Ignite Creation Date:
2025-12-24 @ 9:43 PM
Ignite Modification Date:
2026-01-03 @ 10:01 PM
Study NCT ID:
NCT02024932
Status:
COMPLETED
Last Update Posted:
2021-01-05
First Post:
2013-12-29
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Safety, Tolerability, and Efficacy of BVS857 in Patients With Spinal and Bulbar Muscular Atrophy
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D055534', 'term': 'Bulbo-Spinal Atrophy, X-Linked'}], 'ancestors': [{'id': 'D009134', 'term': 'Muscular Atrophy, Spinal'}, {'id': 'D013118', 'term': 'Spinal Cord Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D020271', 'term': 'Heredodegenerative Disorders, Nervous System'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D016472', 'term': 'Motor Neuron Disease'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D040181', 'term': 'Genetic Diseases, X-Linked'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '862-778-1873', 'title': 'Study Director', 'organization': 'Novartis Pharmaceuticals'}, 'certainAgreement': {'otherDetails': "The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial or disclosure of trial results in their entirety.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'BVS857 Part A Open Label (Cohort 1)', 'description': 'Participants received single doses of 0.01 mg/kg BVS857 intravenously (i.v.) on day 1, 0.01 mg/kg BVS857 subcutaneously (s.c.) on day 15, 0.03 mg/kg BVS857 s.c. on day 29, 0.06 mg/kg BVS857 s.c. on day 43 and 0.10 mg/kg BVS857 s.c. on day 57.', 'otherNumAtRisk': 2, 'otherNumAffected': 2, 'seriousNumAtRisk': 2, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo Part A Double Blind (Cohort 2)', 'description': 'Participants received single doses of matching placebo i.v. on day 1 and matching placebo s.c. on days 15, 29, 43 and 57.', 'otherNumAtRisk': 2, 'otherNumAffected': 2, 'seriousNumAtRisk': 2, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'BVS857 Part A Double Blind (Cohort 2)', 'description': 'Participants received single doses of 0.03 mg/kg BVS857 i.v. on day 1, 0.03 mg/kg BVS857 s.c. on day 15, 0.06 mg/kg BVS857 s.c. on day 29, 0.10 mg/kg BVS857 s.c. on day 43 and 0.10 mg/kg BVS857 s.c. on day 57. (BVS857 concentrations differed on days 43 and 57.)', 'otherNumAtRisk': 4, 'otherNumAffected': 4, 'seriousNumAtRisk': 4, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'BVS857 Part B Open-label (Cohort 4)', 'description': 'Participants received 0.1 mg/kg BVS857 i.v. weekly for 12 weeks.', 'otherNumAtRisk': 2, 'otherNumAffected': 1, 'seriousNumAtRisk': 2, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'BVS857 Part B Double Blind (Cohort 5)', 'description': 'Participants received 0.06 mg/kg (maximum 6 mg) BVS857 i.v. weekly for 12 weeks.', 'otherNumAtRisk': 18, 'otherNumAffected': 17, 'seriousNumAtRisk': 18, 'seriousNumAffected': 0}, {'id': 'EG005', 'title': 'Placebo Part B Double Blind (Cohort 5)', 'description': 'Participants received matching placebo i.v. to BVS857 weekly for 12 weeks.', 'otherNumAtRisk': 9, 'otherNumAffected': 8, 'seriousNumAtRisk': 9, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Eustachian tube dysfunction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Eyelid haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Glaucoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Ocular discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Scleral hyperaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Vision blurred', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 9, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 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'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 9, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Gastrooesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Gingival pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Lip disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Lip oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, 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'Dermatitis contact', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 9, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Skin discolouration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Skin irritation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Flushing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 9, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}], 'frequencyThreshold': '1'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Patients With Adverse Events (AEs), Serious Adverse Events (SAEs) and Deaths as a Measure of Safety and Tolerability', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '18', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'BVS857 Part A Open Label (Cohort 1)', 'description': 'Participants received single doses of 0.01 mg/kg BVS857 intravenously (i.v.) on day 1, 0.01 mg/kg BVS857 subcutaneously (s.c.) on day 15, 0.03 mg/kg BVS857 s.c. on day 29, 0.06 mg/kg BVS857 s.c. on day 43 and 0.10 mg/kg BVS857 s.c. on day 57.'}, {'id': 'OG001', 'title': 'BVS857 Part A Double Blind (Cohort 2)', 'description': 'Participants received single doses of 0.03 mg/kg BVS857 i.v. on day 1, 0.03 mg/kg BVS857 s.c. on day 15, 0.06 mg/kg BVS857 s.c. on day 29, 0.10 mg/kg BVS857 s.c. on day 43 and 0.10 mg/kg BVS857 s.c. on day 57. (BVS857 concentrations differed on days 43 and 57.)'}, {'id': 'OG002', 'title': 'Placebo Part A Double Blind (Cohort 2)', 'description': 'Participants received single doses of matching placebo i.v. on day 1 and matching placebo s.c. on days 15, 29, 43 and 57.'}, {'id': 'OG003', 'title': 'BVS857 Part B Open-label (Cohort 4)', 'description': 'Participants received 0.1 mg/kg BVS857 i.v. weekly for 12 weeks.'}, {'id': 'OG004', 'title': 'BVS857 Part B Double Blind (Cohort 5)', 'description': 'Participants received 0.06 mg/kg (maximum 6 mg) BVS857 i.v. weekly for 12 weeks.'}, {'id': 'OG005', 'title': 'Placebo Part B Double Blind (Cohort 5)', 'description': 'Participants received matching placebo i.v. to BVS857 weekly for 12 weeks.'}], 'classes': [{'title': 'Non-serious AEs', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '17', 'groupId': 'OG004'}, {'value': '8', 'groupId': 'OG005'}]}]}, {'title': 'SAEs', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}, {'title': 'Deaths', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'After 78 days in Part A and after 85 days in Part B.', 'description': 'Safety was monitored throughout the study.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety analysis set, which included participants who received any study drug, was analyzed.'}, {'type': 'PRIMARY', 'title': 'Number of Mild, Moderate and Severe Adverse Events as a Measure of Safety and Tolerability', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '18', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'BVS857 Part A Open Label (Cohort 1)', 'description': 'Participants received single doses of 0.01 mg/kg BVS857 intravenously (i.v.) on day 1, 0.01 mg/kg BVS857 subcutaneously (s.c.) on day 15, 0.03 mg/kg BVS857 s.c. on day 29, 0.06 mg/kg BVS857 s.c. on day 43 and 0.10 mg/kg BVS857 s.c. on day 57.'}, {'id': 'OG001', 'title': 'BVS857 Part A Double Blind (Cohort 2)', 'description': 'Participants received single doses of 0.03 mg/kg BVS857 i.v. on day 1, 0.03 mg/kg BVS857 s.c. on day 15, 0.06 mg/kg BVS857 s.c. on day 29, 0.10 mg/kg BVS857 s.c. on day 43 and 0.10 mg/kg BVS857 s.c. on day 57. (BVS857 concentrations differed on days 43 and 57.)'}, {'id': 'OG002', 'title': 'Placebo Part A Double Blind (Cohort 2)', 'description': 'Participants received single doses of matching placebo i.v. on day 1 and matching placebo s.c. on days 15, 29, 43 and 57.'