Ignite Creation Date:
2025-12-25 @ 12:38 AM
Ignite Modification Date:
2026-02-04 @ 8:28 PM
Study NCT ID:
NCT02573467
Status:
COMPLETED
Last Update Posted:
2018-03-13
First Post:
2015-07-09
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
An Extension Study of the Efficacy, Safety and Tolerability of BYM338 (Bimagrumab) in Patients With Sporadic Inclusion Body Myositis Who Previously Participated in the Core Study CBYM338B2203
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018979', 'term': 'Myositis, Inclusion Body'}, {'id': 'D009133', 'term': 'Muscular Atrophy'}], 'ancestors': [{'id': 'D009220', 'term': 'Myositis'}, {'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D020879', 'term': 'Neuromuscular Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D001284', 'term': 'Atrophy'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000596367', 'term': 'bimagrumab'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '862-778-8300', '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': {'timeFrame': 'Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit, up to 14 months.', 'eventGroups': [{'id': 'EG000', 'title': 'BYM338/Bimagrumab 10 mg/kg', 'description': 'Participants received BYM338 10 mg/kg administered via intravenous infusion every 4 weeks for up to a maximum of 8 months after which they entered a 6-month, treatment-free follow-up period.', 'otherNumAtRisk': 53, 'deathsNumAtRisk': 53, 'otherNumAffected': 40, 'seriousNumAtRisk': 53, 'deathsNumAffected': 1, 'seriousNumAffected': 12}, {'id': 'EG001', 'title': 'BYM338/Bimagrumab 3 mg/kg', 'description': 'Participants received BYM338 3 mg/kg administered via intravenous infusion every 4 weeks for up to a maximum of 8 months after which they entered a 6-month, treatment-free follow-up period..', 'otherNumAtRisk': 52, 'deathsNumAtRisk': 52, 'otherNumAffected': 46, 'seriousNumAtRisk': 52, 'deathsNumAffected': 1, 'seriousNumAffected': 10}, {'id': 'EG002', 'title': 'BYM338/Bimagrumab 1 mg/kg', 'description': 'Participants received BYM338 1 mg/kg administered via intravenous infusion every 4 weeks for up to a maximum of 8 months after which they entered a 6-month, treatment-free follow-up period.', 'otherNumAtRisk': 51, 'deathsNumAtRisk': 51, 'otherNumAffected': 38, 'seriousNumAtRisk': 51, 'deathsNumAffected': 1, 'seriousNumAffected': 7}, {'id': 'EG003', 'title': 'Placebo', 'description': 'Participants received BYM338 1 mg/kg administered via intravenous infusion every 4 weeks for up to a maximum of 8 months after which they entered a 6-month, treatment-free follow-up period.', 'otherNumAtRisk': 55, 'deathsNumAtRisk': 55, 'otherNumAffected': 43, 'seriousNumAtRisk': 55, 'deathsNumAffected': 2, 'seriousNumAffected': 8}, {'id': 'EG004', 'title': 'Pooled Active Treatment Groups', 'description': 'Participants from all 3 BYM338 groups', 'otherNumAtRisk': 156, 'deathsNumAtRisk': 156, 'otherNumAffected': 124, 'seriousNumAtRisk': 156, 'deathsNumAffected': 3, 'seriousNumAffected': 29}], 'otherEvents': [{'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 156, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 51, 'numAffected': 9}, {'groupId': 'EG003', 'numAtRisk': 55, 'numAffected': 5}, {'groupId': 'EG004', 'numAtRisk': 156, 'numAffected': 23}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Seasonal allergy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 51, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 55, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 156, 'numAffected': 3}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 156, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 51, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 55, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 156, 'numAffected': 10}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 51, 'numAffected': 12}, {'groupId': 'EG003', 'numAtRisk': 55, 'numAffected': 8}, {'groupId': 'EG004', 'numAtRisk': 156, 'numAffected': 28}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 30}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 36}, {'groupId': 'EG002', 'numAtRisk': 51, 'numAffected': 30}, {'groupId': 'EG003', 'numAtRisk': 55, 'numAffected': 34}, {'groupId': 'EG004', 'numAtRisk': 156, 'numAffected': 96}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Foot fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 55, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 156, 'numAffected': 4}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 55, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 156, 'numAffected': 4}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Joint injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 156, 'numAffected': 3}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Laceration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 51, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 55, 'numAffected': 6}, {'groupId': 'EG004', 'numAtRisk': 156, 'numAffected': 12}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Ligament sprain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 51, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 55, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 156, 'numAffected': 9}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Limb injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 156, 'numAffected': 5}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Skin abrasion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 51, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 55, 'numAffected': 5}, {'groupId': 'EG004', 'numAtRisk': 156, 'numAffected': 17}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 51, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 55, 'numAffected': 6}, {'groupId': 'EG004', 'numAtRisk': 156, 'numAffected': 12}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 51, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 55, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 156, 'numAffected': 9}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Muscle spasms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 51, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 55, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 156, 'numAffected': 15}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Muscular weakness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 55, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 156, 'numAffected': 4}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Musculoskeletal chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 55, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 156, 'numAffected': 5}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Musculoskeletal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 51, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 55, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 156, 'numAffected': 8}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 51, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 156, 'numAffected': 8}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Neck pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 55, 'numAffected': 5}, {'groupId': 'EG004', 'numAtRisk': 156, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 51, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 55, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 156, 'numAffected': 9}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 55, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 156, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 51, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 55, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 156, 'numAffected': 7}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Productive cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 55, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 156, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Acne', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 51, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 55, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 156, 'numAffected': 6}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 51, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 55, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 156, 'numAffected': 5}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 51, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 55, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 156, 'numAffected': 8}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 51, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 55, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 156, 'numAffected': 4}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 51, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 55, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 156, 'numAffected': 9}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}], 'seriousEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 55, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 156, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Colitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 55, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 156, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 156, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Dysphagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 55, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 156, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Oesophageal achalasia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 156, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 55, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 156, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 156, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 55, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 156, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 55, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 156, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Urosepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 156, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Ankle fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 156, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Avulsion fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 156, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 55, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 156, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Head injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 55, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 156, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Hip fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 156, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Lower limb fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 156, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Patella fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 156, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Pelvic fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 55, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 156, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Subarachnoid haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 55, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 156, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Subdural haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 156, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Ulna fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 156, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 55, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 156, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Hyperkalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 156, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 156, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Inclusion body myositis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 156, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Joint effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 156, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Mobility decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 156, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Muscle haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 55, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 156, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Rotator cuff syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 156, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Basal cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 55, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 156, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Bladder cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 156, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': "Bowen's disease", 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 156, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Haemangioma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 156, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Skin cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 156, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Squamous cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 156, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 156, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Migraine', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 156, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Presyncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 156, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Pneumonia aspiration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 51, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 55, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 156, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 156, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 55, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 156, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Peripheral arterial occlusive disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 156, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Peripheral venous disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 156, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and Deaths.