Ignite Creation Date:
2025-12-25 @ 12:39 AM
Ignite Modification Date:
2026-02-28 @ 2:28 PM
Study NCT ID:
NCT02304367
Status:
COMPLETED
Last Update Posted:
2024-05-06
First Post:
2014-11-24
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study of Burosumab (KRN23) in Adults With Tumor-Induced Osteomalacia (TIO) or Epidermal Nevus Syndrome (ENS)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'C537751', 'term': 'Oncogenic osteomalacia'}, {'id': 'D054000', 'term': 'Nevus, Sebaceous of Jadassohn'}], 'ancestors': [{'id': 'D009506', 'term': 'Nevus'}, {'id': 'D018326', 'term': 'Nevi and Melanomas'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D020752', 'term': 'Neurocutaneous Syndromes'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D000015', 'term': 'Abnormalities, Multiple'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}, '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 up to database lock date (July 07, 2021); median duration of treatment in the TIO analysis set was 1594.0 (range: 168-2106) days.', 'eventGroups': [{'id': 'EG000', 'title': 'KRN23 TIO', 'description': 'Participants with TIO received burosumab at a starting dose of 0.3 mg/kg administered subcutaneously (SC) every 4 weeks (Q4W). Doses may have been titrated up to a maximum of 2.0 mg/kg every 2 weeks (Q2W) in order to achieve fasting peak serum phosphorus levels within the target range of 2.5 to 4.0 mg/dL.', 'otherNumAtRisk': 14, 'deathsNumAtRisk': 14, 'otherNumAffected': 14, 'seriousNumAtRisk': 14, 'deathsNumAffected': 2, 'seriousNumAffected': 8}, {'id': 'EG001', 'title': 'KRN23 XLH and ENS', 'description': 'Participants with XLH and ENS received burosumab at a starting dose of 0.3 mg/kg administered subcutaneously (SC) every 4 weeks (Q4W). Doses may have been titrated up to a maximum of 2.0 mg/kg every 2 weeks (Q2W) in order to achieve fasting peak serum phosphorus levels within the target range of 2.5 to 4.0 mg/dL.', 'otherNumAtRisk': 3, 'deathsNumAtRisk': 3, 'otherNumAffected': 3, 'seriousNumAtRisk': 3, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Coagulopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Leukocytosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Tinnitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Eyelid Ptosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Abdominal Discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Abdominal Distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Abdominal Hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Abdominal Mass', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Abdominal Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Abdominal Pain Lower', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Abdominal Pain Upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Ascites', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Dental Caries', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Dysphagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Flatulence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Gastrooesophageal Reflux Disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Hypoaesthesia Oral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Large Intestine Polyp', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Localised Intraabdominal Fluid Collection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Poor Dental Condition', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Retching', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Toothache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Adverse Drug Reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Application Site Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Calcinosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Chest Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Chills', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Gait Disturbance', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Generalised Oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Influenza Like Illness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Injection Site Bruising', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Injection Site Erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Injection Site Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Injection Site Reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Injection Site Swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Medical Device Site Reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Nodule', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Oedema Peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Peripheral Swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Bile Duct Stone', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Hepatic Cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Hepatic Lesion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Seasonal Allergy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Conjunctivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Corona Virus Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Cystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Diverticulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Gastrointestinal Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Gastrointestinal Viral Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Gingivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'H1n1 Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Incision Site Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Oesophageal Candidiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Oral Candidiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Tonsillitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Tooth Abscess', 'stats': 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'EG000', 'numAtRisk': 14, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Pleural Effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Pulmonary Artery Dilatation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Pulmonary Embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Pulmonary Mass', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Respiratory Acidosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Respiratory Tract Congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Upper Respiratory Tract Congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Actinic Keratosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Decubitus Ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Keloid Scar', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Precancerous Skin Lesion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Rash Papular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Skin Irritation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Skin Lesion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Skin Mass', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Skin Odour Abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Deep Vein Thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Peripheral Venous Disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Vasodilatation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}], 'seriousEvents': [{'term': 'Cardiac Arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Pulseless Electrical Activity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Ascites', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Pancreatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Multi-Organ Failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Cholangitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Septic Shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Sialoadenitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Tooth Abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Hypophosphataemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Rheumatoid Arthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Metastases To Lung', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Neoplasm Progression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Ovarian Cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Tumour Compression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Acute Kidney Injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Acute Respiratory Failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Pickwickian Syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Pleural Effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Pulmonary Embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants Achieving Mean Serum Phosphorus Levels Above 2.5 mg/dL at the Mid-Point of the Dose Intervals Between Baseline and Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Burosumab', 'description': 'Participants received burosumab at a starting dose of 0.3 mg/kg administered subcutaneously (SC) every 4 weeks (Q4W). Doses may have been titrated up to a maximum of 2.0 mg/kg every 2 weeks (Q2W) in order to achieve fasting peak serum phosphorus levels within the target range of 2.5 to 4.0 mg/dL.'}], 'classes': [{'categories': [{'measurements': [{'value': '50.0', 'groupId': 'OG000', 'lowerLimit': '26.80', 'upperLimit': '73.20'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Mid-point of each dose interval from Baseline to Week 24 (Weeks 2, 6, 10, 14 and 22 [there was no study visit at Week 18])', 'description': 'The percentage of participants achieving mean serum phosphorus levels above the lower limit of normal (LLN; 2.5 mg/dL \\[0.81 mmol/L\\]) at the mid-point of the dose interval (2 weeks after dosing), as averaged across dose cycles between Baseline and Week 24 (i.e. the average of serum phosphorus levels at Weeks 2, 6, 10, 14 and 22).', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'TIO analysis set: includes participants with TIO who received at least 1 dose of burosumab during the study.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline to Week 48 in Osteoid Thickness', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Burosumab', 'description': 'Participants received burosumab at a starting dose of 0.3 mg/kg administered subcutaneously (SC) every 4 weeks (Q4W). Doses may have been titrated up to a maximum of 2.0 mg/kg every 2 weeks (Q2W) in order to achieve fasting peak serum phosphorus levels within the target range of 2.5 to 4.0 mg/dL.'}], 'classes': [{'categories': [{'measurements': [{'value': '-5.12', 'groupId': 'OG000', 'lowerLimit': '-10.04', 'upperLimit': '-0.20'}]}]}], 'analyses': [{'pValue': '0.0428', 'groupIds': ['OG000'], 'groupDescription': 'The null hypothesis that the mean change from Baseline to Week 48 in osteoid thickness is zero was tested using a t-test.', 'statisticalMethod': 't-test', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 48', 'description': 'Histomorphometry of trans-iliac crest bone biopsies was assessed by a blinded, central reader.\n\nOsteoid thickness is the mean thickness of osteoid seams.', 'unitOfMeasure': 'µm', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'TIO bone biopsy analysis set'}, {'type': 'PRIMARY', 'title': 'Change From Baseline to Week 48 in Osteoid Surface/Bone Surface (OS/BS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Burosumab', 'description': 'Participants received burosumab at a starting dose of 0.3 mg/kg administered subcutaneously (SC) every 4 weeks (Q4W). Doses may have been titrated up to a maximum of 2.0 mg/kg every 2 weeks (Q2W) in order to achieve fasting peak serum phosphorus levels within the target range of 2.5 to 4.0 mg/dL.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.18', 'groupId': 'OG000', 'lowerLimit': '-13.86', 'upperLimit': '13.50'}]}]}], 'analyses': [{'pValue': '0.9770', 'groupIds': ['OG000'], 'groupDescription': 'The null hypothesis that the mean change from Baseline to Week 48 in OS/BS is zero was tested using a t-test.', 'statisticalMethod': 't-test', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 48', 'description': 'Histomorphometry of trans-iliac crest bone biopsies was assessed by a blinded, central reader.\n\nOsteoid surface/bone surface is expressed as the percentage of bone surface covered in osteoid.', 'unitOfMeasure': 'percentage of bone surface', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'TIO biopsy analysis set'}, {'type': 'PRIMARY', 'title': 'Change From Baseline to Week 48 in Osteoid Volume/Bone Volume (OV/BV)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Burosumab', 'description': 'Participants received burosumab at a starting dose of 0.3 mg/kg administered subcutaneously (SC) every 4 weeks (Q4W). Doses may have been titrated up to a maximum of 2.0 mg/kg every 2 weeks (Q2W) in order to achieve fasting peak serum phosphorus levels within the target range of 2.5 to 4.0 mg/dL.'}], 'classes': [{'categories': [{'measurements': [{'value': '-5.47', 'groupId': 'OG000', 'lowerLimit': '-11.87', 'upperLimit': '0.93'}]}]}], 'analyses': [{'pValue': '0.0858', 'groupIds': ['OG000'], 'groupDescription': 'The null hypothesis that the mean change from Baseline to Week 48 in OV/BV is zero was tested using a t-test.', 'statisticalMethod': 't-test', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 48', 'description': 'Histomorphometry of trans-iliac crest bone biopsies was assessed by a blinded, central reader. Osteoid volume/bone volume is expressed as the percentage of a given volume of bone tissue that consists of unmineralized bone (osteoid).', 'unitOfMeasure': 'percentage of bone volume', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'TIO bone biopsy analysis set'}, {'type': 'PRIMARY', 'title': 'Change From Baseline to Week 48 in Mineralization Lag Time (MLt)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Burosumab', 'description': 'Participants received burosumab at a starting dose of 0.3 mg/kg administered subcutaneously (SC) every 4 weeks (Q4W). Doses may have been titrated up to a maximum of 2.0 mg/kg every 2 weeks (Q2W) in order to achieve fasting peak serum phosphorus levels within the target range of 2.5 to 4.0 mg/dL.'}], 'classes': [{'categories': [{'measurements': [{'value': '-565.20', 'groupId': 'OG000', 'lowerLimit': '-2037.42', 'upperLimit': '907.02'}]}]}], 'analyses': [{'pValue': '0.4077', 'groupIds': ['OG000'], 'groupDescription': 'The null hypothesis that the mean change from Baseline to Week 48 in Mlt is zero was tested using a t-test.', 'statisticalMethod': 't-test', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 48', 'description': 'Mineralization lag time is a dynamic modeling parameter representing the mean time interval between the formation of osteoid and its subsequent mineralization which can be measured using histomorphometry with double tetracycline labeling.\n\nMlt was calculated by dividing the osteoid width by the mineralizing apposition rate (MAR; the average rate at which new bone mineral is being added on any actively forming surface).\n\nIf Mlt could not be calculated directly due to low tetracycline uptake, Mlt was imputed according to the following:\n\nMlt = O.Th/(MAR\\*MS/OS), where O.Th = osteoid thickness, MAR is imputed as 0.3 μm/day, MS/OS=mineralizing surface/osteoid surface, each measured at the same visit.', 'unitOfMeasure': 'days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'TIO biopsy analysis set for whom Mlt could be calculated or imputed'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Achieving Mean Serum Phosphorus Levels Above 2.5 mg/dL at the End of the Dose Intervals Between Baseline and Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Burosumab', 'description': 'Participants received burosumab at a starting dose of 0.3 mg/kg administered subcutaneously (SC) every 4 weeks (Q4W). Doses may have been titrated up to a maximum of 2.0 mg/kg every 2 weeks (Q2W) in order to achieve fasting peak serum phosphorus levels within the target range of 2.5 to 4.0 mg/dL.'}], 'classes': [{'categories': [{'measurements': [{'value': '21.4', 'groupId': 'OG000', 'lowerLimit': '7.57', 'upperLimit': '47.59'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'End of each dose interval from Baseline to Week 24 (Weeks 4, 8, 12, 16, 20, and 24)', 'description': 'The percentage of participants achieving mean serum phosphorus levels above the lower limit of normal (2.5 mg/dL \\[0.81 mmol/L\\]) at the end of the dose interval (4 weeks post-dose, prior to the next dose), as averaged across dose cycles between Baseline and Week 24 (i.e. the average of serum phosphorus levels at Weeks 4, 8, 12, 16, 20, and 24).', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'TIO analysis set'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline in Serum Phosphorus Levels at the Mid-Point of the Dose Interval, as Averaged Across Dose Cycles Between Baseline and Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Burosumab', 'description': 'Participants received burosumab at a starting dose of 0.3 mg/kg administered subcutaneously (SC) every 4 weeks (Q4W). Doses may have been titrated up to a maximum of 2.0 mg/kg every 2 weeks (Q2W) in order to achieve fasting peak serum phosphorus levels within the target range of 2.5 to 4.0 mg/dL.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.039', 'spread': '0.5622', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and the mid-point of each dose interval from Baseline to Week 24 (Weeks 2, 6, 10, 14 and 22)', 'description': 'Mean change from Baseline to the mid-point of the dose interval (2 weeks after dosing) averaged across dose cycles between Baseline and Week 24 (i.e. the average of serum phosphorus levels at Weeks 2, 6, 10, 14 and 22).', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'TIO analysis set'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in Serum Phosphorus Levels at the Mid-Point of the Dose Interval, as Averaged Across Dose Cycles Between Baseline and Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Burosumab', 'description': 'Participants received burosumab at a starting dose of 0.3 mg/kg administered subcutaneously (SC) every 4 weeks (Q4W). Doses may have been titrated up to a maximum of 2.0 mg/kg every 2 weeks (Q2W) in order to achieve fasting peak serum phosphorus levels within the target range of 2.5 to 4.0 mg/dL.'}], 'classes': [{'categories': [{'measurements': [{'value': '69.77', 'spread': '43.743', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and the mid-point of each dose interval from Baseline to Week 24 (Weeks 2, 6, 10, 14 and 22)', 'description': 'Mean percent change from Baseline to the mid-point of the dose interval (2 weeks after dosing) averaged across dose cycles between Baseline and Week 24 (i.e. the average of serum phosphorus levels at Weeks 2, 6, 10, 14 and 22).', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'TIO analysis set'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline in Serum Phosphorus Levels at the End of the Dosing Cycle, as Averaged Across Dose Cycles Between Baseline and Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Burosumab', 'description': 'Participants received burosumab at a starting dose of 0.3 mg/kg administered subcutaneously (SC) every 4 weeks (Q4W). Doses may have been titrated up to a maximum of 2.0 mg/kg every 2 weeks (Q2W) in order to achieve fasting peak serum phosphorus levels within the target range of 2.5 to 4.0 mg/dL.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.550', 'spread': '0.4260', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Weeks 4, 8, 12, 16, 20, and 24', 'description': 'Mean change from Baseline at the end of the dose interval (4 weeks post-dose, prior to the next dose) averaged across dose cycles between Baseline and Week 24 (i.e. the average of serum phosphorus levels at Weeks 4, 8, 12, 16, 20, and 24).', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'TIO analysis set'}, {'type': 'SECONDARY', 'title': 'Percent Mean Change From Baseline in Serum Phosphorus Levels at the End of the Dosing Cycle, as Averaged Across Dose Cycles Between Baseline and Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Burosumab', 'description': 'Participants received burosumab at a starting dose of 0.3 mg/kg administered subcutaneously (SC) every 4 weeks (Q4W). Doses may have been titrated up to a maximum of 2.0 mg/kg every 2 weeks (Q2W) in order to achieve fasting peak serum phosphorus levels within the target range of 2.5 to 4.0 mg/dL.'}], 'classes': [{'categories': [{'measurements': [{'value': '38.56', 'spread': '33.027', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Weeks 4, 8, 12, 16, 20, and 24', 'description': 'Mean percent change from Baseline at the end of the dose interval (4 weeks post-dose, prior to the next dose) averaged across dose cycles between Baseline and Week 24 (i.e. the average of serum phosphorus levels at Weeks 4, 8, 12, 16, 20, and 24).', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'TIO analysis set'}, {'type': 'SECONDARY', 'title': 'Time-Adjusted Area Under the Curve (AUC) of Serum Phosphorus Levels Between Baseline and Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Burosumab', 'description': 'Participants received burosumab at a starting dose of 0.3 mg/kg administered subcutaneously (SC) every 4 weeks (Q4W). Doses may have been titrated up to a maximum of 2.0 mg/kg every 2 weeks (Q2W) in order to achieve fasting peak serum phosphorus levels within the target range of 2.5 to 4.0 mg/dL.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.36', 'spread': '0.632', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-dose on Day 1 and at Weeks 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 21, 22, and 24', 'description': 'Serum phosphorus level versus time AUC was calculated using the trapezoidal rule. Time-adjusted AUC was calculated by dividing the AUC by duration of time included in AUC calculation.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'TIO analysis set'}, {'type': 'SECONDARY', 'title': 'Change From Baseline Over Time in Serum 1,25-dihydroxyvitamin D (1,25(OH)2D) Concentration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Burosumab', 'description': 'Participants received burosumab at a starting dose of 0.3 mg/kg administered subcutaneously (SC) every 4 weeks (Q4W). Doses may have been titrated up to a maximum of 2.0 mg/kg every 2 weeks (Q2W) in order to achieve fasting peak serum phosphorus levels within the target range of 2.5 to 4.0 mg/dL.'}], 'classes': [{'title': 'Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '9.90', 'spread': '4.10', 'groupId': 'OG000'}]}]}, {'title': 'Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '10.49', 'spread': '4.82', 'groupId': 'OG000'}]}]}, {'title': 'Week 96', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4.28', 'spread': '3.80', 'groupId': 'OG000'}]}]}, {'title': 'Week 144', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3.15', 'spread': '3.34', 'groupId': 'OG000'}]}]}, {'title': 'Week 168', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4.91', 'spread': '3.94', 'groupId': 'OG000'}]}]}, {'title': 'Week 192', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.67', 'spread': '4.19', 'groupId': 'OG000'}]}]}, {'title': 'Week 216', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '9.78', 'spread': '3.04', 'groupId': 'OG000'}]}]}, {'title': 'Week 240', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '6.56', 'spread': '3.19', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.016', 'groupIds': ['OG000'], 'groupDescription': 'Week 24', 'statisticalMethod': 'GEE model', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline 1,25(OH)2D.'}, {'pValue': '0.030', 'groupIds': ['OG000'], 'groupDescription': 'Week 48', 'statisticalMethod': 'GEE model', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline 1,25(OH)2D.'}, {'pValue': '0.259', 'groupIds': ['OG000'], 'groupDescription': 'Week 96', 'statisticalMethod': 'GEE model', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline 1,25(OH)2D.'}, {'pValue': '0.346', 'groupIds': ['OG000'], 'groupDescription': 'Week 144', 'statisticalMethod': 'GEE model', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline 1,25(OH)2D.'}, {'pValue': '0.213', 'groupIds': ['OG000'], 'groupDescription': 'Week 168', 'statisticalMethod': 'GEE model', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline 1,25(OH)2D.'}, {'pValue': '0.873', 'groupIds': ['OG000'], 'groupDescription': 'Week 192', 'statisticalMethod': 'GEE model', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline 1,25(OH)2D.'}, {'pValue': '0.001', 'groupIds': ['OG000'], 'groupDescription': 'Week 216', 'statisticalMethod': 'GEE model', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline 1,25(OH)2D.'}, {'pValue': '0.040', 'groupIds': ['OG000'], 'groupDescription': 'Week 240', 'statisticalMethod': 'GEE model', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline 1,25(OH)2D.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Weeks 24, 48, 96, 144, 168, 192, 216, and 240', 'description': 'Least squares (LS) means and standard errors (SE) were estimated from a generalized estimation equation (GEE) model which includes the change from Baseline as the dependent variable, time as the categorical variable and adjusted for Baseline 1,25(OH)2D, with compound symmetry covariance structure.', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'TIO analysis set participants with available data at Baseline and each time point.