Viewing Study NCT02152761

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Ignite Creation Date: 2025-12-24 @ 12:13 PM
Ignite Modification Date: 2026-02-24 @ 2:30 PM
Study NCT ID: NCT02152761
Status: COMPLETED
Last Update Posted: 2020-08-19
First Post: 2014-05-08
Is Gene Therapy: True
Has Adverse Events: True
Brief Title: Study of Efficacy and Safety of Bimagrumab in Patients After Hip Fracture Surgery
Sponsor:
Organization:
Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Romania']}, 'conditionBrowseModule': {'meshes': [{'id': 'D009133', 'term': 'Muscular Atrophy'}, {'id': 'D001284', 'term': 'Atrophy'}, {'id': 'D006620', 'term': 'Hip Fractures'}], 'ancestors': [{'id': 'D020879', 'term': 'Neuromuscular Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D005264', 'term': 'Femoral Fractures'}, {'id': 'D050723', 'term': 'Fractures, Bone'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D025981', 'term': 'Hip Injuries'}, {'id': 'D007869', 'term': 'Leg Injuries'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000596367', 'term': 'bimagrumab'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'novartis.email@novartis.com', 'phone': '+1 (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.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'As there were no statistically significant improvements in functional measures (i.e. gait speed, SPPB) at week 24, the need to test for sustained improvement at wk 48 became irrelevant. So, wk 48 treatment differences were not evaluated'}}, 'adverseEventsModule': {'timeFrame': 'AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks', 'description': 'All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks', 'eventGroups': [{'id': 'EG000', 'title': 'BYM338 700 mg', 'description': 'bimagrumab 700mg administered via intravenous infusion from Day 1 until Week 20', 'otherNumAtRisk': 75, 'deathsNumAtRisk': 75, 'otherNumAffected': 47, 'seriousNumAtRisk': 75, 'deathsNumAffected': 1, 'seriousNumAffected': 15}, {'id': 'EG001', 'title': 'BYM338 210 mg', 'description': 'bimagrumab 210mg administered via intravenous infusion from Day 1 until Week 20', 'otherNumAtRisk': 69, 'deathsNumAtRisk': 69, 'otherNumAffected': 34, 'seriousNumAtRisk': 69, 'deathsNumAffected': 3, 'seriousNumAffected': 17}, {'id': 'EG002', 'title': 'BYM338 70 mg', 'description': 'bimagrumab 70 mg via i.v. infusion', 'otherNumAtRisk': 34, 'deathsNumAtRisk': 34, 'otherNumAffected': 15, 'seriousNumAtRisk': 34, 'deathsNumAffected': 1, 'seriousNumAffected': 9}, {'id': 'EG003', 'title': 'AT:S', 'description': 'Active Total Safety', 'otherNumAtRisk': 178, 'deathsNumAtRisk': 178, 'otherNumAffected': 96, 'seriousNumAtRisk': 178, 'deathsNumAffected': 5, 'seriousNumAffected': 41}, {'id': 'EG004', 'title': 'Placebo', 'description': 'placebo administered via intravenous infusion from Day 1 until Week 20', 'otherNumAtRisk': 72, 'deathsNumAtRisk': 72, 'otherNumAffected': 30, 'seriousNumAtRisk': 72, 'deathsNumAffected': 1, 'seriousNumAffected': 9}], 'otherEvents': [{'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 69, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 178, 'numAffected': 11}, {'groupId': 'EG004', 'numAtRisk': 72, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 69, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 178, 'numAffected': 13}, {'groupId': 'EG004', 'numAtRisk': 72, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 69, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 178, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 72, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 69, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 178, 'numAffected': 8}, {'groupId': 'EG004', 'numAtRisk': 72, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 69, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 178, 'numAffected': 13}, {'groupId': 'EG004', 'numAtRisk': 72, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 69, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 178, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 72, 'numAffected': 5}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 69, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 178, 'numAffected': 32}, {'groupId': 'EG004', 'numAtRisk': 72, 'numAffected': 13}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Weight decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 69, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 178, 'numAffected': 9}, {'groupId': 'EG004', 'numAtRisk': 72, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Hyperglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 69, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 178, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 72, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 69, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 178, 'numAffected': 19}, {'groupId': 'EG004', 'numAtRisk': 72, 'numAffected': 5}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 69, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 178, 'numAffected': 10}, {'groupId': 'EG004', 'numAtRisk': 72, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Muscle spasms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 69, 'numAffected': 17}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 178, 'numAffected': 31}, {'groupId': 'EG004', 'numAtRisk': 72, 'numAffected': 6}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 69, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 