Viewing Study NCT01305356

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Ignite Creation Date: 2025-12-24 @ 11:19 PM
Ignite Modification Date: 2025-12-25 @ 8:59 PM
Study NCT ID: NCT01305356
Status: COMPLETED
Last Update Posted: 2018-12-26
First Post: 2011-02-25
Is NOT Gene Therapy: False
Has Adverse Events: True
Brief Title: Augment® Injectable Bone Graft Compared to Autologous Bone Graft as a Bone Regeneration Device in Hindfoot Fusions
Sponsor:
Organization:
Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D010003', 'term': 'Osteoarthritis'}, {'id': 'D001172', 'term': 'Arthritis, Rheumatoid'}, {'id': 'D000844', 'term': 'Ankylosis'}, {'id': 'D013167', 'term': 'Spondylitis, Ankylosing'}], 'ancestors': [{'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D000089183', 'term': 'Axial Spondyloarthritis'}, {'id': 'D025242', 'term': 'Spondylarthropathies'}, {'id': 'D025241', 'term': 'Spondylarthritis'}, {'id': 'D013166', 'term': 'Spondylitis'}, {'id': 'D013122', 'term': 'Spinal Diseases'}, {'id': 'D001847', 'term': 'Bone Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Justin.Moss@wright.com', 'phone': '615-236-4984', 'title': 'Justin Moss', 'organization': 'Wright Medical'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Patients were assessed through study completion scheduled at 52 weeks following surgery.', 'eventGroups': [{'id': 'EG000', 'title': 'Augment® Injectable Bone Graft', 'description': 'Standard rigid fixation + Augment® Injectable Bone Graft (beta-TCP/bovine collagen matrix + rhPDGF-BB)', 'otherNumAtRisk': 132, 'deathsNumAtRisk': 132, 'otherNumAffected': 116, 'seriousNumAtRisk': 132, 'deathsNumAffected': 0, 'seriousNumAffected': 20}, {'id': 'EG001', 'title': 'Autologous Bone Graft', 'description': 'Standard Rigid Fixation + Autologous bone graft', 'otherNumAtRisk': 167, 'deathsNumAtRisk': 167, 'otherNumAffected': 135, 'seriousNumAtRisk': 167, 'deathsNumAffected': 0, 'seriousNumAffected': 35}], 'otherEvents': [{'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 167, 'numAffected': 12}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Feeling Hot', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 167, 'numAffected': 6}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Local Swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 27}, {'groupId': 'EG001', 'numAtRisk': 167, 'numAffected': 13}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Medical Device Discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 167, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 167, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Tenderness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 167, 'numAffected': 8}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 28}, {'groupId': 'EG001', 'numAtRisk': 167, 'numAffected': 19}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Back Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 167, 'numAffected': 7}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Joint range of motion decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 167, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 44}, {'groupId': 'EG001', 'numAtRisk': 167, 'numAffected': 35}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 167, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypoaesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 167, 'numAffected': 10}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Anemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 167, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Myelodysplastic syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 167, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 167, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Arrhythmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 167, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Arrhythmia supraventricular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 167, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 167, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Atrioventricular block complete', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 167, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 167, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cardiac failure congestive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 167, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Chest discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 167, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 167, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 167, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Congenital foot malformation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 167, 'numAffected': 1}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Talipes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 167, 'numAffected': 1}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Labyrinthitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 167, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Otitis media', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 167, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 167, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Diabetes mellitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 167, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Diabetic neuropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 167, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypothyroidism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 167, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cataract', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 167, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Chalazion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 167, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Eye pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 167, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Optic disc disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 167, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 167, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 167, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 167, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 167, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Flatulence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 167, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Gastric ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 167, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Gastric ulcer haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 167, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 167, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Gastrointestinal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 167, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Gastroesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 167, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hiatus hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 167, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Megacolon', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 167, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Mouth ulceration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 167, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Procedural nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 167, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Tooth infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 167, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Toothache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 167, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 167, 'numAffected': 8}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Administration site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 167, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Chills', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 167, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Drug withdrawal syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 167, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Impaired healing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 167, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 167, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Necrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 167, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Non-cardiac chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 167, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 167, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 167, 'numAffected': 6}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 167, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Soft tissue inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 167, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 167, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 167, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Gallbladder pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 167, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Drug hypersensitivity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 167, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypersensitivity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 167, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 167, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 167, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Clostridium difficile colitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 167, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 167, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Ear infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 167, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Fungal skin infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 167, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Herpes zoster', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 167, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Infected skin ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 167, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 167, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 167, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Kidney infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 167, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Localised infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 167, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Lower respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 167, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 167, 'numAffected': 6}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Onychomycosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 167, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Osteomyelitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 167, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pharyngitis streptococcal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 167, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 167, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Postoperative wound infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 167, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 167, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Sinusitis', 'stats': [{'groupId': 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and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Skin ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 167, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Splinter haemorrhages', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 167, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Bladder