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline Over Time in Total Serum Fibroblast Growth Factor 23 (FGF23) Concentration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Burosumab', 'description': 'Participants received burosumab at a starting dose of 0.3 mg/kg administered subcutaneously (SC) every 4 weeks (Q4W). Doses may have been titrated up to a maximum of 2.0 mg/kg every 2 weeks (Q2W) in order to achieve fasting peak serum phosphorus levels within the target range of 2.5 to 4.0 mg/dL.'}], 'classes': [{'title': 'Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '246335.35', 'spread': '61089.98', 'groupId': 'OG000'}]}]}, {'title': 'Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '180511.74', 'spread': '33529.14', 'groupId': 'OG000'}]}]}, {'title': 'Week 96', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '331267.40', 'spread': '103226.37', 'groupId': 'OG000'}]}]}, {'title': 'Week 144', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '275758.40', 'spread': '102349.79', 'groupId': 'OG000'}]}]}, {'title': 'Week 168', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '185769.23', 'spread': '65423.93', 'groupId': 'OG000'}]}]}, {'title': 'Week 192', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '234826.20', 'spread': '82198.24', 'groupId': 'OG000'}]}]}, {'title': 'Week 216', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '254359.96', 'spread': '81615.67', 'groupId': 'OG000'}]}]}, {'title': 'Week 240', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '210119.10', 'spread': '76610.50', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000'], 'groupDescription': 'Week 24', 'statisticalMethod': 'GEE model', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline total FGF23.'}, {'pValue': '<0.0001', 'groupIds': ['OG000'], 'groupDescription': 'Week 48', 'statisticalMethod': 'GEE model', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline total FGF23.'}, {'pValue': '0.001', 'groupIds': ['OG000'], 'groupDescription': 'Week 96', 'statisticalMethod': 'GEE model', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline total FGF23.'}, {'pValue': '0.007', 'groupIds': ['OG000'], 'groupDescription': 'Week 144', 'statisticalMethod': 'GEE model', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline total FGF23.'}, {'pValue': '0.005', 'groupIds': ['OG000'], 'groupDescription': 'Week 168', 'statisticalMethod': 'GEE model', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline total FGF23.'}, {'pValue': '0.004', 'groupIds': ['OG000'], 'groupDescription': 'Week 192', 'statisticalMethod': 'GEE model', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline total FGF23.'}, {'pValue': '0.002', 'groupIds': ['OG000'], 'groupDescription': 'Week 216', 'statisticalMethod': 'GEE model', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline total FGF23.'}, {'pValue': '0.006', 'groupIds': ['OG000'], 'groupDescription': 'Week 240', 'statisticalMethod': 'GEE model', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline total FGF23.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Weeks 24, 48, 96, 144, 168, 192, 216, and 240', 'description': 'Total FGF23 included free FGF23 and FGF23 bound to burosumab. Least squares means and standard errors were estimated from a generalized estimation equation (GEE) model which includes the change from Baseline as the dependent variable, time as the categorical variable and adjusted for Baseline total FGF23, with compound symmetry covariance structure.', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'TIO analysis set with available data at each time point'}, {'type': 'SECONDARY', 'title': 'Change From Baseline Over Time in Free Serum Fibroblast Growth Factor 23 (FGF23) Concentration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Burosumab', 'description': 'Participants received burosumab at a starting dose of 0.3 mg/kg administered subcutaneously (SC) every 4 weeks (Q4W). Doses may have been titrated up to a maximum of 2.0 mg/kg every 2 weeks (Q2W) in order to achieve fasting peak serum phosphorus levels within the target range of 2.5 to 4.0 mg/dL.'}], 'classes': [{'title': 'Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '624.91', 'spread': '101.89', 'groupId': 'OG000'}]}]}, {'title': 'Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '578.07', 'spread': '95.37', 'groupId': 'OG000'}]}]}, {'title': 'Week 96', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '736.59', 'spread': '139.18', 'groupId': 'OG000'}]}]}, {'title': 'Week 144', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '801.69', 'spread': '103.41', 'groupId': 'OG000'}]}]}, {'title': 'Week 168', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '787.16', 'spread': '95.52', 'groupId': 'OG000'}]}]}, {'title': 'Week 192', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '717.71', 'spread': '115.99', 'groupId': 'OG000'}]}]}, {'title': 'Week 216', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '704.87', 'spread': '115.30', 'groupId': 'OG000'}]}]}, {'title': 'Week 240', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '625.16', 'spread': '125.93', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '< 0.001', 'groupIds': ['OG000'], 'groupDescription': 'Week 24', 'statisticalMethod': 'GEE model', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline free FGF23.'}, {'pValue': '< 0.001', 'groupIds': ['OG000'], 'groupDescription': 'Week 48', 'statisticalMethod': 'GEE model', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline free FGF23.'}, {'pValue': '<0.001', 'groupIds': ['OG000'], 'groupDescription': 'Week 96', 'statisticalMethod': 'GEE model', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline free FGF23.'}, {'pValue': '< 0.001', 'groupIds': ['OG000'], 'groupDescription': 'Week 144', 'statisticalMethod': 'GEE model', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline free FGF23.'}, {'pValue': '< 0.001', 'groupIds': ['OG000'], 'groupDescription': 'Week 168', 'statisticalMethod': 'GEE model', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline free FGF23.'}, {'pValue': '< 0.001', 'groupIds': ['OG000'], 'groupDescription': 'Week 192', 'statisticalMethod': 'GEE model', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline free FGF23.'}, {'pValue': '< 0.001', 'groupIds': ['OG000'], 'groupDescription': 'Week 216', 'statisticalMethod': 'GEE model', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline free FGF23.'}, {'pValue': '< 0.001', 'groupIds': ['OG000'], 'groupDescription': 'Week 240', 'statisticalMethod': 'GEE model', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline free FGF23.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Weeks 24, 48, 96, 144, 168, 192, 216, and 240', 'description': 'Least squares means and standard errors were estimated from a generalized estimation equation (GEE) model which includes the change from Baseline as the dependent variable, time as the categorical variable and adjusted for Baseline free FGF23, with compound symmetry covariance structure.', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'TIO analysis set with available data at each time point'}, {'type': 'SECONDARY', 'title': 'Change From Baseline Over Time in 24-hour Urinary Phosphorus', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Burosumab', 'description': 'Participants received burosumab at a starting dose of 0.3 mg/kg administered subcutaneously (SC) every 4 weeks (Q4W). Doses may have been titrated up to a maximum of 2.0 mg/kg every 2 weeks (Q2W) in order to achieve fasting peak serum phosphorus levels within the target range of 2.5 to 4.0 mg/dL.'}], 'classes': [{'title': 'Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-3.66', 'spread': '8.28', 'groupId': 'OG000'}]}]}, {'title': 'Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3.59', 'spread': '6.73', 'groupId': 'OG000'}]}]}, {'title': 'Week 96', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3.22', 'spread': '6.40', 'groupId': 'OG000'}]}]}, {'title': 'Week 144', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3.25', 'spread': '6.971', 'groupId': 'OG000'}]}]}, {'title': 'Week 168', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4.98', 'spread': '8.18', 'groupId': 'OG000'}]}]}, {'title': 'Week 192', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '8.31', 'spread': '4.54', 'groupId': 'OG000'}]}]}, {'title': 'Week 216', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '13.93', 'spread': '14.30', 'groupId': 'OG000'}]}]}, {'title': 'Week 240', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '13.11', 'spread': '9.35', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.659', 'groupIds': ['OG000'], 'groupDescription': 'Week 24', 'statisticalMethod': 'GEE model', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline 24-hour urinary phosphorus.'}, {'pValue': '0.752', 'groupIds': ['OG000'], 'groupDescription': 'Week 48', 'statisticalMethod': 'GEE model', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline 24-hour urinary phosphorus.'}, {'pValue': '0.594', 'groupIds': ['OG000'], 'groupDescription': 'Week 96', 'statisticalMethod': 'GEE model', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline 24-hour urinary phosphorus.'}, {'pValue': '0.614', 'groupIds': ['OG000'], 'groupDescription': 'Week 144', 'statisticalMethod': 'GEE model', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline 24-hour urinary phosphorus.'}, {'pValue': '0.542', 'groupIds': ['OG000'], 'groupDescription': 'Week 168', 'statisticalMethod': 'GEE model', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline 24-hour urinary phosphorus.'}, {'pValue': '0.067', 'groupIds': ['OG000'], 'groupDescription': 'Week 192', 'statisticalMethod': 'GEE model', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline 24-hour urinary phosphorus.'}, {'pValue': '0.330', 'groupIds': ['OG000'], 'groupDescription': 'Week 216', 'statisticalMethod': 'GEE model', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline 24-hour urinary phosphorus.'}, {'pValue': '0.161', 'groupIds': ['OG000'], 'groupDescription': 'Week 240', 'statisticalMethod': 'GEE model', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline 24-hour urinary phosphorus.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Weeks 24, 48, 96, 144, 168, 192, 216, and 240', 'description': 'Least squares means and standard errors were estimated from a generalized estimation equation (GEE) model which includes the change from Baseline as the dependent variable, time as the categorical variable and adjusted for Baseline 24-hour urinary phosphorus, with compound symmetry covariance structure.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'TIO analysis set participants with available data at each time point.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline Over Time in Tubular Reabsorption of Phosphate (TRP)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Burosumab', 'description': 'Participants received burosumab at a starting dose of 0.3 mg/kg administered subcutaneously (SC) every 4 weeks (Q4W). Doses may have been titrated up to a maximum of 2.0 mg/kg every 2 weeks (Q2W) in order to achieve fasting peak serum phosphorus levels within the target range of 2.5 to 4.0 mg/dL.'}], 'classes': [{'title': 'Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.13', 'spread': '0.02', 'groupId': 'OG000'}]}]}, {'title': 'Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.14', 'spread': '0.02', 'groupId': 'OG000'}]}]}, {'title': 'Week 96', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.10', 'spread': '0.03', 'groupId': 'OG000'}]}]}, {'title': 'Week 144', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.13', 'spread': '0.02', 'groupId': 'OG000'}]}]}, {'title': 'Week 168', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.12', 'spread': '0.02', 'groupId': 'OG000'}]}]}, {'title': 'Week 192', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.14', 'spread': '0.02', 'groupId': 'OG000'}]}]}, {'title': 'Week 216', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.14', 'spread': '0.01', 'groupId': 'OG000'}]}]}, {'title': 'Week 240', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.12', 'spread': '0.02', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '< 0.001', 'groupIds': ['OG000'], 'groupDescription': 'Week 24', 'statisticalMethod': 'GEE model', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline TRP.'}, {'pValue': '< 0.001', 'groupIds': ['OG000'], 'groupDescription': 'Week 48', 'statisticalMethod': 'GEE model', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline TRP.'}, {'pValue': '0.001', 'groupIds': ['OG000'], 'groupDescription': 'Week 96', 'statisticalMethod': 'GEE model', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline TRP.'}, {'pValue': '< 0.001', 'groupIds': ['OG000'], 'groupDescription': 'Week 144', 'statisticalMethod': 'GEE model', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline TRP.'}, {'pValue': '< 0.001', 'groupIds': ['OG000'], 'groupDescription': 'Week 168', 'statisticalMethod': 'GEE model', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline TRP.'}, {'pValue': '< 0.001', 'groupIds': ['OG000'], 'groupDescription': 'Week 192', 'statisticalMethod': 'GEE model', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline TRP.'}, {'pValue': '< 0.001', 'groupIds': ['OG000'], 'groupDescription': 'Week 216', 'statisticalMethod': 'GEE model', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline TRP.'}, {'pValue': '< 0.001', 'groupIds': ['OG000'], 'groupDescription': 'Week 240', 'statisticalMethod': 'GEE model', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline TRP.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Weeks 24, 48, 96, 144, 168, 192, 216, and 240', 'description': 'Tubular reabsorption of phosphate (TRP) is the fraction of filtered phosphorus that is reabsorbed by renal tubules.\n\nLeast squares means and standard errors were estimated from a generalized estimation equation (GEE) model which includes the change from Baseline as the dependent variable, time as the categorical variable and adjusted for Baseline TRP, with compound symmetry covariance structure.', 'unitOfMeasure': 'fraction of phosphorus reabsorbed', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'TIO analysis set participants with available data at Baseline and each time point.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline Over Time in Ratio of Renal Tubular Maximum Phosphate Reabsorption Rate to Glomerular Filtration Rate (TmP/GFR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Burosumab', 'description': 'Participants received burosumab at a starting dose of 0.3 mg/kg administered subcutaneously (SC) every 4 weeks (Q4W). Doses may have been titrated up to a maximum of 2.0 mg/kg every 2 weeks (Q2W) in order to achieve fasting peak serum phosphorus levels within the target range of 2.5 to 4.0 mg/dL.'}], 'classes': [{'title': 'Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.81', 'spread': '0.13', 'groupId': 'OG000'}]}]}, {'title': 'Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.88', 'spread': '0.14', 'groupId': 'OG000'}]}]}, {'title': 'Week 96', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.73', 'spread': '0.23', 'groupId': 'OG000'}]}]}, {'title': 'Week 144', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.13', 'spread': '0.02', 'groupId': 'OG000'}]}]}, {'title': 'Week 168', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.07', 'spread': '0.29', 'groupId': 'OG000'}]}]}, {'title': 'Week 192', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.95', 'spread': '0.16', 'groupId': 'OG000'}]}]}, {'title': 'Week 216', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.88', 'spread': '0.12', 'groupId': 'OG000'}]}]}, {'title': 'Week 240', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.94', 'spread': '0.15', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '< 0.001', 'groupIds': ['OG000'], 'groupDescription': 'Week 24', 'statisticalMethod': 'GEE model', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline TmP/GFR'}, {'pValue': '< 0.001', 'groupIds': ['OG000'], 'groupDescription': 'Week 48', 'statisticalMethod': 'GEE model', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline TmP/GFR'}, {'pValue': '0.002', 'groupIds': ['OG000'], 'groupDescription': 'Week 96', 'statisticalMethod': 'GEE model', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline TmP/GFR'}, {'pValue': '< 0.001', 'groupIds': ['OG000'], 'groupDescription': 'Week 144', 'statisticalMethod': 'GEE model', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline TmP/GFR'}, {'pValue': '< 0.001', 'groupIds': ['OG000'], 'groupDescription': 'Week 168', 'statisticalMethod': 'GEE model', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline TmP/GFR.'}, {'pValue': '< 0.001', 'groupIds': ['OG000'], 'groupDescription': 'Week 192', 'statisticalMethod': 'GEE model', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline TmP/GFR.'}, {'pValue': '< 0.001', 'groupIds': ['OG000'], 'groupDescription': 'Week 216', 'statisticalMethod': 'GEE model', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline TmP/GFR.'}, {'pValue': '< 0.001', 'groupIds': ['OG000'], 'groupDescription': 'Week 240', 'statisticalMethod': 'GEE model', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline TmP/GFR.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Weeks 24, 48, 96, 144, 168, 192, 216, and 240', 'description': 'TmP/GFR measures renal phosphate reabsorption (the primary mechanism by which FGF23 regulates phosphate homeostasis) by comparing the fractional absorption of phosphate relative to the estimated rate of glomerular filtration.\n\nLeast squares means and standard errors were estimated from a generalized estimation equation (GEE) model which includes the change from Baseline as the dependent variable, time as the categorical variable and adjusted for Baseline TmP/GFR, with compound symmetry covariance structure.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'TIO analysis set participants with available data at Baseline and each time point.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline Over Time in Fractional Excretion of Phosphorus (FEP)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Burosumab', 'description': 'Participants received burosumab at a starting dose of 0.3 mg/kg administered subcutaneously (SC) every 4 weeks (Q4W). Doses may have been titrated up to a maximum of 2.0 mg/kg every 2 weeks (Q2W) in order to achieve fasting peak serum phosphorus levels within the target range of 2.5 to 4.0 mg/dL.'}], 'classes': [{'title': 'Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.14', 'spread': '0.02', 'groupId': 'OG000'}]}]}, {'title': 'Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.14', 'spread': '0.02', 'groupId': 'OG000'}]}]}, {'title': 'Week 96', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.10', 'spread': '0.03', 'groupId': 'OG000'}]}]}, {'title': 'Week 144', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.15', 'spread': '0.02', 'groupId': 'OG000'}]}]}, {'title': 'Week 168', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.14', 'spread': '0.02', 'groupId': 'OG000'}]}]}, {'title': 'Week 192', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.14', 'spread': '0.02', 'groupId': 'OG000'}]}]}, {'title': 'Week 216', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.15', 'spread': '0.01', 'groupId': 'OG000'}]}]}, {'title': 'Week 240', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.14', 'spread': '0.02', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '< 0.001', 'groupIds': ['OG000'], 'groupDescription': 'Week 24', 'statisticalMethod': 'GEE model', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline FEP.'}, {'pValue': '< 0.001', 'groupIds': ['OG000'], 'groupDescription': 'Week 48', 'statisticalMethod': 'GEE model', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline FEP.'}, {'pValue': '< 0.001', 'groupIds': ['OG000'], 'groupDescription': 'Week 96', 'statisticalMethod': 'GEE model', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline FEP.'}, {'pValue': '< 0.001', 'groupIds': ['OG000'], 'groupDescription': 'Week 144', 'statisticalMethod': 'GEE model', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline FEP.'}, {'pValue': '< 0.001', 'groupIds': ['OG000'], 'groupDescription': 'Week 168', 'statisticalMethod': 'GEE model', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline FEP.'}, {'pValue': '< 0.001', 'groupIds': ['OG000'], 'groupDescription': 'Week 192', 'statisticalMethod': 'GEE model', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline FEP.'}, {'pValue': '< 0.001', 'groupIds': ['OG000'], 'groupDescription': 'Week 216', 'statisticalMethod': 'GEE model', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline FEP.'}, {'pValue': '< 0.001', 'groupIds': ['OG000'], 'groupDescription': 'Week 240', 'statisticalMethod': 'GEE model', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline FEP.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Weeks 24, 48, 96, 144, 168, 192, 216, and 240', 'description': 'FEP is the percentage of phosphorus filtered by the kidney that is excreted into urine, calculated as 100% \\* (2-hour urine phosphorus\\*serum creatinine)/(2-hour urine creatinine \\* serum phosphorus).\n\nLeast squares means and standard errors were estimated from a generalized estimation equation (GEE) model which includes the change from Baseline as the dependent variable, time as the categorical variable and adjusted for Baseline FEP, with compound symmetry covariance structure.', 'unitOfMeasure': 'percentage of phosphorus', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'TIO analysis set participants with available data at each time point.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline Over Time in Serum Alkaline Phosphatase (ALP)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Burosumab', 'description': 'Participants received burosumab at a starting dose of 0.3 mg/kg administered subcutaneously (SC) every 4 weeks (Q4W). Doses may have been titrated up to a maximum of 2.0 mg/kg every 2 weeks (Q2W) in order to achieve fasting peak serum phosphorus levels within the target range of 2.5 to 4.0 mg/dL.'}], 'classes': [{'title': 'Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.68', 'spread': '10.91', 'groupId': 'OG000'}]}]}, {'title': 'Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-20.36', 'spread': '11.68', 'groupId': 'OG000'}]}]}, {'title': 'Week 96', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-38.23', 'spread': '11.90', 'groupId': 'OG000'}]}]}, {'title': 'Week 144', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-57.45', 'spread': '10.97', 'groupId': 'OG000'}]}]}, {'title': 'Week 168', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-62.80', 'spread': '12.35', 'groupId': 'OG000'}]}]}, {'title': 'Week 192', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-60.40', 'spread': '12.41', 'groupId': 'OG000'}]}]}, {'title': 'Week 216', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-50.14', 'spread': '26.09', 'groupId': 'OG000'}]}]}, {'title': 'Week 240', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-49.71', 'spread': '24.35', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.878', 'groupIds': ['OG000'], 'groupDescription': 'Week 24', 'statisticalMethod': 'GEE model', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline ALP.'}, {'pValue': '0.081', 'groupIds': ['OG000'], 'groupDescription': 'Week 48', 'statisticalMethod': 'GEE model', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline ALP.'}, {'pValue': '0.001', 'groupIds': ['OG000'], 'groupDescription': 'Week 96', 'statisticalMethod': 'GEE model', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline ALP.'}, {'pValue': '< 0.001', 'groupIds': ['OG000'], 'groupDescription': 'Week 144', 'statisticalMethod': 'GEE model', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline ALP.'}, {'pValue': '< 0.001', 'groupIds': ['OG000'], 'groupDescription': 'Week 168', 'statisticalMethod': 'GEE model', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline ALP.'}, {'pValue': '< 0.001', 'groupIds': ['OG000'], 'groupDescription': 'Week 192', 'statisticalMethod': 'GEE model', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline ALP.'}, {'pValue': '0.055', 'groupIds': ['OG000'], 'groupDescription': 'Week 216', 'statisticalMethod': 'GEE model', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline ALP.'}, {'pValue': '0.041', 'groupIds': ['OG000'], 'groupDescription': 'Week 240', 'statisticalMethod': 'GEE model', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline ALP.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Weeks 24, 48, 96, 144, 168, 192, 216, and 240', 'description': 'Least squares means and standard errors were estimated from a generalized estimation equation (GEE) model which includes the change from Baseline as the dependent variable, time as the categorical variable and adjusted for Baseline ALP, with compound symmetry covariance structure.', 'unitOfMeasure': 'U/L', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'TIO analysis set participants with available data at each time point.