Ignite Creation Date:
2025-12-25 @ 4:29 AM
Ignite Modification Date:
2026-01-16 @ 9:30 PM
Study NCT ID:
NCT01746420
Status:
COMPLETED
Last Update Posted:
2019-07-02
First Post:
2012-12-07
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Phase II Study of the Effects of rhPDGF-BB Injection on Lateral Epicondylitis
Sponsor:
Organization:
Raw JSON
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'DNA-Binding Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D001685', 'term': 'Biological Factors'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'justin.moss@wright.com', 'phone': '615-236-4984', 'title': 'Justin Moss', 'organization': 'Wright Medical'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'While this preliminary study suggests similar safety profiles for PDGF and placebo, future studies with larger sample sizes, possibly different concentrations, and tighter inclusion criteria are needed to definitely assess the effectiveness of PDGF.'}}, 'adverseEventsModule': {'timeFrame': 'Patients were assessed through study completion scheduled at 24 weeks following surgery.', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo Control', 'description': 'Dose A - sodium acetate buffer (0 mg rhPDGF-BB)\n\nPlacebo: sodium acetate buffer (0 mg rhPDGF-BB)', 'otherNumAtRisk': 20, 'otherNumAffected': 15, 'seriousNumAtRisk': 20, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': '0.45 mg rhPDGF-BB', 'description': 'Dose B - sodium acetate buffer + 0.45 mg rhPDGF-BB\n\nrhPDGF-BB Injection: Comparison of placebo control (0 mg rhPDGF-BB) and different dosages (0.45, 0.75, 1.5, and 3.0 mg) of rhPDGF-BB Injection administered through a one-time injection', 'otherNumAtRisk': 20, 'otherNumAffected': 20, 'seriousNumAtRisk': 20, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': '0.75 mg rhPDGF-BB', 'description': 'Dose C - sodium acetate buffer + 0.75 mg rhPDGF-BB\n\nrhPDGF-BB Injection: Comparison of placebo control (0 mg rhPDGF-BB) and different dosages (0.45, 0.75, 1.5, and 3.0 mg) of rhPDGF-BB Injection administered through a one-time injection', 'otherNumAtRisk': 20, 'otherNumAffected': 18, 'seriousNumAtRisk': 20, 'seriousNumAffected': 2}, {'id': 'EG003', 'title': '1.5 mg rhPDGF-BB', 'description': 'Dose D - sodium acetate buffer + 1.5 mg rhPDGF-BB\n\nrhPDGF-BB Injection: Comparison of placebo control (0 mg rhPDGF-BB) and different dosages (0.45, 0.75, 1.5, and 3.0 mg) of rhPDGF-BB Injection administered through a one-time injection', 'otherNumAtRisk': 20, 'otherNumAffected': 16, 'seriousNumAtRisk': 20, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': '3.0 mg rhPDGF-BB', 'description': 'Dose E - sodium acetate buffer + 3.0 mg rhPDGF-BB\n\nrhPDGF-BB Injection: Comparison of placebo control (0 mg rhPDGF-BB) and different dosages (0.45, 0.75, 1.5, and 3.0 mg) of rhPDGF-BB Injection administered through a one-time injection', 'otherNumAtRisk': 20, 'otherNumAffected': 18, 'seriousNumAtRisk': 20, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Lacrimation increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 20, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 20, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 20, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 20, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Lip dry', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 20, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 20, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Toothache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 20, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 20, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Feeling hot', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 20, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Injection site calcification', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 20, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Injection site coldness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 20, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Injection site discolouration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 20, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Injection site discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 20, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Injection site erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 20, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Injection site haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 20, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Injection site haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 20, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Injection site inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 20, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Injection site mass', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 20, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 20, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Injection site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 20, 'numAffected': 6}, {'groupId': 'EG004', 'numAtRisk': 20, 'numAffected': 12}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Injection site pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 20, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Injection site rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 20, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Injection site swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 20, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 20, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Injection site warmth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 20, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 20, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Tenderness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 20, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Biliary dyskinesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 20, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Anaphylactic reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 20, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypersensitivity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 20, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 20, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 20, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Clostridium difficile colitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 20, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Eyelid infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 20, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 20, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Infectious mononucleosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 20, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 20, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 20, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Otitis media', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 20, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Parotitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 20, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pharyngitis streptococcal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 20, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 20, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Tooth infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 20, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 20, 'numAffected': 0}], 'organSystem': 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'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dry skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 20, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 20, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pigmentation disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 20, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 20, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 20, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Rash pruritic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 20, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Female sterilisation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 20, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Uterine dilation and curettage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 20, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Injection site calcification', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 20, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Anaphylactic reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 20, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Road traffic accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 20, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Elbow Pain Assessments (VAS), Treated Subjects', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}, {'value': '20', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Control', 'description': 'Dose A - sodium acetate buffer (0 mg rhPDGF-BB)\n\nrhPDGF-BB Injection: Comparison of placebo control (0 mg rhPDGF-BB) and different dosages (0.45, 0.75, 1.5, and 3.0 mg) of rhPDGF-BB Injection administered through a one-time injection'}, {'id': 'OG001', 'title': '0.45 mg rhPDGF-BB', 'description': 'Dose B - sodium acetate buffer + 