178, 'numAffected': 5}, {'groupId': 'EG004', 'numAtRisk': 72, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Cognitive disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 69, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 178, 'numAffected': 5}, {'groupId': 'EG004', 'numAtRisk': 72, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 69, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 178, 'numAffected': 5}, {'groupId': 'EG004', 'numAtRisk': 72, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 69, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 178, 'numAffected': 7}, {'groupId': 'EG004', 'numAtRisk': 72, 'numAffected': 4}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}], 'seriousEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 69, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 178, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 72, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Leukocytosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 69, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 178, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 72, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 69, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 178, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 72, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Cardiac failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 69, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 178, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 72, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Cardiac failure congestive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 69, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 178, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 72, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Retinal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 69, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 178, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 72, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 69, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 178, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 72, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 69, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 178, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 72, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Duodenogastric reflux', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 69, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 178, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 72, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 69, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 178, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 72, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Gastrointestinal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 69, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 178, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 72, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Gastrooesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 69, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 178, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 72, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Haematochezia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 69, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 178, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 72, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Multiple organ dysfunction syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 69, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 178, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 72, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 69, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 178, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 72, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 69, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 178, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 72, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Cholecystitis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 69, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 178, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 72, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Cholelithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 69, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 178, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 72, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 69, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 178, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 72, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Diverticulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 69, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 178, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 72, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Empyema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 69, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 178, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 72, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Enterobacter infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 69, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 178, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 72, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Erysipelas', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 69, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 178, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 72, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Escherichia urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 69, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 178, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 72, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 69, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 178, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 72, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Peritonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 69, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 178, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 72, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 69, 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'EG003', 'numAtRisk': 178, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 72, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Cerebral infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 69, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 178, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 72, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Cerebrovascular accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 69, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 178, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 72, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Transient ischaemic attack', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 69, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 178, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 72, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Device breakage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 69, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 178, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 72, 'numAffected': 1}], 'organSystem': 'Product Issues', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Device dislocation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 69, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 178, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 72, 'numAffected': 0}], 'organSystem': 'Product Issues', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Device extrusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 69, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 178, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 72, 'numAffected': 1}], 'organSystem': 'Product Issues', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 69, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 178, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 72, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Acute kidney injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 69, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 178, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 72, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Chronic obstructive pulmonary disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 69, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 178, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 72, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Pneumonia aspiration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 69, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 178, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 72, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Pulmonary congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 69, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 178, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 72, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 69, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 178, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 72, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Pulmonary oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 69, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 178, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 72, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 69, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 178, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 72, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 69, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 178, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 72, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 69, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 178, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 72, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 69, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 178, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 72, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 69, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 178, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 72, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Varicose vein', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 69, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 178, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 72, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline in Total Lean Body Mass