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline Over Time in Bone-Specific Alkaline Phosphatase (BALP)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Burosumab', 'description': 'Participants received burosumab at a starting dose of 0.3 mg/kg administered subcutaneously (SC) every 4 weeks (Q4W). Doses may have been titrated up to a maximum of 2.0 mg/kg every 2 weeks (Q2W) in order to achieve fasting peak serum phosphorus levels within the target range of 2.5 to 4.0 mg/dL.'}], 'classes': [{'title': 'Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.13', 'spread': '4.87', 'groupId': 'OG000'}]}]}, {'title': 'Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-9.65', 'spread': '4.74', 'groupId': 'OG000'}]}]}, {'title': 'Week 96', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-15.89', 'spread': '4.27', 'groupId': 'OG000'}]}]}, {'title': 'Week 144', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-19.81', 'spread': '4.42', 'groupId': 'OG000'}]}]}, {'title': 'Week 168', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-22.05', 'spread': '4.52', 'groupId': 'OG000'}]}]}, {'title': 'Week 192', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-21.54', 'spread': '4.87', 'groupId': 'OG000'}]}]}, {'title': 'Week 216', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-15.50', 'spread': '11.39', 'groupId': 'OG000'}]}]}, {'title': 'Week 240', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-21.58', 'spread': '6.17', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.817', 'groupIds': ['OG000'], 'groupDescription': 'Week 24', 'statisticalMethod': 'GEE model', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline BALP.'}, {'pValue': '0.042', 'groupIds': ['OG000'], 'groupDescription': 'Week 48', 'statisticalMethod': 'GEE model', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline BALP.'}, {'pValue': '< 0.001', 'groupIds': ['OG000'], 'groupDescription': 'Week 96', 'statisticalMethod': 'GEE model', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline BALP.'}, {'pValue': '< 0.001', 'groupIds': ['OG000'], 'groupDescription': 'Week 144', 'statisticalMethod': 'GEE model', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline BALP.'}, {'pValue': '< 0.001', 'groupIds': ['OG000'], 'groupDescription': 'Week 168', 'statisticalMethod': 'GEE model', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline BALP.'}, {'pValue': '< 0.001', 'groupIds': ['OG000'], 'groupDescription': 'Week 192', 'statisticalMethod': 'GEE model', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline BALP.'}, {'pValue': '0.174', 'groupIds': ['OG000'], 'groupDescription': 'Week 216', 'statisticalMethod': 'GEE model', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline BALP.'}, {'pValue': '< 0.001', 'groupIds': ['OG000'], 'groupDescription': 'Week 240', 'statisticalMethod': 'GEE model', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline BALP.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Weeks 24, 48, 96, 144, 168, 192, 216, and 240', 'description': 'Least squares means and standard errors were estimated from a generalized estimation equation (GEE) model which includes the change from Baseline as the dependent variable, time as the categorical variable and adjusted for Baseline BALP, with compound symmetry covariance structure.', 'unitOfMeasure': 'μg/L', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'TIO analysis set participants with available data at each time point.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline Over Time in BALP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Burosumab', 'description': 'Participants received burosumab at a starting dose of 0.3 mg/kg administered subcutaneously (SC) every 4 weeks (Q4W). Doses may have been titrated up to a maximum of 2.0 mg/kg every 2 weeks (Q2W) in order to achieve fasting peak serum phosphorus levels within the target range of 2.5 to 4.0 mg/dL.'}], 'classes': [{'title': 'Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '5.15', 'spread': '13.06', 'groupId': 'OG000'}]}]}, {'title': 'Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-16.56', 'spread': '8.35', 'groupId': 'OG000'}]}]}, {'title': 'Week 96', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-30.40', 'spread': '8.57', 'groupId': 'OG000'}]}]}, {'title': 'Week 144', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-35.82', 'spread': '9.47', 'groupId': 'OG000'}]}]}, {'title': 'Week 168', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-40.97', 'spread': '9.60', 'groupId': 'OG000'}]}]}, {'title': 'Week 192', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-41.11', 'spread': '9.93', 'groupId': 'OG000'}]}]}, {'title': 'Week 216', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-28.41', 'spread': '20.71', 'groupId': 'OG000'}]}]}, {'title': 'Week 240', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-42.27', 'spread': '11.65', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.694', 'groupIds': ['OG000'], 'groupDescription': 'Week 24', 'statisticalMethod': 'GEE model', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline BALP.'}, {'pValue': '0.047', 'groupIds': ['OG000'], 'groupDescription': 'Week 48', 'statisticalMethod': 'GEE model', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline BALP.'}, {'pValue': '< 0.001', 'groupIds': ['OG000'], 'groupDescription': 'Week 96', 'statisticalMethod': 'GEE model', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline BALP.'}, {'pValue': '< 0.001', 'groupIds': ['OG000'], 'groupDescription': 'Week 144', 'statisticalMethod': 'GEE model', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline 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'OTHER', 'statisticalComment': 'Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline BALP.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Weeks 24, 48, 96, 144, 168, 192, 216, and 240', 'description': 'Least squares means and standard errors were estimated from a generalized estimation equation (GEE) model which includes the change from Baseline as the dependent variable, time as the categorical variable and adjusted for Baseline BALP, with compound symmetry covariance structure.', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'TIO analysis set participants with available data at each time point.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline Over Time in Carboxy Terminal Cross-Linked Telopeptide of Type 1 Collagen (CTx)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Burosumab', 'description': 'Participants received burosumab at a starting dose of 0.3 mg/kg administered subcutaneously (SC) every 4 weeks (Q4W). 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'groupId': 'OG000'}]}]}, {'title': 'Week 168', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-100.84', 'spread': '49.31', 'groupId': 'OG000'}]}]}, {'title': 'Week 192', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-200.40', 'spread': '65.80', 'groupId': 'OG000'}]}]}, {'title': 'Week 216', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-140.71', 'spread': '94.55', 'groupId': 'OG000'}]}]}, {'title': 'Week 240', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-92.14', 'spread': '102.27', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.090', 'groupIds': ['OG000'], 'groupDescription': 'Week 24', 'statisticalMethod': 'GEE model', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline CTx.'}, {'pValue': '0.226', 'groupIds': ['OG000'], 'groupDescription': 'Week 48', 'statisticalMethod': 'GEE model', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline CTx.'}, {'pValue': '0.918', 'groupIds': ['OG000'], 'groupDescription': 'Week 96', 'statisticalMethod': 'GEE model', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline CTx.'}, {'pValue': '0.616', 'groupIds': ['OG000'], 'groupDescription': 'Week 144', 'statisticalMethod': 'GEE model', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline CTx.'}, {'pValue': '0.041', 'groupIds': ['OG000'], 'groupDescription': 'Week 168', 'statisticalMethod': 'GEE model', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline CTx.'}, {'pValue': '0.002', 'groupIds': ['OG000'], 'groupDescription': 'Week 192', 'statisticalMethod': 'GEE model', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline CTx.'}, {'pValue': '0.137', 'groupIds': ['OG000'], 'groupDescription': 'Week 216', 'statisticalMethod': 'GEE model', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline CTx.'}, {'pValue': '0.368', 'groupIds': ['OG000'], 'groupDescription': 'Week 240', 'statisticalMethod': 'GEE model', 'nonInferiorityType': 'OTHER', 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'groupId': 'OG000'}]}]}, {'title': 'Week 168', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.23', 'spread': '8.29', 'groupId': 'OG000'}]}]}, {'title': 'Week 192', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-15.90', 'spread': '11.21', 'groupId': 'OG000'}]}]}, {'title': 'Week 216', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-10.53', 'spread': '7.40', 'groupId': 'OG000'}]}]}, {'title': 'Week 240', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-5.68', 'spread': '10.26', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.018', 'groupIds': ['OG000'], 'groupDescription': 'Week 24', 'statisticalMethod': 'GEE model', 'nonInferiorityType': 'OTHER', 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'0.788', 'groupIds': ['OG000'], 'groupDescription': 'Week 168', 'statisticalMethod': 'GEE model', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline CTx.'}, {'pValue': '0.156', 'groupIds': ['OG000'], 'groupDescription': 'Week 192', 'statisticalMethod': 'GEE model', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline CTx.'}, {'pValue': '0.155', 'groupIds': ['OG000'], 'groupDescription': 'Week 216', 'statisticalMethod': 'GEE model', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline CTx.'}, {'pValue': '0.580', 'groupIds': ['OG000'], 'groupDescription': 'Week 240', 'statisticalMethod': 'GEE model', 'nonInferiorityType': 'OTHER', 'statisticalComment': 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'Participants received burosumab at a starting dose of 0.3 mg/kg administered subcutaneously (SC) every 4 weeks (Q4W). 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'OG000'}]}]}, {'title': 'Week 168', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-12.04', 'spread': '3.36', 'groupId': 'OG000'}]}]}, {'title': 'Week 192', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-11.93', 'spread': '8.11', 'groupId': 'OG000'}]}]}, {'title': 'Week 216', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-7.53', 'spread': '14.58', 'groupId': 'OG000'}]}]}, {'title': 'Week 240', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.67', 'spread': '14.39', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.002', 'groupIds': ['OG000'], 'groupDescription': 'Week 24', 'statisticalMethod': 'GEE model', 'nonInferiorityType': 'OTHER', 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{'pValue': '< 0.001', 'groupIds': ['OG000'], 'groupDescription': 'Week 168', 'statisticalMethod': 'GEE model', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline P1NP.'}, {'pValue': '0.141', 'groupIds': ['OG000'], 'groupDescription': 'Week 192', 'statisticalMethod': 'GEE model', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline P1NP.'}, {'pValue': '0.606', 'groupIds': ['OG000'], 'groupDescription': 'Week 216', 'statisticalMethod': 'GEE model', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline P1NP.'}, {'pValue': '0.907', 'groupIds': ['OG000'], 'groupDescription': 'Week 240', 'statisticalMethod': 'GEE model', 'nonInferiorityType': 'OTHER', 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Doses may have been titrated up to a maximum of 2.0 mg/kg every 2 weeks (Q2W) in order to achieve fasting peak serum phosphorus levels within the target range of 2.5 to 4.0 mg/dL.'}], 'classes': [{'title': 'Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '53.71', 'spread': '16.35', 'groupId': 'OG000'}]}]}, {'title': 'Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '15.64', 'spread': '10.84', 'groupId': 'OG000'}]}]}, {'title': 'Week 96', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '18.09', 'spread': '20.29', 'groupId': 'OG000'}]}]}, {'title': 'Week 144', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '13.65', 'spread': '8.68', 'groupId': 'OG000'}]}]}, {'title': 'Week 168', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-12.40', 'spread': '4.98', 'groupId': 'OG000'}]}]}, {'title': 'Week 192', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.93', 'spread': '19.78', 'groupId': 'OG000'}]}]}, {'title': 'Week 216', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-7.58', 'spread': '17.45', 'groupId': 'OG000'}]}]}, {'title': 'Week 240', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4.47', 'spread': '16.82', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.001', 'groupIds': ['OG000'], 'groupDescription': 'Week 24', 'statisticalMethod': 'GEE model', 'nonInferiorityType': 'OTHER', 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{'pValue': '0.013', 'groupIds': ['OG000'], 'groupDescription': 'Week 168', 'statisticalMethod': 'GEE model', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline P1NP.'}, {'pValue': '0.962', 'groupIds': ['OG000'], 'groupDescription': 'Week 192', 'statisticalMethod': 'GEE model', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline P1NP.'}, {'pValue': '0.664', 'groupIds': ['OG000'], 'groupDescription': 'Week 216', 'statisticalMethod': 'GEE model', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline P1NP.'}, {'pValue': '0.790', 'groupIds': ['OG000'], 'groupDescription': 'Week 240', 'statisticalMethod': 'GEE model', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline P1NP.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Weeks 24, 48, 96, 144, 168, 192, 216, and 240', 'description': 'Least squares means and standard errors were estimated from a generalized estimation equation (GEE) model which includes the change from Baseline as the dependent variable, time as the categorical variable and adjusted for Baseline P1NP, with compound symmetry covariance structure.', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'TIO analysis set participants with available data at each time point.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline Over Time in Osteocalcin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Burosumab', 'description': 'Participants received burosumab at a starting dose of 0.3 mg/kg administered subcutaneously (SC) every 4 weeks (Q4W). Doses may have been titrated up to a maximum of 2.0 mg/kg every 2 weeks (Q2W) in order to achieve fasting peak serum phosphorus levels within the target range of 2.5 to 4.0 mg/dL.'}], 'classes': [{'title': 'Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '9.51', 'spread': '4.85', 'groupId': 'OG000'}]}]}, {'title': 'Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.20', 'spread': '3.48', 'groupId': 'OG000'}]}]}, {'title': 'Week 96', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.54', 'spread': '2.75', 'groupId': 'OG000'}]}]}, {'title': 'Week 144', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.52', 'spread': '1.89', 'groupId': 'OG000'}]}]}, {'title': 'Week 168', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-3.14', 'spread': '1.35', 'groupId': 'OG000'}]}]}, {'title': 'Week 192', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-6.91', 'spread': '2.49', 'groupId': 'OG000'}]}]}, {'title': 'Week 216', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-7.97', 'spread': '5.35', 'groupId': 'OG000'}]}]}, {'title': 'Week 240', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-8.55', 'spread': '5.22', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.050', 'groupIds': ['OG000'], 'groupDescription': 'Week 24', 'statisticalMethod': 'GEE model', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline osteocalcin.'}, {'pValue': '0.526', 'groupIds': ['OG000'], 'groupDescription': 'Week 48', 'statisticalMethod': 'GEE model', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline osteocalcin.'}, {'pValue': '0.845', 'groupIds': ['OG000'], 'groupDescription': 'Week 96', 'statisticalMethod': 'GEE model', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline osteocalcin.'}, {'pValue': '0.782', 'groupIds': ['OG000'], 'groupDescription': 'Week 144', 'statisticalMethod': 'GEE model', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline osteocalcin.'}, {'pValue': '0.020', 'groupIds': ['OG000'], 'groupDescription': 'Week 168', 'statisticalMethod': 'GEE model', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline osteocalcin.'}, {'pValue': '0.005', 'groupIds': ['OG000'], 'groupDescription': 'Week 192', 'statisticalMethod': 'GEE model', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline osteocalcin.'}, {'pValue': '0.136', 'groupIds': ['OG000'], 'groupDescription': 'Week 216', 'statisticalMethod': 'GEE model', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline osteocalcin.'}, {'pValue': '0.101', 'groupIds': ['OG000'], 'groupDescription': 'Week 240', 'statisticalMethod': 'GEE model', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline osteocalcin.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Weeks 24, 48, 96, 144, 168, 192, 216, and 240', 'description': 'Least squares means and standard errors were estimated from a generalized estimation equation (GEE) model which includes the change from Baseline as the dependent variable, time as the categorical variable and adjusted for Baseline osteocalcin, with compound symmetry covariance structure.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'TIO analysis set with available data at each time point'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline Over Time in Osteocalcin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Burosumab', 'description': 'Participants received burosumab at a starting dose of 0.3 mg/kg administered subcutaneously (SC) every 4 weeks (Q4W). Doses may have been titrated up to a maximum of 2.0 mg/kg every 2 weeks (Q2W) in order to achieve fasting peak serum phosphorus levels within the target range of 2.5 to 4.0 mg/dL.'}], 'classes': [{'title': 'Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '41.49', 'spread': '12.19', 'groupId': 'OG000'}]}]}, {'title': 'Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '16.28', 'spread': '13.79', 'groupId': 'OG000'}]}]}, {'title': 'Week 96', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '15.04', 'spread': '14.10', 'groupId': 'OG000'}]}]}, {'title': 'Week 144', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '14.08', 'spread': '8.38', 'groupId': 'OG000'}]}]}, {'title': 'Week 168', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.98', 'spread': '7.11', 'groupId': 'OG000'}]}]}, {'title': 'Week 192', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-19.67', 'spread': '10.42', 'groupId': 'OG000'}]}]}, {'title': 'Week 216', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-5.65', 'spread': '11.48', 'groupId': 'OG000'}]}]}, {'title': 'Week 240', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-8.37', 'spread': '10.17', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '< 0.001', 'groupIds': ['OG000'], 'groupDescription': 'Week 24', 'statisticalMethod': 'GEE model', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline osteocalcin.'}, {'pValue': '0.238', 'groupIds': ['OG000'], 'groupDescription': 'Week 48', 'statisticalMethod': 'GEE model', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline osteocalcin.'}, {'pValue': '0.286', 'groupIds': ['OG000'], 'groupDescription': 'Week 96', 'statisticalMethod': 'GEE model', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline osteocalcin.'}, {'pValue': '0.093', 'groupIds': ['OG000'], 'groupDescription': 'Week 144', 'statisticalMethod': 'GEE model', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline osteocalcin.'}, {'pValue': '0.890', 'groupIds': ['OG000'], 'groupDescription': 'Week 168', 'statisticalMethod': 'GEE model', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline osteocalcin.'}, {'pValue': '0.059', 'groupIds': ['OG000'], 'groupDescription': 'Week 192', 'statisticalMethod': 'GEE model', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline osteocalcin.'}, {'pValue': '0.623', 'groupIds': ['OG000'], 'pValueComment': 'Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline osteocalcin.', 'groupDescription': 'Week 216', 'statisticalMethod': 'GEE model', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.411', 'groupIds': ['OG000'], 'groupDescription': 'Week 240', 'statisticalMethod': 'GEE model', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline osteocalcin.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Weeks 24, 48, 96, 144, 168, 192, 216, and 240', 'description': 'Least squares means and standard errors were estimated from a generalized estimation equation (GEE) model which includes the change from Baseline as the dependent variable, time as the categorical variable and adjusted for Baseline osteocalcin, with compound symmetry covariance structure.', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'TIO analysis set with available data at each time point'}, {'type': 'SECONDARY', 'title': 'Change From Baseline Over Time in Hand-Held Dynamometry (HHD) Elbow Measurements', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Elbow Flexion', 'description': 'Elbow flexor (biceps brachii, brachioradialis, and brachialis) muscle strength was measured in participants who received burosumab at a starting dose of 0.3 mg/kg administered subcutaneously Q4W. Doses may have been titrated up to a maximum of 2.0 mg/kg Q2W.'}, {'id': 'OG001', 'title': 'Elbow Extension', 'description': 'Elbow extensor (triceps brachii and anconeus) muscle strength was measured in participants who received burosumab at a starting dose of 0.3 mg/kg administered subcutaneously Q4W. Doses may have been titrated up to a maximum of 2.0 mg/kg Q2W.'}], 'classes': [{'title': 'Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.12', 'spread': '0.512', 'groupId': 'OG000'}, {'value': '0.75', 'spread': '0.704', 'groupId': 'OG001'}]}]}, {'title': 'Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.32', 'spread': '0.753', 'groupId': 'OG000'}, {'value': '1.06', 'spread': '0.760', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.8209', 'groupIds': ['OG000'], 'groupDescription': 'Week 24', 'statisticalMethod': 'GEE model', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.'}, {'pValue': '0.2851', 'groupIds': ['OG001'], 'groupDescription': 'Week 24', 'statisticalMethod': 'GEE model', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.'}, {'pValue': '0.6689', 'groupIds': ['OG000'], 'groupDescription': 'Week 48', 'statisticalMethod': 'GEE model', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.'}, {'pValue': '0.1612', 'groupIds': ['OG001'], 'groupDescription': 'Week 48', 'statisticalMethod': 'GEE model', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Weeks 24 and 48', 'description': 'To assess muscle strength, hand-held dynamometry was conducted using a standardized technique. Bilateral strength (defined as the average of the left and the right scores, measured in kilograms) of the elbow flexors and extensors was measured by the maximum voluntary isometric contraction against a dynamometer.\n\nLeast squares means and standard errors were estimated from a generalized estimation equation (GEE) model which includes the change from Baseline as the dependent variable, time as the categorical variable and adjusted for Baseline strength measurements, with compound symmetry covariance structure.', 'unitOfMeasure': 'kg', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'TIO analysis set with available elbow dynamometry measurements at Baseline and each time point.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline Over Time in Hand-Held Dynamometry (HHD) Knee Measurements', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Knee Flexion', 'description': 'Knee flexor (hamstring) muscle strength was measured in participants who received burosumab at a starting dose of 0.3 mg/kg administered subcutaneously Q4W. Doses may have been titrated up to a maximum of 2.0 mg/kg Q2W.'}, {'id': 'OG001', 'title': 'Knee Extension', 'description': 'Knee extensor (quadriceps) muscle strength was measured in participants who received burosumab at a starting dose of 0.3 mg/kg administered subcutaneously Q4W. Doses may have been titrated up to a maximum of 2.0 mg/kg Q2W.'}], 'classes': [{'title': 'Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.94', 'spread': '1.139', 'groupId': 'OG000'}, {'value': '-0.89', 'spread': '1.573', 'groupId': 'OG001'}]}]}, {'title': 'Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.21', 'spread': '1.297', 'groupId': 'OG000'}, {'value': '0.75', 'spread': '1.158', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.4093', 'groupIds': ['OG000'], 'groupDescription': 'Week 24', 'statisticalMethod': 'GEE model', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.'}, {'pValue': '0.5720', 'groupIds': ['OG001'], 'groupDescription': 'Week 24', 'statisticalMethod': 'GEE model', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.'