0.45 mg rhPDGF-BB\n\nrhPDGF-BB Injection: Comparison of placebo control (0 mg rhPDGF-BB) and different dosages (0.45, 0.75, 1.5, and 3.0 mg) of rhPDGF-BB Injection administered through a one-time injection'}, {'id': 'OG002', 'title': '0.75 mg rhPDGF-BB', 'description': 'Dose C - sodium acetate buffer + 0.75 mg rhPDGF-BB\n\nrhPDGF-BB Injection: Comparison of placebo control (0 mg rhPDGF-BB) and different dosages (0.45, 0.75, 1.5, and 3.0 mg) of rhPDGF-BB Injection administered through a one-time injection'}, {'id': 'OG003', 'title': '1.5 mg rhPDGF-BB', 'description': 'Dose D - sodium acetate buffer + 1.5 mg rhPDGF-BB\n\nrhPDGF-BB Injection: Comparison of placebo control (0 mg rhPDGF-BB) and different dosages (0.45, 0.75, 1.5, and 3.0 mg) of rhPDGF-BB Injection administered through a one-time injection'}, {'id': 'OG004', 'title': '3.0 mg rhPDGF-BB', 'description': 'Dose E - sodium acetate buffer + 3.0 mg rhPDGF-BB\n\nrhPDGF-BB Injection: Comparison of placebo control (0 mg rhPDGF-BB) and different dosages (0.45, 0.75, 1.5, and 3.0 mg) of rhPDGF-BB Injection administered through a one-time injection'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}, {'value': '20', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '76.6', 'spread': '14.4', 'groupId': 'OG000'}, {'value': '77.7', 'spread': '9.2', 'groupId': 'OG001'}, {'value': '75.9', 'spread': '16.9', 'groupId': 'OG002'}, {'value': '72', 'spread': '19.9', 'groupId': 'OG003'}, {'value': '72.2', 'spread': '20.6', 'groupId': 'OG004'}]}]}, {'title': 'Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}, {'value': '20', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '67.1', 'spread': '15', 'groupId': 'OG000'}, {'value': '73.2', 'spread': '14.6', 'groupId': 'OG001'}, {'value': '78.5', 'spread': '18.4', 'groupId': 'OG002'}, {'value': '59.7', 'spread': '22.7', 'groupId': 'OG003'}, {'value': '70', 'spread': '26.6', 'groupId': 'OG004'}]}]}, {'title': 'Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}, {'value': '20', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '49.9', 'spread': '18', 'groupId': 'OG000'}, {'value': '49.8', 'spread': '21.1', 'groupId': 'OG001'}, {'value': '55.5', 'spread': '27', 'groupId': 'OG002'}, {'value': '40.2', 'spread': '24.1', 'groupId': 'OG003'}, {'value': '52.5', 'spread': '27.3', 'groupId': 'OG004'}]}]}, {'title': 'Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}, {'value': '20', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '35.9', 'spread': '23.4', 'groupId': 'OG000'}, {'value': '39.7', 'spread': '19.5', 'groupId': 'OG001'}, {'value': '47.2', 'spread': '20.8', 'groupId': 'OG002'}, {'value': '33', 'spread': '27.2', 'groupId': 'OG003'}, {'value': '39.1', 'spread': '28.8', 'groupId': 'OG004'}]}]}, {'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}, {'value': '18', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '28.7', 'spread': '20.2', 'groupId': 'OG000'}, {'value': '31.2', 'spread': '21.6', 'groupId': 'OG001'}, {'value': '36.7', 'spread': '25.3', 'groupId': 'OG002'}, {'value': '29.8', 'spread': '29.7', 'groupId': 'OG003'}, {'value': '40.4', 'spread': '29', 'groupId': 'OG004'}]}]}, {'title': 'Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}, {'value': '20', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '16.9', 'spread': '21', 'groupId': 'OG000'}, {'value': '23.1', 'spread': '25.6', 'groupId': 'OG001'}, {'value': '28.5', 'spread': '26', 'groupId': 'OG002'}, {'value': '23.8', 'spread': '28.2', 'groupId': 'OG003'}, {'value': '32.1', 'spread': '31.4', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 2, 4, 8, 12, and 24 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': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis conducted on patients at Baseline, 2, 4, 8, 12, and 24 weeks time points.'}, {'type': 'PRIMARY', 'title': 'Disabilities of the Arm, Shoulder and Hand (DASH), Treated Subjects', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}, {'value': '20', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Control', 'description': 'Dose A - sodium acetate buffer (0 mg rhPDGF-BB)\n\nPlacebo: sodium acetate buffer (0 mg rhPDGF-BB)'}, {'id': 'OG001', 'title': '0.45 mg rhPDGF-BB', 'description': 'Dose B - sodium acetate buffer + 0.45 mg rhPDGF-BB\n\nrhPDGF-BB Injection: Comparison of placebo control (0 mg rhPDGF-BB) and different dosages (0.45, 0.75, 1.5, and 3.0 mg) of rhPDGF-BB Injection administered through a one-time injection'}, {'id': 'OG002', 'title': '0.75 mg rhPDGF-BB', 'description': 'Dose C - sodium acetate buffer + 0.75 mg rhPDGF-BB\n\nrhPDGF-BB Injection: Comparison of placebo control (0 mg rhPDGF-BB) and different dosages (0.45, 0.75, 1.5, and 3.0 mg) of rhPDGF-BB Injection administered