neoplasm surgery', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 167, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cast application', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 167, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Endodontic procedure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 167, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Gastric banding', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 167, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Incisional drainage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 167, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Mole excision', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 167, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Splint application', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 167, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Ureteral stent removal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 167, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Wound drainage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 167, 'numAffected': 2}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Aneurysm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 167, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Aortic arteriosclerosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 167, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Aortic stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 167, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 167, 'numAffected': 4}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 167, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 167, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 167, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 167, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Procedural hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 167, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 167, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Rectal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 167, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Varicose vein', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 167, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Anemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 167, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 167, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Arrhythmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 167, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 167, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Atrioventricular block complete', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 167, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cardiac failure congestive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 167, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 167, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Congenital foot malformation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 167, 'numAffected': 1}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'gastrointestinal hemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 167, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Megacolon', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 167, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Impaired healing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 167, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Gallbladder pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 167, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypersensitivity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 167, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Clostridium difficile colitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 167, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 167, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Osteomyelitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 167, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 167, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Postoperative wound infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 167, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Staphylococcal infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 167, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 167, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Wound infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 167, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 167, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 167, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Osteoporosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 167, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 167, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Endometrial cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 167, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Renal cell carcinoma stage unspecified', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 167, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pregnancy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 167, 'numAffected': 1}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Alcohol withdrawal syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 167, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Suicidal ideation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 167, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Ureteric injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 167, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 167, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Chronic obstructive pulmonary disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 167, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 167, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 167, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 167, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Aneurysm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 167, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Aortic stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 167, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 167, 'numAffected': 3}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 167, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 167, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Device related infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 167, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Overdose', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 167, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Wound infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 167, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Pain on Weight Bearing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '132', 'groupId': 'OG000'}, {'value': '167', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Augment® Injectable Bone Graft', 'description': 'Standard rigid fixation + Augment® Injectable Bone Graft (beta-TCP/bovine collagen matrix + rhPDGF-BB)'}, {'id': 'OG001', 'title': 'Autologous Bone Graft', 'description': 'Standard Rigid Fixation + Autologous bone graft'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '132', 'groupId': 'OG000'}, {'value': '164', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '71.0', 'spread': '2.0', 'groupId': 'OG000'}, {'value': '70.7', 'spread': '1.8', 'groupId': 'OG001'}]}]}, {'title': 'Week 9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '108', 'groupId': 'OG000'}, {'value': '136', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '29.5', 'spread': '2.9', 'groupId': 'OG000'}, {'value': '28.2', 'spread': '2.5', 'groupId': 'OG001'}]}]}, {'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '124', 'groupId': 'OG000'}, {'value': '154', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '26.8', 'spread': '2.5', 'groupId': 'OG000'}, {'value': '24.6', 'spread': '2.2', 'groupId': 'OG001'}]}]}, {'title': 'Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '129', 'groupId': 'OG000'}, {'value': '159', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '26.4', 'spread': '2.4', 'groupId': 'OG000'}, {'value': '24.4', 'spread': '2.1', 'groupId': 'OG001'}]}]}, {'title': 'Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '128', 'groupId': 'OG000'}, {'value': '160', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '25.1', 'spread': '2.4', 'groupId': 'OG000'}, {'value': '18.3', 'spread': '2.1', 'groupId': 'OG001'}]}]}, {'title': 'Week 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '124', 'groupId': 'OG000'}, {'value': '156', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '18.7', 'spread': '2.3', 'groupId': 'OG000'}, {'value': '15.8', 'spread': '2.0', 'groupId': 'OG001'}]}]}, {'title': 'Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '124', 'groupId': 'OG000'}, {'value': '157', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '16.6', 'spread': '2.4', 'groupId': 'OG000'}, {'value': '15.9', 'spread': '2.1', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 9, 12, 16, 24, 36, and 52 weeks', 'description': 'Subjects were asked to stand and report pain on a 100 mm Visual Analog Scale (with 0 being no pain and 100 being worst pain imaginable).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis conducted on patients at Baseline, 9, 12, 16, 24, 36, and 52 weeks time points.'}, {'type': 'SECONDARY', 'title': 'Foot Function Index (FFI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '132', 'groupId': 'OG000'}, {'value': '167', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Augment® Injectable Bone Graft', 'description': 'Standard rigid fixation + Augment® Injectable Bone Graft (beta-TCP/bovine collagen matrix + rhPDGF-BB)'}, {'id': 'OG001', 'title': 'Autologous Bone Graft', 'description': 'Standard Rigid Fixation + Autologous bone graft'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '132', 'groupId': 'OG000'}, {'value': '167', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '50.6', 'spread': '1.6', 'groupId': 'OG000'}, {'value': '50.0', 'spread': '1.4', 'groupId': 'OG001'}]}]}, {'title': '9 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '126', 'groupId': 'OG000'}, {'value': '157', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '41.8', 'spread': '1.7', 'groupId': 'OG000'}, {'value': '45.0', 'spread': '1.5', 'groupId': 'OG001'}]}]}, {'title': '12 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '126', 'groupId': 'OG000'}, {'value': '161', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '33.3', 'spread': '1.8', 'groupId': 'OG000'}, {'value': '34.5', 'spread': '1.6', 'groupId': 'OG001'}]}]}, {'title': '16 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '127', 'groupId': 'OG000'}, {'value': '162', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '29.7', 'spread': '2.0', 'groupId': 'OG000'}, {'value': '28.0', 'spread': '1.7', 'groupId': 'OG001'}]}]}, {'title': '24 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '129', 'groupId': 'OG000'}, {'value': '164', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '26.3', 'spread': '1.8', 'groupId': 'OG000'}, {'value': '19.8', 'spread': '1.6', 'groupId': 'OG001'}]}]}, {'title': '36 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '124', 'groupId': 'OG000'}, {'value': '159', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '21.8', 'spread': '1.8', 'groupId': 'OG000'}, {'value': '16.7', 'spread': '1.6', 'groupId': 'OG001'}]}]}, {'title': '52 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '123', 'groupId': 'OG000'}, {'value': '160', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '19.6', 'spread': '1.9', 'groupId': 