}, {'pValue': '0.3501', 'groupIds': ['OG000'], 'groupDescription': 'Week 48', 'statisticalMethod': 'GEE model', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.'}, {'pValue': '0.5172', 'groupIds': ['OG001'], 'groupDescription': 'Week 48', 'statisticalMethod': 'GEE model', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Weeks 24 and 48', 'description': 'To assess muscle strength, hand-held dynamometry was conducted using a standardized technique. Bilateral strength (defined as the average of the left and the right scores, measured in kilograms) of the knee flexors and extensors was measured by the maximum voluntary isometric contraction against a dynamometer.\n\nLeast squares means and standard errors were estimated from a generalized estimation equation (GEE) model which includes the change from Baseline as the dependent variable, time as the categorical variable and adjusted for Baseline strength measurements, with compound symmetry covariance structure.', 'unitOfMeasure': 'kg', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'TIO analysis set with available knee dynamometry measurements at Baseline and each time point.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline Over Time in Sit-to-Stand (STS) Test', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Burosumab', 'description': 'Participants received burosumab at a starting dose of 0.3 mg/kg administered subcutaneously (SC) every 4 weeks (Q4W). Doses may have been titrated up to a maximum of 2.0 mg/kg every 2 weeks (Q2W) in order to achieve fasting peak serum phosphorus levels within the target range of 2.5 to 4.0 mg/dL.'}], 'classes': [{'title': 'Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.5', 'spread': '0.54', 'groupId': 'OG000'}]}]}, {'title': 'Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.6', 'spread': '0.50', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.0046', 'groupIds': ['OG000'], 'groupDescription': 'Week 24', 'statisticalMethod': 'GEE model', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline STS measurement.'}, {'pValue': '0.0012', 'groupIds': ['OG000'], 'groupDescription': 'Week 48', 'statisticalMethod': 'GEE model', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline STS measurement.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Weeks 24 and 48', 'description': 'The STS test measures lower extremity strength and mobility as a participant moves repeatedly from a seated position to standing. This study used a modified STS test that allowed participants to use the arms of the chair to help them stand and sit if necessary. The number of sit-to-stand repetitions performed in a 30-second period was recorded.\n\nLeast squares means and standard errors were estimated from a generalized estimation equation (GEE) model which includes the change from Baseline as the dependent variable, time as the categorical variable and adjusted for Baseline measurement, with compound symmetry covariance structure.', 'unitOfMeasure': 'sit-to-stand repetitions', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'TIO analysis set with available STS data at each time point; One participant did not perform the test at Baseline as it was not included in the original protocol, and 2 participants were unable to perform the test due to underlying medical issues.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline Over Time in Weighted Arm Lift (WAL) Test', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Left Upper Extremity', 'description': 'Left arm lifts in participants who received burosumab at a starting dose of 0.3 mg/kg administered subcutaneously Q4W, titrated up to a maximum of 2.0 mg/kg Q2W.'}, {'id': 'OG001', 'title': 'Right Upper Extremity', 'description': 'Right arm lifts in participants who received burosumab at a starting dose of 0.3 mg/kg administered subcutaneously Q4W, titrated up to a maximum of 2.0 mg/kg Q2W.'}], 'classes': [{'title': 'Week 24', 'categories': [{'measurements': [{'value': '-0.5', 'spread': '1.09', 'groupId': 'OG000'}, {'value': '0.6', 'spread': '0.89', 'groupId': 'OG001'}]}]}, {'title': 'Week 48', 'categories': [{'measurements': [{'value': '0.1', 'spread': '1.25', 'groupId': 'OG000'}, {'value': '1.7', 'spread': '1.17', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.6475', 'groupIds': ['OG000'], 'groupDescription': 'Week 24', 'statisticalMethod': 'GEE model', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.'}, {'pValue': '0.5319', 'groupIds': ['OG001'], 'groupDescription': 'Week 24', 'statisticalMethod': 'GEE model', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.'}, {'pValue': '0.9206', 'groupIds': ['OG000'], 'groupDescription': 'Week 48', 'statisticalMethod': 'GEE model', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.'}, {'pValue': '0.1530', 'groupIds': ['OG001'], 'groupDescription': 'Week 48', 'statisticalMethod': 'GEE model', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Weeks 24 and 48', 'description': 'The Weighted arm lift (WAL) test assesses upper extremity strength, mobility and reaching ability. The test was administered bilaterally to determine the number of times the participant could raise a 1 kg weight above the head in a 30-second period. The number of repetitions completed with each arm was recorded.\n\nLeast squares means and standard errors were estimated from a generalized estimation equation (GEE) model which includes the change from Baseline as the dependent variable, time as the categorical variable and adjusted for Baseline WAL measurements, with compound symmetry covariance structure.', 'unitOfMeasure': 'arm lifts', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'TIO analysis set with available WAL measurements at Baseline and each time point.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline Over Time in Six-Minute Walk Test (6MWT)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Burosumab', 'description': 'Participants received burosumab at a starting dose of 0.3 mg/kg administered subcutaneously (SC) every 4 weeks (Q4W). Doses may have been titrated up to a maximum of 2.0 mg/kg every 2 weeks (Q2W) in order to achieve fasting peak serum phosphorus levels within the target range of 2.5 to 4.0 mg/dL.'}], 'classes': [{'title': 'Week 24', 'categories': [{'measurements': [{'value': '19.5', 'spread': '15.64', 'groupId': 'OG000'}]}]}, {'title': 'Week 48', 'categories': [{'measurements': [{'value': '25.5', 'spread': '16.58', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.2125', 'groupIds': ['OG000'], 'groupDescription': 'Week 24', 'statisticalMethod': 'GEE model', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.'}, {'pValue': '0.1241', 'groupIds': ['OG000'], 'groupDescription': 'Week 48', 'statisticalMethod': 'GEE model', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Weeks 24 and 48', 'description': 'The 6MWT is a commonly used measure of mobility and was conducted in accordance with general principles set forth in the American Thoracic Society guidelines (ATS 2002). Participants were instructed to walk the length of a pre-measured course for 6 consecutive minutes (assistive devices could be used). The total distance walked at the end of 6 minutes was recorded in meters.\n\nLeast squares means and standard errors were estimated from a generalized estimation equation (GEE) model which includes the change from Baseline as the dependent variable, time as the categorical variable and adjusted for Baseline 6MWT measurement, with compound symmetry covariance structure.', 'unitOfMeasure': 'meters', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'TIO analysis set with available 6MWT measurements at Baseline and each time point. Six participants did not perform the test at Baseline as it was not included in the original protocol, and 2 participants were unable to perform the test due to underlying medical issues.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline Over Time in Brief Pain Inventory (BPI) Worst Pain Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Burosumab', 'description': 'Participants received burosumab at a starting dose of 0.3 mg/kg administered subcutaneously (SC) every 4 weeks (Q4W). Doses may have been titrated up to a maximum of 2.0 mg/kg every 2 weeks (Q2W) in order to achieve fasting peak serum phosphorus levels within the target range of 2.5 to 4.0 mg/dL.'}], 'classes': [{'title': 'Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.6', 'spread': '0.7', 'groupId': 'OG000'}]}]}, {'title': 'Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.9', 'spread': '0.7', 'groupId': 'OG000'}]}]}, {'title': 'Week 96', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.7', 'spread': '0.4', 'groupId': 'OG000'}]}]}, {'title': 'Week 144', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.1', 'spread': '0.6', 'groupId': 'OG000'}]}]}, {'title': 'Week 168', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.9', 'spread': '0.7', 'groupId': 'OG000'}]}]}, {'title': 'Week 192', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.9', 'spread': '0.6', 'groupId': 'OG000'}]}]}, {'title': 'Week 216', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.9', 'spread': '0.8', 'groupId': 'OG000'}]}]}, {'title': 'Week 240', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.9', 'spread': '0.9', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.410', 'groupIds': ['OG000'], 'groupDescription': 'Week 24', 'statisticalMethod': 'GEE model', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.'}, {'pValue': '0.210', 'groupIds': ['OG000'], 'groupDescription': 'Week 48', 'statisticalMethod': 'GEE model', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.'}, {'pValue': '0.060', 'groupIds': ['OG000'], 'groupDescription': 'Week 96', 'statisticalMethod': 'GEE model', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.'}, {'pValue': '0.076', 'groupIds': ['OG000'], 'groupDescription': 'Week 144', 'statisticalMethod': 'GEE model', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.'}, {'pValue': '0.171', 'groupIds': ['OG000'], 'groupDescription': 'Week 168', 'statisticalMethod': 'GEE model', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.'}, {'pValue': '0.141', 'groupIds': ['OG000'], 'groupDescription': 'Week 192', 'statisticalMethod': 'GEE model', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.'}, {'pValue': '0.263', 'groupIds': ['OG000'], 'groupDescription': 'Week 216', 'statisticalMethod': 'GEE model', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.'}, {'pValue': '0.320', 'groupIds': ['OG000'], 'groupDescription': 'Week 240', 'statisticalMethod': 'GEE model', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Weeks 24, 48, 96, 144, 168, 192, 216, and 240', 'description': 'The Brief Pain Inventory (BPI) is a self-reported, pain-specific questionnaire with a recall period of 24 hours. Worst pain is defined as the answer to Question 3, in which participants rated their pain at its worst in the last 24 hours on a scale from 0 (no pain) to 10 (pain as bad as you can imagine).\n\nA negative change from Baseline score indicates improvement.\n\nLeast squares means and standard errors were estimated from a generalized estimation equation (GEE) model which includes the change from Baseline as the dependent variable, time as the categorical variable and adjusted for Baseline BPI measurement, with compound symmetry covariance structure.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'TIO analysis set participants with available data at each time point'}, {'type': 'SECONDARY', 'title': 'Change From Baseline Over Time in Brief Pain Inventory (BPI) Pain Severity Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Burosumab', 'description': 'Participants received burosumab at a starting dose of 0.3 mg/kg administered subcutaneously (SC) every 4 weeks (Q4W). Doses may have been titrated up to a maximum of 2.0 mg/kg every 2 weeks (Q2W) in order to achieve fasting peak serum phosphorus levels within the target range of 2.5 to 4.0 mg/dL.'}], 'classes': [{'title': 'Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.51', 'spread': '0.62', 'groupId': 'OG000'}]}]}, {'title': 'Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.87', 'spread': '0.66', 'groupId': 'OG000'}]}]}, {'title': 'Week 96', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.62', 'spread': '0.38', 'groupId': 'OG000'}]}]}, {'title': 'Week 144', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.99', 'spread': '0.42', 'groupId': 'OG000'}]}]}, {'title': 'Week 168', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.21', 'spread': '0.40', 'groupId': 'OG000'}]}]}, {'title': 'Week 192', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.81', 'spread': '0.66', 'groupId': 'OG000'}]}]}, {'title': 'Week 216', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.75', 'spread': '0.63', 'groupId': 'OG000'}]}]}, {'title': 'Week 240', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.91', 'spread': '0.76', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.407', 'groupIds': ['OG000'], 'groupDescription': 'Week 24', 'statisticalMethod': 'GEE model', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.'}, {'pValue': '0.192', 'groupIds': ['OG000'], 'groupDescription': 'Week 48', 'statisticalMethod': 'GEE model', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.'}, {'pValue': '0.106', 'groupIds': ['OG000'], 'groupDescription': 'Week 96', 'statisticalMethod': 'GEE model', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.'}, {'pValue': '0.020', 'groupIds': ['OG000'], 'groupDescription': 'Week 144', 'statisticalMethod': 'GEE model', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.'}, {'pValue': '0.002', 'groupIds': ['OG000'], 'groupDescription': 'Week 168', 'statisticalMethod': 'GEE model', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.'}, {'pValue': '0.220', 'groupIds': ['OG000'], 'groupDescription': 'Week 192', 'statisticalMethod': 'GEE model', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.'}, {'pValue': '0.230', 'groupIds': ['OG000'], 'groupDescription': 'Week 216', 'statisticalMethod': 'GEE model', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.'}, {'pValue': '0.232', 'groupIds': ['OG000'], 'groupDescription': 'Week 240', 'statisticalMethod': 'GEE model', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Weeks 24, 48, 96, 144, 168, 192, 216, and 240', 'description': 'The Brief Pain Inventory (BPI) is a self-reported, pain-specific questionnaire with a recall period of 24 hours.\n\nPain severity is defined as the average of 4 questions (Questions 3 through 6) assessing worst pain, least pain, average pain, and pain right now, rated on a scale from 0 (no pain) to 10 (pain as bad as you can imagine). Mild pain is defined as a score of 1 to 4, moderate pain is defined as a score of 5 to 6, and severe pain is defined as a score of 7 to 10. A negative change from Baseline score indicates improvement.\n\nLeast squares means and standard errors were estimated from a generalized estimation equation (GEE) model which includes the change from Baseline as the dependent variable, time as the categorical variable and adjusted for Baseline BPI measurement, with compound symmetry covariance structure.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'TIO analysis set participants with available data at each time point'}, {'type': 'SECONDARY', 'title': 'Change From Baseline Over Time in Brief Pain Inventory (BPI) Pain Interference Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Burosumab', 'description': 'Participants received burosumab at a starting dose of 0.3 mg/kg administered subcutaneously (SC) every 4 weeks (Q4W). Doses may have been titrated up to a maximum of 2.0 mg/kg every 2 weeks (Q2W) in order to achieve fasting peak serum phosphorus levels within the target range of 2.5 to 4.0 mg/dL.'}], 'classes': [{'title': 'Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.15', 'spread': '0.66', 'groupId': 'OG000'}]}]}, {'title': 'Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.09', 'spread': '0.80', 'groupId': 'OG000'}]}]}, {'title': 'Week 96', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.08', 'spread': '0.55', 'groupId': 'OG000'}]}]}, {'title': 'Week 144', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.46', 'spread': '0.61', 'groupId': 'OG000'}]}]}, {'title': 'Week 168', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.76', 'spread': '0.37', 'groupId': 'OG000'}]}]}, {'title': 'Week 192', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.11', 'spread': '0.58', 'groupId': 'OG000'}]}]}, {'title': 'Week 216', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.56', 'spread': '0.87', 'groupId': 'OG000'}]}]}, {'title': 'Week 240', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.00', 'spread': '1.10', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.082', 'groupIds': ['OG000'], 'groupDescription': 'Week 24', 'statisticalMethod': 'GEE model', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.'}, {'pValue': '0.176', 'groupIds': ['OG000'], 'groupDescription': 'Week 48', 'statisticalMethod': 'GEE model', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.'}, {'pValue': '0.047', 'groupIds': ['OG000'], 'groupDescription': 'Week 96', 'statisticalMethod': 'GEE model', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.'}, {'pValue': '0.017', 'groupIds': ['OG000'], 'groupDescription': 'Week 144', 'statisticalMethod': 'GEE model', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.'}, {'pValue': '0.000', 'groupIds': ['OG000'], 'groupDescription': 'Week 168', 'statisticalMethod': 'GEE model', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.'}, {'pValue': '0.057', 'groupIds': ['OG000'], 'groupDescription': 'Week 192', 'statisticalMethod': 'GEE model', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.'}, {'pValue': '0.071', 'groupIds': ['OG000'], 'groupDescription': 'Week 216', 'statisticalMethod': 'GEE model', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.'}, {'pValue': '0.070', 'groupIds': ['OG000'], 'groupDescription': 'Week 240', 'statisticalMethod': 'GEE model', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Weeks 24, 48, 96, 144, 168, 192, 216, and 240', 'description': 'The Brief Pain Inventory (BPI) is a self-reported, pain-specific questionnaire with a recall period of 24 hours.\n\nPain interference is defined as the average of 7 questions (9A through 9G) regarding the extent to which pain interfered with daily activities, including general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life in the last 24 hours, rated on a scale from 0 (does not interfere) to 10 (completely interferes).\n\nA negative change from Baseline score indicates improvement. Least squares means and standard errors were estimated from a generalized estimation equation (GEE) model which includes the change from Baseline as the dependent variable, time as the categorical variable and adjusted for Baseline BPI measurement, with compound symmetry covariance structure.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'TIO analysis set participants with available data at each time point'}, {'type': 'SECONDARY', 'title': 'Change From Baseline Over Time in Brief Fatigue Inventory (BFI) Worst Fatigue Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Burosumab', 'description': 'Participants received burosumab at a starting dose of 0.3 mg/kg administered subcutaneously (SC) every 4 weeks (Q4W). Doses may have been titrated up to a maximum of 2.0 mg/kg every 2 weeks (Q2W) in order to achieve fasting peak serum phosphorus levels within the target range of 2.5 to 4.0 mg/dL.'}], 'classes': [{'title': 'Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.3', 'spread': '0.5', 'groupId': 'OG000'}]}]}, {'title': 'Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.9', 'spread': '0.8', 'groupId': 'OG000'}]}]}, {'title': 'Week 96', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.0', 'spread': '0.5', 'groupId': 'OG000'}]}]}, {'title': 'Week 144', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.9', 'spread': '0.6', 'groupId': 'OG000'}]}]}, {'title': 'Week 168', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.6', 'spread': '0.6', 'groupId': 'OG000'}]}]}, {'title': 'Week 192', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.0', 'spread': '0.4', 'groupId': 'OG000'}]}]}, {'title': 'Week 216', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.1', 'spread': '0.9', 'groupId': 'OG000'}]}]}, {'title': 'Week 240', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.6', 'spread': '0.9', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.014', 'groupIds': ['OG000'], 'groupDescription': 'Week 24', 'statisticalMethod': 'GEE model', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.'}, {'pValue': '0.309', 'groupIds': ['OG000'], 'groupDescription': 'Week 48', 'statisticalMethod': 'GEE model', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.'}, {'pValue': '0.036', 'groupIds': ['OG000'], 'groupDescription': 'Week 96', 'statisticalMethod': 'GEE model', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.'}, {'pValue': '0.096', 'groupIds': ['OG000'], 'groupDescription': 'Week 144', 'statisticalMethod': 'GEE model', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.'}, {'pValue': '0.005', 'groupIds': ['OG000'], 'groupDescription': 'Week 168', 'statisticalMethod': 'GEE model', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.'}, {'pValue': '0.022', 'groupIds': ['OG000'], 'groupDescription': 'Week 192', 'statisticalMethod': 'GEE model', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.'}, {'pValue': '0.022', 'groupIds': ['OG000'], 'groupDescription': 'Week 216', 'statisticalMethod': 'GEE model', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.'}, {'pValue': '0.004', 'groupIds': ['OG000'], 'groupDescription': 'Week 240', 'statisticalMethod': 'GEE model', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Weeks 24, 48, 96, 144, 168, 192, 216, and 240', 'description': 'The Brief Fatigue Inventory (BFI) is a self-reported questionnaire consisting of 9 items related to fatigue that are rated on a 0 to 10 numerical rating scale with a recall period of 24 hours.\n\nWorst fatigue is defined as the answer to Question 3 in which participants rated their fatigue at its worst in the last 24 hours on a scale from 0 (no fatigue) to 10 (as bad as you can imagine).\n\nA negative change from Baseline score indicates improvement. Least squares means and standard errors were estimated from a generalized estimation equation (GEE) model which includes the change from Baseline as the dependent variable, time as the categorical variable and adjusted for Baseline BFI measurement, with compound symmetry covariance structure.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'TIO analysis set participants with available data at Baseline and each time point.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline Over Time in Brief Fatigue Inventory (BFI) Fatigue Severity Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Burosumab', 'description': 'Participants received burosumab at a starting dose of 0.3 mg/kg administered subcutaneously (SC) every 4 weeks (Q4W). Doses may have been titrated up to a maximum of 2.0 mg/kg every 2 weeks (Q2W) in order to achieve fasting peak serum phosphorus levels within the target range of 2.5 to 4.0 mg/dL.'}], 'classes': [{'title': 'Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.47', 'spread': '0.53', 'groupId': 'OG000'}]}]}, {'title': 'Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.31', 'spread': '0.56', 'groupId': 'OG000'}]}]}, {'title': 'Week 96', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.58', 'spread': '0.43', 'groupId': 'OG000'}]}]}, {'title': 'Week 144', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.44', 'spread': '0.53', 'groupId': 'OG000'}]}]}, {'title': 'Week 168', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.34', 'spread': '0.43', 'groupId': 'OG000'}]}]}, {'title': 'Week 192', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.62', 'spread': '0.43', 'groupId': 'OG000'}]}]}, {'title': 'Week 216', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.62', 'spread': '0.85', 'groupId': 'OG000'}]}]}, {'title': 'Week 240', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.57', 'spread': '0.81', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.005', 'groupIds': ['OG000'], 'groupDescription': 'Week 24', 'statisticalMethod': 'GEE model', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.'}, {'pValue': '0.019', 'groupIds': ['OG000'], 'groupDescription': 'Week 48', 'statisticalMethod': 'GEE model', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.'}, {'pValue': '< 0.001', 'groupIds': ['OG000'], 'groupDescription': 'Week 96', 'statisticalMethod': 'GEE model', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.'}, {'pValue': '0.006', 'groupIds': ['OG000'], 'groupDescription': 'Week 144', 'statisticalMethod': 'GEE model', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.'}, {'pValue': '< 0.001', 'groupIds': ['OG000'], 'groupDescription': 'Week 168', 'statisticalMethod': 'GEE model', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.'}, {'pValue': '< 0.001', 'groupIds': ['OG000'], 'groupDescription': 'Week 192', 'statisticalMethod': 'GEE model', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.'