through a one-time injection'}, {'id': 'OG003', 'title': '1.5 mg rhPDGF-BB', 'description': 'Dose D - sodium acetate buffer + 1.5 mg rhPDGF-BB\n\nrhPDGF-BB Injection: Comparison of placebo control (0 mg rhPDGF-BB) and different dosages (0.45, 0.75, 1.5, and 3.0 mg) of rhPDGF-BB Injection administered through a one-time injection'}, {'id': 'OG004', 'title': '3.0 mg rhPDGF-BB', 'description': 'Dose E - sodium acetate buffer + 3.0 mg rhPDGF-BB\n\nrhPDGF-BB Injection: Comparison of placebo control (0 mg rhPDGF-BB) and different dosages (0.45, 0.75, 1.5, and 3.0 mg) of rhPDGF-BB Injection administered through a one-time injection'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}, {'value': '20', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '43.7', 'spread': '13.9', 'groupId': 'OG000'}, {'value': '43.5', 'spread': '13.5', 'groupId': 'OG001'}, {'value': '40.1', 'spread': '19.8', 'groupId': 'OG002'}, {'value': '40', 'spread': '15.3', 'groupId': 'OG003'}, {'value': '41.3', 'spread': '18.5', 'groupId': 'OG004'}]}]}, {'title': 'Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}, {'value': '20', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '29.2', 'spread': '12.5', 'groupId': 'OG000'}, {'value': '30.9', 'spread': '12.8', 'groupId': 'OG001'}, {'value': '34.1', 'spread': '18.3', 'groupId': 'OG002'}, {'value': '27.8', 'spread': '20.2', 'groupId': 'OG003'}, {'value': '38.3', 'spread': '22.9', 'groupId': 'OG004'}]}]}, {'title': 'Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}, {'value': '20', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '21.8', 'spread': '11.5', 'groupId': 'OG000'}, {'value': '23', 'spread': '14.2', 'groupId': 'OG001'}, {'value': '24.7', 'spread': '14.9', 'groupId': 'OG002'}, {'value': '19.7', 'spread': '16.4', 'groupId': 'OG003'}, {'value': '25.1', 'spread': '22.5', 'groupId': 'OG004'}]}]}, {'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}, {'value': '18', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '12.6', 'spread': '8.6', 'groupId': 'OG000'}, {'value': '16.7', 'spread': '13.2', 'groupId': 'OG001'}, {'value': '19.8', 'spread': '15.3', 'groupId': 'OG002'}, {'value': '16.1', 'spread': '15.9', 'groupId': 'OG003'}, {'value': '24.5', 'spread': '23.7', 'groupId': 'OG004'}]}]}, {'title': 'Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}, {'value': '20', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '7.2', 'spread': '9.6', 'groupId': 'OG000'}, {'value': '11.4', 'spread': '9.9', 'groupId': 'OG001'}, {'value': '14.5', 'spread': '17.3', 'groupId': 'OG002'}, {'value': '13.8', 'spread': '15.6', 'groupId': 'OG003'}, {'value': '19.6', 'spread': '24.3', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 4, 8, 12, and 24 weeks', 'description': 'The disabilities of the arm, shoulder and hand (DASH) questionnaire is a self-administered region-specific outcome instrument developed as a measure of self-rated upper-extremity disability and symptoms. The DASH consists mainly of a 30-item disability/symptom scale, scored 0 (no disability) to 100.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis conducted on patients at Baseline, 4, 8, 12, and 24 weeks time points.'}, {'type': 'PRIMARY', 'title': 'Total Score Patient Rated Tennis Elbow Evaluation (PRTEE), All Treated Subjects', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}, {'value': '20', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Control', 'description': 'Dose A - sodium acetate buffer (0 mg rhPDGF-BB)\n\nPlacebo: sodium acetate buffer (0 mg rhPDGF-BB)'}, {'id': 'OG001', 'title': '0.45 mg rhPDGF-BB', 'description': 'Dose B - sodium acetate buffer + 0.45 mg rhPDGF-BB\n\nrhPDGF-BB Injection: Comparison of placebo control (0 mg rhPDGF-BB) and different dosages (0.45, 0.75, 1.5, and 3.0 mg) of rhPDGF-BB Injection administered through a one-time injection'}, {'id': 'OG002', 'title': '0.75 mg rhPDGF-BB', 'description': 'Dose C - sodium acetate buffer + 0.75 mg rhPDGF-BB\n\nrhPDGF-BB Injection: Comparison of placebo control (0 mg rhPDGF-BB) and different dosages (0.45, 0.75, 1.5, and 3.0 mg) of rhPDGF-BB Injection administered through a one-time injection'}, {'id': 'OG003', 'title': '1.5 mg rhPDGF-BB', 'description': 'Dose D - sodium acetate buffer + 1.5 mg rhPDGF-BB\n\nrhPDGF-BB Injection: Comparison of placebo control (0 mg rhPDGF-BB) and different dosages (0.45, 0.75, 1.5, and 3.0 mg) of rhPDGF-BB Injection administered through a one-time injection'}, {'id': 'OG004', 'title': '3.0 mg rhPDGF-BB', 'description': 'Dose E - sodium acetate buffer + 3.0 mg rhPDGF-BB\n\nrhPDGF-BB Injection: Comparison of placebo control (0 mg rhPDGF-BB) and different dosages (0.45, 0.75, 1.5, and 3.0 mg) of rhPDGF-BB Injection administered through