'OG000'}, {'value': '16.9', 'spread': '1.6', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 9, 12, 16, 24, 36, and 52 weeks', 'description': 'The Foot Function Index (FFI) measures the impact of foot pathology on function in terms of pain, disability and activity restriction. The FFI is a self-administered index consisting of 23 items divided into 3 sub-scales all ranging from 0-100. To obtain a sub-scale score, the item scores for a sub-scale are totaled and then divided by the maximum total possible for all of the sub-scale items which the subject indicated were applicable. Any item marked as not applicable is excluded from the total possible. Sub-scales are an average of the completed ratings within that sub-scale. The total foot function score is an average of the three sub-scale scores and ranges from 0-100. Lower scores are indicative of better outcomes whereas higher scores indicate greater impairment.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis conducted on patients at Baseline, 9, 12, 16, 24, 36, and 52 weeks time points.'}, {'type': 'SECONDARY', 'title': 'AOFAS Hindfoot and Ankle Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '132', 'groupId': 'OG000'}, {'value': '167', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Augment® Injectable Bone Graft', 'description': 'Standard rigid fixation + Augment® Injectable Bone Graft (beta-TCP/bovine collagen matrix + rhPDGF-BB)'}, {'id': 'OG001', 'title': 'Autologous Bone Graft', 'description': 'Standard Rigid Fixation + Autologous bone graft'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '132', 'groupId': 'OG000'}, {'value': '167', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '43.3', 'spread': '1.5', 'groupId': 'OG000'}, {'value': '43.6', 'spread': '1.3', 'groupId': 'OG001'}]}]}, {'title': '9 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '126', 'groupId': 'OG000'}, {'value': '155', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '61.5', 'spread': '1.1', 'groupId': 'OG000'}, {'value': '61.5', 'spread': '1.0', 'groupId': 'OG001'}]}]}, {'title': '12 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '124', 'groupId': 'OG000'}, {'value': '162', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '66.9', 'spread': '1.3', 'groupId': 'OG000'}, {'value': '66.6', 'spread': '1.1', 'groupId': 'OG001'}]}]}, {'title': '16 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '129', 'groupId': 'OG000'}, {'value': '163', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '69.9', 'spread': '1.3', 'groupId': 'OG000'}, {'value': '71.2', 'spread': '1.1', 'groupId': 'OG001'}]}]}, {'title': '24 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '129', 'groupId': 'OG000'}, {'value': '164', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '73.4', 'spread': '1.5', 'groupId': 'OG000'}, {'value': '75.5', 'spread': '1.3', 'groupId': 'OG001'}]}]}, {'title': '36 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '124', 'groupId': 'OG000'}, {'value': '160', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '77.5', 'spread': '1.5', 'groupId': 'OG000'}, {'value': '78.9', 'spread': '1.3', 'groupId': 'OG001'}]}]}, {'title': '52 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'OG000'}, {'value': '160', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '79.5', 'spread': '1.6', 'groupId': 'OG000'}, {'value': '79.3', 'spread': '1.4', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 9, 12, 16, 24, 36, and 52 weeks', 'description': 'Subjects were asked to report pain, functionality and ability levels while the physician performed assessments based on alignment, abnormality, motion, and stability. The total score ranges from a low of zero to a high of 100, with subscales measuring pain (40 points), function (50 points), and alignment (10 points), with higher scores showing better outcomes.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis conducted on patients at Baseline, 9, 12, 16, 24, 36, and 52 weeks time points.'}, {'type': 'SECONDARY', 'title': 'Fusion Site Pain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '132', 'groupId': 'OG000'}, {'value': '167', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Augment® Injectable Bone Graft', 'description': 'Standard rigid fixation + Augment® Injectable Bone Graft (beta-TCP/bovine collagen matrix + rhPDGF-BB)'}, {'id': 'OG001', 'title': 'Autologous Bone Graft', 'description': 'Standard Rigid Fixation + Autologous bone graft'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '132', 'groupId': 'OG000'}, {'value': '167', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '51.4', 'spread': '2.4', 'groupId': 'OG000'}, {'value': '50.4', 'spread': '2.1', 'groupId': 'OG001'}]}]}, {'title': 'Week 9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '126', 'groupId': 'OG000'}, {'value': '158', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '20.5', 'spread': '2.1', 'groupId': 'OG000'}, {'value': '15.4', 'spread': '1.8', 'groupId': 'OG001'}]}]}, {'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '126', 'groupId': 'OG000'}, {'value': '162', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '18.9', 'spread': '2.1', 'groupId': 'OG000'}, {'value': '17.8', 'spread': '1.8', 'groupId': 'OG001'}]}]}, {'title': 'Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '129', 'groupId': 'OG000'}, {'value': '162', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '21.7', 'spread': '2.2', 'groupId': 'OG000'}, {'value': '18.9', 'spread': '2.0', 'groupId': 'OG001'}]}]}, {'title': 'Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '129', 'groupId': 'OG000'}, {'value': '164', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '20.9', 'spread': '2.2', 'groupId': 'OG000'}, {'value': '15.3', 'spread': '1.9', 'groupId': 'OG001'}]}]}, {'title': 'Week 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '124', 'groupId': 'OG000'}, {'value': '159', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '17.4', 'spread': '2.1', 'groupId': 'OG000'}, {'value': '12.4', 'spread': '1.8', 'groupId': 'OG001'}]}]}, {'title': 'Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'OG000'}, {'value': '160', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '15.8', 'spread': '2.2', 'groupId': 'OG000'}, {'value': '12.6', 'spread': '1.9', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 9, 12, 16, 24, 36, and 52 weeks', 'description': 'Subjects were asked to report current pain level at the fusion site on a 100 mm Visual Analog Scale (with 0 being no pain and 100 being worst pain imaginable).