Measured by DXA (Dual-energy X-ray Absorptiometry) at Weeks 12 and 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '75', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}, {'value': '144', 'groupId': 'OG002'}, {'value': '72', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Bimagrumab 700 mg', 'description': 'Change from baseline in total LBM'}, {'id': 'OG001', 'title': 'Bimagrumab 210 mg', 'description': 'Change from baseline in total LBM'}, {'id': 'OG002', 'title': 'Active Total Efficacy (AT:E)', 'description': 'Change from baseline in total LBM'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'placebo'}], 'classes': [{'title': 'week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}, {'value': '114', 'groupId': 'OG002'}, {'value': '66', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1.066', 'spread': '0.0107', 'groupId': 'OG000'}, {'value': '1.052', 'spread': '0.0109', 'groupId': 'OG001'}, {'value': '1.059', 'spread': '0.0096', 'groupId': 'OG002'}, {'value': '1.009', 'spread': '0.0103', 'groupId': 'OG003'}]}]}, {'title': 'week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '104', 'groupId': 'OG002'}, {'value': '63', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1.064', 'spread': '0.0113', 'groupId': 'OG000'}, {'value': '1.042', 'spread': '0.0115', 'groupId': 'OG001'}, {'value': '1.053', 'spread': '0.0101', 'groupId': 'OG002'}, {'value': '0.996', 'spread': '0.0109', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '<.0001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Treatment Group Ratio (BYM - Placebo)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.057', 'ciLowerLimit': '1.037', 'ciUpperLimit': '1.076', 'estimateComment': 'Holm-Bonferroni method: Used to adjust the Type I error for two comparisons (BYM338 700 mg/Placebo) at Week 24. No control for multiplicity was made at Week 12.', 'groupDescription': 'week 12', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<.0001', 'groupIds': ['OG001', 'OG003'], 'paramType': 'Treatment group rratio (BYM - Placebo)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.043', 'ciLowerLimit': '1.024', 'ciUpperLimit': '1.064', 'estimateComment': 'Holm-Bonferroni method: Used to adjust the Type I error for two comparisons (BYM338 700 mg/Placebo) at Week 24. No control for multiplicity was made at Week 12.', 'groupDescription': 'week 12', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'baseline, weeks 12 and 24', 'description': 'Mixed Model for Repeated Measures (MMRM) of change from baseline in total LBM (kg) by treatment and visit To assess dose-response relationship of bimagrumab and facilitate an adequate dose selection for future phase III studies, without the need for supportive data from another dose-response finding study, at least three doses were required, ranging from a non-effective or minimally effective dose to a dose where maximal efficacy is expected. Original study was initiated with only two doses of bimagrumab, therefore, a lower dose arm of 70mg has been added to this study with Amendment 2, changing the randomization ratio from 1:1:1 to 2:1:2:2 to either placebo, bimagrumab 70mg, bimagrumab 210mg, or bimagrumab 700mg. Since the 70mg dose was expected to show suboptimal efficacy and fewer patients were randomized to this group, it was used only for dose response modelling and not for hypothesis testing. Consequently, no efficacy evaluations for the bimagrumab 70mg Arm were performed', 'unitOfMeasure': 'kg', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The Full Analysis Set (FAS) used for all efficacy analyses consists of all randomized patients who received at least one dose of treatment after randomization and had at least one post-dose efficacy assessment. Patients who were randomized in error were excluded. Patients were analyzed according to treatment they were assigned to at randomization.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Gait Speed at Week 24 (Meters/Sec)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '75', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}, {'value': '72', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Bimagrumab 700 mg', 'description': 'bimagrumab 700mg administered via intravenous infusion from Day 1 until Week 20'}, {'id': 'OG001', 'title': 'Bimagrumab 210 mg', 'description': 'bimagrumab 210 mg administered via intravenous infusion from Day 1 until Week 20'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'placbo administered via intravenous infusion from Day 1 until Week 20'}], 'classes': [{'categories': [{'measurements': [{'value': '0.268', 'spread': '0.0599', 'groupId': 'OG000'}, {'value': '0.350', 'spread': '0.0617', 'groupId': 'OG001'}, {'value': '0.339', 'spread': '0.0607', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.1829', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean of Treatment Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.071', 'ciLowerLimit': '-0.175', 'ciUpperLimit': '0.034', 'pValueComment': 'Treatment Difference (BYM-Placebo)', 'groupDescription': 'week 24', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.8365', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean of Treatment Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.011', 'ciLowerLimit': '-0.096', 'ciUpperLimit': '0.119', 'groupDescription': 'week 24', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 24', 'description': 'Mixed Model for Repeated Measures (MMRM) of