a one-time injection'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}, {'value': '20', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '52.6', 'spread': '17.9', 'groupId': 'OG000'}, {'value': '56', 'spread': '14.3', 'groupId': 'OG001'}, {'value': '48.3', 'spread': '16.3', 'groupId': 'OG002'}, {'value': '52.6', 'spread': '20.7', 'groupId': 'OG003'}, {'value': '52.3', 'spread': '22.9', 'groupId': 'OG004'}]}]}, {'title': 'Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}, {'value': '20', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '34.7', 'spread': '14.5', 'groupId': 'OG000'}, {'value': '39.2', 'spread': '15.3', 'groupId': 'OG001'}, {'value': '39.3', 'spread': '21.7', 'groupId': 'OG002'}, {'value': '32.2', 'spread': '23.9', 'groupId': 'OG003'}, {'value': '43.4', 'spread': '24.3', 'groupId': 'OG004'}]}]}, {'title': 'Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}, {'value': '20', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '25.2', 'spread': '15.2', 'groupId': 'OG000'}, {'value': '26.9', 'spread': '17.4', 'groupId': 'OG001'}, {'value': '28.9', 'spread': '15.1', 'groupId': 'OG002'}, {'value': '25.4', 'spread': '21', 'groupId': 'OG003'}, {'value': '28.6', 'spread': '24.9', 'groupId': 'OG004'}]}]}, {'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}, {'value': '18', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '13.5', 'spread': '8', 'groupId': 'OG000'}, {'value': '18.2', 'spread': '16.4', 'groupId': 'OG001'}, {'value': '22.3', 'spread': '16.4', 'groupId': 'OG002'}, {'value': '20.1', 'spread': '22.7', 'groupId': 'OG003'}, {'value': '26.8', 'spread': '24.8', 'groupId': 'OG004'}]}]}, {'title': 'Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}, {'value': '20', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '7.8', 'spread': '10', 'groupId': 'OG000'}, {'value': '12.1', 'spread': '12.4', 'groupId': 'OG001'}, {'value': '16.2', 'spread': '17.9', 'groupId': 'OG002'}, {'value': '16.8', 'spread': '19.3', 'groupId': 'OG003'}, {'value': '22.3', 'spread': '27.3', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 4, 8, 12, and 24 weeks', 'description': 'The Pain and disability measured by the Patient Rated Tennis Elbow Evaluation (PRTEE) is a 15-item questionnaire designed to measure forearm pain and disability in patients with lateral epicondylitis (also known as "tennis elbow"). The PRTEE allows patients to rate their levels of tennis elbow pain and disability from 0 to 10, and consists of 2 subscales:\n\n1. PAIN subscale (0 = no pain, 10 = worst imaginable)\n\n -Pain - 5 items\n2. FUNCTION subscale (0 = no difficulty, 10 = unable to do)\n\n * Specific activities - 6 items\n * Usual activities - 4 items\n\nIn addition to the individual subscale scores, a total score can be computed on a scale of 100 (0 = no disability), where pain and functional problems are weighted equally', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis conducted on patients at Baseline, 4, 8, 12, and 24 weeks time points.'}, {'type': 'PRIMARY', 'title': 'Grip Strength Test, All Treated Subjects', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}, {'value': '20', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Control', 'description': 'Dose A - sodium acetate buffer (0 mg rhPDGF-BB)\n\nPlacebo: sodium acetate buffer (0 mg rhPDGF-BB)'}, {'id': 'OG001', 'title': '0.45 mg rhPDGF-BB', 'description': 'Dose B - sodium acetate buffer + 0.45 mg rhPDGF-BB\n\nrhPDGF-BB Injection: Comparison of placebo control (0 mg rhPDGF-BB) and different dosages (0.45, 0.75, 1.5, and 3.0 mg) of rhPDGF-BB Injection administered through a one-time injection'}, {'id': 'OG002', 'title': '0.75 mg rhPDGF-BB', 'description': 'Dose C - sodium acetate buffer + 0.75 mg rhPDGF-BB\n\nrhPDGF-BB Injection: Comparison of placebo control (0 mg rhPDGF-BB) and different dosages (0.45, 0.75, 1.5, and 3.0 mg) of rhPDGF-BB Injection administered through a one-time injection'}, {'id': 'OG003', 'title': '1.5 mg rhPDGF-BB', 'description': 'Dose D - sodium acetate buffer + 1.5 mg rhPDGF-BB\n\nrhPDGF-BB Injection: Comparison of placebo control (0 mg rhPDGF-BB) and different dosages (0.45, 0.75, 1.5, and 3.0 mg) of rhPDGF-BB Injection administered through a one-time injection'}, {'id': 'OG004', 'title': '3.0 mg rhPDGF-BB', 'description': 'Dose E - sodium acetate buffer + 3.0 mg rhPDGF-BB\n\nrhPDGF-BB Injection: Comparison of placebo control (0 mg rhPDGF-BB) and different dosages (0.45, 0.75, 1.5, and 3.0 mg) of rhPDGF-BB Injection administered through a one-time injection'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}, {'value': '20', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '42.6', 'spread': '30.1', 'groupId': 'OG000'}, {'value': '33.4', 