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}, {'value': '51', 'groupId': 'OG002'}, {'value': '55', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'BYM338/Bimagrumab 10 mg/kg', 'description': 'Participants received BYM338 10 mg/kg administered via intravenous infusion every 4 weeks for up to a maximum of 8 months after which they entered a 6-month, treatment-free follow-up period.'}, {'id': 'OG001', 'title': 'BYM338/Bimagrumab 3 mg/kg', 'description': 'Participants received BYM338 3 mg/kg administered via intravenous infusion every 4 weeks for up to a maximum of 8 months after which they entered a 6-month, treatment-free follow-up period..'}, {'id': 'OG002', 'title': 'BYM338/Bimagrumab 1 mg/kg', 'description': 'Participants received BYM338 1 mg/kg administered via intravenous infusion every 4 weeks for up to a maximum of 8 months after which they entered a 6-month, treatment-free follow-up period.'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Participants received BYM338 1 mg/kg administered via intravenous infusion every 4 weeks for up to a maximum of 8 months after which they entered a 6-month, treatment-free follow-up period.'}], 'classes': [{'title': 'Adverse events', 'categories': [{'measurements': [{'value': '48', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '44', 'groupId': 'OG002'}, {'value': '49', 'groupId': 'OG003'}]}]}, {'title': 'Serious adverse events', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}]}, {'title': 'Deaths', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'to end of study (up to 14 months, including the 6-month treatment-free follow-up period)', 'description': 'Safety monitoring was conducted throughout the study. AEs starting on or after the day of first administration of extension study drug until last administration of study drug + 56 days are considered. SAEs starting on or after the day of first administration of extension study drug are considered. Deaths which occurred on or after the day of first administration of extension study drug are considered.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety set: The safety set consisted of all participants who received at least one dose of study drug during the extension study.'}, {'type': 'PRIMARY', 'title': 'Change From Core Study Baseline in 6 Minute Walking Distance Test (6MWD)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}, {'value': '51', 'groupId': 'OG002'}, {'value': '55', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'BYM338/Bimagrumab 10 mg/kg', 'description': 'Participants received BYM338 10 mg/kg administered via intravenous infusion every 4 weeks for up to a maximum of 8 months after which they entered a 6-month, treatment-free follow-up period.'}, {'id': 'OG001', 'title': 'BYM338/Bimagrumab 3 mg/kg', 'description': 'Participants received BYM338 3 mg/kg administered via intravenous infusion every 4 weeks for up to a maximum of 8 months after which they entered a 6-month, treatment-free follow-up period..'}, {'id': 'OG002', 'title': 'BYM338/Bimagrumab 1 mg/kg', 'description': 'Participants received BYM338 1 mg/kg administered via intravenous infusion every 4 weeks for up to a maximum of 8 months after which they entered a 6-month, treatment-free follow-up period.'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Participants received BYM338 1 mg/kg administered via intravenous infusion every 4 weeks for up to a maximum of 8 months after which they entered a 6-month, treatment-free follow-up period.'}], 'classes': [{'title': 'Week 52 (n=53,52,51,54)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}, {'value': '51', 'groupId': 'OG002'}, {'value': '54', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '6.88', 'spread': '68.948', 'groupId': 'OG000'}, {'value': '9.48', 'spread': '81.676', 'groupId': 'OG001'}, {'value': '-14.26', 'spread': '81.029', 'groupId': 'OG002'}, {'value': '-5.98', 'spread': '78.817', 'groupId': 'OG003'}]}]}, {'title': 'Week 78', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}, {'value': '50', 'groupId': 'OG002'}, {'value': '54', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-5.25', 'spread': '122.002', 'groupId': 'OG000'}, {'value': '-9.73', 'spread': '68.302', 'groupId': 'OG001'}, {'value': '-18.66', 'spread': '81.536', 'groupId': 'OG002'}, {'value': '-32.78', 'spread': '96.494', 'groupId': 'OG003'}]}]}, {'title': 'Week 104', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}, {'value': '39', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-22.68', 'spread': '102.549', 'groupId': 'OG000'}, {'value': '-50.58', 'spread': '118.012', 'groupId': 'OG001'}, {'value': '-25.08', 'spread': '95.737', 'groupId': 'OG002'}, {'value': '-61.30', 'spread': '107.399', 'groupId': 'OG003'}]}]}, {'title': '>=Week 117', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-206.65', 'spread': '281.923', 'groupId': 'OG000'}, {'value': '-5.0', 'spread': 'NA', 'comment': 'Standard deviation (SD) does not apply when n = 1.', 'groupId': 'OG001'}, {'value': '-53.65', 'spread': '114.322', 'groupId': 'OG002'}, {'value': '31.60', 'spread': 'NA', 'comment': 'SD does not apply when n = 1.', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Core study baseline, weeks 52, 78, 104, and >=117', 'description': 'The 6MWD test measures the distance (in meters) that a participant can walk in a 6 minute time frame. A positive change from baseline indicates improvement. The efficacy analysis and time points were based on windowed visits relative to the first dose of the double-blind treatment in the core study.', 'unitOfMeasure': 'meters', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The full analysis set, which consisted of all participants who were assigned to treatment in the core study and who received at least one dose of study drug during the extension, was considered for the analysis. Participants with both core baseline (BL) and post core-BL values for each time point were analyzed for that time point.'}, {'type': 'SECONDARY', 'title': 'Change From Core Study Baseline in Quadriceps Quantitative Muscle Testing (QMT) on the Right Side', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}, {'value': '51', 'groupId': 'OG002'}, {'value': '55', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'BYM338/Bimagrumab 10 mg/kg', 'description': 'Participants received BYM338 10 mg/kg administered via intravenous infusion every 4 weeks for up to a maximum of 8 months after which they entered a 6-month, treatment-free follow-up period.'