}, {'id': 'OG003', 'title': 'BVS857 Part B Open-label (Cohort 4)', 'description': 'Participants received 0.1 mg/kg BVS857 i.v. weekly for 12 weeks.'}, {'id': 'OG004', 'title': 'BVS857 Part B Double Blind (Cohort 5)', 'description': 'Participants received 0.06 mg/kg (maximum 6 mg) BVS857 i.v. weekly for 12 weeks.'}, {'id': 'OG005', 'title': 'Placebo Part B Double Blind (Cohort 5)', 'description': 'Participants received matching placebo i.v. to BVS857 weekly for 12 weeks.'}], 'classes': [{'title': 'Mild', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}]}]}, {'title': 'Moderate', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '11', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}]}]}, {'title': 'Severe', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'After 78 days in Part A and after 85 days in Part B.', 'description': 'Safety was monitored throughout the study.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety analysis set, which included participants who received any study drug, was analyzed.'}, {'type': 'PRIMARY', 'title': 'Mean Percent Change From Baseline in Thigh Muscle Volume in Part B, Cohort 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'BVS857 Part B Double Blind (Cohort 5)', 'description': 'Participants received 0.06 mg/kg (maximum 6 mg) BVS857 i.v. weekly for 12 weeks.'}, {'id': 'OG001', 'title': 'Placebo Part B Double Blind (Cohort 5)', 'description': 'Participants received matching placebo i.v. to BVS857 weekly for 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0', 'spread': '2.42', 'groupId': 'OG000'}, {'value': '-3.4', 'spread': '4.79', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0164', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Geo-mean ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '1.037', 'ciLowerLimit': '1.009', 'ciUpperLimit': '1.065', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Day 85', 'description': 'Thigh muscle volume was assessed by magnetic resonance imaging (MRI). Change from baseline was calculated from the ratio of the post-baseline mean value to the baseline mean value: \\[(Day 85/baseline) - 1)\\] x 100. A positive change from baseline indicates improvement.', 'unitOfMeasure': 'Percent change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PD analysis set was considered for the analysis. However, only participants who had evaluable data at both baseline and day 85, were included in the analysis. The PD set included participants with evaluable PD data who received any study drug and had no protocol deviations with relevant impact on PD data.'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline in Score on the Adult Myopathy Assessment Tool (AMAT) in Part B, Cohort 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'BVS857 Part B Double Blind (Cohort 5)', 'description': 'Participants received 0.06 mg/kg (maximum 6 mg) BVS857 i.v. weekly for 12 weeks.'}, {'id': 'OG001', 'title': 'Placebo Part B Double Blind (Cohort 5)', 'description': 'Participants received matching placebo i.v. to BVS857 weekly for 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.0', 'spread': '4.20', 'groupId': 'OG000'}, {'value': '2.3', 'spread': '1.87', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Day 85', 'description': 'The AMAT rated physical function and muscle endurance, with higher scores indicating better performance. The tool includes 7 timed functional tasks rated on a scale from 0 - 21 and 6 endurance tasks rated on a scale from 0 - 24. The range for the total score was from 0 (worst) to 45 (best). A positive change from baseline indicates improvement.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PD set included, which included participants with evaluable PD data who received any study drug and had no protocol deviations with relevant impact on PD data, was analyzed.'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline in Total Lean Body Mass (LBM) in Part B, Cohort 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'BVS857 Part B Double Blind (Cohort 5)', 'description': 'Participants received 0.06 mg/kg (maximum 6 mg) BVS857 i.v. weekly for 12 weeks.'}, {'id': 'OG001', 'title': 'Placebo Part B Double Blind (Cohort 5)', 'description': 'Participants received matching placebo i.v. to BVS857 weekly for 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.77', 'spread': '1.556', 'groupId': 'OG000'}, {'value': '0.16', 'spread': '1.199', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Day 85', 'description': 'LBM was assessed by dual-energy X-ray (DXA) absorptiometry. A positive change from baseline indicate improvement.', 'unitOfMeasure': 'kilograms', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PD analysis set was considered for the analysis. However, only participants who had evaluable data at both baseline and day 85, were included in the analysis. The PD set included participants with evaluable PD data who received any study drug and had no protocol deviations with relevant impact on PD data.'}, {'type': 'SECONDARY', 'title': 'Plasma Pharmacokinetics (PK) of BVS857: Observed Maximum Concentration Following Drug Administration (Cmax) in Part A, Cohort 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'BVS857 Part A Open Label (Cohort 1)', 'description': 'Participants received single doses of 0.01 mg/kg BVS857 intravenously (i.v.) on day 1, 0.01 mg/kg BVS857 subcutaneously (s.c.) on day 15, 0.03 mg/kg BVS857 s.c. on day 29, 0.06 mg/kg BVS857 s.c. on day 43 and 0.10 mg/kg BVS857 s.c. on day 57.'}], 'classes': [{'title': 'Day 1, 0.01 mg/kg BVS857 i.v.', 'categories': [{'measurements': [{'value': '184', 'spread': '6.36', 'groupId': 'OG000'}]}]}, {'title': 'Day 15, 0.01 mg/kg BVS857 s.c.', 'categories': [{'measurements': [{'value': '34.6', 'spread': '48.9', 'groupId': 'OG000'}]}]}, {'title': 'Day 29, 0.03 mg/kg BVS857 s.c', 'categories': [{'measurements': [{'value': '83.1', 'spread': '20.3', 'groupId': 'OG000'}]}]}, {'title': 'Day 43, 0.06 mg/kg BVS857 s.c.', 'categories': [{'measurements': [{'value': '74.2', 'spread': '16.1', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Days 1, 15, 29, 43: pre-dose, 1, 4, 12, 24, 48, 168 hours post-dose', 'description': 'Serum samples were obtained for PK assessment.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'For each time point, only participants from the PK set with valid measurements at that time point were analyzed. The PK analysis set included participants with at least one available valid PK concentration measurement who received any study drug and experienced no protocol deviations with relevant impact on PK data.'}, {'type': 'SECONDARY', 'title': 'Plasma Pharmacokinetics (PK) of BVS857: Observed Maximum Concentration Following Drug Administration (Cmax) in Part A, Cohort 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'BVS857 Part A Double Blind (Cohort 2)', 'description': 'Participants received single doses of 0.03 mg/kg BVS857 i.v. on day 1, 0.03 mg/kg BVS857 s.c. on day 15, 0.06 mg/kg BVS857 s.c. on day 29, 0.10 mg/kg BVS857 s.c. on day 43 and 0.10 mg/kg BVS857 s.c. on day 57. (BVS857 concentrations differed on days 43 and 57.)'