of a Randomized Double-Blind Placebo-Controlled Phase 3 Study. Calcif Tissue Int. 2022 Oct;111(4):409-418. doi: 10.1007/s00223-022-01006-7. Epub 2022 Aug 4.'}, {'pmid': '34548383', 'type': 'DERIVED', 'citation': 'Briot K, Portale AA, Brandi ML, Carpenter TO, Cheong HI, Cohen-Solal M, Crowley RK, Eastell R, Imanishi Y, Ing S, Insogna K, Ito N, Jan de Beur S, Javaid MK, Kamenicky P, Keen R, Kubota T, Lachmann RH, Perwad F, Pitukcheewanont P, Ralston SH, Takeuchi Y, Tanaka H, Weber TJ, Yoo HW, Nixon A, Nixon M, Sun W, Williams A, Imel EA. Burosumab treatment in adults with X-linked hypophosphataemia: 96-week patient-reported outcomes and ambulatory function from a randomised phase 3 trial and open-label extension. RMD Open. 2021 Sep;7(3):e001714. doi: 10.1136/rmdopen-2021-001714.'}]}, 'descriptionModule': {'briefSummary': 'The primary efficacy objective of this study is to establish the effect of burosumab treatment compared with placebo on increasing serum phosphorus levels in adults with XLH.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Male or female, aged 18 - 65 years, inclusive\n2. Diagnosis of XLH supported by classic clinical features of adult XLH (such as short stature or bowed legs) and at least ONE of the following at Screening:\n\n * Documented phosphate-regulating gene with homologies to endopeptidases on the X chromosome (PHEX) mutation in the patient or a directly related family member with appropriate X-linked inheritance\n * Serum intact FGF23 (iFGF23) level \\> 30 pg/mL by Kainos assay\n3. Biochemical findings consistent with XLH at Screening Visit 2 following overnight fasting (min. 8 hours):\n\n * Serum phosphorus \\< 2.5 mg/dL\n * TmP/GFR of \\< 2.5 mg/dL\n4. Presence of skeletal pain attributed to XLH/osteomalacia, as defined by a score of ≥ 4 on Brief Pain Inventory (BPI) Questions 3 (Worst Pain) at Screening Visit 1. (Skeletal pain that, in the opinion of the investigator, is attributed solely to causes other than XLH/osteomalacia-for example, back or joint pain in the presence of severe osteoarthritis by radiograph in that anatomical location-in the absence of any skeletal pain likely attributed to XLH/osteomalacia should not be considered for eligibility)\n5. Estimated glomerular filtration rate (eGFR) ≥ 60 mL/min (using the Chronic Kidney Disease Epidemiology Collaboration \\[CKD-EPI\\] equation) or eGFR of 45 60 mL/min at Screening Visit 2 with confirmation that the renal insufficiency is not due to nephrocalcinosis\n6. If taking chronic pain medications (including narcotic pain medications/opioids), must be on a stable regimen for at least 21 days prior to Screening Visit 1, and be willing to maintain medications at the same stable dose(s) and schedule throughout the Placebo-controlled Treatment Period of the study. The dose must not exceed 60 mg oral morphine equivalents/day\n7. Provide written informed consent or if a minor, provide written consent and have a legally authorized representative willing and able to provide written informed consent, after the nature of the study has been explained, and prior to any research-related procedures\n8. Willing to provide access to prior medical records for the collection of biochemical and radiographic data and disease history\n9. Females of child-bearing potential must have a negative urine pregnancy test at Screening and be willing to have additional pregnancy tests during the study. Females considered not to be of childbearing potential include those who have been in menopause for at least two years prior to Screening, or have had tubal ligation at least one year prior to Screening, or have had a total hysterectomy or bilateral salpingo-oophorectomy\n10. Participants of child-bearing potential or with partners of child-bearing potential who have not undergone a bilateral salpingo-oophorectomy and are sexually active must consent to use an effective method of contraception as determined by the site investigator (i.e. oral hormonal contraceptives, patch hormonal contraceptives, vaginal ring, intrauterine device, physical double-barrier methods, surgical hysterectomy, vasectomy, tubal ligation, or true abstinence) from the period following the signing of the informed consent through 12 weeks after last dose of study drug\n11. 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\n12. Must have completed at least 4 of 7 days of the patient diaries before the Baseline visit.