change from baseline in derived gait speed (m/sec) by treatment and visit\n\nTo assess dose-response relationship of bimagrumab and facilitate an adequate dose selection for future phase III studies, without the need for supportive data from another dose-response finding study, at least 3 doses were required, ranging from a non-effective or minimally effective dose to a dose where maximal efficacy is expected. Original study was initiated with only two doses of bimagrumab, therefore, a lower dose arm of 70mg was added to this study with Amendment 2, changing the randomization ratio from 1:1:1 to 2:1:2:2 to either placebo, bimagrumab 70mg, bimagrumab 210mg, or bimagrumab 700mg. Since the 70mg dose was expected to show suboptimal efficacy and fewer patients were randomized to this group, it was used only for dose response modelling and not for hypothesis testing. Consequently, no efficacy evaluations for the bimagrumab 70mg Arm were performed', 'unitOfMeasure': 'meters per second', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The Full Analysis Set (FAS) used for all efficacy analyses consisted of all randomized subjects who received at least 1 dose of investigational drug. Subjects were analyzed according to the treatment they were assigned to at randomization.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Short Physical Performance Battery at Weeks 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '75', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}, {'value': '72', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Bimagrumab 700 mg', 'description': 'bimagrumab 700mg administered via intravenous infusion from Day 1 until Week 20'}, {'id': 'OG001', 'title': 'Bimagrumab 210 mg', 'description': 'bimagrumab 210 mg administered via intravenous infusion from Day 1 until Week 20'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'placbo administered via intravenous infusion from Day 1 until Week 20'}], 'classes': [{'categories': [{'measurements': [{'value': '2.331', 'spread': '0.5436', 'groupId': 'OG000'}, {'value': '3.535', 'spread': '0.5623', 'groupId': 'OG001'}, {'value': '2.702', 'spread': '0.5516', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.5802', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean of Treatment Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.371', 'ciLowerLimit': '-1.311', 'ciUpperLimit': '1.053', 'groupDescription': 'week 24', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0913', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean of the Treatment Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.833', 'ciLowerLimit': '-0.135', 'ciUpperLimit': '1.801', 'groupDescription': 'week 24', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Week 24', 'description': 'MMRM change from baseline in total score by treatment \\& visit to Week 24 in physical performance measured by Short Physical Performance Battery (SPPB) that evaluates lower extremity function. Score range is 0 (worst performance) to 12 (best) to assess dose-response relationship of bimagrumab \\& facilitate adequate dose selection for future phase III studies, without need for supportive data from another dose-response finding study, at least 3 doses were required, ranging from non- or minimally effective dose to a dose where maximal efficacy was expected. Original study was initiated with only 2 doses, therefore, lower 70mg arm was added to this study, changing randomization ratio from 1:1:1 to 2:1:2:2 to either placebo, bimagrumab 70mg, 210mg, or 700mg. Since 70mg dose was expected to show suboptimal efficacy, fewer patients were randomized to this group \\& it was used only for dose response modelling \\& not hypothesis testing. Consequently, no efficacy evaluation for 70mg were performed', 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The Full Analysis Set (FAS) used for all efficacy analyses consists of all randomized patients who received at least one dose of treatment after randomization and had at least one post-dose efficacy assessment. Patients who were randomized in error were excluded. Patients were analyzed according to treatment they were assigned to at randomization.'}, {'type': 'SECONDARY', 'title': 'Incidence of Falls up to Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '75', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}, {'value': '34', 'groupId': 'OG002'}, {'value': '72', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Bimagrumab 700 mg', 'description': 'bimagrumab 700mg administered via intravenous infusion from Day 1 until Week 20'}, {'id': 'OG001', 'title': 'Bimagrumab 210 mg', 'description': 'bimagrumab 210 mg administered via intravenous infusion from Day 1 until Week 20'}, {'id': 'OG002', 'title': 'Bimagrumab 70mg', 'description': 'bimagrumab 70 mg administered via intravenous infusion from Day 1 until Week 20'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'placbo administered via intravenous infusion from Day 1 until Week 20'}], 'classes': [{'categories': [{'measurements': [{'value': '0.31', 'groupId': 'OG000', 'lowerLimit': '0.14', 'upperLimit': '0.70'}, {'value': '0.45', 'groupId': 'OG001', 'lowerLimit': '0.20', 'upperLimit': '0.99'}, {'value': '0.36', 'groupId': 'OG002', 'lowerLimit': '0.13', 'upperLimit': '0.97'}, {'value': '0.29', 'groupId': 'OG003', 'lowerLimit': '0.13', 'upperLimit': '0.64'}]}]}], 'analyses': [{'pValue': '0.8353', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Falls