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis conducted on patients at Baseline, 9, 12, 16, 24, 36, and 52 weeks time points.'}, {'type': 'SECONDARY', 'title': 'SF-12 Physical Component Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '132', 'groupId': 'OG000'}, {'value': '167', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Augment® Injectable Bone Graft', 'description': 'Standard rigid fixation + Augment® Injectable Bone Graft (beta-TCP/bovine collagen matrix + rhPDGF-BB)'}, {'id': 'OG001', 'title': 'Autologous Bone Graft', 'description': 'Standard Rigid Fixation + Autologous bone graft'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '132', 'groupId': 'OG000'}, {'value': '167', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '30.8', 'spread': '0.8', 'groupId': 'OG000'}, {'value': '30.8', 'spread': '0.7', 'groupId': 'OG001'}]}]}, {'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '126', 'groupId': 'OG000'}, {'value': '158', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '36.9', 'spread': '0.8', 'groupId': 'OG000'}, {'value': '36.3', 'spread': '0.7', 'groupId': 'OG001'}]}]}, {'title': 'Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '128', 'groupId': 'OG000'}, {'value': '162', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '37.9', 'spread': '0.8', 'groupId': 'OG000'}, {'value': '39.0', 'spread': '0.7', 'groupId': 'OG001'}]}]}, {'title': 'Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '129', 'groupId': 'OG000'}, {'value': '164', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '40.3', 'spread': '0.9', 'groupId': 'OG000'}, {'value': '42.2', 'spread': '0.7', 'groupId': 'OG001'}]}]}, {'title': 'Week 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '124', 'groupId': 'OG000'}, {'value': '159', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '42.1', 'spread': '0.9', 'groupId': 'OG000'}, {'value': '44.5', 'spread': '0.8', 'groupId': 'OG001'}]}]}, {'title': 'Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '123', 'groupId': 'OG000'}, {'value': '160', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '42.9', 'spread': '0.9', 'groupId': 'OG000'}, {'value': '45.5', 'spread': '0.8', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 9, 12, 16, 24, 36, and 52 weeks', 'description': 'The SF-12 Physical Component Score is a validated quality of life metric with a minimum of zero and a maximum of 100, with higher scores denoting higher quality of life.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis conducted on patients at Baseline, 12, 16, 24, 36, and 52 weeks time points.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Augment® Injectable Bone Graft', 'description': 'Standard rigid fixation + Augment® Injectable Bone Graft (beta-TCP/bovine collagen matrix + rhPDGF-BB)'}, {'id': 'FG001', 'title': 'Autologous Bone Graft', 'description': 'Standard Rigid Fixation + Autologous bone graft'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '132'}, {'groupId': 'FG001', 'numSubjects': '167'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '132'}, {'groupId': 'FG001', 'numSubjects': '167'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'A propensity score matching analysis was performed in order to identify a single set of investigational and control subjects derived from the datasets (BMTI-2006-01, BMTI-2009-01, BMTI-2010-01) that were comparable and could be evaluated for the purpose of assessing the safety and effectiveness of AUGMENT® Injectable.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '132', 'groupId': 'BG000'}, {'value': '167', 'groupId': 'BG001'}, {'value': '299', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Augment® Injectable Bone Graft', 'description': 'Standard rigid fixation + Augment® Injectable Bone Graft (beta-TCP/bovine collagen matrix + rhPDGF-BB)\n\nAugment® Injectable Bone Graft: Implantation of up to 9cc of Augment® Injectable Bone Graft'}, {'id': 'BG001', 'title': 'Autologous Bone Graft', 'description': 'Standard Rigid Fixation + Autologous bone graft\n\nAutologous bone graft: Implantation of up to 9cc of autologous bone graft'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '97', 'groupId': 'BG000'}, {'value': '109', 'groupId': 'BG001'}, {'value': '206', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '35', 'groupId': 'BG000'}, {'value': '58', 'groupId': 'BG001'}, {'value': '93', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '62', 'groupId': 'BG000'}, {'value': '81', 'groupId': 'BG001'}, {'value': '143', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '70', 'groupId': 'BG000'}, {'value': '86', 'groupId': 'BG001'}, {'value': '156', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Affected Foot/Ankle', 'classes': [{'categories': [{'title': 'Ankle fusion', 'measurements': [{'value': '31', 'groupId': 'BG000'}, {'value': '46', 'groupId': 'BG001'}, {'value': '77', 'groupId': 'BG002'}]}, {'title': 'Subtalar fusion', 'measurements': [{'value': '52', 'groupId': 'BG000'}, {'value': '59', 'groupId': 'BG001'}, {'value': '111', 'groupId': 'BG002'}]}, {'title': 'Calcaneocuboid fusion', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'Talonavicular fusion', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}, {'title': 'Double fusion', 'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '38', 