}], 'classes': [{'title': 'Day 1, 0.03 mg/kg BVS857 i.v. (n=4)', 'categories': [{'measurements': [{'value': '393', 'spread': '30.1', 'groupId': 'OG000'}]}]}, {'title': 'Day 15, 0.03 mg/kg BVS857 s.c. (n=3)', 'categories': [{'measurements': [{'value': '77.3', 'spread': '46.5', 'groupId': 'OG000'}]}]}, {'title': 'Day 29, 0.06 mg/kg BVS857 s.c. (n=2)', 'categories': [{'measurements': [{'value': '113', 'spread': '2.12', 'groupId': 'OG000'}]}]}, {'title': 'Day 43, 0.10 mg/kg BVS857 s.c. (n=3)', 'categories': [{'measurements': [{'value': '191', 'spread': '19.2', 'groupId': 'OG000'}]}]}, {'title': 'Day 57, 0.10 mg/kg BVS857 s.c. (n=1)', 'categories': [{'measurements': [{'value': '232', 'spread': 'NA', 'comment': 'Standard deviation does not apply when n = 1.', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Days 1, 15, 29, 43: pre-dose, 1, 4, 12, 24, 48, 168 hours post-dose. Day 57: pre-dose, 1, 4, 12, 24, 48, 168, 504 hours post-dose', 'description': 'Serum samples were obtained for PK assessment.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'For each time point, only participants from the PK set with valid measurements at that time point were analyzed. The PK analysis set included participants with at least one available valid PK concentration measurement who received any study drug and experienced no protocol deviations with relevant impact on PK data.'}, {'type': 'SECONDARY', 'title': 'Plasma Pharmacokinetics (PK) of BVS857: Time to Reach the Maximum Concentration After Drug Administration (Tmax) in Part A, Cohort 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'BVS857 Part A Open Label (Cohort 1)', 'description': 'Participants received single doses of 0.01 mg/kg BVS857 intravenously (i.v.) on day 1, 0.01 mg/kg BVS857 subcutaneously (s.c.) on day 15, 0.03 mg/kg BVS857 s.c. on day 29, 0.06 mg/kg BVS857 s.c. on day 43 and 0.10 mg/kg BVS857 s.c. on day 57.'}], 'classes': [{'title': 'Day 1, 0.01 mg/kg BVS857 i.v. (n=2)', 'categories': [{'measurements': [{'value': '4.04', 'spread': '0.0566', 'groupId': 'OG000'}]}]}, {'title': 'Day 15, 0.01 mg/kg BVS857 s.c. (n=1)', 'categories': [{'measurements': [{'value': '12.1', 'spread': 'NA', 'comment': 'Standard deviation does not apply when n = 1.', 'groupId': 'OG000'}]}]}, {'title': 'Day 29, 0.03 mg/kg BVS857 s.c.(n=2)', 'categories': [{'measurements': [{'value': '18.1', 'spread': '8.41', 'groupId': 'OG000'}]}]}, {'title': 'Day 43, 0.06 mg/kg BVS857 s.c. (n=2)', 'categories': [{'measurements': [{'value': '36.0', 'spread': '16.8', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Days 1, 15, 29, 43: pre-dose, 1, 4, 12, 24, 48, 168 hours post-dose', 'description': 'Serum samples were obtained for PK assessment.', 'unitOfMeasure': 'hours', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'For each time point, only participants from the PK set with valid measurements at that time point were analyzed. The PK analysis set included participants with at least one available valid PK concentration measurement who received any study drug and experienced no protocol deviations with relevant impact on PK data.'}, {'type': 'SECONDARY', 'title': 'Plasma Pharmacokinetics (PK) of BVS857: Time to Reach the Maximum Concentration After Drug Administration (Tmax) in Part A, Cohort 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'BVS857 Part A Double Blind (Cohort 2)', 'description': 'Participants received single doses of 0.03 mg/kg BVS857 i.v. on day 1, 0.03 mg/kg BVS857 s.c. on day 15, 0.06 mg/kg BVS857 s.c. on day 29, 0.10 mg/kg BVS857 s.c. on day 43 and 0.10 mg/kg BVS857 s.c. on day 57. (BVS857 concentrations differed on days 43 and 57.)'}], 'classes': [{'title': 'Day 1, 0.03 mg/kg BVS857 i.v. (n=4)', 'categories': [{'measurements': [{'value': '2.53', 'spread': '1.70', 'groupId': 'OG000'}]}]}, {'title': 'Day 15, 0.03 mg/kg BVS857 s.c.(n=3)', 'categories': [{'measurements': [{'value': '24.1', 'spread': '0.100', 'groupId': 'OG000'}]}]}, {'title': 'Day 29, 0.06 mg/kg BVS857 s.c. (n=2)', 'categories': [{'measurements': [{'value': '24.0', 'spread': '0', 'groupId': 'OG000'}]}]}, {'title': 'Day 43, 0.10 mg/kg BVS857 s.c. (n=3)', 'categories': [{'measurements': [{'value': '24.0', 'spread': '0.200', 'groupId': 'OG000'}]}]}, {'title': 'Day 57, 0.10 mg/kg BVS857 s.c. (n=1)', 'categories': [{'measurements': [{'value': '48.0', 'spread': 'NA', 'comment': 'Standard deviation does not apply when n = 1.', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1, 15, 29, 43: pre-dose, 1, 4, 12, 24, 48, 168 hours post-dose. Day 57: pre-dose, 1, 4, 12, 24, 48, 168, 504 hours post-dose', 'description': 'Serum samples were obtained for PK assessment.', 'unitOfMeasure': 'hours', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'For each time point, only participants from the PK set with valid measurements at that time point were analyzed. The PK analysis set included participants with at least one available valid PK concentration measurement who received any study drug and experienced no protocol deviations with relevant impact on PK data.'}, {'type': 'SECONDARY', 'title': 'Plasma Pharmacokinetics (PK) of BVS857: The Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) in Part A, Cohort 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'BVS857 Part A Open Label (Cohort 1)', 'description': 'Participants received single doses of 0.01 mg/kg BVS857 intravenously (i.v.) on day 1, 0.01 mg/kg BVS857 subcutaneously (s.c.) on day 15, 0.03 mg/kg BVS857 s.c. on day 29, 0.06 mg/kg BVS857 s.c. on day 43 and 0.10 mg/kg BVS857 s.c. on day 57.'}], 'classes': [{'title': 'Day 1, 0.01 mg/kg BVS857 i.v.(n=2)', 'categories': [{'measurements': [{'value': '4630', 'spread': '1200', 'groupId': 'OG000'}]}]}, {'title': 'Day 15, 0.01 mg/kg BVS857 s.c. (n=2)', 'categories': [{'measurements': [{'value': '1060', 'spread': '1500', 'groupId': 'OG000'}]}]}, {'title': 'Day 29, 0.03 mg/kg BVS857 s.c.(n=2)', 'categories': [{'measurements': [{'value': '2720', 'spread': '870', 'groupId': 'OG000'}]}]}, {'title': 'Day 43, 0.06 mg/kg BVS857 s.c.(n=2)', 'categories': [{'measurements': [{'value': '5310', 'spread': '4720', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Days 1, 15, 29, 43: pre-dose, 1, 4, 12, 24, 48, 168 hours post-dose', 'description': 'Serum samples were obtained for PK assessment.', 'unitOfMeasure': 'h*ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'For each time point, only participants from the PK set with valid measurements at that time point were analyzed. The PK analysis set included participants with at least one available valid PK concentration measurement who received any study drug and experienced no protocol deviations with relevant impact on PK data.'}, {'type': 'SECONDARY', 'title': 'Plasma Pharmacokinetics (PK) of BVS857: The Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) in Part A, Cohort 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'BVS857 Part A Double Blind (Cohort 2)', 'description': 'Participants received single doses of 0.03 mg/kg BVS857 i.v. on day 1, 0.03 mg/kg BVS857 s.c. on day 15, 0.06 mg/kg BVS857 s.c. on day 29, 0.10 mg/kg BVS857 s.c. on day 43 and 0.10 mg/kg BVS857 s.c. on day 57. (BVS857 concentrations differed on days 43 and 57.)'}], 'classes': [{'title': 'Day 1, 0.03 mg/kg BVS857 i.v.(n=4)', 'categories': [{'measurements': [{'value': '9850', 'spread': '4480', 'groupId': 'OG000'}]}]}, {'title': 'Day 15, 0.03 mg/kg BVS857 s.c. (n=3)', 'categories': [{'measurements': [{'value': '6480', 'spread': '5850', 'groupId': 'OG000'}]}]}, {'title': 'Day 29, 0.06 mg/kg BVS857 s.c. (n=2)', 'categories': [{'measurements': [{'value': '7340', 'spread': '5610', 'groupId': 'OG000'}]}]}, {'title': 'Day 43, 0.10 mg/kg BVS857 s.c. (n=3)', 'categories': [{'measurements': [{'value': '14400', 'spread': '3320', 'groupId': 'OG000'}]}]}, {'title': 'Day 57, 0.10 mg/kg BVS857 s.c. (n=1)', 'categories': [{'measurements': [{'value': '28400', 'spread': 'NA', 'comment': 'Standard deviation does not apply when n = 1.', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Days 1, 15, 29, 43: pre-dose, 1, 4, 12, 24, 48, 168 hours post-dose. Day 57: pre-dose, 1, 4, 12, 24, 48, 168, 504 hours post-dose', 'description': 'Serum samples were obtained for PK assessment.', 'unitOfMeasure': 'H*ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'For each time point, only participants from the PK set with valid measurements at that time point were analyzed. The PK analysis set included participants with at least one available valid PK concentration measurement who received any study drug and experienced no protocol deviations with relevant impact on PK data.'