Rate Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.08', 'ciLowerLimit': '0.53', 'ciUpperLimit': '2.21', 'statisticalMethod': 'Negative binomial regression', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.2015', 'groupIds': ['OG001', 'OG003'], 'paramType': 'Falls Rate Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.58', 'ciLowerLimit': '0.78', 'ciUpperLimit': '3.18', 'statisticalMethod': 'Negative binomial regression', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.3999', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Falls Rate Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.25', 'ciLowerLimit': '0.52', 'ciUpperLimit': '3.00', 'groupDescription': 'week 24', 'statisticalMethod': 'Negative binomial regression', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Up to Week 48', 'description': 'Group falls rate\n\nThe frequency of having at least one fall up to Week 48 was summarized by treatment groups\n\nIncidence of falls was calculated for each arm up to Week 48. The ratio of these fall rates versus Placebo were calculated and presented as the Falls Rate Ratio. As mentioned in comment 5.1 above, the Falls Rate Ratio for Placebo does not apply because it would entail comparing the group to itself', 'unitOfMeasure': 'Number of Falls per week', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The Full Analysis Set (FAS) used for all efficacy analyses consisted of all randomized subjects who received at least one dose of investigational drug. Subjects were analyzed according to the treatment they were assigned to at randomization'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Bimagrumab 700 mg', 'description': 'bimagrumab 700mg administered via intravenous infusion from Day 1 until Week 20'}, {'id': 'FG001', 'title': 'Bimagrumab 210 mg', 'description': 'bimagrumab 210 mg administered via intravenous infusion from Day 1 until Week 20'}, {'id': 'FG002', 'title': 'Bimagrumab 70 mg', 'description': 'bimagrumad 70 mg administered via intravenous infusion starting Day 1 until Week 20'}, {'id': 'FG003', 'title': 'Placebo', 'description': 'placbo administered via intravenous infusion from Day 1 until Week 20'}], 'periods': [{'title': 'Epoch: Treatment Epoch', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '75'}, {'groupId': 'FG001', 'numSubjects': '70'}, {'groupId': 'FG002', 'numSubjects': '34'}, {'groupId': 'FG003', 'numSubjects': '72'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '64'}, {'groupId': 'FG001', 'numSubjects': '50'}, {'groupId': 'FG002', 'numSubjects': '29'}, {'groupId': 'FG003', 'numSubjects': '64'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '20'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '8'}]}], 'dropWithdraws': [{'type': 'Technical problems', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '5'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '2'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Non-compliance with treatment', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}, {'title': 'Epoch: Post-treatment Follow-up Epoch', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '67'}, {'groupId': 'FG001', 'numSubjects': '54'}, {'groupId': 'FG002', 'numSubjects': '30'}, {'groupId': 'FG003', 'numSubjects': '68'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '63'}, {'groupId': 'FG001', 'numSubjects': '47'}, {'groupId': 'FG002', 'numSubjects': '30'}, {'groupId': 'FG003', 'numSubjects': '66'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}]}]}], 'recruitmentDetails': '384 subjects were screened, and 252 subjects completed Screening period. One was lost to follow-up after screening and did not attend any visits for treatment epoch therefore, 251 were recruited to study. 2 subjects died during Screening epoch (1 was reported as discontinued and 1 was reported as a screen failure)', 'preAssignmentDetails': '251 subjects entered treatment epoch and were randomized to one of the three bimagrumab dose groups (70 mg, 210 mg and 700 mg) or the placebo group. 1 from the 210 mg group was randomized in error and did not receive study drug. Of the 250 subjects who were randomized and treated, 207 completed the 24 weeks treatment epoch.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '75', 'groupId': 'BG000'}, {'value': '69', 'groupId': 'BG001'}, {'value': '34', 'groupId': 'BG002'}, {'value': '72', 'groupId': 'BG003'}, {'value': '250', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Bimagrumab 700 mg', 'description': 'bimagrumab 700mg administered via intravenous infusion from Day 1 until Week 20'}, {'id': 'BG001', 'title': 'Bimagrumab 210 mg', 'description': 'bimagrumab 210 mg administered via intravenous infusion from Day 1 until Week 20'}, {'id': 'BG002', 'title': 'Bimagrumab 70 mg', 'description': 'bimagrumad 70 mg administered via intravenous infusion starting Day 1 until Week 20'}, {'id': 'BG003', 'title': 'Placebo', 'description': 'placbo administered via intravenous infusion from Day 1 until Week 20'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '76.1', 'spread': '8.58', 'groupId': 'BG000'}, {'value': '74.8', 'spread': '8.94', 'groupId': 'BG001'}, {'value': '76.1', 'spread': '8.59', 'groupId': 'BG002'}, {'value': '76.4', 'spread': '7.88', 'groupId': 'BG003'}, {'value': '75.8', 'spread': '8.46', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Age, Customized', 'classes': [{'title': '< 65 years', 