}, {'id': 'OG001', 'title': 'BYM338/Bimagrumab 3 mg/kg', 'description': 'Participants received BYM338 3 mg/kg administered via intravenous infusion every 4 weeks for up to a maximum of 8 months after which they entered a 6-month, treatment-free follow-up period..'}, {'id': 'OG002', 'title': 'BYM338/Bimagrumab 1 mg/kg', 'description': 'Participants received BYM338 1 mg/kg administered via intravenous infusion every 4 weeks for up to a maximum of 8 months after which they entered a 6-month, treatment-free follow-up period.'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Participants received BYM338 1 mg/kg administered via intravenous infusion every 4 weeks for up to a maximum of 8 months after which they entered a 6-month, treatment-free follow-up period.'}], 'classes': [{'title': 'Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}, {'value': '51', 'groupId': 'OG002'}, {'value': '55', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-6.29', 'spread': '31.121', 'groupId': 'OG000'}, {'value': '-19.70', 'spread': '77.820', 'groupId': 'OG001'}, {'value': '-5.62', 'spread': '32.245', 'groupId': 'OG002'}, {'value': '-14.22', 'spread': '27.577', 'groupId': 'OG003'}]}]}, {'title': 'Week 78', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}, {'value': '53', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-9.43', 'spread': '41.285', 'groupId': 'OG000'}, {'value': '-23.76', 'spread': '73.729', 'groupId': 'OG001'}, {'value': '-17.04', 'spread': '25.696', 'groupId': 'OG002'}, {'value': '-21.02', 'spread': '31.391', 'groupId': 'OG003'}]}]}, {'title': 'Week 104', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}, {'value': '37', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-11.92', 'spread': '35.243', 'groupId': 'OG000'}, {'value': '-16.99', 'spread': '34.379', 'groupId': 'OG001'}, {'value': '-18.63', 'spread': '37.968', 'groupId': 'OG002'}, {'value': '-21.91', 'spread': '39.985', 'groupId': 'OG003'}]}]}, {'title': '>=Week 117', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '67.64', 'spread': 'NA', 'comment': 'SD does not apply when n = 1.', 'groupId': 'OG000'}, {'value': '33.38', 'spread': 'NA', 'comment': 'SD does not apply when n = 1.', 'groupId': 'OG001'}, {'value': '-19.36', 'spread': '18.475', 'groupId': 'OG002'}, {'value': '-18.24', 'spread': 'NA', 'comment': 'SD does not apply when n = 1.', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Core study baseline, week 52, week 78, week 104 and >=week 117', 'description': 'Quantitative Muscle Testing (QMT) was used to describe the long-term evolution of quadriceps muscle strength on the right side. The QMT was performed using the same portable fixed dynamometry (PFD) used in the core study. A negative change from baseline indicates deterioration. The efficacy analysis and time points were based on windowed visits relative to the first dose of the double-blind treatment in the core study.', 'unitOfMeasure': 'newtons', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The full analysis set, which consisted of all participants who were assigned to treatment in the core study and who received at least one dose of study drug during the extension, was considered for the analysis. Participants with both core baseline (BL) and post core-BL values for each time point were analyzed for that time point.'}, {'type': 'SECONDARY', 'title': 'Change From Core Study Baseline in Sporadic Inclusion Body Myositis (sIBM) Functional Assessment (sIFA) Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}, {'value': '51', 'groupId': 'OG002'}, {'value': '55', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'BYM338/Bimagrumab 10 mg/kg', 'description': 'Participants received BYM338 10 mg/kg administered via intravenous infusion every 4 weeks for up to a maximum of 8 months after which they entered a 6-month, treatment-free follow-up period.'}, {'id': 'OG001', 'title': 'BYM338/Bimagrumab 3 mg/kg', 'description': 'Participants received BYM338 3 mg/kg administered via intravenous infusion every 4 weeks for up to a maximum of 8 months after which they entered a 6-month, treatment-free follow-up period..'}, {'id': 'OG002', 'title': 'BYM338/Bimagrumab 1 mg/kg', 'description': 'Participants received BYM338 1 mg/kg administered via intravenous infusion every 4 weeks for up to a maximum of 8 months after which they entered a 6-month, treatment-free follow-up period.'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Participants received BYM338 1 mg/kg administered via intravenous infusion every 4 weeks for up to a maximum of 8 months after which they entered a 6-month, treatment-free follow-up period.'}], 'classes': [{'title': 'Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}, {'value': '52', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-1.34', 'spread': '15.249', 'groupId': 'OG000'}, {'value': '1.80', 'spread': '11.910', 'groupId': 'OG001'}, {'value': '3.17', 'spread': '11.380', 'groupId': 'OG002'}, {'value': '5.16', 'spread': '13.889', 'groupId': 'OG003'}]}]}, {'title': 'Week 78', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}, {'value': '48', 'groupId': 'OG002'}, {'value': '54', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-0.27', 'spread': '13.745', 'groupId': 'OG000'}, {'value': '5.33', 'spread': '13.099', 'groupId': 'OG001'}, {'value': '6.52', 'spread': '12.918', 'groupId': 'OG002'}, {'value': '7.41', 'spread': '14.410', 'groupId': 'OG003'}]}]}, {'title': 'Week 104', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}, {'value': '35', 'groupId': 'OG002'}, {'value': '40', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '3.54', 'spread': '14.998', 'groupId': 'OG000'}, {'value': '8.04', 'spread': '16.861', 'groupId': 'OG001'}, {'value': '5.97', 'spread': '12.849', 'groupId': 'OG002'}, {'value': '7.39', 'spread': '15.580', 'groupId': 'OG003'}]}]}, {'title': '>=Week 117', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-16.37', 'spread': '21.857', 'groupId': 'OG000'}, {'value': '10.91', 'spread': 'NA', 'comment': 'SD does not apply when n = 1.', 'groupId': 'OG001'}, {'value': '1.37', 'spread': '17.655', 'groupId': 'OG002'}, {'value': '6.36', 'spread': 'NA', 'comment': 'SD does not apply when n = 1.', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Core study baseline, week 52, week 78, week 104, and >=week 117', 'description': 'Self-reported physical function was assessed by a newly developed patient reported outcome named sporadic inclusion body myositis (sIBM) functional assessment (sIFA). The sIFA consists of 11 items scored on an 11 point numerical rating scale from 0 (no difficulty) to 10 (unable to do) across 3 domains: upper body functioning, lower body functioning and general functioning. Participants completed the assessment where the recall period was the past week prior to completing the patient reported outcome (PRO). The total score on the sIFA scale ranges from 0 (minimum) to 110 (maximum). Higher values represent a worse outcome. A positive change from baseline indicates deterioration. The efficacy analysis and time points were based on windowed visits relative to the first dose of the double-blind treatment in the core study.