}, {'type': 'SECONDARY', 'title': 'Plasma Pharmacokinetics (PK) of BVS857: The Area Under the Plasma Concentration-time Curve From Zero to 48 Hours (AUC0_48h) in Part A, Cohort 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'BVS857 Part A Open Label (Cohort 1)', 'description': 'Participants received single doses of 0.01 mg/kg BVS857 intravenously (i.v.) on day 1, 0.01 mg/kg BVS857 subcutaneously (s.c.) on day 15, 0.03 mg/kg BVS857 s.c. on day 29, 0.06 mg/kg BVS857 s.c. on day 43 and 0.10 mg/kg BVS857 s.c. on day 57.'}], 'classes': [{'title': 'Day 1, 0.01 mg/kg BVS857 i.v.(n=2)', 'categories': [{'measurements': [{'value': '4620', 'spread': '1200', 'groupId': 'OG000'}]}]}, {'title': 'Day 15, 0.01 mg/kg BVS857 s.c. (n=1)', 'categories': [{'measurements': [{'value': '2120', 'spread': 'NA', 'comment': 'Standard deviation does not apply when n = 1.', 'groupId': 'OG000'}]}]}, {'title': 'Day 29, 0.03 mg/kg BVS857 s.c. (n=2)', 'categories': [{'measurements': [{'value': '2720', 'spread': '870', 'groupId': 'OG000'}]}]}, {'title': 'Day 43, 0.06 mg/kg BVS857 s.c. (n=2)', 'categories': [{'measurements': [{'value': '2210', 'spread': '339', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Days 1, 15, 29, 43: pre-dose, 1, 4, 12, 24, 48, 168 hours post-dose', 'description': 'Serum samples were obtained for PK assessment.', 'unitOfMeasure': 'h*ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'For each time point, only participants from the PK set with valid measurements at that time point were analyzed. The PK analysis set included participants with at least one available valid PK concentration measurement who received any study drug and experienced no protocol deviations with relevant impact on PK data.'}, {'type': 'SECONDARY', 'title': 'Plasma Pharmacokinetics (PK) of BVS857: The Area Under the Plasma Concentration-time Curve From Zero to 48 Hours (AUC0_48h) in Part A, Cohort 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'BVS857 Part A Double Blind (Cohort 2)', 'description': 'Participants received single doses of 0.03 mg/kg BVS857 i.v. on day 1, 0.03 mg/kg BVS857 s.c. on day 15, 0.06 mg/kg BVS857 s.c. on day 29, 0.10 mg/kg BVS857 s.c. on day 43 and 0.10 mg/kg BVS857 s.c. on day 57. (BVS857 concentrations differed on days 43 and 57.)'}], 'classes': [{'title': 'Day 1, 0.03 mg/kg BVS857 i.v. (n=4)', 'categories': [{'measurements': [{'value': '7980', 'spread': '1710', 'groupId': 'OG000'}]}]}, {'title': 'Day 15, 0.03 mg/kg BVS857 s.c. (n=3)', 'categories': [{'measurements': [{'value': '2640', 'spread': '1500', 'groupId': 'OG000'}]}]}, {'title': 'Day 29, 0.06 mg/kg BVS857 s.c. (n=2)', 'categories': [{'measurements': [{'value': '3880', 'spread': '735', 'groupId': 'OG000'}]}]}, {'title': 'Day 43, 0.10 mg/kg BVS857 s.c. (n=3)', 'categories': [{'measurements': [{'value': '6390', 'spread': '925', 'groupId': 'OG000'}]}]}, {'title': 'Day 57, 0.10 mg/kg BVS857 s.c. (n=1)', 'categories': [{'measurements': [{'value': '7360', 'spread': 'NA', 'comment': 'Standard deviation does not apply when n = 1.', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Days 1, 15, 29, 43: pre-dose, 1, 4, 12, 24, 48, 168 hours post-dose. Day 57: pre-dose, 1, 4, 12, 24, 48, 168, 504 hours post-dose', 'description': 'Serum samples were obtained for PK assessment.', 'unitOfMeasure': 'h*ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'For each time point, only participants from the PK set with valid measurements at that time point were analyzed. The PK analysis set included participants with at least one available valid PK concentration measurement who received any study drug and experienced no protocol deviations with relevant impact on PK data.'}, {'type': 'SECONDARY', 'title': 'Plasma Pharmacokinetics (PK) of BVS857: Observed Maximum Concentration Following Drug Administration (Cmax) in Part B, Cohort 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'BVS857 Part B Open-label (Cohort 4)', 'description': 'Participants received 0.1 mg/kg BVS857 i.v. weekly for 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '2490', 'spread': '799', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Days 1: pre-dose, 1, 4, 24, 48 hours post-dose', 'description': 'Serum samples were obtained for PK assessment.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK analysis set, which included participants with at least one available valid PK concentration measurement who received any study drug and experienced no protocol deviations with relevant impact on PK data, was analyzed.'}, {'type': 'SECONDARY', 'title': 'Plasma Pharmacokinetics (PK) of BVS857: Observed Maximum Concentration Following Drug Administration (Cmax) in Part B, Cohort 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'BVS857 Part B Double Blind (Cohort 5)', 'description': 'Participants received 0.06 mg/kg (maximum 6 mg) BVS857 i.v. weekly for 12 weeks.'}], 'classes': [{'title': 'Day 1, 0.06 mg/kg BVS857 i.v. (n=18)', 'categories': [{'measurements': [{'value': '854', 'spread': '669', 'groupId': 'OG000'}]}]}, {'title': 'Day 36, 0.06 mg/kg BVS857 i.v. (n=16)', 'categories': [{'measurements': [{'value': '790', 'spread': '184', 'groupId': 'OG000'}]}]}, {'title': 'Day 78, 0.06 mg/kg BVS857 i.v. (n=16)', 'categories': [{'measurements': [{'value': '712', 'spread': '218', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Days 1 and 36: pre-dose, 1, 4, 24, 48 hours post-dose. Day 78: pre-dose, 1, 4, 24, 48, 168 hours post-dose.', 'description': 'Serum samples were obtained for PK assessment.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'For each time point, only participants from the PK set with valid measurements at that time point were analyzed. The PK analysis set included participants with at least one available valid PK concentration measurement who received any study drug and experienced no protocol deviations with relevant impact on PK data.'}, {'type': 'SECONDARY', 'title': 'Plasma Pharmacokinetics (PK) of BVS857: Time to Reach the Maximum Concentration After Drug Administration (Tmax) in Part B, Cohort 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'BVS857 Part B Open-label (Cohort 4)', 'description': 'Participants received 0.1 mg/kg BVS857 i.v. weekly for 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.08', 'spread': '0.0707', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Days 1: pre-dose, 1, 4, 24, 48 hours post-dose', 'description': 'Serum samples were obtained for PK assessment.', 'unitOfMeasure': 'hours', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK analysis set, which included participants with at least one available valid PK concentration measurement who received any study drug and experienced no protocol deviations with relevant impact on PK data, was analyzed.'}, {'type': 'SECONDARY', 'title': 'Plasma Pharmacokinetics (PK) of BVS857: Time to Reach the Maximum Concentration After Drug Administration (Tmax) in Part B, Cohort 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'BVS857 Part B Double Blind (Cohort 5)', 'description': 'Participants received 0.06 mg/kg (maximum 6 mg) BVS857 i.v. weekly for 12 weeks.'