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '25', 'groupId': 'BG004'}]}]}, {'title': '65 - 74 years', 'categories': [{'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '27', 'groupId': 'BG003'}, {'value': '82', 'groupId': 'BG004'}]}]}, {'title': '75 - 84 years', 'categories': [{'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}, {'value': '32', 'groupId': 'BG003'}, {'value': '104', 'groupId': 'BG004'}]}]}, {'title': '=>85 years', 'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}, {'value': '39', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '54', 'groupId': 'BG000'}, {'value': '48', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}, {'value': '53', 'groupId': 'BG003'}, {'value': '176', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}, {'value': '19', 'groupId': 'BG003'}, {'value': '74', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Caucasian', 'categories': [{'measurements': [{'value': '57', 'groupId': 'BG000'}, {'value': '58', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}, {'value': '53', 'groupId': 'BG003'}, {'value': '194', 'groupId': 'BG004'}]}]}, {'title': 'Black', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '17', 'groupId': 'BG003'}, {'value': '44', 'groupId': 'BG004'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '11', 'groupId': 'BG004'}]}]}, {'title': 'Native American', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'The Full Analysis Set (FAS) used for all efficacy analyses consists of all randomized patients who received at least one dose of treatment after randomization and had at least one post-dose efficacy assessment. Patients who were randomized in error were excluded. Patients were analyzed according to treatment they were assigned to at randomization.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-02-08', 'size': 864082, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2019-10-17T15:24', 'hasProtocol': True}, {'date': '2018-06-22', 'size': 804661, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2019-10-17T15:25', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'randomized, interventional, multicenter, placebo-controlled, phase IIa/IIb trial in patients'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 251}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-09-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-08', 'dispFirstSubmitDate': '2018-10-10', 'completionDateStruct': {'date': '2018-10-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-08-09', 'studyFirstSubmitDate': '2014-05-08', 'dispFirstSubmitQcDate': '2018-10-10', 'resultsFirstSubmitDate': '2019-10-17', 'studyFirstSubmitQcDate': '2014-05-30', 'dispFirstPostDateStruct': {'date': '2018-10-12', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2020-08-19', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-08-09', 'studyFirstPostDateStruct': {'date': '2014-06-02', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-08-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-05-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline in Total Lean Body Mass Measured by DXA (Dual-energy X-ray Absorptiometry) at Weeks 12 and 24', 'timeFrame': 'baseline, weeks 12 and 24', 'description': 'Mixed Model for Repeated Measures (MMRM) of change from baseline in total LBM (kg) by treatment and visit To assess dose-response relationship of bimagrumab and facilitate an adequate dose selection for future phase III studies, without the need for supportive data from another dose-response finding study, at least three doses were required, ranging from a non-effective or minimally effective dose to a dose where maximal efficacy is expected. Original study was initiated with only two doses of bimagrumab, therefore, a lower dose arm of 70mg has been added to this study with Amendment 2, changing the randomization ratio from 1:1:1 to 2:1:2:2 to either placebo, bimagrumab 70mg, bimagrumab 210mg, or bimagrumab 700mg. Since the 70mg dose was expected to show suboptimal efficacy and fewer patients were randomized to this group, it was used only for dose response modelling and not for hypothesis testing. Consequently, no efficacy evaluations for the bimagrumab 70mg Arm were performed'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in Gait Speed at Week 24 (Meters/Sec)', 'timeFrame': 'Baseline, Week 24', 'description': 'Mixed Model for Repeated Measures (MMRM) of change from baseline in derived gait speed (m/sec) by treatment and visit\n\nTo assess dose-response relationship of bimagrumab and facilitate an adequate dose selection for future phase III studies, without the need for supportive data from another dose-response finding study, at least 3 doses were required, ranging from a non-effective or minimally effective dose to a dose where maximal efficacy is expected. Original study was initiated with only two doses of bimagrumab, therefore, a lower dose arm of 70mg was added to this study with Amendment 2, changing the randomization ratio from 1:1:1 to 2:1:2:2 to either placebo, bimagrumab 70mg, bimagrumab 210mg, or bimagrumab 700mg. Since the 70mg dose was expected to show suboptimal efficacy and fewer patients were randomized to this group, it was used only for dose response modelling and not for hypothesis testing. Consequently, no efficacy evaluations for the bimagrumab 70mg Arm were performed'}, {'measure': 'Change From Baseline in Short Physical Performance Battery at Weeks 24', 'timeFrame': 'Week 24', 'description': 