}, {'pValue': '0.002', 'groupIds': ['OG000'], 'groupDescription': 'Week 216', 'statisticalMethod': 'GEE model', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.'}, {'pValue': '0.002', 'groupIds': ['OG000'], 'groupDescription': 'Week 240', 'statisticalMethod': 'GEE model', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Weeks 24, 48, 96, 144, 168, 192, 216, and 240', 'description': 'The Brief Fatigue Inventory (BFI) is a self-reported questionnaire consisting of 9 items related to fatigue that are rated on a 0 to 10 numerical rating scale with a recall period of 24 hours.\n\nFatigue severity is defined as the average of 3 questions (Questions 1 through 3) assessing fatigue right now, usual level of fatigue, and worst fatigue, rated on a scale from 0 (no fatigue) to 10 (as bad as you can imagine).\n\nA negative change from Baseline score indicates improvement.\n\nLeast squares means and standard errors were estimated from a generalized estimation equation (GEE) model which includes the change from Baseline as the dependent variable, time as the categorical variable and adjusted for Baseline BFI measurement, with compound symmetry covariance structure.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'TIO analysis set participants with available data at Baseline and each time point.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline Over Time in Brief Fatigue Inventory (BFI) Fatigue Interference Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Burosumab', 'description': 'Participants received burosumab at a starting dose of 0.3 mg/kg administered subcutaneously (SC) every 4 weeks (Q4W). Doses may have been titrated up to a maximum of 2.0 mg/kg every 2 weeks (Q2W) in order to achieve fasting peak serum phosphorus levels within the target range of 2.5 to 4.0 mg/dL.'}], 'classes': [{'title': 'Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.57', 'spread': '0.65', 'groupId': 'OG000'}]}]}, {'title': 'Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.88', 'spread': '0.66', 'groupId': 'OG000'}]}]}, {'title': 'Week 96', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.98', 'spread': '0.47', 'groupId': 'OG000'}]}]}, {'title': 'Week 144', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.67', 'spread': '0.44', 'groupId': 'OG000'}]}]}, {'title': 'Week 168', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.20', 'spread': '0.38', 'groupId': 'OG000'}]}]}, {'title': 'Week 192', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.24', 'spread': '0.59', 'groupId': 'OG000'}]}]}, {'title': 'Week 216', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.72', 'spread': '1.02', 'groupId': 'OG000'}]}]}, {'title': 'Week 240', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-3.00', 'spread': '1.14', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.016', 'groupIds': ['OG000'], 'groupDescription': 'Week 24', 'statisticalMethod': 'GEE model', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.'}, {'pValue': '0.004', 'groupIds': ['OG000'], 'groupDescription': 'Week 48', 'statisticalMethod': 'GEE model', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.'}, {'pValue': '< 0.001', 'groupIds': ['OG000'], 'groupDescription': 'Week 96', 'statisticalMethod': 'GEE model', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.'}, {'pValue': '< 0.001', 'groupIds': ['OG000'], 'groupDescription': 'Week 144', 'statisticalMethod': 'GEE model', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.'}, {'pValue': '< 0.001', 'groupIds': ['OG000'], 'groupDescription': 'Week 168', 'statisticalMethod': 'GEE model', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.'}, {'pValue': '0.036', 'groupIds': ['OG000'], 'groupDescription': 'Week 192', 'statisticalMethod': 'GEE model', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.'}, {'pValue': '0.008', 'groupIds': ['OG000'], 'groupDescription': 'Week 216', 'statisticalMethod': 'GEE model', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.'}, {'pValue': '0.008', 'groupIds': ['OG000'], 'groupDescription': 'Week 240', 'statisticalMethod': 'GEE model', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Weeks 24, 48, 96, 144, 168, 192, 216, and 240', 'description': 'The Brief Fatigue Inventory (BFI) is a self-reported questionnaire consisting of 9 items related to fatigue that are rated on a 0 to 10 numerical rating scale with a recall period of 24 hours.\n\nThe fatigue interference score is defined as the average of 6 questions (Questions 4A through 4F) regarding the extent to which fatigue interfered with daily activities, including general activity, mood, walking ability, work, relations with others, and enjoyment of life in the last 24 hours, rated on a scale from 0 (does not interfere) to 10 (completely interferes).\n\nA negative change from Baseline score indicates improvement. Least squares means and standard errors were estimated from a generalized estimation equation (GEE) model which includes the change from Baseline as the dependent variable, time as the categorical variable and adjusted for Baseline BFI measurement, with compound symmetry covariance structure.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'TIO analysis set participants with available data at Baseline and each time point.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline Over Time in Brief Fatigue Inventory (BFI) Global Fatigue Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Burosumab', 'description': 'Participants received burosumab at a starting dose of 0.3 mg/kg administered subcutaneously (SC) every 4 weeks (Q4W). Doses may have been titrated up to a maximum of 2.0 mg/kg every 2 weeks (Q2W) in order to achieve fasting peak serum phosphorus levels within the target range of 2.5 to 4.0 mg/dL.'}], 'classes': [{'title': 'Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.54', 'spread': '0.56', 'groupId': 'OG000'}]}]}, {'title': 'Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.66', 'spread': '0.56', 'groupId': 'OG000'}]}]}, {'title': 'Week 96', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.83', 'spread': '0.44', 'groupId': 'OG000'}]}]}, {'title': 'Week 144', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.58', 'spread': '0.44', 'groupId': 'OG000'}]}]}, {'title': 'Week 168', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.23', 'spread': '0.37', 'groupId': 'OG000'}]}]}, {'title': 'Week 192', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.34', 'spread': '0.50', 'groupId': 'OG000'}]}]}, {'title': 'Week 216', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.66', 'spread': '0.95', 'groupId': 'OG000'}]}]}, {'title': 'Week 240', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.83', 'spread': '1.02', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.006', 'groupIds': ['OG000'], 'groupDescription': 'Week 24', 'statisticalMethod': 'GEE model', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.'}, {'pValue': '0.003', 'groupIds': ['OG000'], 'groupDescription': 'Week 48', 'statisticalMethod': 'GEE model', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.'}, {'pValue': '<0.001', 'groupIds': ['OG000'], 'groupDescription': 'Week 96', 'statisticalMethod': 'GEE model', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.'}, {'pValue': '< 0.001', 'groupIds': ['OG000'], 'groupDescription': 'Week 144', 'statisticalMethod': 'GEE model', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.'}, {'pValue': '< 0.001', 'groupIds': ['OG000'], 'groupDescription': 'Week 168', 'statisticalMethod': 'GEE model', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.'}, {'pValue': '0.007', 'groupIds': ['OG000'], 'groupDescription': 'Week 192', 'statisticalMethod': 'GEE model', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.'}, {'pValue': '0.005', 'groupIds': ['OG000'], 'groupDescription': 'Week 216', 'statisticalMethod': 'GEE model', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.'}, {'pValue': '0.006', 'groupIds': ['OG000'], 'groupDescription': 'Week 240', 'statisticalMethod': 'GEE model', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Weeks 24, 48, 96, 144, 168, 192, 216, and 240', 'description': 'The Brief Fatigue Inventory (BFI) is a self-reported questionnaire consisting of 9 items related to fatigue that are rated on a 0 to 10 numerical rating scale with a recall period of 24 hours. The first 3 questions measure fatigue severity and the next 6 questions assess the impact of fatigue on daily activities.\n\nThe global fatigue score is defined as the average of all 9 questions on the BFI including severity and interference, and ranges from from 0 to 10, where higher scores correspond to greater levels of fatigue.\n\nA negative change from Baseline score indicates improvement. Least squares means and standard errors were estimated from a generalized estimation equation (GEE) model which includes the change from Baseline as the dependent variable, time as the categorical variable and adjusted for Baseline BFI measurement, with compound symmetry covariance structure.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'TIO analysis set participants with available data at Baseline and each time point.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline Over Time in 36-Item Short Form Health Survey (SF-36) Physical Component Summary Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Burosumab', 'description': 'Participants received burosumab at a starting dose of 0.3 mg/kg administered subcutaneously (SC) every 4 weeks (Q4W). Doses may have been titrated up to a maximum of 2.0 mg/kg every 2 weeks (Q2W) in order to achieve fasting peak serum phosphorus levels within the target range of 2.5 to 4.0 mg/dL.'}], 'classes': [{'title': 'Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3.71', 'spread': '1.42', 'groupId': 'OG000'}]}]}, {'title': 'Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '5.43', 'spread': '2.33', 'groupId': 'OG000'}]}]}, {'title': 'Week 96', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.75', 'spread': '1.37', 'groupId': 'OG000'}]}]}, {'title': 'Week 144', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '7.98', 'spread': '2.40', 'groupId': 'OG000'}]}]}, {'title': 'Week 168', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '5.20', 'spread': '2.14', 'groupId': 'OG000'}]}]}, {'title': 'Week 192', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3.82', 'spread': '2.49', 'groupId': 'OG000'}]}]}, {'title': 'Week 216', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '6.17', 'spread': '2.17', 'groupId': 'OG000'}]}]}, {'title': 'Week 240', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '5.82', 'spread': '2.45', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.009', 'groupIds': ['OG000'], 'groupDescription': 'Week 24', 'statisticalMethod': 'GEE model', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.'}, {'pValue': '0.020', 'groupIds': ['OG000'], 'groupDescription': 'Week 48', 'statisticalMethod': 'GEE model', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.'}, {'pValue': '0.044', 'groupIds': ['OG000'], 'groupDescription': 'Week 96', 'statisticalMethod': 'GEE model', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.'}, {'pValue': '< 0.001', 'groupIds': ['OG000'], 'groupDescription': 'Week 144', 'statisticalMethod': 'GEE model', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.'}, {'pValue': '0.015', 'groupIds': ['OG000'], 'groupDescription': 'Week 168', 'statisticalMethod': 'GEE model', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.'}, {'pValue': '0.125', 'groupIds': ['OG000'], 'groupDescription': 'Week 192', 'statisticalMethod': 'GEE model', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.'}, {'pValue': '0.004', 'groupIds': ['OG000'], 'groupDescription': 'Week 216', 'statisticalMethod': 'GEE model', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.'}, {'pValue': '0.018', 'groupIds': ['OG000'], 'groupDescription': 'Week 240', 'statisticalMethod': 'GEE model', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Weeks 24, 48, 96, 144, 168, 192, 216, and 240', 'description': 'The SF-36 v2 is a self-administered questionnaire that measures the impact of disease on overall quality of life during the past 4 weeks. The SF-36 consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health).\n\nThe physical component summary score (PCS) is a weighted combination of the 8 subscales with positive weighting for physical functioning, role-physical, bodily pain, and general health. The PCS was calculated using norm-based scoring so that 50 is the average score and the standard deviation equals 10. Higher scores are associated with better functioning/quality of life; a positive change from Baseline score indicates an improvement.\n\nLS means and SEs were estimated from a GEE model which includes the change from Baseline as the dependent variable, time as the categorical variable and adjusted for Baseline SF-36, with compound symmetry covariance struct', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'TIO analysis set participants with available data at each time point'}, {'type': 'SECONDARY', 'title': 'Change From Baseline Over Time in 36-Item Short Form Health Survey (SF-36) Physical Functioning Domain Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Burosumab', 'description': 'Participants received burosumab at a starting dose of 0.3 mg/kg administered subcutaneously (SC) every 4 weeks (Q4W). Doses may have been titrated up to a maximum of 2.0 mg/kg every 2 weeks (Q2W) in order to achieve fasting peak serum phosphorus levels within the target range of 2.5 to 4.0 mg/dL.'}], 'classes': [{'title': 'Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.29', 'spread': '1.58', 'groupId': 'OG000'}]}]}, {'title': 'Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.63', 'spread': '2.51', 'groupId': 'OG000'}]}]}, {'title': 'Week 96', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3.77', 'spread': '1.58', 'groupId': 'OG000'}]}]}, {'title': 'Week 144', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '7.89', 'spread': '2.00', 'groupId': 'OG000'}]}]}, {'title': 'Week 168', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '5.50', 'spread': '2.24', 'groupId': 'OG000'}]}]}, {'title': 'Week 192', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3.02', 'spread': '2.04', 'groupId': 'OG000'}]}]}, {'title': 'Week 216', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '6.75', 'spread': '1.96', 'groupId': 'OG000'}]}]}, {'title': 'Week 240', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4.56', 'spread': '3.11', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.148', 'groupIds': ['OG000'], 'groupDescription': 'Week 24', 'statisticalMethod': 'GEE model', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.'}, {'pValue': '0.295', 'groupIds': ['OG000'], 'groupDescription': 'Week 48', 'statisticalMethod': 'GEE model', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.'}, {'pValue': '0.005', 'groupIds': ['OG000'], 'groupDescription': 'Week 96', 'statisticalMethod': 'GEE model', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.'}, {'pValue': '< 0.001', 'groupIds': ['OG000'], 'groupDescription': 'Week 144', 'statisticalMethod': 'GEE model', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.'}, {'pValue': '0.014', 'groupIds': ['OG000'], 'groupDescription': 'Week 168', 'statisticalMethod': 'GEE model', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.'}, {'pValue': '0.140', 'groupIds': ['OG000'], 'groupDescription': 'Week 192', 'statisticalMethod': 'GEE model', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.'}, {'pValue': '< 0.001', 'groupIds': ['OG000'], 'groupDescription': 'Week 216', 'statisticalMethod': 'GEE model', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.'}, {'pValue': '0.142', 'groupIds': ['OG000'], 'groupDescription': 'Week 240', 'statisticalMethod': 'GEE model', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Weeks 24, 48, 96, 144, 168, 192, 216, and 240', 'description': 'The SF-36 v2 is a self-administered questionnaire that measures the impact of disease on overall quality of life during the past 4 weeks. The SF-36 consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health).\n\nThe physical functioning (PF) domain includes 10 questions that assess limitations in physical activities because of health problems. The PF domain score was calculated using norm-based scoring so that 50 is the average score and the standard deviation equals 10. Higher scores are associated with better functioning/quality of life; a positive change from Baseline score indicates an improvement.\n\nLS means and SEs were estimated from a GEE model which includes the change from Baseline as the dependent variable, time as the categorical variable and adjusted for Baseline SF-36, with compound symmetry covariance structure.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'TIO analysis set participants with available data at each time point'}, {'type': 'SECONDARY', 'title': 'Change From Baseline Over Time in 36-Item Short Form Health Survey (SF-36) Role Physical Domain Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Burosumab', 'description': 'Participants received burosumab at a starting dose of 0.3 mg/kg administered subcutaneously (SC) every 4 weeks (Q4W). Doses may have been titrated up to a maximum of 2.0 mg/kg every 2 weeks (Q2W) in order to achieve fasting peak serum phosphorus levels within the target range of 2.5 to 4.0 mg/dL.'}], 'classes': [{'title': 'Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4.85', 'spread': '1.74', 'groupId': 'OG000'}]}]}, {'title': 'Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '5.00', 'spread': '2.83', 'groupId': 'OG000'}]}]}, {'title': 'Week 96', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3.25', 'spread': '1.63', 'groupId': 'OG000'}]}]}, {'title': 'Week 144', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '5.53', 'spread': '2.81', 'groupId': 'OG000'}]}]}, {'title': 'Week 168', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '5.70', 'spread': '1.93', 'groupId': 'OG000'}]}]}, {'title': 'Week 192', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '5.03', 'spread': '2.80', 'groupId': 'OG000'}]}]}, {'title': 'Week 216', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4.82', 'spread': '3.01', 'groupId': 'OG000'}]}]}, {'title': 'Week 240', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '8.99', 'spread': '3.28', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.005', 'groupIds': ['OG000'], 'groupDescription': 'Week 24', 'statisticalMethod': 'GEE model', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.'}, {'pValue': '0.077', 'groupIds': ['OG000'], 'groupDescription': 'Week 48', 'statisticalMethod': 'GEE model', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.'}, {'pValue': '0.046', 'groupIds': ['OG000'], 'groupDescription': 'Week 96', 'statisticalMethod': 'GEE model', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.'}, {'pValue': '0.049', 'groupIds': ['OG000'], 'groupDescription': 'Week 144', 'statisticalMethod': 'GEE model', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.'}, {'pValue': '0.003', 'groupIds': ['OG000'], 'groupDescription': 'Week 168', 'statisticalMethod': 'GEE model', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.'}, {'pValue': '0.073', 'groupIds': ['OG000'], 'groupDescription': 'Week 192', 'statisticalMethod': 'GEE model', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.'}, {'pValue': '0.109', 'groupIds': ['OG000'], 'groupDescription': 'Week 216', 'statisticalMethod': 'GEE model', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.'}, {'pValue': '0.006', 'groupIds': ['OG000'], 'groupDescription': 'Week 240', 'statisticalMethod': 'GEE model', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Weeks 24, 48, 96, 144, 168, 192, 216, and 240', 'description': 'The SF-36 v2 is a self-administered questionnaire that measures the impact of disease on overall quality of life during the past 4 weeks. The SF-36 consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health).\n\nThe role-physical (RP) domain includes 4 questions that assess limitations in usual role activities because of physical health problems. The RP domain score was calculated using norm-based scoring so that 50 is the average score and the standard deviation equals 10. Higher scores are associated with better functioning/quality of life; a positive change from Baseline score indicates an improvement.\n\nLS means and SEs were estimated from a GEE model which includes the change from Baseline as the dependent variable, time as the categorical variable and adjusted for Baseline SF-36, with compound symmetry covariance structure.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'TIO analysis set participants with available data at each time point'}, {'type': 'SECONDARY', 'title': 'Change From Baseline Over Time in 36-Item Short Form Health Survey (SF-36) Bodily Pain Domain Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Burosumab', 'description': 'Participants received burosumab at a starting dose of 0.3 mg/kg administered subcutaneously (SC) every 4 weeks (Q4W). Doses may have been titrated up to a maximum of 2.0 mg/kg every 2 weeks (Q2W) in order to achieve fasting peak serum phosphorus levels within the target range of 2.5 to 4.0 mg/dL.'}], 'classes': [{'title': 'Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.61', 'spread': '1.65', 'groupId': 'OG000'}]}]}, {'title': 'Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3.61', 'spread': '1.48', 'groupId': 'OG000'}]}]}, {'title': 'Week 96', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.52', 'spread': '1.08', 'groupId': 'OG000'}]}]}, {'title': 'Week 144', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '5.40', 'spread': '1.90', 'groupId': 'OG000'}]}]}, {'title': 'Week 168', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '5.01', 'spread': '2.16', 'groupId': 'OG000'}]}]}, {'title': 'Week 192', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4.92', 'spread': '2.81', 'groupId': 'OG000'}]}]}, {'title': 'Week 216', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '6.64', 'spread': '1.88', 'groupId': 'OG000'}]}]}, {'title': 'Week 240', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '6.59', 'spread': '2.20', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.328', 'groupIds': ['OG000'], 'groupDescription': 'Week 24', 'statisticalMethod': 'GEE model', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.'}, {'pValue': '0.015', 'groupIds': ['OG000'], 'groupDescription': 'Week 48', 'statisticalMethod': 'GEE model', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.'}, {'pValue': '0.020', 'groupIds': ['OG000'], 'groupDescription': 'Week 96', 'statisticalMethod': 'GEE model', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.'}, {'pValue': '0.004', 'groupIds': ['OG000'], 'groupDescription': 'Week 144', 'statisticalMethod': 'GEE model', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.'}, {'pValue': '0.021', 'groupIds': ['OG000'], 'groupDescription': 'Week 168', 'statisticalMethod': 'GEE model', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.'}, {'pValue': '0.080', 'groupIds': ['OG000'], 'groupDescription': 'Week 192', 'statisticalMethod': 'GEE model', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.'}, {'pValue': '< 0.001', 'groupIds': ['OG000'], 'groupDescription': 'Week 216', 'statisticalMethod': 'GEE model', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.'}, {'pValue': '0.003', 'groupIds': ['OG000'], 'groupDescription': 'Week 240', 'statisticalMethod': 'GEE model', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Weeks 24, 48, 96, 144, 168, 192, 216, and 240', 'description': 'The SF-36 v2 is a self-administered questionnaire that measures the impact of disease on overall quality of life during the past 4 weeks. The SF-36 consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health).\n\nThe bodily pain (BP) domain includes 2 questions that assess pain level and impact of pain on normal work. The BP domain score was calculated using norm-based scoring so that 50 is the average score and the standard deviation equals 10. Higher scores are associated with better functioning/quality of life; a positive change from Baseline score indicates an improvement.\n\nLS means and SEs were estimated from a GEE model which includes the change from Baseline as the dependent variable, time as the categorical variable and adjusted for Baseline SF-36, with compound symmetry covariance structure.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'TIO analysis set participants with available data at each time point'}, {'type': 'SECONDARY', 'title': 'Change From Baseline Over Time in 36-Item Short Form Health Survey (SF-36) General Health Perceptions Domain Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Burosumab', 'description': 'Participants received burosumab at a starting dose of 0.3 mg/kg administered subcutaneously (SC) every 4 weeks (Q4W). Doses may have been titrated up to a maximum of 2.0 mg/kg every 2 weeks (Q2W) in order to achieve fasting peak serum phosphorus levels within the target range of 2.5 to 4.0 mg/dL.'