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The full analysis set, which consisted of all participants who were assigned to treatment in the core study and who received at least one dose of study drug during the extension, was considered for the analysis. Participants with both core baseline (BL) and post core-BL values for each time point were analyzed for that time point.'}, {'type': 'SECONDARY', 'title': 'Estimated Annual Number of Falls Per Participant Within Treatment Group', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}, {'value': '51', 'groupId': 'OG002'}, {'value': '55', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'BYM338/Bimagrumab 10 mg/kg', 'description': 'Participants received BYM338 10 mg/kg administered via intravenous infusion every 4 weeks for up to a maximum of 8 months after which they entered a 6-month, treatment-free follow-up period.'}, {'id': 'OG001', 'title': 'BYM338/Bimagrumab 3 mg/kg', 'description': 'Participants received BYM338 3 mg/kg administered via intravenous infusion every 4 weeks for up to a maximum of 8 months after which they entered a 6-month, treatment-free follow-up period..'}, {'id': 'OG002', 'title': 'BYM338/Bimagrumab 1 mg/kg', 'description': 'Participants received BYM338 1 mg/kg administered via intravenous infusion every 4 weeks for up to a maximum of 8 months after which they entered a 6-month, treatment-free follow-up period.'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Participants received BYM338 1 mg/kg administered via intravenous infusion every 4 weeks for up to a maximum of 8 months after which they entered a 6-month, treatment-free follow-up period.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.164', 'groupId': 'OG000'}, {'value': '3.879', 'groupId': 'OG001'}, {'value': '3.480', 'groupId': 'OG002'}, {'value': '3.835', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Core baseline to end of extension double-blind treatment (up to a maximum of 32 months)', 'description': 'Participants documented any fall occurrences in a paper diary during the study.', 'unitOfMeasure': 'Annual number of falls per participant', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety set: The safety set consisted of all participants who were assigned to treatment in the core study and who received at least one dose of study drug during the extension.'}, {'type': 'SECONDARY', 'title': 'Change From Core Study Baseline in Short Physical Performance Battery (SPPB) Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}, {'value': '51', 'groupId': 'OG002'}, {'value': '55', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'BYM338/Bimagrumab 10 mg/kg', 'description': 'Participants received BYM338 10 mg/kg administered via intravenous infusion every 4 weeks for up to a maximum of 8 months after which they entered a 6-month, treatment-free follow-up period.'}, {'id': 'OG001', 'title': 'BYM338/Bimagrumab 3 mg/kg', 'description': 'Participants received BYM338 3 mg/kg administered via intravenous infusion every 4 weeks for up to a maximum of 8 months after which they entered a 6-month, treatment-free follow-up period..'}, {'id': 'OG002', 'title': 'BYM338/Bimagrumab 1 mg/kg', 'description': 'Participants received BYM338 1 mg/kg administered via intravenous infusion every 4 weeks for up to a maximum of 8 months after which they entered a 6-month, treatment-free follow-up period.'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Participants received BYM338 1 mg/kg administered via intravenous infusion every 4 weeks for up to a maximum of 8 months after which they entered a 6-month, treatment-free follow-up period.'}], 'classes': [{'title': 'Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}, {'value': '51', 'groupId': 'OG002'}, {'value': '55', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.3', 'spread': '1.73', 'groupId': 'OG000'}, {'value': '0.2', 'spread': '1.61', 'groupId': 'OG001'}, {'value': '-0.4', 'spread': '1.74', 'groupId': 'OG002'}, {'value': '-0.3', 'spread': '1.31', 'groupId': 'OG003'}]}]}, {'title': 'Week 78', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}, {'value': '50', 'groupId': 'OG002'}, {'value': '55', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-0.5', 'spread': '2.58', 'groupId': 'OG000'}, {'value': '-0.1', 'spread': '1.54', 'groupId': 'OG001'}, {'value': '-0.4', 'spread': '1.69', 'groupId': 'OG002'}, {'value': '-0.9', 'spread': '1.92', 'groupId': 'OG003'}]}]}, {'title': 'Week 104', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}, {'value': '39', 'groupId': 'OG002'}, {'value': '41', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-1.4', 'spread': '3.29', 'groupId': 'OG000'}, {'value': '-0.9', 'spread': '2.77', 'groupId': 'OG001'}, {'value': '-1.1', 'spread': '2.56', 'groupId': 'OG002'}, {'value': '-1.3', 'spread': '2.35', 'groupId': 'OG003'}]}]}, {'title': '>=Week 117', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-3.0', 'spread': '4.24', 'groupId': 'OG000'}, {'value': '0.0', 'spread': 'NA', 'comment': 'SD does not apply when n = 1.', 'groupId': 'OG001'}, {'value': '0.3', 'spread': '2.06', 'groupId': 'OG002'}, {'value': '0.0', 'spread': 'NA', 'comment': 'SD does not apply when n = 1.', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Core study baseline, week 52, week 78, week 104 and >=week 117', 'description': 'The SPPB evaluated lower extremities function by testing gait speed, ability to keep standing balance and time to rise from a chair five times. The sub-score for each test ranged from 0 to 4. The summary score, which was a summation of scores from the 3 tests, ranged from 0 to 12. An increase in score indicates improvement in physical performance. A negative change from baseline indicates deterioration. The efficacy analysis and time points were based on windowed visits relative to the first dose of the double-blind treatment in the core study.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The full analysis set, which consisted of all participants who were assigned to treatment in the core study and who received at least one dose of study drug during the extension, was considered for the analysis. Participants with both core baseline (BL) and post core-BL values for each time point were analyzed for that time point.'}, {'type': 'SECONDARY', 'title': 'Change in Muscles of the Thigh', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'BYM338/Bimagrumab 10 mg/kg', 'description': 'Participants received BYM338 10 mg/kg administered via intravenous infusion every 4 weeks for up to a maximum of 8 months after which they entered a 6-month, treatment-free follow-up period.'