}], 'classes': [{'title': 'Day 1, 0.06 mg/kg BVS857 i.v. (n=18)', 'categories': [{'measurements': [{'value': '2.39', 'spread': '1.54', 'groupId': 'OG000'}]}]}, {'title': 'Day 36, 0.06 mg/kg BVS857 i.v. (n=16)', 'categories': [{'measurements': [{'value': '1.73', 'spread': '1.20', 'groupId': 'OG000'}]}]}, {'title': 'Day 78, 0.06 mg/kg BVS857 i.v. (n=16)', 'categories': [{'measurements': [{'value': '1.49', 'spread': '1.04', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Days 1 and 36: pre-dose, 1, 4, 24, 48 hours post-dose. Day 78: pre-dose, 1, 4, 24, 48, 168 hours post-dose.', 'description': 'Serum samples were obtained for PK assessment.', 'unitOfMeasure': 'hours', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'For each time point, only participants from the PK set with valid measurements at that time point were analyzed. The PK analysis set included participants with at least one available valid PK concentration measurement who received any study drug and experienced no protocol deviations with relevant impact on PK data.'}, {'type': 'SECONDARY', 'title': 'Plasma Pharmacokinetics (PK) of BVS857: The Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) in Part B, Cohort 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'BVS857 Part B Double Blind (Cohort 5)', 'description': 'Participants received 0.06 mg/kg (maximum 6 mg) BVS857 i.v. weekly for 12 weeks.'}], 'classes': [{'title': 'Day 36, 0.06 mg/kg BVS857 i.v. (n=1)', 'categories': [{'measurements': [{'value': '13100', 'spread': 'NA', 'comment': 'Standard deviation does not apply when n = 1.', 'groupId': 'OG000'}]}]}, {'title': 'Day 78, 0.06 mg/kg BVS857 i.v. (n=15)', 'categories': [{'measurements': [{'value': '28000', 'spread': '13500', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 36: pre-dose, 1, 4, 24, 48 hours post-dose. Day 78: pre-dose, 1, 4, 24, 48, 168 hours post-dose.', 'description': 'Serum samples were obtained for PK assessment.', 'unitOfMeasure': 'h*ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'For each time point, only participants from the PK set with valid measurements at that time point were analyzed. The PK analysis set included participants with at least one available valid PK concentration measurement who received any study drug and experienced no protocol deviations with relevant impact on PK data.'}, {'type': 'SECONDARY', 'title': 'Plasma Pharmacokinetics (PK) of BVS857:The Area Under the Plasma Concentration-time Curve From Zero to 48 Hours (AUC0_48h) in Part B, Cohort 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'BVS857 Part B Open-label (Cohort 4)', 'description': 'Participants received 0.1 mg/kg BVS857 i.v. weekly for 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '40600', 'spread': '1270', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Days 1: pre-dose, 1, 4, 24, 48 hours post-dose', 'description': 'Serum samples were obtained for the PK assessment.', 'unitOfMeasure': 'H*ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK analysis set, which included participants with at least one available valid PK concentration measurement who received any study drug and experienced no protocol deviations with relevant impact on PK data, was analyzed.'}, {'type': 'SECONDARY', 'title': 'Plasma Pharmacokinetics (PK) of BVS857:The Area Under the Plasma Concentration-time Curve From Zero to 48 Hours (AUC0_48h) in Part B, Cohort 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'BVS857 Part B Double Blind (Cohort 5)', 'description': 'Participants received 0.06 mg/kg (maximum 6 mg) BVS857 i.v. weekly for 12 weeks.'}], 'classes': [{'title': 'Day 1, 0.06 mg/kg BVS857 i.v. (n=18)', 'categories': [{'measurements': [{'value': '19400', 'spread': '4160', 'groupId': 'OG000'}]}]}, {'title': 'Day 36, 0.06 mg/kg BVS857 i.v.(n=16)', 'categories': [{'measurements': [{'value': '19600', 'spread': '5240', 'groupId': 'OG000'}]}]}, {'title': 'Day 78, 0.06 mg/kg BVS857 i.v. (n=16)', 'categories': [{'measurements': [{'value': '18100', 'spread': '5850', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Days 1 and 36: pre-dose, 1, 4, 24, 48 hours post-dose. Day 78: pre-dose, 1, 4, 24, 48, 168 hours post-dose.', 'unitOfMeasure': 'h*ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'For each time point, only participants from the PK set with valid measurements at that time point were analyzed. The PK analysis set included participants with at least one available valid PK concentration measurement who received any study drug and experienced no protocol deviations with relevant impact on PK data.'}, {'type': 'SECONDARY', 'title': 'Plasma Pharmacokinetics (PK) of BVS857: The Area Under the Serum Concentration-time Curve From Time Zero to the End of the Dosing Interval Tau (AUCtau)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'BVS857 Part A Open Label (Cohort 1)', 'description': 'Participants received single doses of 0.01 mg/kg BVS857 intravenously (i.v.) on day 1, 0.01 mg/kg BVS857 subcutaneously (s.c.) on day 15, 0.03 mg/kg BVS857 s.c. on day 29, 0.06 mg/kg BVS857 s.c. on day 43 and 0.10 mg/kg BVS857 s.c. on day 57.'}, {'id': 'OG001', 'title': 'BVS857 Part A Double Blind (Cohort 2)', 'description': 'Participants received single doses of 0.03 mg/kg BVS857 i.v. on day 1, 0.03 mg/kg BVS857 s.c. on day 15, 0.06 mg/kg BVS857 s.c. on day 29, 0.10 mg/kg BVS857 s.c. on day 43 and 0.10 mg/kg BVS857 s.c. on day 57. (BVS857 concentrations differed on days 43 and 57.)'}, {'id': 'OG002', 'title': 'BVS857 Part B Open-label (Cohort 4)', 'description': 'Participants received 0.1 mg/kg BVS857 i.v. weekly for 12 weeks.'}, {'id': 'OG003', 'title': 'BVS857 Part B Double Blind (Cohort 5)', 'description': 'Participants received 0.06 mg/kg (maximum 6 mg) BVS857 i.v. weekly for 12 weeks.'}], 'timeFrame': 'Part A: days 1, 15, 29, 43: pre-dose, 1, 4, 12, 24, 48, 168 hours post-dose. Day 57: pre-dose, 1, 4, 12, 24, 48, 168, 504 hours post-dose. Part B: days 1 and 36: pre-dose, 1, 4, 24, 48 hours post-dose. Day 78: pre-dose, 1, 4, 24, 48, 168 hours post-dose.', 'description': 'Serum samples were obtained for PK assessment.', 'reportingStatus': 'POSTED', 'populationDescription': 'This PK parameter was not analyzed in either Part A or Part B because there were insufficient data points after Cmax. Therefore, this parameter could not be calculated.'}, {'type': 'SECONDARY', 'title': 'Plasma Pharmacokinetics (PK) of BVS857: The Terminal Elimination Half-life (T1/2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'BVS857 Part A Open Label (Cohort 1)', 'description': 'Participants received single doses of 0.01 mg/kg BVS857 intravenously (i.v.) on day 1, 0.01 mg/kg BVS857 subcutaneously (s.c.) on day 15, 0.03 mg/kg BVS857 s.c. on day 29, 0.06 mg/kg BVS857 s.c. on day 43 and 0.10 mg/kg BVS857 s.c. on day 57.'}, {'id': 'OG001', 'title': 'BVS857 Part A Double Blind (Cohort 2)', 'description': 'Participants received single doses of 0.03 mg/kg BVS857 i.v. on day 1, 0.03 mg/kg BVS857 s.c. on day 15, 0.06 mg/kg BVS857 s.c. on day 29, 0.10 mg/kg BVS857 s.c. on day 43 and 0.10 mg/kg BVS857 s.c. on day 57. (BVS857 concentrations differed on days 43 and 57.)'}, {'id': 'OG002', 'title': 'BVS857 Part B Open-label (Cohort 4)', 'description': 'Participants received 0.1 mg/kg BVS857 i.v. weekly for 12 weeks.'}, {'id': 'OG003', 'title': 'BVS857 Part B Double Blind (Cohort 5)', 'description': 'Participants received 0.06 mg/kg (maximum 6 mg) BVS857 i.v. weekly for 12 weeks.'