}], 'classes': [{'title': 'Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.38', 'spread': '1.88', 'groupId': 'OG000'}]}]}, {'title': 'Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '6.09', 'spread': '2.28', 'groupId': 'OG000'}]}]}, {'title': 'Week 96', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.03', 'spread': '1.96', 'groupId': 'OG000'}]}]}, {'title': 'Week 144', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3.12', 'spread': '2.64', 'groupId': 'OG000'}]}]}, {'title': 'Week 168', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.32', 'spread': '2.51', 'groupId': 'OG000'}]}]}, {'title': 'Week 192', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.60', 'spread': '2.94', 'groupId': 'OG000'}]}]}, {'title': 'Week 216', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.51', 'spread': '2.05', 'groupId': 'OG000'}]}]}, {'title': 'Week 240', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.81', 'spread': '3.30', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.207', 'groupIds': ['OG000'], 'groupDescription': 'Week 24', 'statisticalMethod': 'GEE model', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.'}, {'pValue': '0.008', 'groupIds': ['OG000'], 'groupDescription': 'Week 48', 'statisticalMethod': 'GEE model', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.'}, {'pValue': '0.598', 'groupIds': ['OG000'], 'groupDescription': 'Week 96', 'statisticalMethod': 'GEE model', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.'}, {'pValue': '0.237', 'groupIds': ['OG000'], 'groupDescription': 'Week 144', 'statisticalMethod': 'GEE model', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.'}, {'pValue': '0.899', 'groupIds': ['OG000'], 'groupDescription': 'Week 168', 'statisticalMethod': 'GEE model', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.'}, {'pValue': '0.585', 'groupIds': ['OG000'], 'groupDescription': 'Week 192', 'statisticalMethod': 'GEE model', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.'}, {'pValue': '0.461', 'groupIds': ['OG000'], 'groupDescription': 'Week 216', 'statisticalMethod': 'GEE model', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.'}, {'pValue': '0.583', 'groupIds': ['OG000'], 'groupDescription': 'Week 240', 'statisticalMethod': 'GEE model', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Weeks 24, 48, 96, 144, 168, 192, 216, and 240', 'description': "The SF-36 v2 is a self-administered questionnaire that measures the impact of disease on overall quality of life during the past 4 weeks. The SF-36 consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health).\n\nThe general health perceptions (GH) domain includes 5 questions that assess participants' perception of their own general health. The GH domain score was calculated using norm-based scoring so that 50 is the average score and the standard deviation equals 10. Higher scores are associated with better functioning/quality of life; a positive change from Baseline score indicates an improvement.\n\nLS means and SEs were estimated from a GEE model which includes the change from Baseline as the dependent variable, time as the categorical variable and adjusted for Baseline SF-36, with compound symmetry covariance structure.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'TIO analysis set participants with available data at each time point'}, {'type': 'SECONDARY', 'title': 'Change From Baseline Over Time in 36-Item Short Form Health Survey (SF-36) Mental Component Summary Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Burosumab', 'description': 'Participants received burosumab at a starting dose of 0.3 mg/kg administered subcutaneously (SC) every 4 weeks (Q4W). Doses may have been titrated up to a maximum of 2.0 mg/kg every 2 weeks (Q2W) in order to achieve fasting peak serum phosphorus levels within the target range of 2.5 to 4.0 mg/dL.'}], 'classes': [{'title': 'Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.07', 'spread': '2.38', 'groupId': 'OG000'}]}]}, {'title': 'Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.37', 'spread': '2.47', 'groupId': 'OG000'}]}]}, {'title': 'Week 96', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3.91', 'spread': '2.53', 'groupId': 'OG000'}]}]}, {'title': 'Week 144', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.85', 'spread': '2.29', 'groupId': 'OG000'}]}]}, {'title': 'Week 168', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.05', 'spread': '1.81', 'groupId': 'OG000'}]}]}, {'title': 'Week 192', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.55', 'spread': '2.95', 'groupId': 'OG000'}]}]}, {'title': 'Week 216', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.51', 'spread': '2.67', 'groupId': 'OG000'}]}]}, {'title': 'Week 240', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '5.13', 'spread': '3.59', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.654', 'groupIds': ['OG000'], 'groupDescription': 'Week 24', 'statisticalMethod': 'GEE model', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.'}, {'pValue': '0.579', 'groupIds': ['OG000'], 'groupDescription': 'Week 48', 'statisticalMethod': 'GEE model', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.'}, {'pValue': '0.123', 'groupIds': ['OG000'], 'groupDescription': 'Week 96', 'statisticalMethod': 'GEE model', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.'}, {'pValue': '0.712', 'groupIds': ['OG000'], 'groupDescription': 'Week 144', 'statisticalMethod': 'GEE model', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.'}, {'pValue': '0.258', 'groupIds': ['OG000'], 'groupDescription': 'Week 168', 'statisticalMethod': 'GEE model', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.'}, {'pValue': '0.851', 'groupIds': ['OG000'], 'groupDescription': 'Week 192', 'statisticalMethod': 'GEE model', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.'}, {'pValue': '0.849', 'groupIds': ['OG000'], 'groupDescription': 'Week 216', 'statisticalMethod': 'GEE model', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.'}, {'pValue': '0.153', 'groupIds': ['OG000'], 'groupDescription': 'Week 240', 'statisticalMethod': 'GEE model', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Weeks 24, 48, 96, 144, 168, 192, 216, and 240', 'description': 'The SF-36 v2 is a self-administered questionnaire that measures the impact of disease on overall quality of life during the past 4 weeks. The SF-36 consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health).\n\nThe mental component summary score (MCS) is a weighted combination of the 8 subscales with positive weighting for vitality, social function, role limitations due to emotional problems, and mental health. The MCS was calculated using norm-based scoring so that 50 is the average score and the standard deviation equals 10. Higher scores are associated with better functioning/quality of life; a positive change from Baseline indicates an improvement.\n\nLS means and SEs were estimated from a GEE model which includes the change from Baseline as the dependent variable, time as the categorical variable and adjusted for Baseline SF-36, with compound symmetry covariance structure.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'TIO analysis set participants with available data at each time point'}, {'type': 'SECONDARY', 'title': 'Change From Baseline Over Time in 36-Item Short Form Health Survey (SF-36) Vitality Domain Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Burosumab', 'description': 'Participants received burosumab at a starting dose of 0.3 mg/kg administered subcutaneously (SC) every 4 weeks (Q4W). Doses may have been titrated up to a maximum of 2.0 mg/kg every 2 weeks (Q2W) in order to achieve fasting peak serum phosphorus levels within the target range of 2.5 to 4.0 mg/dL.'}], 'classes': [{'title': 'Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '5.98', 'spread': '1.96', 'groupId': 'OG000'}]}]}, {'title': 'Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '5.27', 'spread': '2.42', 'groupId': 'OG000'}]}]}, {'title': 'Week 96', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '6.71', 'spread': '2.64', 'groupId': 'OG000'}]}]}, {'title': 'Week 144', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3.05', 'spread': '2.30', 'groupId': 'OG000'}]}]}, {'title': 'Week 168', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '6.04', 'spread': '2.74', 'groupId': 'OG000'}]}]}, {'title': 'Week 192', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.78', 'spread': '2.85', 'groupId': 'OG000'}]}]}, {'title': 'Week 216', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '6.79', 'spread': '3.77', 'groupId': 'OG000'}]}]}, {'title': 'Week 240', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '8.06', 'spread': '4.03', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.002', 'groupIds': ['OG000'], 'groupDescription': 'Week 24', 'statisticalMethod': 'GEE model', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.'}, {'pValue': '0.030', 'groupIds': ['OG000'], 'groupDescription': 'Week 48', 'statisticalMethod': 'GEE model', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.'}, {'pValue': '0.011', 'groupIds': ['OG000'], 'groupDescription': 'Week 96', 'statisticalMethod': 'GEE model', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.'}, {'pValue': '0.186', 'groupIds': ['OG000'], 'groupDescription': 'Week 144', 'statisticalMethod': 'GEE model', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.'}, {'pValue': '0.027', 'groupIds': ['OG000'], 'groupDescription': 'Week 168', 'statisticalMethod': 'GEE model', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.'}, {'pValue': '0.330', 'groupIds': ['OG000'], 'groupDescription': 'Week 192', 'statisticalMethod': 'GEE model', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.'}, {'pValue': '0.072', 'groupIds': ['OG000'], 'groupDescription': 'Week 216', 'statisticalMethod': 'GEE model', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.'}, {'pValue': '0.045', 'groupIds': ['OG000'], 'groupDescription': 'Week 240', 'statisticalMethod': 'GEE model', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Weeks 24, 48, 96, 144, 168, 192, 216, and 240', 'description': 'The SF-36 v2 is a self-administered questionnaire that measures the impact of disease on overall quality of life during the past 4 weeks. The SF-36 consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health).\n\nThe vitality (VT) domain includes 4 questions that assess energy levels and fatigue. The VT domain score was calculated using norm-based scoring so that 50 is the average score and the standard deviation equals 10. Higher scores are associated with better functioning/quality of life; a positive change from Baseline score indicates an improvement.\n\nLS means and SEs were estimated from a GEE model which includes the change from Baseline as the dependent variable, time as the categorical variable and adjusted for Baseline SF-36, with compound symmetry covariance structure.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'TIO analysis set participants with available data at each time point'}, {'type': 'SECONDARY', 'title': 'Change From Baseline Over Time in 36-Item Short Form Health Survey (SF-36) Social Functioning Domain Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Burosumab', 'description': 'Participants received burosumab at a starting dose of 0.3 mg/kg administered subcutaneously (SC) every 4 weeks (Q4W). Doses may have been titrated up to a maximum of 2.0 mg/kg every 2 weeks (Q2W) in order to achieve fasting peak serum phosphorus levels within the target range of 2.5 to 4.0 mg/dL.'}], 'classes': [{'title': 'Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.02', 'spread': '2.24', 'groupId': 'OG000'}]}]}, {'title': 'Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '5.54', 'spread': '2.48', 'groupId': 'OG000'}]}]}, {'title': 'Week 96', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4.63', 'spread': '1.34', 'groupId': 'OG000'}]}]}, {'title': 'Week 144', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3.22', 'spread': '2.71', 'groupId': 'OG000'}]}]}, {'title': 'Week 168', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '5.34', 'spread': '2.06', 'groupId': 'OG000'}]}]}, {'title': 'Week 192', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.84', 'spread': '2.62', 'groupId': 'OG000'}]}]}, {'title': 'Week 216', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4.15', 'spread': '2.08', 'groupId': 'OG000'}]}]}, {'title': 'Week 240', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '6.30', 'spread': '2.98', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.369', 'groupIds': ['OG000'], 'groupDescription': 'Week 24', 'statisticalMethod': 'GEE model', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.'}, {'pValue': '0.026', 'groupIds': ['OG000'], 'groupDescription': 'Week 48', 'statisticalMethod': 'GEE model', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.'}, {'pValue': '< 0.001', 'groupIds': ['OG000'], 'groupDescription': 'Week 96', 'statisticalMethod': 'GEE model', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.'}, {'pValue': '0.235', 'groupIds': ['OG000'], 'groupDescription': 'Week 144', 'statisticalMethod': 'GEE model', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.'}, {'pValue': '0.009', 'groupIds': ['OG000'], 'groupDescription': 'Week 168', 'statisticalMethod': 'GEE model', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.'}, {'pValue': '0.278', 'groupIds': ['OG000'], 'groupDescription': 'Week 192', 'statisticalMethod': 'GEE model', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.'}, {'pValue': '0.046', 'groupIds': ['OG000'], 'groupDescription': 'Week 216', 'statisticalMethod': 'GEE model', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.'}, {'pValue': '0.035', 'groupIds': ['OG000'], 'groupDescription': 'Week 240', 'statisticalMethod': 'GEE model', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Weeks 24, 48, 96, 144, 168, 192, 216, and 240', 'description': 'The SF-36 v2 is a self-administered questionnaire that measures the impact of disease on overall quality of life during the past 4 weeks. The SF-36 consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health).\n\nThe social functioning (SF) domain includes 2 questions that assess limitations in social activities because of physical health or emotional problems. The SF domain score was calculated using norm-based scoring so that 50 is the average score and the standard deviation equals 10. Higher scores are associated with better functioning/quality of life; a positive change from Baseline score indicates an improvement.\n\nLS means and SEs were estimated from a GEE model which includes the change from Baseline as the dependent variable, time as the categorical variable and adjusted for Baseline SF-36, with compound symmetry covariance structure.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'TIO analysis set participants with available data at each time point'}, {'type': 'SECONDARY', 'title': 'Change From Baseline Over Time in 36-Item Short Form Health Survey (SF-36) Role Emotional Domain Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Burosumab', 'description': 'Participants received burosumab at a starting dose of 0.3 mg/kg administered subcutaneously (SC) every 4 weeks (Q4W). Doses may have been titrated up to a maximum of 2.0 mg/kg every 2 weeks (Q2W) in order to achieve fasting peak serum phosphorus levels within the target range of 2.5 to 4.0 mg/dL.'}], 'classes': [{'title': 'Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.52', 'spread': '1.98', 'groupId': 'OG000'}]}]}, {'title': 'Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.13', 'spread': '2.72', 'groupId': 'OG000'}]}]}, {'title': 'Week 96', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '6.73', 'spread': '3.03', 'groupId': 'OG000'}]}]}, {'title': 'Week 144', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.10', 'spread': '2.60', 'groupId': 'OG000'}]}]}, {'title': 'Week 168', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4.90', 'spread': '2.22', 'groupId': 'OG000'}]}]}, {'title': 'Week 192', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3.51', 'spread': '3.47', 'groupId': 'OG000'}]}]}, {'title': 'Week 216', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3.56', 'spread': '3.08', 'groupId': 'OG000'}]}]}, {'title': 'Week 240', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '6.04', 'spread': '3.69', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.442', 'groupIds': ['OG000'], 'groupDescription': 'Week 24', 'statisticalMethod': 'GEE model', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.'}, {'pValue': '0.677', 'groupIds': ['OG000'], 'groupDescription': 'Week 48', 'statisticalMethod': 'GEE model', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.'}, {'pValue': '0.027', 'groupIds': ['OG000'], 'groupDescription': 'Week 96', 'statisticalMethod': 'GEE model', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.'}, {'pValue': '0.420', 'groupIds': ['OG000'], 'groupDescription': 'Week 144', 'statisticalMethod': 'GEE model', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.'}, {'pValue': '0.027', 'groupIds': ['OG000'], 'groupDescription': 'Week 168', 'statisticalMethod': 'GEE model', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.'}, {'pValue': '0.312', 'groupIds': ['OG000'], 'groupDescription': 'Week 192', 'statisticalMethod': 'GEE model', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.'}, {'pValue': '0.249', 'groupIds': ['OG000'], 'groupDescription': 'Week 216', 'statisticalMethod': 'GEE model', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.'}, {'pValue': '0.102', 'groupIds': ['OG000'], 'groupDescription': 'Week 240', 'statisticalMethod': 'GEE model', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Weeks 24, 48, 96, 144, 168, 192, 216, and 240', 'description': 'The SF-36 v2 is a self-administered questionnaire that measures the impact of disease on overall quality of life during the past 4 weeks. The SF-36 consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health).\n\nThe role-emotional (RE) domain includes 3 questions that assess limitations in usual role activities because of emotional problems. The RE domain score was calculated using norm-based scoring so that 50 is the average score and the standard deviation equals 10. Higher scores are associated with better functioning/quality of life; a positive change from Baseline score indicates an improvement.\n\nLS means and SEs were estimated from a GEE model which includes the change from Baseline as the dependent variable, time as the categorical variable and adjusted for Baseline SF-36, with compound symmetry covariance structure.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'TIO analysis set participants with available data at each time point'}, {'type': 'SECONDARY', 'title': 'Change From Baseline Over Time in 36-Item Short Form Health Survey (SF-36) Mental Health Domain Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Burosumab', 'description': 'Participants received burosumab at a starting dose of 0.3 mg/kg administered subcutaneously (SC) every 4 weeks (Q4W). Doses may have been titrated up to a maximum of 2.0 mg/kg every 2 weeks (Q2W) in order to achieve fasting peak serum phosphorus levels within the target range of 2.5 to 4.0 mg/dL.'}], 'classes': [{'title': 'Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.46', 'spread': '2.54', 'groupId': 'OG000'}]}]}, {'title': 'Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.32', 'spread': '2.48', 'groupId': 'OG000'}]}]}, {'title': 'Week 96', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.58', 'spread': '2.12', 'groupId': 'OG000'}]}]}, {'title': 'Week 144', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.17', 'spread': '1.97', 'groupId': 'OG000'}]}]}, {'title': 'Week 168', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.97', 'spread': '1.61', 'groupId': 'OG000'}]}]}, {'title': 'Week 192', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.24', 'spread': '2.23', 'groupId': 'OG000'}]}]}, {'title': 'Week 216', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.11', 'spread': '2.87', 'groupId': 'OG000'}]}]}, {'title': 'Week 240', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3.50', 'spread': '3.10', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.856', 'groupIds': ['OG000'], 'groupDescription': 'Week 24', 'statisticalMethod': 'GEE model', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.'}, {'pValue': '0.898', 'groupIds': ['OG000'], 'groupDescription': 'Week 48', 'statisticalMethod': 'GEE model', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.'}, {'pValue': '0.785', 'groupIds': ['OG000'], 'groupDescription': 'Week 96', 'statisticalMethod': 'GEE model', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.'}, {'pValue': '0.932', 'groupIds': ['OG000'], 'groupDescription': 'Week 144', 'statisticalMethod': 'GEE model', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.'}, {'pValue': '0.545', 'groupIds': ['OG000'], 'groupDescription': 'Week 168', 'statisticalMethod': 'GEE model', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.'}, {'pValue': '0.580', 'groupIds': ['OG000'], 'groupDescription': 'Week 192', 'statisticalMethod': 'GEE model', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.'}, {'pValue': '0.462', 'groupIds': ['OG000'], 'groupDescription': 'Week 216', 'statisticalMethod': 'GEE model', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.'}, {'pValue': '0.260', 'groupIds': ['OG000'], 'groupDescription': 'Week 240', 'statisticalMethod': 'GEE model', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Weeks 24, 48, 96, 144, 168, 192, 216, and 240', 'description': 'The SF-36 v2 is a self-administered questionnaire that measures the impact of disease on overall quality of life during the past 4 weeks. The SF-36 consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health).\n\nThe mental health (MH) domain includes 5 questions that assess general mental health (psychological distress and well-being). The MH domain score was calculated using norm-based scoring so that 50 is the average score and the standard deviation equals 10. Higher scores are associated with better functioning/quality of life; a positive change from Baseline score indicates an improvement.\n\nLS means and SEs were estimated from a GEE model which includes the change from Baseline as the dependent variable, time as the categorical variable and adjusted for Baseline SF-36, with compound symmetry covariance structure.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'TIO analysis set participants with available data at each time point'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Participants With Adverse Events (AEs), Treatment Emergent AEs (TEAEs), Serious TEAEs, and TEAEs Leading to Discontinuation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Burosumab', 'description': 'Participants received burosumab at a starting dose of 0.3 mg/kg administered subcutaneously (SC) every 4 weeks (Q4W). Doses may have been titrated up to a maximum of 2.0 mg/kg every 2 weeks (Q2W) in order to achieve fasting peak serum phosphorus levels within the target range of 2.5 to 4.0 mg/dL.'}], 'classes': [{'title': 'Any adverse event', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}]}]}, {'title': 'Serious adverse events (SAEs)', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}]}]}, {'title': 'Related adverse events', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}]}]}, {'title': 'Serious related adverse events', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Grade 3 or 4 adverse event', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}]}]}, {'title': 'TEAE leading to study discontinuation', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'TEAE leading to treatment discontinuation', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'TEAE leading to death', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From first dose of study drug up to database lock date (July 07, 2021); median duration of treatment in the TIO analysis set was 1594.0 (range: 168-2106) days.', 'description': 'An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug, whether or not considered drug related. A serious AE was defined as an AE that at any dose, in the view of either the Investigator or Sponsor, results in any of the following outcomes: death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant incapacity or disability, a congenital anomaly/birth defect, or other important medical events (according to the investigator). An AE was considered a TEAE if it occurred on or after the first dose and was not present prior to the first dose, or it was present prior to the first dose but increased in severity during the study. Events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0: grade 1 (mild), grade 2 (moderate), grade 3 (severe), grade 4 (life-threatening), grade 5 (death).', 'calculatePct': False, 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'TIO analysis set'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Participants With Anti-burosumab Antibodies', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Burosumab', 'description': 'Participants received burosumab at a starting dose of 0.3 mg/kg administered subcutaneously (SC) every 4 weeks (Q4W). Doses may have been titrated up to a maximum of 2.0 mg/kg every 2 weeks (Q2W) in order to achieve fasting peak serum phosphorus levels within the target range of 2.5 to 4.0 mg/dL.'