}, {'id': 'OG001', 'title': 'BYM338/Bimagrumab 3 mg/kg', 'description': 'Participants received BYM338 3 mg/kg administered via intravenous infusion every 4 weeks for up to a maximum of 8 months after which they entered a 6-month, treatment-free follow-up period..'}, {'id': 'OG002', 'title': 'BYM338/Bimagrumab 1 mg/kg', 'description': 'Participants received BYM338 1 mg/kg administered via intravenous infusion every 4 weeks for up to a maximum of 8 months after which they entered a 6-month, treatment-free follow-up period.'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Participants received BYM338 1 mg/kg administered via intravenous infusion every 4 weeks for up to a maximum of 8 months after which they entered a 6-month, treatment-free follow-up period.'}], 'timeFrame': 'up to 1 year, up to 2 years', 'description': 'Magnetic resonance imaging (MRI) was planned to be used to characterize changes in muscles of the thigh in a subset of patients.', 'reportingStatus': 'POSTED', 'populationDescription': 'No participants were analyzed. The optional MRI assessment was not initiated as the study was stopped.'}, {'type': 'SECONDARY', 'title': 'Number of Patients With Anti-BYM338 Antibodies', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}, {'value': '38', 'groupId': 'OG002'}, {'value': '39', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'BYM338/Bimagrumab 10 mg/kg', 'description': 'Participants received BYM338 10 mg/kg administered via intravenous infusion every 4 weeks for up to a maximum of 8 months after which they entered a 6-month, treatment-free follow-up period.'}, {'id': 'OG001', 'title': 'BYM338/Bimagrumab 3 mg/kg', 'description': 'Participants received BYM338 3 mg/kg administered via intravenous infusion every 4 weeks for up to a maximum of 8 months after which they entered a 6-month, treatment-free follow-up period..'}, {'id': 'OG002', 'title': 'BYM338/Bimagrumab 1 mg/kg', 'description': 'Participants received BYM338 1 mg/kg administered via intravenous infusion every 4 weeks for up to a maximum of 8 months after which they entered a 6-month, treatment-free follow-up period.'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Participants received BYM338 1 mg/kg administered via intravenous infusion every 4 weeks for up to a maximum of 8 months after which they entered a 6-month, treatment-free follow-up period.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'end of double-blind treatment (up to 8 months)', 'description': 'Investigated the development of immunogenicity against BYM338.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety set: The safety set consisted of all participants who were assigned to treatment in the core study and who received at least one dose of study drug during the extension. Only those participants who provided a sample were analyzed.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'BYM338/Bimagrumab 10 mg/kg', 'description': 'Participants received BYM338 10 mg/kg administered via intravenous infusion every 4 weeks for up to a maximum of 8 months after which they entered a 6-month, treatment-free follow-up period.'}, {'id': 'FG001', 'title': 'BYM338/Bimagrumab 3 mg/kg', 'description': 'Participants received BYM338 3 mg/kg administered via intravenous infusion every 4 weeks for up to a maximum of 8 months after which they entered a 6-month, treatment-free follow-up period..'}, {'id': 'FG002', 'title': 'BYM338/Bimagrumab 1 mg/kg', 'description': 'Participants received BYM338 1 mg/kg administered via intravenous infusion every 4 weeks for up to a maximum of 8 months after which they entered a 6-month, treatment-free follow-up period.'}, {'id': 'FG003', 'title': 'Placebo', 'description': 'Participants received BYM338 1 mg/kg administered via intravenous infusion every 4 weeks for up to a maximum of 8 months after which they entered a 6-month, treatment-free follow-up period.'}], 'periods': [{'title': 'Double-blind Treatment Epoch', 'milestones': [{'type': 'STARTED', 'comment': 'Mean duration of exposure during the extension double-blind treatment period was 197.2 to 212.3 days', 'achievements': [{'groupId': 'FG000', 'numSubjects': '53'}, {'groupId': 'FG001', 'numSubjects': '52'}, {'groupId': 'FG002', 'numSubjects': '51'}, {'groupId': 'FG003', 'numSubjects': '55'}]}, {'type': 'Full Analysis Set', 'achievements': [{'groupId': 'FG000', 'numSubjects': '53'}, {'groupId': 'FG001', 'numSubjects': '52'}, {'groupId': 'FG002', 'numSubjects': '51'}, {'groupId': 'FG003', 'numSubjects': '55'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '53'}, {'groupId': 'FG001', 'numSubjects': '52'}, {'groupId': 'FG002', 'numSubjects': '51'}, {'groupId': 'FG003', 'numSubjects': '55'}]}], 'dropWithdraws': [{'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Study Terminated by sponsor', 'reasons': [{'groupId': 'FG000', 'numSubjects': '50'}, {'groupId': 'FG001', 'numSubjects': '51'}, {'groupId': 'FG002', 'numSubjects': '48'}, {'groupId': 'FG003', 'numSubjects': '55'}]}]}, {'title': 'Post-treatment Follow up Epoch', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '41'}, {'groupId': 'FG001', 'numSubjects': '46'}, {'groupId': 'FG002', 'numSubjects': '44'}, {'groupId': 'FG003', 'numSubjects': '47'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '35'}, {'groupId': 'FG001', 'numSubjects': '41'}, {'groupId': 'FG002', 'numSubjects': '34'}, {'groupId': 'FG003', 'numSubjects': '44'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '10'}, {'groupId': 'FG003', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '9'}, {'groupId': 'FG003', 'numSubjects': '2'}]}, {'type': 'Technical problems', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Participants entered extension study treatment period after completing the core study and continued on the study drug to which they were randomized in the core study (one of 3 bimagrumab doses (1mg/kg, 3mg/kg or 10mg/kg) or placebo). Participants discontinued from the treatment period were to enter a 6-month, treatment-free Follow-up Period (FUP).', 'preAssignmentDetails': 'All participants (N=211) were discontinued from the double-blind treatment period, 178 of whom entered the FUP. Overall 154 participants completed the FUP and 20 discontinued due to subject/guardian decision and 1 for technical reasons. Three discontinued FUP due to death (one each in the 10mg/kg, 3mg/kg, and placebo groups).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'BG000'}, {'value': '52', 'groupId': 'BG001'}, {'value': '51', 'groupId': 'BG002'}, {'value': '55', 'groupId': 'BG003'}, {'value': '211', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'BYM338/Bimagrumab 10 mg/kg', 'description': 'Participants received BYM338 10 mg/kg administered via intravenous infusion every 4 weeks for up to a maximum of 8 months after which they entered a 6-month, treatment-free follow-up period.'}, {'id': 'BG001', 'title': 'BYM338/Bimagrumab 3 mg/kg', 'description': 'Participants received BYM338 3 mg/kg administered via intravenous infusion every 4 weeks for up to a maximum of 8 months after which they entered a 6-month, treatment-free follow-up period..'