'groupId': 'BG002'}]}, {'title': 'Triple arthordesis', 'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '36', 'groupId': 'BG001'}, {'value': '55', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ever smoked', 'classes': [{'categories': [{'title': 'No', 'measurements': [{'value': '61', 'groupId': 'BG000'}, {'value': '83', 'groupId': 'BG001'}, {'value': '144', 'groupId': 'BG002'}]}, {'title': 'Yes', 'measurements': [{'value': '71', 'groupId': 'BG000'}, {'value': '84', 'groupId': 'BG001'}, {'value': '155', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 299}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-12', 'completionDateStruct': {'date': '2014-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-12-04', 'studyFirstSubmitDate': '2011-02-25', 'resultsFirstSubmitDate': '2018-10-30', 'studyFirstSubmitQcDate': '2011-02-25', 'lastUpdatePostDateStruct': {'date': '2018-12-26', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-12-04', 'studyFirstPostDateStruct': {'date': '2011-02-28', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-12-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2013-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain on Weight Bearing', 'timeFrame': 'Baseline, 9, 12, 16, 24, 36, and 52 weeks', 'description': 'Subjects were asked to stand and report pain on a 100 mm Visual Analog Scale (with 0 being no pain and 100 being worst pain imaginable).'}], 'secondaryOutcomes': [{'measure': 'Foot Function Index (FFI)', 'timeFrame': 'Baseline, 9, 12, 16, 24, 36, and 52 weeks', 'description': 'The Foot Function Index (FFI) measures the impact of foot pathology on function in terms of pain, disability and activity restriction. The FFI is a self-administered index consisting of 23 items divided into 3 sub-scales all ranging from 0-100. To obtain a sub-scale score, the item scores for a sub-scale are totaled and then divided by the maximum total possible for all of the sub-scale items which the subject indicated were applicable. Any item marked as not applicable is excluded from the total possible. Sub-scales are an average of the completed ratings within that sub-scale. The total foot function score is an average of the three sub-scale scores and ranges from 0-100. Lower scores are indicative of better outcomes whereas higher scores indicate greater impairment.'}, {'measure': 'AOFAS Hindfoot and Ankle Score', 'timeFrame': 'Baseline, 9, 12, 16, 24, 36, and 52 weeks', 'description': 'Subjects were asked to report pain, functionality and ability levels while the physician performed assessments based on alignment, abnormality, motion, and stability. The total score ranges from a low of zero to a high of 100, with subscales measuring pain (40 points), function (50 points), and alignment (10 points), with higher scores showing better outcomes.'}, {'measure': 'Fusion Site Pain', 'timeFrame': 'Baseline, 9, 12, 16, 24, 36, and 52 weeks', 'description': 'Subjects were asked to report current pain level at the fusion site on a 100 mm Visual Analog Scale (with 0 being no pain and 100 being worst pain imaginable).'}, {'measure': 'SF-12 Physical Component Score', 'timeFrame': 'Baseline, 9, 12, 16, 24, 36, and 52 weeks', 'description': 'The SF-12 Physical Component Score is a validated quality of life metric with a minimum of zero and a maximum of 100, with higher scores denoting higher quality of life.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['degenerative joint disease', 'DJD', 'joint fusion', 'hindfoot', 'congenital deformity', 'osteoarthritis', 'rheumatoid arthritis', 'post-traumatic arthritis', 'ankylosing spondylitis', 'Augment(tm) Injectable Bone Graft', 'autologous bone graft', 'autogenous bone graft', 'beta-TCP', 'bovine collagen', 'rhPDGF(bb)'], 'conditions': ['Degenerative Joint Disease', 'Congenital Deformity', 'Arthritis', 'Osteoarthritis', 'Rheumatoid Arthritis']}, 'referencesModule': {'references': [{'pmid': '25848134', 'type': 'RESULT', 'citation': 'Daniels TR, Younger AS, Penner MJ, Wing KJ, Le IL, Russell IS, Lalonde KA, Evangelista PT, Quiton JD, Glazebrook M, DiGiovanni CW. Prospective Randomized Controlled Trial of Hindfoot and Ankle Fusions Treated With rhPDGF-BB in Combination With a beta-TCP-Collagen Matrix. Foot Ankle Int. 2015 Jul;36(7):739-48. doi: 10.1177/1071100715576370. Epub 2015 Apr 6.'}, {'pmid': '23824386', 'type': 'RESULT', 'citation': 'DiGiovanni CW, Lin SS, Baumhauer JF, Daniels T, Younger A, Glazebrook M, Anderson J, Anderson R, Evangelista P, Lynch SE; North American Orthopedic Foot and Ankle Study Group. Recombinant human platelet-derived growth factor-BB and beta-tricalcium phosphate (rhPDGF-BB/beta-TCP): an alternative to autogenous bone graft. J Bone Joint Surg Am. 2013 Jul 3;95(13):1184-92. doi: 10.2106/JBJS.K.01422.'}]}, 'descriptionModule': {'briefSummary': 'STUDY OBJECTIVES:\n\nTo demonstrate equivalent clinical and radiologic outcomes as "gold standard" (Autologous Bone Graft) in a representative clinical model (hindfoot fusions)\n\nSTUDY HYPOTHESIS:\n\nAugment® Injectable is an equivalent bone grafting substitute to autologous bone graft in applications as shown by superiority analysis for safety and non-inferiority analysis for effectiveness\n\nSTUDY RATIONALE:\n\nTo evaluate a fully synthetic bone graft material to facilitate fusion in conditions or injuries requiring bone graft in a representative clinical fusion model and thus the opportunity to provide equivalent union rates as Autologous Bone Graft without necessitating an additional invasive procedure to harvest the graft', 'detailedDescription': 'STUDY DESIGN:\n\nProspective, randomized, controlled, non-inferiority, multi-center trial\n\nNUMBER OF STUDY CENTERS:\n\n25\n\nNUMBER OF SUBJECTS:\n\n299 Subjects (see "Study Population"). The subject population included subjects enrolled in 3 separate Clinical Trials. (BMTI-2006-01, BMTI-2009-01, and BMTI-2010-01)\n\nSTUDY POPULATION:\n\nMale and female subjects 18 years of age or older requiring a hindfoot fusion procedure involving a bone grafting procedure.