}], 'timeFrame': 'Part A: days 1, 15, 29, 43: pre-dose, 1, 4, 12, 24, 48, 168 hours post-dose. Day 57: pre-dose, 1, 4, 12, 24, 48, 168, 504 hours post-dose. Part B: days 1 and 36: pre-dose, 1, 4, 24, 48 hours post-dose. Day 78: pre-dose, 1, 4, 24, 48, 168 hours post-dose.', 'description': 'Serum samples were obtained for PK assessment.', 'reportingStatus': 'POSTED', 'populationDescription': 'This PK parameter was not analyzed in either Part A or Part B because there were insufficient data points after Cmax. Therefore, this parameter could not be calculated.'}, {'type': 'SECONDARY', 'title': 'Plasma Pharmacokinetics (PK) of BVS857: The Area Under the Serum Concentration-time Curve From Time Zero to Infinity (AUCinf)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'BVS857 Part A Open Label (Cohort 1)', 'description': 'Participants received single doses of 0.01 mg/kg BVS857 intravenously (i.v.) on day 1, 0.01 mg/kg BVS857 subcutaneously (s.c.) on day 15, 0.03 mg/kg BVS857 s.c. on day 29, 0.06 mg/kg BVS857 s.c. on day 43 and 0.10 mg/kg BVS857 s.c. on day 57.'}, {'id': 'OG001', 'title': 'BVS857 Part A Double Blind (Cohort 2)', 'description': 'Participants received single doses of 0.03 mg/kg BVS857 i.v. on day 1, 0.03 mg/kg BVS857 s.c. on day 15, 0.06 mg/kg BVS857 s.c. on day 29, 0.10 mg/kg BVS857 s.c. on day 43 and 0.10 mg/kg BVS857 s.c. on day 57. (BVS857 concentrations differed on days 43 and 57.)'}, {'id': 'OG002', 'title': 'BVS857 Part B Open-label (Cohort 4)', 'description': 'Participants received 0.1 mg/kg BVS857 i.v. weekly for 12 weeks.'}, {'id': 'OG003', 'title': 'BVS857 Part B Double Blind (Cohort 5)', 'description': 'Participants received 0.06 mg/kg (maximum 6 mg) BVS857 i.v. weekly for 12 weeks.'}], 'timeFrame': 'Part A: days 1, 15, 29, 43: pre-dose, 1, 4, 12, 24, 48, 168 hours post-dose. Day 57: pre-dose, 1, 4, 12, 24, 48, 168, 504 hours post-dose. Part B: days 1 and 36: pre-dose, 1, 4, 24, 48 hours post-dose. Day 78: pre-dose, 1, 4, 24, 48, 168 hours post-dose.', 'description': 'Serum samples were obtained for PK assessment.', 'reportingStatus': 'POSTED', 'populationDescription': 'This PK parameter was not analyzed in either Part A or Part B because there were insufficient data points after Cmax. Therefore, this parameter could not be calculated.'}, {'type': 'SECONDARY', 'title': 'Compare Dose Normalized Log-transformed AUCinf Following IV and SC Administrations', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'BVS857 Part A Open Label (Cohort 1)', 'description': 'Participants received single doses of 0.01 mg/kg BVS857 intravenously (i.v.) on day 1, 0.01 mg/kg BVS857 subcutaneously (s.c.) on day 15, 0.03 mg/kg BVS857 s.c. on day 29, 0.06 mg/kg BVS857 s.c. on day 43 and 0.10 mg/kg BVS857 s.c. on day 57.'}, {'id': 'OG001', 'title': 'BVS857 Part A Double Blind (Cohort 2)', 'description': 'Participants received single doses of 0.03 mg/kg BVS857 i.v. on day 1, 0.03 mg/kg BVS857 s.c. on day 15, 0.06 mg/kg BVS857 s.c. on day 29, 0.10 mg/kg BVS857 s.c. on day 43 and 0.10 mg/kg BVS857 s.c. on day 57. (BVS857 concentrations differed on days 43 and 57.)'}, {'id': 'OG002', 'title': 'BVS857 Part B Open-label (Cohort 4)', 'description': 'Participants received 0.1 mg/kg BVS857 i.v. weekly for 12 weeks.'}, {'id': 'OG003', 'title': 'BVS857 Part B Double Blind (Cohort 5)', 'description': 'Participants received 0.06 mg/kg (maximum 6 mg) BVS857 i.v. weekly for 12 weeks.'}], 'timeFrame': 'In Part A: days 1 and 15, pre-dose, 1, 4, 12, 24, 48, 168 hours post-dose.', 'description': 'Serum samples were obtained for PK assessment.', 'reportingStatus': 'POSTED', 'populationDescription': 'This PK parameter was not analyzed in either Part A or Part B because there were insufficient data points after Cmax. Therefore, this parameter could not be calculated.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'BVS857 Part A Open Label (Cohort 1)', 'description': 'Participants received single doses of 0.01 mg/kg BVS857 intravenously (i.v.) on day 1, 0.01 mg/kg BVS857 subcutaneously (s.c.) on day 15, 0.03 mg/kg BVS857 s.c. on day 29, 0.06 mg/kg BVS857 s.c. on day 43 and 0.10 mg/kg BVS857 s.c. on day 57.'}, {'id': 'FG001', 'title': 'BVS857 Part A Double Blind (Cohort 2)', 'description': 'Participants received single doses of 0.03 mg/kg BVS857 i.v. on day 1, 0.03 mg/kg BVS857 s.c. on day 15, 0.06 mg/kg BVS857 s.c. on day 29, 0.10 mg/kg BVS857 s.c. on day 43 and 0.10 mg/kg BVS857 s.c. on day 57. (BVS857 concentrations differed on days 43 and 57.)'}, {'id': 'FG002', 'title': 'Placebo Part A Double Blind (Cohort 2)', 'description': 'Participants received single doses of matching placebo i.v. on day 1 and matching placebo s.c. on days 15, 29, 43 and 57.'}, {'id': 'FG003', 'title': 'BVS857 Part B Open-label (Cohort 4)', 'description': 'Participants received 0.1 mg/kg BVS857 i.v. weekly for 12 weeks.'}, {'id': 'FG004', 'title': 'BVS857 Part B Double Blind (Cohort 5)', 'description': 'Participants received 0.06 mg/kg (maximum 6 mg) BVS857 i.v. weekly for 12 weeks.'}, {'id': 'FG005', 'title': 'Placebo Part B Double Blind (Cohort 5)', 'description': 'Participants received matching placebo i.v. to BVS857 weekly for 12 weeks.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '18'}, {'groupId': 'FG005', 'numSubjects': '9'}]}, {'type': 'Safety Analysis Set', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '18'}, {'groupId': 'FG005', 'numSubjects': '9'}]}, {'type': 'Pharmacokinetic (PK) Analysis Set', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '18'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Pharmacodynamic (PD) Analysis Set', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '18'}, {'groupId': 'FG005', 'numSubjects': '9'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '16'}, {'groupId': 'FG005', 'numSubjects': '9'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '2'}, {'groupId': 'FG005', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '2'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Abnormal laboratory value', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'This study was conducted in 2 parts, Part A and Part B. In Part A, Cohort 1 participants received open-label BVS857. Cohort 2 participants were randomized to double-blind BVS857 or double-blind placebo in a 2:1 ratio.', 'preAssignmentDetails': 'In Part B, Cohort 3 was not enrolled. Cohort 4 participants received open-label BVS857. Cohort 5 participants were randomized to double-blind BVS857 or double-blind placebo in a ratio of 18:10.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '18', 'groupId': 'BG004'}, {'value': '9', 'groupId': 'BG005'}, {'value': '37', 'groupId': 'BG006'}]}], 'groups': [{'id': 'BG000', 'title': 'BVS857 Part A Open Label (Cohort 1)', 'description': 'Participants received single doses of 0.01 mg/kg BVS857 intravenously (i.v.) on day 1, 0.01 mg/kg BVS857 subcutaneously (s.c.) on day 15, 0.03 mg/kg BVS857 s.c. on day 29, 0.06 mg/kg BVS857 s.c. on day 43 and 0.10 mg/kg BVS857 s.c. on day 57.'}, {'id': 'BG001', 'title': 'BVS857 Part A Double Blind (Cohort 2)', 'description': 'Participants received single doses of 0.03 mg/kg BVS857 i.v. on day 1, 0.03 mg/kg BVS857 s.c. on day 15, 0.06 mg/kg BVS857 s.c. on day 29, 0.10 mg/kg BVS857 s.c. on day 43 and 0.10 mg/kg BVS857 s.c. on day 57. (BVS857 concentrations differed on days 43 and 57.)'}, {'id': 'BG002', 'title': 'Placebo Part A Double Blind (Cohort 2)', 'description': 'Participants received single doses of matching placebo i.v. on day 1 and matching placebo s.c. on days 15, 29, 43 and 57.'}, {'id': 'BG003', 'title': 'BVS857 Part B Open-label (Cohort 4)', 'description': 'Participants received 0.1 mg/kg BVS857 i.v. weekly for 12 weeks.'}, {'id': 'BG004', 'title': 'BVS857 Part B Double Blind (Cohort 5)', 'description': 'Participants received 0.06 mg/kg (maximum 6 mg) BVS857 i.v. weekly for 12 weeks.'