}], 'classes': [{'title': 'Anti-burosumab binding antibodies', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Anti-burosumab neutralizing antibodies', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From first dose of study drug up to database lock date (July 07, 2021); median duration of treatment in the TIO analysis set was 1594.0 (range: 168-2106) days.', 'calculatePct': False, 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'TIO analysis set'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Burosumab', 'description': 'Participants received burosumab at a starting dose of 0.3 mg/kg administered subcutaneously (SC) every 4 weeks (Q4W). Doses may have been titrated up to a maximum of 2.0 mg/kg every 2 weeks (Q2W) in order to achieve fasting peak serum phosphorus levels within the target range of 2.5 to 4.0 mg/dL.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': '14 participants with TIO; 1 participant with ENS; 2 participants with XLH', 'groupId': 'FG000', 'numSubjects': '17'}]}, {'type': 'Completed 48 Weeks of Study Drug', 'achievements': [{'groupId': 'FG000', 'numSubjects': '16'}]}, {'type': 'Completed 144 Weeks of Study Drug', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}]}], 'dropWithdraws': [{'type': 'Lack of Response to Bruosumab', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Sponsor Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Unable to Return Due to Corona Virus Pandemic', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'This study was conducted at 8 centers in the United States, and enrolled adults with tumor-induced osteomalacia (TIO), epidermal nevus syndrome (ENS)-associated osteomalacia, or x-linked hypophosphatemia (XLH).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Burosumab', 'description': 'Participants received burosumab at a starting dose of 0.3 mg/kg administered subcutaneously (SC) every 4 weeks (Q4W). Doses may have been titrated up to a maximum of 2.0 mg/kg every 2 weeks (Q2W) in order to achieve fasting peak serum phosphorus levels within the target range of 2.5 to 4.0 mg/dL.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '53.1', 'spread': '13.86', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '8', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '9', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '17', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'BG000'}]}], 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '15', 'groupId': 'BG000'}]}, {'title': 'Other', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Diagnosis', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Tumor-Induced osteomalacia (TIO)', 'measurements': [{'value': '14', 'groupId': 'BG000'}]}, {'title': 'Epidermal nevus syndrome-associated osteomalacia', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'X-linked hypophosphatemia (XLH)', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Two participants who were enrolled in the study with a clinical diagnosis of TIO were later found to have X-linked hypophosphatemia (XLH) based on genetic testing.', 'unitOfMeasure': 'Participants'}, {'title': 'Serum Total Fibroblast Growth Factor 23 (FGF23)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '770.06', 'spread': '797.654', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Tumor-induced osteomalacia (TIO) analysis set includes the 14 participants with TIO who received at least 1 dose of study drug.'}, {'title': 'Serum Phosphorus', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '1.60', 'spread': '0.474', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'TIO analysis set'}, {'title': 'Osteoid Volume/Bone Volume (OB/BV)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '17.61', 'spread': '19.485', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'The percentage of a given volume of bone tissue that consists of unmineralized bone (osteoid).', 'unitOfMeasure': 'percentage of bone volume', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'TIO biopsy analysis set includes 11 participants with TIO who received at least 1 dose of study drug and who had paired bone biopsies at Baseline and Week 48.'}, {'title': 'Osteoid Surface/Bone Surface (OS/BS)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '56.82', 'spread': '31.003', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'The percentage of bone surface covered in osteoid.', 'unitOfMeasure': 'percentage of bone surface', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'TIO biopsy analysis set'}, {'title': 'Osteoid Thickness (O.Th)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '16.45', 'spread': '12.044', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'Mean thickness, given in micrometers, for osteoid seams', 'unitOfMeasure': 'μm', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'TIO biopsy analysis set'}, {'title': 'Mineralization Lag Time (Mlt)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '1597.73', 'spread': '1326.832', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'Mineralization lag time is the average time interval between osteoid formation and its subsequent mineralization, calculated by dividing the osteoid width by the mineralizing apposition rate (MAR; the average rate at which new bone mineral is being added on any actively forming surface).\n\nIf Mlt could not be calculated directly due to low tetracycline uptake, Mlt was imputed according to the following:\n\nMlt = O.Th/(MAR\\*MS/OS), where O.Th = osteoid thickness, MAR is imputed as 0.3 μm/day, MS/OS=Mineralizing Surface/Osteoid Surface, each measured at the same visit.', 'unitOfMeasure': 'days', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'TIO biopsy analysis set for whom Mlt could be calculated or imputed'}], 'populationDescription': 'All enrolled participants'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-09-26', 'size': 4774110, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2020-07-10T14:18', 'hasProtocol': True}, {'date': '2016-05-04', 'size': 2334611, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2020-07-10T14:19', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 17}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-03-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'nctId': 'NCT03775187', 'statusForNctId': 'AVAILABLE', 'hasExpandedAccess': True}, 'statusVerifiedDate': '2024-05', 'dispFirstSubmitDate': '2018-07-16', 'completionDateStruct': {'date': '2021-01-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-05-02', 'studyFirstSubmitDate': '2014-11-24', 'dispFirstSubmitQcDate': '2018-07-18', 'resultsFirstSubmitDate': '2020-07-10', 'studyFirstSubmitQcDate': '2014-11-25', 'dispFirstPostDateStruct': {'date': '2018-07-20', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2024-05-06', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-07-10', 'studyFirstPostDateStruct': {'date': '2014-12-01', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-07-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-07-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Number of Participants With Adverse Events (AEs), Treatment Emergent AEs (TEAEs), Serious TEAEs, and TEAEs Leading to Discontinuation', 'timeFrame': 'From first dose of study drug up to database lock date (July 07, 2021); median duration of treatment in the TIO analysis set was 1594.0 (range: 168-2106) days.', 'description': 'An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug, whether or not considered drug related. A serious AE was defined as an AE that at any dose, in the view of either the Investigator or Sponsor, results in any of the following outcomes: death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant incapacity or disability, a congenital anomaly/birth defect, or other important medical events (according to the investigator). An AE was considered a TEAE if it occurred on or after the first dose and was not present prior to the first dose, or it was present prior to the first dose but increased in severity during the study. Events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0: grade 1 (mild), grade 2 (moderate), grade 3 (severe), grade 4 (life-threatening), grade 5 (death).'}, {'measure': 'Number of Participants With Anti-burosumab Antibodies', 'timeFrame': 'From first dose of study drug up to database lock date (July 07, 2021); median duration of treatment in the TIO analysis set was 1594.0 (range: 168-2106) days.'}], 'primaryOutcomes': [{'measure': 'Percentage of Participants Achieving Mean Serum Phosphorus Levels Above 2.5 mg/dL at the Mid-Point of the Dose Intervals Between Baseline and Week 24', 'timeFrame': 'Mid-point of each dose interval from Baseline to Week 24 (Weeks 2, 6, 10, 14 and 22 [there was no study visit at Week 18])', 'description': 'The percentage of participants achieving mean serum phosphorus levels above the lower limit of normal (LLN; 2.5 mg/dL \\[0.81 mmol/L\\]) at the mid-point of the dose interval (2 weeks after dosing), as averaged across dose cycles between Baseline and Week 24 (i.e. the average of serum phosphorus levels at Weeks 2, 6, 10, 14 and 22).'}, {'measure': 'Change From Baseline to Week 48 in Osteoid Thickness', 'timeFrame': 'Baseline, Week 48', 'description': 'Histomorphometry of trans-iliac crest bone biopsies was assessed by a blinded, central reader.\n\nOsteoid thickness is the mean thickness of osteoid seams.'}, {'measure': 'Change From Baseline to Week 48 in Osteoid Surface/Bone Surface (OS/BS)', 'timeFrame': 'Baseline, Week 48', 'description': 'Histomorphometry of trans-iliac crest bone biopsies was assessed by a blinded, central reader.\n\nOsteoid surface/bone surface is expressed as the percentage of bone surface covered in osteoid.'}, {'measure': 'Change From Baseline to Week 48 in Osteoid Volume/Bone Volume (OV/BV)', 'timeFrame': 'Baseline, Week 48', 'description': 'Histomorphometry of trans-iliac crest bone biopsies was assessed by a blinded, central reader. Osteoid volume/bone volume is expressed as the percentage of a given volume of bone tissue that consists of unmineralized bone (osteoid).'}, {'measure': 'Change From Baseline to Week 48 in Mineralization Lag Time (MLt)', 'timeFrame': 'Baseline, Week 48', 'description': 'Mineralization lag time is a dynamic modeling parameter representing the mean time interval between the formation of osteoid and its subsequent mineralization which can be measured using histomorphometry with double tetracycline labeling.\n\nMlt was calculated by dividing the osteoid width by the mineralizing apposition rate (MAR; the average rate at which new bone mineral is being added on any actively forming surface).\n\nIf Mlt could not be calculated directly due to low tetracycline uptake, Mlt was imputed according to the following:\n\nMlt = O.Th/(MAR\\*MS/OS), where O.Th = osteoid thickness, MAR is imputed as 0.3 μm/day, MS/OS=mineralizing surface/osteoid surface, each measured at the same visit.'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants Achieving Mean Serum Phosphorus Levels Above 2.5 mg/dL at the End of the Dose Intervals Between Baseline and Week 24', 'timeFrame': 'End of each dose interval from Baseline to Week 24 (Weeks 4, 8, 12, 16, 20, and 24)', 'description': 'The percentage of participants achieving mean serum phosphorus levels above the lower limit of normal (2.5 mg/dL \\[0.81 mmol/L\\]) at the end of the dose interval (4 weeks post-dose, prior to the next dose), as averaged across dose cycles between Baseline and Week 24 (i.e. the average of serum phosphorus levels at Weeks 4, 8, 12, 16, 20, and 24).'}, {'measure': 'Mean Change From Baseline in Serum Phosphorus Levels at the Mid-Point of the Dose Interval, as Averaged Across Dose Cycles Between Baseline and Week 24', 'timeFrame': 'Baseline and the mid-point of each dose interval from Baseline to Week 24 (Weeks 2, 6, 10, 14 and 22)', 'description': 'Mean change from Baseline to the mid-point of the dose interval (2 weeks after dosing) averaged across dose cycles between Baseline and Week 24 (i.e. the average of serum phosphorus levels at Weeks 2, 6, 10, 14 and 22).'}, {'measure': 'Percent Change From Baseline in Serum Phosphorus Levels at the Mid-Point of the Dose Interval, as Averaged Across Dose Cycles Between Baseline and Week 24', 'timeFrame': 'Baseline and the mid-point of each dose interval from Baseline to Week 24 (Weeks 2, 6, 10, 14 and 22)', 'description': 'Mean percent change from Baseline to the mid-point of the dose interval (2 weeks after dosing) averaged across dose cycles between Baseline and Week 24 (i.e. the average of serum phosphorus levels at Weeks 2, 6, 10, 14 and 22).'}, {'measure': 'Mean Change From Baseline in Serum Phosphorus Levels at the End of the Dosing Cycle, as Averaged Across Dose Cycles Between Baseline and Week 24', 'timeFrame': 'Baseline and Weeks 4, 8, 12, 16, 20, and 24', 'description': 'Mean change from Baseline at the end of the dose interval (4 weeks post-dose, prior to the next dose) averaged across dose cycles between Baseline and Week 24 (i.e. the average of serum phosphorus levels at Weeks 4, 8, 12, 16, 20, and 24).'}, {'measure': 'Percent Mean Change From Baseline in Serum Phosphorus Levels at the End of the Dosing Cycle, as Averaged Across Dose Cycles Between Baseline and Week 24', 'timeFrame': 'Baseline and Weeks 4, 8, 12, 16, 20, and 24', 'description': 'Mean percent change from Baseline at the end of the dose interval (4 weeks post-dose, prior to the next dose) averaged across dose cycles between Baseline and Week 24 (i.e. the average of serum phosphorus levels at Weeks 4, 8, 12, 16, 20, and 24).'}, {'measure': 'Time-Adjusted Area Under the Curve (AUC) of Serum Phosphorus Levels Between Baseline and Week 24', 'timeFrame': 'Pre-dose on Day 1 and at Weeks 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 21, 22, and 24', 'description': 'Serum phosphorus level versus time AUC was calculated using the trapezoidal rule. Time-adjusted AUC was calculated by dividing the AUC by duration of time included in AUC calculation.'}, {'measure': 'Change From Baseline Over Time in Serum 1,25-dihydroxyvitamin D (1,25(OH)2D) Concentration', 'timeFrame': 'Baseline and Weeks 24, 48, 96, 144, 168, 192, 216, and 240', 'description': 'Least squares (LS) means and standard errors (SE) were estimated from a generalized estimation equation (GEE) model which includes the change from Baseline as the dependent variable, time as the categorical variable and adjusted for Baseline 1,25(OH)2D, with compound symmetry covariance structure.'}, {'measure': 'Change From Baseline Over Time in Total Serum Fibroblast Growth Factor 23 (FGF23) Concentration', 'timeFrame': 'Baseline and Weeks 24, 48, 96, 144, 168, 192, 216, and 240', 'description': 'Total FGF23 included free FGF23 and FGF23 bound to burosumab. Least squares means and standard errors were estimated from a generalized estimation equation (GEE) model which includes the change from Baseline as the dependent variable, time as the categorical variable and adjusted for Baseline total FGF23, with compound symmetry covariance structure.'}, {'measure': 'Change From Baseline Over Time in Free Serum Fibroblast Growth Factor 23 (FGF23) Concentration', 'timeFrame': 'Baseline and Weeks 24, 48, 96, 144, 168, 192, 216, and 240', 'description': 'Least squares means and standard errors were estimated from a generalized estimation equation (GEE) model which includes the change from Baseline as the dependent variable, time as the categorical variable and adjusted for Baseline free FGF23, with compound symmetry covariance structure.'}, {'measure': 'Change From Baseline Over Time in 24-hour Urinary Phosphorus', 'timeFrame': 'Baseline and Weeks 24, 48, 96, 144, 168, 192, 216, and 240', 'description': 'Least squares means and standard errors were estimated from a generalized estimation equation (GEE) model which includes the change from Baseline as the dependent variable, time as the categorical variable and adjusted for Baseline 24-hour urinary phosphorus, with compound symmetry covariance structure.'}, {'measure': 'Change From Baseline Over Time in Tubular Reabsorption of Phosphate (TRP)', 'timeFrame': 'Baseline and Weeks 24, 48, 96, 144, 168, 192, 216, and 240', 'description': 'Tubular reabsorption of phosphate (TRP) is the fraction of filtered phosphorus that is reabsorbed by renal tubules.\n\nLeast squares means and standard errors were estimated from a generalized estimation equation (GEE) model which includes the change from Baseline as the dependent variable, time as the categorical variable and adjusted for Baseline TRP, with compound symmetry covariance structure.'}, {'measure': 'Change From Baseline Over Time in Ratio of Renal Tubular Maximum Phosphate Reabsorption Rate to Glomerular Filtration Rate (TmP/GFR)', 'timeFrame': 'Baseline and Weeks 24, 48, 96, 144, 168, 192, 216, and 240', 'description': 'TmP/GFR measures renal phosphate reabsorption (the primary mechanism by which FGF23 regulates phosphate homeostasis) by comparing the fractional absorption of phosphate relative to the estimated rate of glomerular filtration.\n\nLeast squares means and standard errors were estimated from a generalized estimation equation (GEE) model which includes the change from Baseline as the dependent variable, time as the categorical variable and adjusted for Baseline TmP/GFR, with compound symmetry covariance structure.'}, {'measure': 'Change From Baseline Over Time in Fractional Excretion of Phosphorus (FEP)', 'timeFrame': 'Baseline and Weeks 24, 48, 96, 144, 168, 192, 216, and 240', 'description': 'FEP is the percentage of phosphorus filtered by the kidney that is excreted into urine, calculated as 100% \\* (2-hour urine phosphorus\\*serum creatinine)/(2-hour urine creatinine \\* serum phosphorus).\n\nLeast squares means and standard errors were estimated from a generalized estimation equation (GEE) model which includes the change from Baseline as the dependent variable, time as the categorical variable and adjusted for Baseline FEP, with compound symmetry covariance structure.'}, {'measure': 'Change From Baseline Over Time in Serum Alkaline Phosphatase (ALP)', 'timeFrame': 'Baseline and Weeks 24, 48, 96, 144, 168, 192, 216, and 240', 'description': 'Least squares means and standard errors were estimated from a generalized estimation equation (GEE) model which includes the change from Baseline as the dependent variable, time as the categorical variable and adjusted for Baseline ALP, with compound symmetry covariance structure.'}, {'measure': 'Change From Baseline Over Time in Bone-Specific Alkaline Phosphatase (BALP)', 'timeFrame': 'Baseline and Weeks 24, 48, 96, 144, 168, 192, 216, and 240', 'description': 'Least squares means and standard errors were estimated from a generalized estimation equation (GEE) model which includes the change from Baseline as the dependent variable, time as the categorical variable and adjusted for Baseline BALP, with compound symmetry covariance structure.'}, {'measure': 'Percent Change From Baseline Over Time in BALP', 'timeFrame': 'Baseline and Weeks 24, 48, 96, 144, 168, 192, 216, and 240', 'description': 'Least squares means and standard errors were estimated from a generalized estimation equation (GEE) model which includes the change from Baseline as the dependent variable, time as the categorical variable and adjusted for Baseline BALP, with compound symmetry covariance structure.'}, {'measure': 'Change From Baseline Over Time in Carboxy Terminal Cross-Linked Telopeptide of Type 1 Collagen (CTx)', 'timeFrame': 'Baseline and Weeks 24, 48, 96, 144, 168, 192, 216, and 240', 'description': 'Least squares means and standard errors were estimated from a generalized estimation equation (GEE) model which includes the change from Baseline as the dependent variable, time as the categorical variable and adjusted for Baseline CTx, with compound symmetry covariance structure.'}, {'measure': 'Percent Change From Baseline Over Time in CTx', 'timeFrame': 'Baseline and Weeks 24, 48, 96, 144, 168, 192, 216, and 240', 'description': 'Least squares means and standard errors were estimated from a generalized estimation equation (GEE) model which includes the change from Baseline as the dependent variable, time as the categorical variable and adjusted for Baseline CTx, with compound symmetry covariance structure.'}, {'measure': 'Change From Baseline Over Time in Procollagen Type 1 N-Propeptide (P1NP)', 'timeFrame': 'Baseline and Weeks 24, 48, 96, 144, 168, 192, 216, and 240', 'description': 'Least squares means and standard errors were estimated from a generalized estimation equation (GEE) model which includes the change from Baseline as the dependent variable, time as the categorical variable and adjusted for Baseline P1NP, with compound symmetry covariance structure.'}, {'measure': 'Percent Change From Baseline Over Time in P1NP', 'timeFrame': 'Baseline and Weeks 24, 48, 96, 144, 168, 192, 216, and 240', 'description': 'Least squares means and standard errors were estimated from a generalized estimation equation (GEE) model which includes the change from Baseline as the dependent variable, time as the categorical variable and adjusted for Baseline P1NP, with compound symmetry covariance structure.'}, {'measure': 'Change From Baseline Over Time in Osteocalcin', 'timeFrame': 'Baseline and Weeks 24, 48, 96, 144, 168, 192, 216, and 240', 'description': 'Least squares means and standard errors were estimated from a generalized estimation equation (GEE) model which includes the change from Baseline as the dependent variable, time as the categorical variable and adjusted for Baseline osteocalcin, with compound symmetry covariance structure.'}, {'measure': 'Percent Change From Baseline Over Time in Osteocalcin', 'timeFrame': 'Baseline and Weeks 24, 48, 96, 144, 168, 192, 216, and 240', 'description': 'Least squares means and standard errors were estimated from a generalized estimation equation (GEE) model which includes the change from Baseline as the dependent variable, time as the categorical variable and adjusted for Baseline osteocalcin, with compound symmetry covariance structure.'}, {'measure': 'Change From Baseline Over Time in Hand-Held Dynamometry (HHD) Elbow Measurements', 'timeFrame': 'Baseline and Weeks 24 and 48', 'description': 'To assess muscle strength, hand-held dynamometry was conducted using a standardized technique. Bilateral strength (defined as the average of the left and the right scores, measured in kilograms) of the elbow flexors and extensors was measured by the maximum voluntary isometric contraction against a dynamometer.\n\nLeast squares means and standard errors were estimated from a generalized estimation equation (GEE) model which includes the change from Baseline as the dependent variable, time as the categorical variable and adjusted for Baseline strength measurements, with compound symmetry covariance structure.'}, {'measure': 'Change From Baseline Over Time in Hand-Held Dynamometry (HHD) Knee Measurements', 'timeFrame': 'Baseline and Weeks 24 and 48', 'description': 'To assess muscle strength, hand-held dynamometry was conducted using a standardized technique. Bilateral strength (defined as the average of the left and the right scores, measured in kilograms) of the knee flexors and extensors was measured by the maximum voluntary isometric contraction against a dynamometer.\n\nLeast squares means and standard errors were estimated from a generalized estimation equation (GEE) model which includes the change from Baseline as the dependent variable, time as the categorical variable and adjusted for Baseline strength measurements, with compound symmetry covariance structure.'}, {'measure': 'Change From Baseline Over Time in Sit-to-Stand (STS) Test', 'timeFrame': 'Baseline and Weeks 24 and 48', 'description': 'The STS test measures lower extremity strength and mobility as a participant moves repeatedly from a seated position to standing. This study used a modified STS test that allowed participants to use the arms of the chair to help them stand and sit if necessary. The number of sit-to-stand repetitions performed in a 30-second period was recorded.\n\nLeast squares means and standard errors were estimated from a generalized estimation equation (GEE) model which includes the change from Baseline as the dependent variable, time as the categorical variable and adjusted for Baseline measurement, with compound symmetry covariance structure.'}, {'measure': 'Change From Baseline Over Time in Weighted Arm Lift (WAL) Test', 'timeFrame': 'Baseline and Weeks 24 and 48', 'description': 'The Weighted arm lift (WAL) test assesses upper extremity strength, mobility and reaching ability. The test was administered bilaterally to determine the number of times the participant could raise a 1 kg weight above the head in a 30-second period. The number of repetitions completed with each arm was recorded.\n\nLeast squares means and standard errors were estimated from a generalized estimation equation (GEE) model which includes the change from Baseline as the dependent variable, time as the categorical variable and adjusted for Baseline WAL measurements, with compound symmetry covariance structure.'