\n\nTREATMENT GROUPS:\n\nGroup I: Standard Rigid Fixation + Autologous Bone Graft Group II: Standard Rigid Fixation + Augment® Injectable Bone Graft\n\nSubjects will be randomized in a 2:1 ratio (Augment® Injectable:Autologous Bone Graft).\n\nROUTE OF ADMINISTRATION:\n\nInvestigational device is manually implanted inside and around the fusion space to ensure Augment® Injectable Bone Graft (beta-TCP/bovine collagen matrix +rhPDGF-BB) or autologous bone graft is contained within the joint space\n\nSTUDY DURATION:\n\nTwenty-four month follow-up post-surgery'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "KEY INCLUSION CRITERIA:\n\n* at least 18 years old and considered skeletally mature\n* diagnosed with degenerative joint disease (DJD) affecting the hindfoot due to a congenital or acquired deformity, osteoarthritis, rheumatoid arthritis, post- traumatic arthritis or ankylosing spondylitis of the ankle, subtalar, calcaneocuboid, and/or talonavicular joints\n* requires one of the following hindfoot fusion proceduress with supplemental bone graft/substitute: ankle fusion (tibiotalar), subtalar fusion (talocalcaneal), calcaneocuboid fusion, talonavicular fusion, triple arthrodesis (subtalar, talonavicular and calcaneocuboid joints) OR double fusions (any combination of any two of the following: subtalar, talonavicular and calcaneocuboid joints)\n* fusion site able to be rigidly stabilized with no more than 3 screws across the fusion site\n\n * supplemental pins or staples allowed\n * supplemental screws external to the fusion site(s) allowed\n* signed informed consent document, independent, ambulatory, and can comply with all post-operative evaluations and visits\n\nKEY EXCLUSION CRITERIA:\n\n* undergone previous fusion surgery at the proposed location, i.e., revision of a failed fusion\n* more than one previous procedure at the involved joints\n* retained hardware spanning the joint(s) intended for fusion\n* procedure anticipated to require plate fixation (including claw plates), IM nails or more than 3 screws to achieve rigid fixation based on pre-op planning\n* procedure expected to require more than 9cc of graft material based on pre-op planning\n* procedure expected to require structural bone graft, allograft, bone graft substitute, platelet rich plasma (PRP) or bone marrow aspirate\n* procedure expected to require a pantalar fusion, i.e., fusion of ankle plus all hindfoot joints (talonavicular, subtalar, and calcaneocuboid) or an ankle fusion in combination with any hindfoot fusion\n* radiographic evidence of bone cysts, segmental defects or growth plate fracture near the fusion site that could negatively impact the proposed fusion procedure\n* tested positive or been treated for a malignancy in the past or is suspected of having a malignancy or currently undergoing radio- or chemotherapy treatment for a malignancy anywhere in the body, whether adjacent to or distant from the proposed surgical site\n* pre-existing sensory impairment, e.g., diabetics with baseline sensory impairment, which limits ability to perform objective functional measurements and may be at risk for complications\n\n \\- diabetics not sensitive to the 5.07 monofilament (Semmes-Weinstein) are to be excluded\n* metabolic disorder known to adversely affect the skeleton other than primary osteoporosis or diabetes, e.g., renal osteodystrophy or hypercalcemia\n* use of chronic medications known to affect the skeleton, e.g., glucocorticoid usage \\> 10mg/day\n* pre-fracture neuromuscular or musculoskeletal deficiency which limits the ability to perform objective functional measurements\n* physically or mentally compromised, e.g., current treatment for a psychiatric disorder, senile dementia, Alzheimer's disease, etc., to the extent that the Investigator judges the subject to be unable or unlikely to remain compliant\n* allergic to yeast-derived products or bovine collagen or other bovine-sourced products\n* received an investigational therapy within 30 days of proposed surgery or during the follow-up phase of the study\n* is a prisoner, known or suspected transient or a history of drug/alcohol abuse within the 12 months prior to screening\n* pregnant or intending to become pregnant within 12 months of the study procedure\n* morbidly obese defined as BMI \\> 45 kg/m2\n* currently has an acute infection at the surgical site"}, 'identificationModule': {'nctId': 'NCT01305356', 'briefTitle': 'Augment® Injectable Bone Graft Compared to Autologous Bone Graft as a Bone Regeneration Device in Hindfoot Fusions', 'nctIdAliases': ['NCT01008891'], 'organization': {'class': 'INDUSTRY', 'fullName': 'BioMimetic Therapeutics'}, 'officialTitle': 'A Prospective, Randomized, Controlled, Multi-Center, Pivotal Human Clinical Trial to Evaluate the Safety and Effectiveness of Augment® Injectable Bone Graft Compared to Autologous Bone Graft as a Bone Regeneration Device in Hindfoot Fusions', 'orgStudyIdInfo': {'id': 'BMTI-2010-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Augment® Injectable Bone Graft', 'description': 'Standard rigid fixation + Augment® Injectable Bone Graft (beta-TCP/bovine collagen matrix + rhPDGF-BB)', 'interventionNames': ['Device: Augment® Injectable Bone Graft']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Autologous bone graft', 'description': 'Standard Rigid Fixation + Autologous bone graft', 'interventionNames': ['Procedure: Autologous bone graft']}], 'interventions': [{'name': 'Augment® Injectable Bone Graft', 'type': 'DEVICE', 'description': 'Implantation of up to 9cc of Augment® Injectable Bone Graft', 'armGroupLabels': ['Augment® Injectable Bone Graft']}, {'name': 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