}, {'id': 'BG002', 'title': 'BYM338/Bimagrumab 1 mg/kg', 'description': 'Participants received BYM338 1 mg/kg administered via intravenous infusion every 4 weeks for up to a maximum of 8 months after which they entered a 6-month, treatment-free follow-up period.'}, {'id': 'BG003', 'title': 'Placebo', 'description': 'Participants received BYM338 1 mg/kg administered via intravenous infusion every 4 weeks for up to a maximum of 8 months after which they entered a 6-month, treatment-free follow-up period.'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '69.2', 'spread': '8.19', 'groupId': 'BG000'}, {'value': '67.3', 'spread': '9.04', 'groupId': 'BG001'}, {'value': '70.0', 'spread': '7.69', 'groupId': 'BG002'}, {'value': '69.9', 'spread': '7.95', 'groupId': 'BG003'}, {'value': '69.1', 'spread': '8.24', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}, {'value': '19', 'groupId': 'BG003'}, {'value': '73', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '35', 'groupId': 'BG000'}, {'value': '33', 'groupId': 'BG001'}, {'value': '34', 'groupId': 'BG002'}, {'value': '36', 'groupId': 'BG003'}, {'value': '138', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 211}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-11-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-02', 'completionDateStruct': {'date': '2017-02-13', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-02-12', 'studyFirstSubmitDate': '2015-07-09', 'resultsFirstSubmitDate': '2018-02-12', 'studyFirstSubmitQcDate': '2015-10-08', 'lastUpdatePostDateStruct': {'date': '2018-03-13', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-02-12', 'studyFirstPostDateStruct': {'date': '2015-10-09', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-03-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-08-17', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and Deaths.', 'timeFrame': 'to end of study (up to 14 months, including the 6-month treatment-free follow-up period)', 'description': 'Safety monitoring was conducted throughout the study. AEs starting on or after the day of first administration of extension study drug until last administration of study drug + 56 days are considered. SAEs starting on or after the day of first administration of extension study drug are considered. Deaths which occurred on or after the day of first administration of extension study drug are considered.'}, {'measure': 'Change From Core Study Baseline in 6 Minute Walking Distance Test (6MWD)', 'timeFrame': 'Core study baseline, weeks 52, 78, 104, and >=117', 'description': 'The 6MWD test measures the distance (in meters) that a participant can walk in a 6 minute time frame. A positive change from baseline indicates improvement. The efficacy analysis and time points were based on windowed visits relative to the first dose of the double-blind treatment in the core study.'}], 'secondaryOutcomes': [{'measure': 'Change From Core Study Baseline in Quadriceps Quantitative Muscle Testing (QMT) on the Right Side', 'timeFrame': 'Core study baseline, week 52, week 78, week 104 and >=week 117', 'description': 'Quantitative Muscle Testing (QMT) was used to describe the long-term evolution of quadriceps muscle strength on the right side. The QMT was performed using the same portable fixed dynamometry (PFD) used in the core study. A negative change from baseline indicates deterioration. The efficacy analysis and time points were based on windowed visits relative to the first dose of the double-blind treatment in the core study.'}, {'measure': 'Change From Core Study Baseline in Sporadic Inclusion Body Myositis (sIBM) Functional Assessment (sIFA) Score', 'timeFrame': 'Core study baseline, week 52, week 78, week 104, and >=week 117', 'description': 'Self-reported physical function was assessed by a newly developed patient reported outcome named sporadic inclusion body myositis (sIBM) functional assessment (sIFA). The sIFA consists of 11 items scored on an 11 point numerical rating scale from 0 (no difficulty) to 10 (unable to do) across 3 domains: upper body functioning, lower body functioning and general functioning. Participants completed the assessment where the recall period was the past week prior to completing the patient reported outcome (PRO). The total score on the sIFA scale ranges from 0 (minimum) to 110 (maximum). Higher values represent a worse outcome. A positive change from baseline indicates deterioration. The efficacy analysis and time points were based on windowed visits relative to the first dose of the double-blind treatment in the core study.'}, {'measure': 'Estimated Annual Number of Falls Per Participant Within Treatment Group', 'timeFrame': 'Core baseline to end of extension double-blind treatment (up to a maximum of 32 months)', 'description': 'Participants documented any fall occurrences in a paper diary during the study.'}, {'measure': 'Change From Core Study Baseline in Short Physical Performance Battery (SPPB) Score', 'timeFrame': 'Core study baseline, week 52, week 78, week 104 and >=week 117', 'description': 'The SPPB evaluated lower extremities function by testing gait speed, ability to keep standing balance and time to rise from a chair five times. The sub-score for each test ranged from 0 to 4. The summary score, which was a summation of scores from the 3 tests, ranged from 0 to 12. An increase in score indicates improvement in physical performance. A negative change from baseline indicates deterioration. The efficacy analysis and time points were based on windowed visits relative to the first dose of the double-blind treatment in the core study.'}, {'measure': 'Change in Muscles of the Thigh', 'timeFrame': 'up to 1 year, up to 2 years', 'description': 'Magnetic resonance imaging (MRI) was planned to be used to characterize changes in muscles of the thigh in a subset of patients.'}, {'measure': 'Number of Patients With Anti-BYM338 Antibodies', 'timeFrame': 'end of double-blind treatment (up to 8 months)', 'description': 'Investigated the development of immunogenicity against BYM338.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['sporadic inclusion body myositis,', 'muscle wasting,', 'extension study,', 'BYM338,', 'bimagrumab,'], 'conditions': ['Sporadic Inclusion Body Myositis']}, 'referencesModule': {'references': [{'pmid': '33597289', 'type': 'DERIVED', 'citation': 'Amato AA, Hanna MG, Machado PM, Badrising UA, Chinoy H, Benveniste O, Karanam AK, Wu M, Tanko LB, Schubert-Tennigkeit AA, Papanicolaou DA, Lloyd TE, Needham M, Liang C, Reardon KA, de Visser M, Ascherman DP, Barohn RJ, Dimachkie MM, Miller JAL, Kissel JT, Oskarsson B, Joyce NC, Van den Bergh P, Baets J, De Bleecker JL, Karam C, David WS, Mirabella M, Nations SP, Jung HH, Pegoraro E, Maggi L, Rodolico C, Filosto M, Shaibani AI, Sivakumar K, Goyal NA, Mori-Yoshimura M, Yamashita S, Suzuki N, Aoki M, Katsuno M, Morihata H, Murata K, Nodera H, Nishino I, Romano CD, Williams VSL, Vissing J, Zhang Auberson L; RESILIENT Study Extension Group. Efficacy and Safety of Bimagrumab in Sporadic Inclusion Body Myositis: Long-term Extension of RESILIENT. Neurology. 