}, {'id': 'BG005', 'title': 'Placebo Part B Double Blind (Cohort 5)', 'description': 'Participants received matching placebo i.v. to BVS857 weekly for 12 weeks.'}, {'id': 'BG006', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '67.0', 'spread': '5.66', 'groupId': 'BG000'}, {'value': '56.0', 'spread': '12.33', 'groupId': 'BG001'}, {'value': '59.5', 'spread': '7.78', 'groupId': 'BG002'}, {'value': '41.5', 'spread': '4.95', 'groupId': 'BG003'}, {'value': '57.0', 'spread': '55.5', 'groupId': 'BG004'}, {'value': '54.0', 'spread': '5.94', 'groupId': 'BG005'}, {'value': '56.0', 'spread': '10.33', 'groupId': 'BG006'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex/Gender, Customized', 'classes': [{'title': 'Male', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '18', 'groupId': 'BG004'}, {'value': '9', 'groupId': 'BG005'}, {'value': '37', 'groupId': 'BG006'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 37}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-02-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-03', 'completionDateStruct': {'date': '2016-04-13', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-12-09', 'studyFirstSubmitDate': '2013-12-29', 'resultsFirstSubmitDate': '2017-04-12', 'studyFirstSubmitQcDate': '2013-12-29', 'lastUpdatePostDateStruct': {'date': '2021-01-05', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-07-12', 'studyFirstPostDateStruct': {'date': '2013-12-31', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-08-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-04-13', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Patients With Adverse Events (AEs), Serious Adverse Events (SAEs) and Deaths as a Measure of Safety and Tolerability', 'timeFrame': 'After 78 days in Part A and after 85 days in Part B.', 'description': 'Safety was monitored throughout the study.'}, {'measure': 'Number of Mild, Moderate and Severe Adverse Events as a Measure of Safety and Tolerability', 'timeFrame': 'After 78 days in Part A and after 85 days in Part B.', 'description': 'Safety was monitored throughout the study.'}, {'measure': 'Mean Percent Change From Baseline in Thigh Muscle Volume in Part B, Cohort 5', 'timeFrame': 'Baseline, Day 85', 'description': 'Thigh muscle volume was assessed by magnetic resonance imaging (MRI). Change from baseline was calculated from the ratio of the post-baseline mean value to the baseline mean value: \\[(Day 85/baseline) - 1)\\] x 100. A positive change from baseline indicates improvement.'}], 'secondaryOutcomes': [{'measure': 'Mean Change From Baseline in Score on the Adult Myopathy Assessment Tool (AMAT) in Part B, Cohort 5', 'timeFrame': 'Baseline, Day 85', 'description': 'The AMAT rated physical function and muscle endurance, with higher scores indicating better performance. The tool includes 7 timed functional tasks rated on a scale from 0 - 21 and 6 endurance tasks rated on a scale from 0 - 24. The range for the total score was from 0 (worst) to 45 (best). A positive change from baseline indicates improvement.'}, {'measure': 'Mean Change From Baseline in Total Lean Body Mass (LBM) in Part B, Cohort 5', 'timeFrame': 'Baseline, Day 85', 'description': 'LBM was assessed by dual-energy X-ray (DXA) absorptiometry. A positive change from baseline indicate improvement.'}, {'measure': 'Plasma Pharmacokinetics (PK) of BVS857: Observed Maximum Concentration Following Drug Administration (Cmax) in Part A, Cohort 1', 'timeFrame': 'Days 1, 15, 29, 43: pre-dose, 1, 4, 12, 24, 48, 168 hours post-dose', 'description': 'Serum samples were obtained for PK assessment.'}, {'measure': 'Plasma Pharmacokinetics (PK) of BVS857: Observed Maximum Concentration Following Drug Administration (Cmax) in Part A, Cohort 2', 'timeFrame': 'Days 1, 15, 29, 43: pre-dose, 1, 4, 12, 24, 48, 168 hours post-dose. Day 57: pre-dose, 1, 4, 12, 24, 48, 168, 504 hours post-dose', 'description': 'Serum samples were obtained for PK assessment.'}, {'measure': 'Plasma Pharmacokinetics (PK) of BVS857: Time to Reach the Maximum Concentration After Drug Administration (Tmax) in Part A, Cohort 1', 'timeFrame': 'Days 1, 15, 29, 43: pre-dose, 1, 4, 12, 24, 48, 168 hours post-dose', 'description': 'Serum samples were obtained for PK assessment.'}, {'measure': 'Plasma Pharmacokinetics (PK) of BVS857: Time to Reach the Maximum Concentration After Drug Administration (Tmax) in Part A, Cohort 2', 'timeFrame': 'Day 1, 15, 29, 43: pre-dose, 1, 4, 12, 24, 48, 168 hours post-dose. Day 57: pre-dose, 1, 4, 12, 24, 48, 168, 504 hours post-dose', 'description': 'Serum samples were obtained for PK assessment.'}, {'measure': 'Plasma Pharmacokinetics (PK) of BVS857: The Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) in Part A, Cohort 1', 'timeFrame': 'Days 1, 15, 29, 43: pre-dose, 1, 4, 12, 24, 48, 168 hours post-dose', 'description': 'Serum samples were obtained for PK assessment.'}, {'measure': 'Plasma Pharmacokinetics (PK) of BVS857: The Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) in Part A, Cohort 2', 'timeFrame': 'Days 1, 15, 29, 43: pre-dose, 1, 4, 12, 24, 48, 168 hours post-dose. Day 57: pre-dose, 1, 4, 12, 24, 48, 168, 504 hours post-dose', 'description': 'Serum samples were obtained for PK assessment.'}, {'measure': 'Plasma Pharmacokinetics (PK) of BVS857: The Area Under the Plasma Concentration-time Curve From Zero to 48 Hours (AUC0_48h) in Part A, Cohort 1', 'timeFrame': 'Days 1, 15, 29, 43: pre-dose, 1, 4, 12, 24, 48, 168 hours post-dose', 'description': 'Serum samples were obtained for PK assessment.'}, {'measure': 'Plasma Pharmacokinetics (PK) of BVS857: The Area Under the Plasma Concentration-time Curve From Zero to 48 Hours (AUC0_48h) in Part A, Cohort 2', 'timeFrame': 'Days 1, 15, 29, 43: pre-dose, 1, 4, 12, 24, 48, 168 hours post-dose. Day 57: pre-dose, 1, 4, 12, 24, 48, 168, 504 hours post-dose', 'description': 'Serum samples were obtained for PK assessment.'}, {'measure': 'Plasma Pharmacokinetics (PK) of BVS857: Observed Maximum Concentration Following Drug Administration (Cmax) in Part B, Cohort 4', 'timeFrame': 'Days 1: pre-dose, 1, 4, 24, 48 hours post-dose', 'description': 'Serum samples were obtained for PK assessment.'}, {'measure': 'Plasma Pharmacokinetics (PK) of BVS857: Observed Maximum Concentration Following Drug Administration (Cmax) in Part B, Cohort 5', 'timeFrame': 'Days 1 and 36: pre-dose, 1, 4, 24, 48 hours post-dose. Day 78: pre-dose, 1, 4, 24, 48, 168 hours post-dose.', 'description': 'Serum samples were obtained for PK assessment.'}, {'measure': 'Plasma Pharmacokinetics (PK) of BVS857: Time to Reach the Maximum Concentration After Drug Administration (Tmax) in Part B, Cohort 4', 'timeFrame': 'Days 1: pre-dose, 1, 4, 24, 48 hours post-dose', 'description': 'Serum samples were obtained for PK assessment.'}, {'measure': 'Plasma Pharmacokinetics (PK) of BVS857: Time to Reach the Maximum Concentration After Drug Administration (Tmax) in Part B, Cohort 5', 'timeFrame': 'Days 1 and 36: pre-dose, 1, 4, 24, 48 hours post-dose. Day 78: pre-dose, 1, 4, 24, 48, 168 hours post-dose.', 'description': 'Serum samples were obtained for PK assessment.'}, {'measure': 'Plasma Pharmacokinetics (PK) of BVS857: The Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) in Part B, Cohort 5', 'timeFrame': 'Day 36: pre-dose, 1, 4, 24, 48 hours post-dose. Day 78: pre-dose, 1, 4, 24, 48, 168 hours post-dose.', 'description': 'Serum samples were obtained for PK assessment.'}, {'measure': 'Plasma Pharmacokinetics (PK) of BVS857:The Area Under the Plasma Concentration-time Curve From Zero to 48 Hours (AUC0_48h) in Part B, Cohort 4', 'timeFrame': 'Days 1: pre-dose, 1, 4, 24, 48 hours post-dose', 'description': 'Serum samples were obtained for the PK assessment.'