\n\nExclusion Criteria:\n\n1. Use of a pharmacologic vitamin D metabolite or analog (calcitriol, doxercalciferol, and paricalcitol) within 14 days prior to Screening Visit 2\n2. Use of oral phosphate within 14 days prior to Screening Visit 2\n3. Use of aluminum hydroxide antacids, acetazolamides, and thiazides within 7 days prior to Screening Visit 2\n4. Chronic use of systemic corticosteroids defined as more than 10 days in the previous 2 months\n5. Corrected serum calcium level ≥ 10.8 mg/dL (2.7 mmol/L) at Screening Visit 2\n6. Serum intact parathyroid hormone (iPTH) ≥ 2.5 upper limit of normal (ULN) at Screening Visit 1\n7. Use of medication to suppress parathyroid hormone (PTH) (cinacalcet for example) within 60 days prior to Screening Visit 1\n8. Use of oral bisphosphonates for 6 months or more in the 2 years prior to Screening Visit 1\n9. Use of denosumab in the 6 months prior to Screening Visit 1\n10. Use of teriparatide in the 2 months prior to Screening Visit 1\n11. Planned or recommended orthopedic surgery within the first 24 weeks of the clinical trial period\n12. History of traumatic fracture or orthopedic surgery within 6 months prior to Screening Visit 1\n13. Use of KRN23, or any other therapeutic monoclonal antibody within 90 days prior to Screening Visit 1\n14. Use of any investigational product or investigational medical device within 30 days prior to Screening Visit 1, or requirement for any investigational agent prior to completion of all scheduled study assessments.\n\n 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.\n15. Pregnant or breastfeeding at Screening /Baseline or planning to become pregnant (self or partner) at any time during the study\n16. Unable or unwilling to withhold prohibited medications throughout the study\n17. Presence or history of any hypersensitivity, allergic or anaphylactic reactions to any monoclonal antibody or KRN23 excipients that, in the judgment of the investigator, places the subject at increased risk for adverse effects.\n18. Prior history of positive test for human immunodeficiency virus antibody, hepatitis B surface antigen, and/or hepatitis C antibody\n19. History of recurrent infection or predisposition to infection, or of known immunodeficiency\n20. Presence of malignant neoplasm (except basal cell carcinoma)\n21. Presence of a concurrent disease or condition that would interfere with study participation or affect safety\n22. 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'}, 'identificationModule': {'nctId': 'NCT02526160', 'briefTitle': 'Study of KRN23 in Adults With X-linked Hypophosphatemia (XLH)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Kyowa Kirin Co., Ltd.'}, 'officialTitle': 'A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study With Open-Label Extension to Assess the Efficacy and Safety of KRN23 in Adults With X-linked Hypophosphatemia (XLH)', 'orgStudyIdInfo': {'id': 'UX023-CL303'}, 'secondaryIdInfos': [{'id': '2014-005529-11', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Burosumab 1 mg/kg', 'description': 'Burosumab 1 mg/kg administered subcutaneously (SC) every 4 weeks, for the duration of the study.', 'interventionNames': ['Biological: burosumab']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo administered SC every 4 weeks through Week 24, followed by burosumab 1 mg/kg, for the duration of the study.', 'interventionNames': ['Biological: burosumab', 'Other: Placebo']}], 'interventions': [{'name': 'burosumab', 'type': 'BIOLOGICAL', 'otherNames': ['UX023', 'KRN23', 'Crysvita'], 'description': 'solution for SC injection', 'armGroupLabels': ['Burosumab 1 mg/kg', 'Placebo']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'saline solution for SC injection', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90027', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': "Children's Hospital of Los Angeles", 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '94158', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'University of California-San Francisco Medical Center', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '06510', 'city': 'New Haven', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Yale University School of Medicine', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}, {'zip': '46202', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Indiana University Department of Medicine', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '21224', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Johns Hopkins University', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '27710', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke University Medical Center', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'zip': '43203', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'The Ohio State University Wexner Medical Center', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Houston Methodist Hospital', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '94275', 'city': 'Le Kremlin-Bicêtre', 'country': 'France', 'facility': "CHU de Bicêtre, Service d'Endocrinologie et des Maladies de la Reproduction", 'geoPoint': {'lat': 48.81471, 'lon': 2.36073}}, {'zip': '75010', 'city': 'Paris', 'country': 'France', 'facility': 'Hôpital Lariboisière, Dept. of Rheumatology', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '75014', 'city': 'Paris', 'country': 'France', 'facility': 'CHU Paris Centre-Hôpital Cochin', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '4', 'city': 'Dublin', 'country': 'Ireland', 'facility': "St. Vincent's University Hospital", 'geoPoint': {'lat': 53.33306, 'lon': -6.24889}}, {'zip': '50139', 'city': 'Florence', 'country': 'Italy', 'facility': 'Azienda Ospedaliero Universitaria Careggi - 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