2021 Mar 23;96(12):e1595-e1607. doi: 10.1212/WNL.0000000000011626. Epub 2021 Feb 17.'}]}, 'descriptionModule': {'briefSummary': "This extension study will provide data to further evaluate the efficacy, safety, and tolerability of three doses of BYM338 and to assess the long-term effects of BYM338 in patients with sporadic inclusion body myositis. The extension study was planned to consist of a Screening epoch (to assess patient eligibility), followed by a Treatment Period 1 epoch (double-blind and placebo-controlled), and a Treatment Period 2 epoch (open-label). A Post-treatment Follow-up (FUP) epoch was also planned for patients who discontinued prematurely. Patients who complete the core study and qualify for this extension study entered Treatment Period 1 and continued on the study drug to which they were randomized in the core study (either to one of the three bimagrumab doses (1 mg/kg, 3 mg/kg, and 10mg/kg) or placebo) during Treatment Period 1. Thus, Treatment Period 1 was double-blind and placebo-controlled. Participants were to continue in Treatment Period 1 until the dose with the best benefit-risk profile was determined from the core study data and selected (duration of Treatment Period 1 was estimated to be between 6 and 8 months). Once the dose with the best benefit-risk profile was selected, all participants (including those who were receiving placebo) were planned to enter Treatment Period 2 and switch to open-label treatment with bimagrumab at the selected dose. The core study has been completed but since the core study did not meet the primary end point (no bimagrumab dose was identified based on the core study efficacy results) the extension study was terminated as per protocol/sponsor's decision; therefore, no patients had entered Treatment Period 2. Instead, all patients were to return for the End of Treatment Period 1 (EOT1) visit at their next scheduled visit. As per protocol, all patients who discontinued study medication during Treatment Period 1 for any reason, including due to the study having been stopped as per protocol/sponsor's decision, were to have entered and complete the 6-month FUP after their EOT1 visit.\n\nDue to the nature of the design of the core and extension studies and termination of study medication in the extension study, the treatment duration for individual patients varied considerably. Consequently, the number of patients contributing data to the efficacy analyses at Week 104 and later timepoints was decreased."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '36 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients who completed the core study\n* Written informed consent must be obtained before any extension study assessment is performed.\n* Able to communicate well with the investigator.\n* Willing to participate for the entire duration of the extension study with commitment to follow study requirements and procedures.\n\nExclusion Criteria:\n\n* Women who are pregnant\n* Women of child-bearing potential unless they are using highly effective methods of contraception during dosing and for 6 months after the last BYM338 dose.\n* Current use of prohibited treatments\n* History of severe hypersensitivity reaction in the core study\n* History of adverse event(s) (including those from the core study) prior to the start of study drug in the extension study that, in the judgment of the investigator, taking into account the subject's overall status, prevent the subject from entering the extension study\n* Clinically significant abnormal liver function tests\n* Any medical condition or laboratory finding which, in the opinion of the investigator may interfere with participation in the study, might confound the results of the study, or pose an additional safety risk in administering BYM338"}, 'identificationModule': {'nctId': 'NCT02573467', 'briefTitle': 'An Extension Study of the Efficacy, Safety and Tolerability of BYM338 (Bimagrumab) in Patients With Sporadic Inclusion Body Myositis Who Previously Participated in the Core Study CBYM338B2203', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'Extension of the CBYM338B2203 Phase IIb/III Study to Evaluate the Long-term Efficacy, Safety and Tolerability of Intravenous BYM338 in Patients With Sporadic Inclusion Body Myositis', 'orgStudyIdInfo': {'id': 'CBYM338B2203E1'}, 'secondaryIdInfos': [{'id': '2015-001411-12', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'BYM338/bimagrumab 10 mg/kg', 'description': 'Participants received BYM338 10 mg/kg administered via intravenous infusion every 4 weeks for up to a maximum of 8 months after which they entered a 6-month, treatment-free follow-up period.', 'interventionNames': ['Drug: Bimagrumab']}, {'type': 'EXPERIMENTAL', 'label': 'BYM338/bimagrumab 3 mg/kg', 'description': 'Participants received BYM338 3 mg/kg administered via intravenous infusion every 4 weeks for up to a maximum of 8 months after which they entered a 6-month, treatment-free follow-up period.', 'interventionNames': ['Drug: Bimagrumab']}, {'type': 'EXPERIMENTAL', 'label': 'BYM338/bimagrumab 1 mg/kg', 'description': 'Participants received BYM338 1 mg/kg administered via intravenous infusion every 4 weeks for up to a maximum of 8 months after which they entered a 6-month, treatment-free follow-up period.', 'interventionNames': ['Drug: Bimagrumab']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Participants received placebo administered via intravenous infusion every 4 weeks for up to a maximum of 8 months after which they entered a 6-month, treatment-free follow-up period.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Bimagrumab', 'type': 'DRUG', 'otherNames': ['BYM338'], 'description': 'BYM338, a 150 mg/mL concentrate for solution for i.v. infusion, was provided in colorless glass vials with a rubber stopper and aluminum flip-off caps.', 'armGroupLabels': ['BYM338/bimagrumab 1 mg/kg', 'BYM338/bimagrumab 10 mg/kg', 'BYM338/bimagrumab 3 mg/kg']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Matching placebo to BYM338 was provided in colorless glass vials with a rubber stopper and aluminum flip-off caps.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85028', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '92868', 'city': 'Orange', 'state': 'California', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 33.78779, 'lon': -117.85311}}, {'zip': '95817', 'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}, {'zip': '33101', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '66160', 'city': 'Kansas City', 'state': 'Kansas', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 39.11417, 'lon': -94.62746}}, {'zip': '21287', 'city': 'Baltimore', 'state': 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