}, {'measure': 'Plasma Pharmacokinetics (PK) of BVS857:The Area Under the Plasma Concentration-time Curve From Zero to 48 Hours (AUC0_48h) in Part B, Cohort 5', 'timeFrame': 'Days 1 and 36: pre-dose, 1, 4, 24, 48 hours post-dose. Day 78: pre-dose, 1, 4, 24, 48, 168 hours post-dose.'}, {'measure': 'Plasma Pharmacokinetics (PK) of BVS857: The Area Under the Serum Concentration-time Curve From Time Zero to the End of the Dosing Interval Tau (AUCtau)', 'timeFrame': 'Part A: days 1, 15, 29, 43: pre-dose, 1, 4, 12, 24, 48, 168 hours post-dose. Day 57: pre-dose, 1, 4, 12, 24, 48, 168, 504 hours post-dose. Part B: days 1 and 36: pre-dose, 1, 4, 24, 48 hours post-dose. Day 78: pre-dose, 1, 4, 24, 48, 168 hours post-dose.', 'description': 'Serum samples were obtained for PK assessment.'}, {'measure': 'Plasma Pharmacokinetics (PK) of BVS857: The Terminal Elimination Half-life (T1/2)', 'timeFrame': 'Part A: days 1, 15, 29, 43: pre-dose, 1, 4, 12, 24, 48, 168 hours post-dose. Day 57: pre-dose, 1, 4, 12, 24, 48, 168, 504 hours post-dose. Part B: days 1 and 36: pre-dose, 1, 4, 24, 48 hours post-dose. Day 78: pre-dose, 1, 4, 24, 48, 168 hours post-dose.', 'description': 'Serum samples were obtained for PK assessment.'}, {'measure': 'Plasma Pharmacokinetics (PK) of BVS857: The Area Under the Serum Concentration-time Curve From Time Zero to Infinity (AUCinf)', 'timeFrame': 'Part A: days 1, 15, 29, 43: pre-dose, 1, 4, 12, 24, 48, 168 hours post-dose. Day 57: pre-dose, 1, 4, 12, 24, 48, 168, 504 hours post-dose. Part B: days 1 and 36: pre-dose, 1, 4, 24, 48 hours post-dose. Day 78: pre-dose, 1, 4, 24, 48, 168 hours post-dose.', 'description': 'Serum samples were obtained for PK assessment.'}, {'measure': 'Compare Dose Normalized Log-transformed AUCinf Following IV and SC Administrations', 'timeFrame': 'In Part A: days 1 and 15, pre-dose, 1, 4, 12, 24, 48, 168 hours post-dose.', 'description': 'Serum samples were obtained for PK assessment.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Spinal and Bulbar Muscular Atrophy']}, 'referencesModule': {'references': [{'pmid': '30337273', 'type': 'DERIVED', 'citation': 'Grunseich C, Miller R, Swan T, Glass DJ, El Mouelhi M, Fornaro M, Petricoul O, Vostiar I, Roubenoff R, Meriggioli MN, Kokkinis A, Guber RD, Budron MS, Vissing J, Soraru G, Mozaffar T, Ludolph A, Kissel JT, Fischbeck KH; BVS857 study group. Safety, tolerability, and preliminary efficacy of an IGF-1 mimetic in patients with spinal and bulbar muscular atrophy: a randomised, placebo-controlled trial. Lancet Neurol. 2018 Dec;17(12):1043-1052. doi: 10.1016/S1474-4422(18)30320-X. Epub 2018 Oct 15.'}], 'seeAlsoLinks': [{'url': 'https://www.novctrd.com/ctrdweb/patientsummary/patientsummaries?patientSummaryId=168', 'label': 'A Plain Language Trial Summary is available on novartisclinicaltrials.com'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study was to determine if BVS857 is safe, tolerable and increases thigh muscle thickness in patients with spinal bulbar and muscular atrophy (SBMA).'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Key Inclusion Criteria:\n\n* Genetic diagnosis of SBMA with symptomatic muscle weakness\n* Able to complete 2 minute timed walk\n* Serum IGF-1 level less than or equal to 170 ng/mL\n\nKey Exclusion Criteria:\n\n* Medically treated diabetes mellitus or known history of hypoglycemia\n* History of Bell's palsy\n* Treatment with systemic steroids \\> 10 mg/day (or equivalent dose); androgens or androgen reducing agents; systemic beta agonists; or other muscle anabolic drugs within the previous 3 months\n* History of cancer, other than non-melanomatous skin cancer\n* Retinopathy\n* Papilledema Other protocol defined inclusion/exclusion criteria may apply"}, 'identificationModule': {'nctId': 'NCT02024932', 'briefTitle': 'Safety, Tolerability, and Efficacy of BVS857 in Patients With Spinal and Bulbar Muscular Atrophy', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'A Two-part Placebo-controlled Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of BVS857 in Patients With Spinal and Bulbar Muscular Atrophy (SBMA)', 'orgStudyIdInfo': {'id': 'CBVS857X2202'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'BVS857 Part A Open label (Cohort 1)', 'description': 'Participants received single doses of 0.01 mg/kg BVS857 intravenously (i.v.) on day 1, 0.01 mg/kg BVS857 subcutaneously (s.c.) on day 15, 0.03 mg/kg BVS857 s.c. on day 29, 0.06 mg/kg BVS857 s.c. on day 43 and 0.10 mg/kg BVS857 s.c. on day 57.', 'interventionNames': ['Drug: BVS857']}, {'type': 'EXPERIMENTAL', 'label': 'BVS857 Part A double blind (Cohort 2)', 'description': 'Participants received single doses of 0.03 mg/kg BVS857 i.v on day 1, 0.03 mg/kg BVS857 s.c. on day 15, 0.06 mg/kg BVS857 s.c. on day 29, 0.10 mg/kg BVS857 s.c. on day 43 and 0.10 mg/kg BVS857 s.c. on day 57. (BVS857 concentrations differed on days 43 and 57.)', 'interventionNames': ['Drug: BVS857']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo Part A double blind (Cohort 2)', 'description': 'Participants received single doses of matching placebo i.v. on day 1 and matching placebo s.c. on days 15, 29, 43 and 57.', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'BVS857 Part B open-label (Cohort 4)', 'description': 'Participants received 0.1 mg/kg BVS857 i.v. weekly for 12 weeks.', 'interventionNames': ['Drug: BVS857']}, {'type': 'EXPERIMENTAL', 'label': 'BVS857 Part B double blind (Cohort 5)', 'description': 'Participants received 0.06 mg/kg (maximum 6 mg) BVS857 i.v. weekly for 12 weeks.', 'interventionNames': ['Drug: BVS857']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo Part B double blind (Cohort 5)', 'description': 'Participants received matching placebo i.v. to BVS857 weekly for 12 weeks.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'BVS857', 'type': 'DRUG', 'description': 'BVS857 lyophilisate in vial; the lyophilisate was reconstituted with sterile water for injection, diluted as appropriate, and administered either i.v. or s.c..', 'armGroupLabels': ['BVS857 Part A Open label (Cohort 1)', 'BVS857 Part A double blind (Cohort 2)', 'BVS857 Part B double blind (Cohort 5)', 'BVS857 Part B open-label (Cohort 4)']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo lyophilisate in vial; the lyophilisate was reconstituted with sterile water for injection, diluted as appropriate, and administered either i.v. or s.c..', 'armGroupLabels': ['Placebo Part A double blind (Cohort 2)', 'Placebo Part B double blind (Cohort 5)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92868', 'city': 'Orange', 'state': 'California', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 33.78779, 'lon': -117.85311}}, {'zip': '20892', 'city': 'Bethesda', 'state': 'Maryland', 'country': 'United States', 'facility': 'National Institutes of Health', 'geoPoint': {'lat': 38.98067, 'lon': -77.10026}}, {'zip': '43210', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '2100', 'city': 'Copenhagen', 'country': 'Denmark', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}, {'zip': '89081', 'city': 'Ulm', 'country': 'Germany', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 48.39841, 'lon': 9.99155}}, {'zip': '35128', 'city': 'Padua', 'state': 'PD', 'country': 'Italy', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 45.40797, 'lon': 11.88586}}], 'overallOfficials': [{'name': 'Novartis Pharmaceuticals', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Novartis Pharmaceuticals'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novartis Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}