}, {'measure': 'Change From Baseline Over Time in Six-Minute Walk Test (6MWT)', 'timeFrame': 'Baseline and Weeks 24 and 48', 'description': 'The 6MWT is a commonly used measure of mobility and was conducted in accordance with general principles set forth in the American Thoracic Society guidelines (ATS 2002). Participants were instructed to walk the length of a pre-measured course for 6 consecutive minutes (assistive devices could be used). The total distance walked at the end of 6 minutes was recorded in meters.\n\nLeast squares means and standard errors were estimated from a generalized estimation equation (GEE) model which includes the change from Baseline as the dependent variable, time as the categorical variable and adjusted for Baseline 6MWT measurement, with compound symmetry covariance structure.'}, {'measure': 'Change From Baseline Over Time in Brief Pain Inventory (BPI) Worst Pain Score', 'timeFrame': 'Baseline and Weeks 24, 48, 96, 144, 168, 192, 216, and 240', 'description': 'The Brief Pain Inventory (BPI) is a self-reported, pain-specific questionnaire with a recall period of 24 hours. Worst pain is defined as the answer to Question 3, in which participants rated their pain at its worst in the last 24 hours on a scale from 0 (no pain) to 10 (pain as bad as you can imagine).\n\nA negative change from Baseline score indicates improvement.\n\nLeast squares means and standard errors were estimated from a generalized estimation equation (GEE) model which includes the change from Baseline as the dependent variable, time as the categorical variable and adjusted for Baseline BPI measurement, with compound symmetry covariance structure.'}, {'measure': 'Change From Baseline Over Time in Brief Pain Inventory (BPI) Pain Severity Score', 'timeFrame': 'Baseline and Weeks 24, 48, 96, 144, 168, 192, 216, and 240', 'description': 'The Brief Pain Inventory (BPI) is a self-reported, pain-specific questionnaire with a recall period of 24 hours.\n\nPain severity is defined as the average of 4 questions (Questions 3 through 6) assessing worst pain, least pain, average pain, and pain right now, rated on a scale from 0 (no pain) to 10 (pain as bad as you can imagine). Mild pain is defined as a score of 1 to 4, moderate pain is defined as a score of 5 to 6, and severe pain is defined as a score of 7 to 10. A negative change from Baseline score indicates improvement.\n\nLeast squares means and standard errors were estimated from a generalized estimation equation (GEE) model which includes the change from Baseline as the dependent variable, time as the categorical variable and adjusted for Baseline BPI measurement, with compound symmetry covariance structure.'}, {'measure': 'Change From Baseline Over Time in Brief Pain Inventory (BPI) Pain Interference Score', 'timeFrame': 'Baseline and Weeks 24, 48, 96, 144, 168, 192, 216, and 240', 'description': 'The Brief Pain Inventory (BPI) is a self-reported, pain-specific questionnaire with a recall period of 24 hours.\n\nPain interference is defined as the average of 7 questions (9A through 9G) regarding the extent to which pain interfered with daily activities, including general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life in the last 24 hours, rated on a scale from 0 (does not interfere) to 10 (completely interferes).\n\nA negative change from Baseline score indicates improvement. Least squares means and standard errors were estimated from a generalized estimation equation (GEE) model which includes the change from Baseline as the dependent variable, time as the categorical variable and adjusted for Baseline BPI measurement, with compound symmetry covariance structure.'}, {'measure': 'Change From Baseline Over Time in Brief Fatigue Inventory (BFI) Worst Fatigue Score', 'timeFrame': 'Baseline and Weeks 24, 48, 96, 144, 168, 192, 216, and 240', 'description': 'The Brief Fatigue Inventory (BFI) is a self-reported questionnaire consisting of 9 items related to fatigue that are rated on a 0 to 10 numerical rating scale with a recall period of 24 hours.\n\nWorst fatigue is defined as the answer to Question 3 in which participants rated their fatigue at its worst in the last 24 hours on a scale from 0 (no fatigue) to 10 (as bad as you can imagine).\n\nA negative change from Baseline score indicates improvement. Least squares means and standard errors were estimated from a generalized estimation equation (GEE) model which includes the change from Baseline as the dependent variable, time as the categorical variable and adjusted for Baseline BFI measurement, with compound symmetry covariance structure.'}, {'measure': 'Change From Baseline Over Time in Brief Fatigue Inventory (BFI) Fatigue Severity Score', 'timeFrame': 'Baseline and Weeks 24, 48, 96, 144, 168, 192, 216, and 240', 'description': 'The Brief Fatigue Inventory (BFI) is a self-reported questionnaire consisting of 9 items related to fatigue that are rated on a 0 to 10 numerical rating scale with a recall period of 24 hours.\n\nFatigue severity is defined as the average of 3 questions (Questions 1 through 3) assessing fatigue right now, usual level of fatigue, and worst fatigue, rated on a scale from 0 (no fatigue) to 10 (as bad as you can imagine).\n\nA negative change from Baseline score indicates improvement.\n\nLeast squares means and standard errors were estimated from a generalized estimation equation (GEE) model which includes the change from Baseline as the dependent variable, time as the categorical variable and adjusted for Baseline BFI measurement, with compound symmetry covariance structure.'}, {'measure': 'Change From Baseline Over Time in Brief Fatigue Inventory (BFI) Fatigue Interference Score', 'timeFrame': 'Baseline and Weeks 24, 48, 96, 144, 168, 192, 216, and 240', 'description': 'The Brief Fatigue Inventory (BFI) is a self-reported questionnaire consisting of 9 items related to fatigue that are rated on a 0 to 10 numerical rating scale with a recall period of 24 hours.\n\nThe fatigue interference score is defined as the average of 6 questions (Questions 4A through 4F) regarding the extent to which fatigue interfered with daily activities, including general activity, mood, walking ability, work, relations with others, and enjoyment of life in the last 24 hours, rated on a scale from 0 (does not interfere) to 10 (completely interferes).\n\nA negative change from Baseline score indicates improvement. Least squares means and standard errors were estimated from a generalized estimation equation (GEE) model which includes the change from Baseline as the dependent variable, time as the categorical variable and adjusted for Baseline BFI measurement, with compound symmetry covariance structure.'}, {'measure': 'Change From Baseline Over Time in Brief Fatigue Inventory (BFI) Global Fatigue Score', 'timeFrame': 'Baseline and Weeks 24, 48, 96, 144, 168, 192, 216, and 240', 'description': 'The Brief Fatigue Inventory (BFI) is a self-reported questionnaire consisting of 9 items related to fatigue that are rated on a 0 to 10 numerical rating scale with a recall period of 24 hours. The first 3 questions measure fatigue severity and the next 6 questions assess the impact of fatigue on daily activities.\n\nThe global fatigue score is defined as the average of all 9 questions on the BFI including severity and interference, and ranges from from 0 to 10, where higher scores correspond to greater levels of fatigue.\n\nA negative change from Baseline score indicates improvement. Least squares means and standard errors were estimated from a generalized estimation equation (GEE) model which includes the change from Baseline as the dependent variable, time as the categorical variable and adjusted for Baseline BFI measurement, with compound symmetry covariance structure.'}, {'measure': 'Change From Baseline Over Time in 36-Item Short Form Health Survey (SF-36) Physical Component Summary Score', 'timeFrame': 'Baseline and Weeks 24, 48, 96, 144, 168, 192, 216, and 240', 'description': 'The SF-36 v2 is a self-administered questionnaire that measures the impact of disease on overall quality of life during the past 4 weeks. The SF-36 consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health).\n\nThe physical component summary score (PCS) is a weighted combination of the 8 subscales with positive weighting for physical functioning, role-physical, bodily pain, and general health. The PCS was calculated using norm-based scoring so that 50 is the average score and the standard deviation equals 10. Higher scores are associated with better functioning/quality of life; a positive change from Baseline score indicates an improvement.\n\nLS means and SEs were estimated from a GEE model which includes the change from Baseline as the dependent variable, time as the categorical variable and adjusted for Baseline SF-36, with compound symmetry covariance struct'}, {'measure': 'Change From Baseline Over Time in 36-Item Short Form Health Survey (SF-36) Physical Functioning Domain Score', 'timeFrame': 'Baseline and Weeks 24, 48, 96, 144, 168, 192, 216, and 240', 'description': 'The SF-36 v2 is a self-administered questionnaire that measures the impact of disease on overall quality of life during the past 4 weeks. The SF-36 consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health).\n\nThe physical functioning (PF) domain includes 10 questions that assess limitations in physical activities because of health problems. The PF domain score was calculated using norm-based scoring so that 50 is the average score and the standard deviation equals 10. Higher scores are associated with better functioning/quality of life; a positive change from Baseline score indicates an improvement.\n\nLS means and SEs were estimated from a GEE model which includes the change from Baseline as the dependent variable, time as the categorical variable and adjusted for Baseline SF-36, with compound symmetry covariance structure.'}, {'measure': 'Change From Baseline Over Time in 36-Item Short Form Health Survey (SF-36) Role Physical Domain Score', 'timeFrame': 'Baseline and Weeks 24, 48, 96, 144, 168, 192, 216, and 240', 'description': 'The SF-36 v2 is a self-administered questionnaire that measures the impact of disease on overall quality of life during the past 4 weeks. The SF-36 consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health).\n\nThe role-physical (RP) domain includes 4 questions that assess limitations in usual role activities because of physical health problems. The RP domain score was calculated using norm-based scoring so that 50 is the average score and the standard deviation equals 10. Higher scores are associated with better functioning/quality of life; a positive change from Baseline score indicates an improvement.\n\nLS means and SEs were estimated from a GEE model which includes the change from Baseline as the dependent variable, time as the categorical variable and adjusted for Baseline SF-36, with compound symmetry covariance structure.'}, {'measure': 'Change From Baseline Over Time in 36-Item Short Form Health Survey (SF-36) Bodily Pain Domain Score', 'timeFrame': 'Baseline and Weeks 24, 48, 96, 144, 168, 192, 216, and 240', 'description': 'The SF-36 v2 is a self-administered questionnaire that measures the impact of disease on overall quality of life during the past 4 weeks. The SF-36 consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health).\n\nThe bodily pain (BP) domain includes 2 questions that assess pain level and impact of pain on normal work. The BP domain score was calculated using norm-based scoring so that 50 is the average score and the standard deviation equals 10. Higher scores are associated with better functioning/quality of life; a positive change from Baseline score indicates an improvement.\n\nLS means and SEs were estimated from a GEE model which includes the change from Baseline as the dependent variable, time as the categorical variable and adjusted for Baseline SF-36, with compound symmetry covariance structure.'}, {'measure': 'Change From Baseline Over Time in 36-Item Short Form Health Survey (SF-36) General Health Perceptions Domain Score', 'timeFrame': 'Baseline and Weeks 24, 48, 96, 144, 168, 192, 216, and 240', 'description': "The SF-36 v2 is a self-administered questionnaire that measures the impact of disease on overall quality of life during the past 4 weeks. The SF-36 consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health).\n\nThe general health perceptions (GH) domain includes 5 questions that assess participants' perception of their own general health. The GH domain score was calculated using norm-based scoring so that 50 is the average score and the standard deviation equals 10. Higher scores are associated with better functioning/quality of life; a positive change from Baseline score indicates an improvement.\n\nLS means and SEs were estimated from a GEE model which includes the change from Baseline as the dependent variable, time as the categorical variable and adjusted for Baseline SF-36, with compound symmetry covariance structure."}, {'measure': 'Change From Baseline Over Time in 36-Item Short Form Health Survey (SF-36) Mental Component Summary Score', 'timeFrame': 'Baseline and Weeks 24, 48, 96, 144, 168, 192, 216, and 240', 'description': 'The SF-36 v2 is a self-administered questionnaire that measures the impact of disease on overall quality of life during the past 4 weeks. The SF-36 consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health).\n\nThe mental component summary score (MCS) is a weighted combination of the 8 subscales with positive weighting for vitality, social function, role limitations due to emotional problems, and mental health. The MCS was calculated using norm-based scoring so that 50 is the average score and the standard deviation equals 10. Higher scores are associated with better functioning/quality of life; a positive change from Baseline indicates an improvement.\n\nLS means and SEs were estimated from a GEE model which includes the change from Baseline as the dependent variable, time as the categorical variable and adjusted for Baseline SF-36, with compound symmetry covariance structure.'}, {'measure': 'Change From Baseline Over Time in 36-Item Short Form Health Survey (SF-36) Vitality Domain Score', 'timeFrame': 'Baseline and Weeks 24, 48, 96, 144, 168, 192, 216, and 240', 'description': 'The SF-36 v2 is a self-administered questionnaire that measures the impact of disease on overall quality of life during the past 4 weeks. The SF-36 consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health).\n\nThe vitality (VT) domain includes 4 questions that assess energy levels and fatigue. The VT domain score was calculated using norm-based scoring so that 50 is the average score and the standard deviation equals 10. Higher scores are associated with better functioning/quality of life; a positive change from Baseline score indicates an improvement.\n\nLS means and SEs were estimated from a GEE model which includes the change from Baseline as the dependent variable, time as the categorical variable and adjusted for Baseline SF-36, with compound symmetry covariance structure.'}, {'measure': 'Change From Baseline Over Time in 36-Item Short Form Health Survey (SF-36) Social Functioning Domain Score', 'timeFrame': 'Baseline and Weeks 24, 48, 96, 144, 168, 192, 216, and 240', 'description': 'The SF-36 v2 is a self-administered questionnaire that measures the impact of disease on overall quality of life during the past 4 weeks. The SF-36 consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health).\n\nThe social functioning (SF) domain includes 2 questions that assess limitations in social activities because of physical health or emotional problems. The SF domain score was calculated using norm-based scoring so that 50 is the average score and the standard deviation equals 10. Higher scores are associated with better functioning/quality of life; a positive change from Baseline score indicates an improvement.\n\nLS means and SEs were estimated from a GEE model which includes the change from Baseline as the dependent variable, time as the categorical variable and adjusted for Baseline SF-36, with compound symmetry covariance structure.'}, {'measure': 'Change From Baseline Over Time in 36-Item Short Form Health Survey (SF-36) Role Emotional Domain Score', 'timeFrame': 'Baseline and Weeks 24, 48, 96, 144, 168, 192, 216, and 240', 'description': 'The SF-36 v2 is a self-administered questionnaire that measures the impact of disease on overall quality of life during the past 4 weeks. The SF-36 consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health).\n\nThe role-emotional (RE) domain includes 3 questions that assess limitations in usual role activities because of emotional problems. The RE domain score was calculated using norm-based scoring so that 50 is the average score and the standard deviation equals 10. Higher scores are associated with better functioning/quality of life; a positive change from Baseline score indicates an improvement.\n\nLS means and SEs were estimated from a GEE model which includes the change from Baseline as the dependent variable, time as the categorical variable and adjusted for Baseline SF-36, with compound symmetry covariance structure.'}, {'measure': 'Change From Baseline Over Time in 36-Item Short Form Health Survey (SF-36) Mental Health Domain Score', 'timeFrame': 'Baseline and Weeks 24, 48, 96, 144, 168, 192, 216, and 240', 'description': 'The SF-36 v2 is a self-administered questionnaire that measures the impact of disease on overall quality of life during the past 4 weeks. The SF-36 consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health).\n\nThe mental health (MH) domain includes 5 questions that assess general mental health (psychological distress and well-being). The MH domain score was calculated using norm-based scoring so that 50 is the average score and the standard deviation equals 10. Higher scores are associated with better functioning/quality of life; a positive change from Baseline score indicates an improvement.\n\nLS means and SEs were estimated from a GEE model which includes the change from Baseline as the dependent variable, time as the categorical variable and adjusted for Baseline SF-36, with compound symmetry covariance structure.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['TIO', 'ENS', 'FGF23', 'KRN23'], 'conditions': ['Tumor Induced Osteomalacia (TIO)', 'Epidermal Nevus Syndrome (ENS)']}, 'referencesModule': {'references': [{'pmid': '34660853', 'type': 'DERIVED', 'citation': 'Khadora M, Mughal MZ. Burosumab treatment in a child with cutaneous skeletal hypophosphatemia syndrome: A case report. Bone Rep. 2021 Oct 1;15:101138. doi: 10.1016/j.bonr.2021.101138. eCollection 2021 Dec.'}]}, 'descriptionModule': {'briefSummary': 'The primary objectives of this study are to evaluate the effect of burosumab treatment on:\n\n* Increasing serum phosphorus levels in adults with TIO or ENS-associated osteomalacia\n* Improvement in TIO/ENS-associated osteomalacia as determined by osteoid thickness (O.Th), osteoid surface/bone surface (OS/BS), osteoid volume/bone volume (OV/BV) and mineralization lag time (MLt).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Have a clinical diagnosis of TIO/ENS-associated osteomalacia based on evidence of excessive fibroblast growth factor 23 (FGF23) that was not amenable to cure by surgical excision of the underlying tumor/lesion (documented by Investigator).\n2. Be ≥ 18 years of age\n3. Have a fasting serum phosphorus level \\< 2.5 mg/dL\n4. Have an FGF23 level ≥ 100 pg/mL by Kainos assay\n5. Have a ratio of renal tubular maximum reabsorption rate of phosphate to glomerular filtration rate (TmP/GFR) \\< 2.5 mg/dL\n6. Have an estimated glomerular filtration rate (eGFR) ≥ 60 mL/min (using Cockcroft-Gault formula). Subjects with eGFR ≥ 30 but \\< 60 mL/min will be considered eligible as long as in the opinion of the investigator the decline in renal function is not related to nephrocalcinosis.\n7. Have a corrected serum calcium level \\< 10.8 mg/dL\n8. Females of child-bearing potential must have a negative urine pregnancy test at Screening and Baseline and be willing to have additional pregnancy tests during the study. Females considered not to be of childbearing potential include those who have not experienced menarche, are post-menopausal (defined as having no menses for at least 12 months without an alternative medical cause) or are permanently sterile due to total hysterectomy, bilateral salpingectomy, or bilateral oophorectomy.\n9. Be willing to use 2 forms of effective methods of contraception while participating in the study (sexually active subjects) and for 12 weeks after last dose of study drug.\n10. Be willing to provide access to prior medical records to determine eligibility including imaging, biochemical, and diagnostic, medical, and surgical history data\n11. Provide written informed consent after the nature of the study has been explained, and prior to any research-related procedures\n12. Be willing and able to complete all aspects of the study, adhere to the study visit schedule and comply with the assessments (in the opinion of the investigator)\n\nExclusion Criteria:\n\n1. Have a prior diagnosis of human immunodeficiency virus (HIV), hepatitis B and/or hepatitis C\n2. Have a history of recurrent infection, a predisposition to infection, or a known immunodeficiency\n3. Are pregnant or breastfeeding at Screening or are planning to become pregnant (self or partner) at any time during the study\n4. Have participated in an investigational drug or device trial within 30 days prior to Screening or are currently enrolled in another study of an investigational product or device\n5. Have used a therapeutic monoclonal antibody (mAb), including KRN23, within 90 days prior to Screening or have a history of allergic or anaphylactic reactions to any mAb\n6. Have or a have a history of any hypersensitivity to KRN23 excipients that, in the judgment of the investigator, places the subject at increased risk for adverse effects\n7. Have used a pharmacologic vitamin D metabolite or its analog (e.g., calcitriol, doxercalciferol, and paricalcitol), phosphate, or aluminum hydroxide antacids (e.g., Maalox® and Mylanta®) within 2 weeks prior to Screening or during the study\n8. Have used medication to suppress parathyroid hormone (PTH) (e.g., Sensipar®, cinacalcet, calcimimetics) within 2 months prior to Screening\n9. Have a history of malignancy within 5 years of study entry with the exception of phosphaturic mesenchymal tumors (PMTs) of the mixed connective tissue type or non-melanoma skin cancers such as basal cell skin cancer\n10. Have donated blood or blood products within 60 days prior to Screening\n11. Have a history of allergic reaction to or have shown adverse reactions to a tetracycline (e.g., tetracycline hydrochloride \\[HCl\\] and demeclocycline), benzodiazepines, fentanyl or lidocaine\n12. Have any condition, which in the opinion of the investigator and sponsor, could present a concern for either subject safety or difficulty with data interpretation'}, 'identificationModule': {'nctId': 'NCT02304367', 'briefTitle': 'Study of Burosumab (KRN23) in Adults With Tumor-Induced Osteomalacia (TIO) or Epidermal Nevus Syndrome (ENS)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Kyowa Kirin Co., Ltd.'}, 'officialTitle': 'A Phase 2 Open-Label Trial to Assess the Efficacy and Safety of KRN23, an Antibody to FGF23, in Subjects With Tumor-Induced Osteomalacia (TIO) or Epidermal Nevus Syndrome (ENS)-Associated Osteomalacia', 'orgStudyIdInfo': {'id': 'UX023T-CL201'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Burosumab', 'description': 'Participants received burosumab at a starting dose of 0.3 mg/kg administered subcutaneously (SC) every 4 weeks (Q4W). Doses may have been titrated up to a maximum of 2.0 mg/kg every 2 weeks (Q2W) in order to achieve fasting peak serum phosphorus levels within the target range of 2.5 to 4.0 mg/dL.', 'interventionNames': ['Biological: Burosumab']}], 'interventions': [{'name': 'Burosumab', 'type': 'BIOLOGICAL', 'otherNames': ['KRN23', 'Crysvita®', 'UX023'], 'description': 'Solution for subcutaneous injection', 'armGroupLabels': ['Burosumab']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80401', 'city': 'Golden', 'state': 'Colorado', 'country': 'United States', 'facility': 'Colorado Center for Bone Research at Panorama Orthopedics and Spine Center', 'geoPoint': {'lat': 39.75554, 'lon': -105.2211}}, {'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 Hospital', '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': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}, {'zip': '27710', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke University', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Houston Methodist Research Institute', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'overallOfficials': [{'name': 'Medical Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Ultragenyx Pharmaceutical Inc'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kyowa Kirin, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}