'MMRM change from baseline in total score by treatment \\& visit to Week 24 in physical performance measured by Short Physical Performance Battery (SPPB) that evaluates lower extremity function. Score range is 0 (worst performance) to 12 (best) to assess dose-response relationship of bimagrumab \\& facilitate adequate dose selection for future phase III studies, without need for supportive data from another dose-response finding study, at least 3 doses were required, ranging from non- or minimally effective dose to a dose where maximal efficacy was expected. Original study was initiated with only 2 doses, therefore, lower 70mg arm was added to this study, changing randomization ratio from 1:1:1 to 2:1:2:2 to either placebo, bimagrumab 70mg, 210mg, or 700mg. Since 70mg dose was expected to show suboptimal efficacy, fewer patients were randomized to this group \\& it was used only for dose response modelling \\& not hypothesis testing. Consequently, no efficacy evaluation for 70mg were performed'}, {'measure': 'Incidence of Falls up to Week 48', 'timeFrame': 'Up to Week 48', 'description': 'Group falls rate\n\nThe frequency of having at least one fall up to Week 48 was summarized by treatment groups\n\nIncidence of falls was calculated for each arm up to Week 48. The ratio of these fall rates versus Placebo were calculated and presented as the Falls Rate Ratio. As mentioned in comment 5.1 above, the Falls Rate Ratio for Placebo does not apply because it would entail comparing the group to itself'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['bimagrumab', 'BYM338', 'hip fracture', 'elderly', 'controlled clinical trial', 'randomized', 'muscle wasting', 'atrophy'], 'conditions': ['Muscle Wasting (Atrophy) After Hip Fracture Surgery']}, 'referencesModule': {'references': [{'pmid': '36098133', 'type': 'DERIVED', 'citation': 'Hofbauer LC, Witvrouw R, Varga Z, Shiota N, Cremer M, Tanko LB, Rooks D, Auberson LZ, Arkuszewski M, Fretault N, Schubert-Tennigkeit AA, Papanicolaou DA, Recknor C. Bimagrumab to improve recovery after hip fracture in older adults: a multicentre, double-blind, randomised, parallel-group, placebo-controlled, phase 2a/b trial. Lancet Healthy Longev. 2021 May;2(5):e263-e274. doi: 10.1016/S2666-7568(21)00084-2.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study was to assess if bimagrumab is safe and effective in patients with muscle wasting (atrophy) after hip fracture surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '60 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nMust have X-ray confirmed successful hip fracture repair; Must have completed surgical wound healing; Ability to walk a specified distance with or without a walking aid; Must weigh at least 35 kg.\n\nExclusion Criteria:\n\nMust not have history of any other lower limb fractures in the past 6 months; Must not have certain cardiovascular conditions; Must not have a chronic active infection (e.g. HIV, hepatitis B or C, etc); Must not have used high-dose corticosteroid medications for at least 3 months in the past year;'}, 'identificationModule': {'nctId': 'NCT02152761', 'briefTitle': 'Study of Efficacy and Safety of Bimagrumab in Patients After Hip Fracture Surgery', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'A 24-week Double-blind Treatment and 24-week Follow-up, Randomized, Multicenter, Placebo-controlled, Phase IIa/IIb Study to Evaluate Safety and Efficacy of i.v. Bimagrumab on Total Lean Body Mass and Physical Performance in Patients After Surgical Treatment of Hip Fracture', 'orgStudyIdInfo': {'id': 'CBYM338D2201'}, 'secondaryIdInfos': [{'id': '2013-003439-31', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'bimagrumab 700 mg', 'description': 'Approximately 70 patients who met all inclusion criteria and none of the exclusion criteria were treated with the bimagrumab high dose administered via intravenous infusion starting Day 1 until Week 20', 'interventionNames': ['Drug: bimagrumab']}, {'type': 'EXPERIMENTAL', 'label': 'bimagrumab 210 mg', 'description': 'Approximately 70 patients who met all inclusion criteria and none of the exclusion criteria were treated with the bimagrumab medium dose administered via intravenous infusion starting Day 1 until Week 20', 'interventionNames': ['Drug: bimagrumab']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'placebo', 'description': 'Approximately 70 patients who met all inclusion criteria and none of the exclusion criteria received matching placbo administered via intravenous infusion starting Day 1 until Week 20', 'interventionNames': ['Other: placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Bimagrumab 70 mg', 'description': 'Approximately 35 patients who met all inclusion criteria and none of the exclusion criteria were treated with bimagrumad low dose administered via intravenous infusion starting Day 1 until Week 20', 'interventionNames': ['Drug: bimagrumab']}], 'interventions': [{'name': 'bimagrumab', 'type': 'DRUG', 'otherNames': ['BYM338'], 'description': 'Bimagrumab was administered as intravenous infusion starting on Day 1 until week 20.', 'armGroupLabels': ['Bimagrumab 70 mg', 'bimagrumab 210 mg', 'bimagrumab 700 mg']}, {'name': 'placebo', 'type': 'OTHER', 'description': 'Matching placebo was administered as intravenous infusion starting on Day 1 until week 20.', 'armGroupLabels': ['placebo']}]}, 'contactsLocationsModule': 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