'spread': '24.1', 'groupId': 'OG001'}, {'value': '47.6', 'spread': '29.4', 'groupId': 'OG002'}, {'value': '39.6', 'spread': '28.9', 'groupId': 'OG003'}, {'value': '39.7', 'spread': '23.2', 'groupId': 'OG004'}]}]}, {'title': 'Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}, {'value': '19', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '40.2', 'spread': '25.6', 'groupId': 'OG000'}, {'value': '44.5', 'spread': '32', 'groupId': 'OG001'}, {'value': '48.3', 'spread': '33', 'groupId': 'OG002'}, {'value': '52', 'spread': '30.2', 'groupId': 'OG003'}, {'value': '41.9', 'spread': '26.3', 'groupId': 'OG004'}]}]}, {'title': 'Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}, {'value': '20', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '53.5', 'spread': '27.8', 'groupId': 'OG000'}, {'value': '50.6', 'spread': '36.3', 'groupId': 'OG001'}, {'value': '64.6', 'spread': '35', 'groupId': 'OG002'}, {'value': '53.3', 'spread': '29', 'groupId': 'OG003'}, {'value': '54.8', 'spread': '26.4', 'groupId': 'OG004'}]}]}, {'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}, {'value': '18', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '58.2', 'spread': '28.1', 'groupId': 'OG000'}, {'value': '61', 'spread': '37.7', 'groupId': 'OG001'}, {'value': '67.5', 'spread': '38.3', 'groupId': 'OG002'}, {'value': '61.1', 'spread': '32.1', 'groupId': 'OG003'}, {'value': '45.1', 'spread': '25.3', 'groupId': 'OG004'}]}]}, {'title': 'Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}, {'value': '19', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '66.4', 'spread': '26.4', 'groupId': 'OG000'}, {'value': '69.1', 'spread': '37.5', 'groupId': 'OG001'}, {'value': '79.9', 'spread': '33.4', 'groupId': 'OG002'}, {'value': '69.9', 'spread': '29.1', 'groupId': 'OG003'}, {'value': '62.9', 'spread': '25.7', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 4, 8, 12, and 24 weeks', 'description': 'Grip strength testing will be performed to evaluate changes in the strength and sincerity of effort as a result of treatment for lateral epicondylitis. Testing will be performed to assess the pain-free grip strength (performing the test until discomfort is felt) and maximum grip strength (performing the test to the maximum of their ability). The test will be performed while the patient is standing with the elbow in full extension, as this position has been used to assess grip strength in patients with lateral epicondylitis. A Jamar Plus+ Digital Hand Dynamometer with the grip in the second position will be used because the second position has been assumed to be the most reliable and consistent position. Patients will be asked to perform three repetitions of each test (pain-free and maximum) at each study interval and the mean score will be calculated and used for analysis.', 'unitOfMeasure': 'lbs.', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis conducted on patients at Baseline, 4, 8, 12, and 24 weeks time points.'}, {'type': 'PRIMARY', 'title': 'Maximum Grip Strength, Treated Subjects', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}, {'value': '20', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Control', 'description': 'Dose A - sodium acetate buffer (0 mg rhPDGF-BB)\n\nPlacebo: sodium acetate buffer (0 mg rhPDGF-BB)'}, {'id': 'OG001', 'title': '0.45 mg rhPDGF-BB', 'description': 'Dose B - sodium acetate buffer + 0.45 mg rhPDGF-BB\n\nrhPDGF-BB Injection: Comparison of placebo control (0 mg rhPDGF-BB) and different dosages (0.45, 0.75, 1.5, and 3.0 mg) of rhPDGF-BB Injection administered through a one-time injection'}, {'id': 'OG002', 'title': '0.75 mg rhPDGF-BB', 'description': 'Dose C - sodium acetate buffer + 0.75 mg rhPDGF-BB\n\nrhPDGF-BB Injection: Comparison of placebo control (0 mg rhPDGF-BB) and different dosages (0.45, 0.75, 1.5, and 3.0 mg) of rhPDGF-BB Injection administered through a one-time injection'}, {'id': 'OG003', 'title': '1.5 mg rhPDGF-BB', 'description': 'Dose D - sodium acetate buffer + 1.5 mg rhPDGF-BB\n\nrhPDGF-BB Injection: Comparison of placebo control (0 mg rhPDGF-BB) and different dosages (0.45, 0.75, 1.5, and 3.0 mg) of rhPDGF-BB Injection administered through a one-time injection'}, {'id': 'OG004', 'title': '3.0 mg rhPDGF-BB', 'description': 'Dose E - sodium acetate buffer + 3.0 mg rhPDGF-BB\n\nrhPDGF-BB Injection: Comparison of placebo control (0 mg rhPDGF-BB) and different dosages (0.45, 0.75, 1.5, and 3.0 mg) of rhPDGF-BB Injection administered through a one-time injection'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '60.4', 'spread': '35', 'groupId': 'OG000'}, {'value': '58.7', 'spread': '33.1', 'groupId': 'OG001'}, {'value': '71.8', 'spread': '38.9', 'groupId': 'OG002'}, {'value': '60.3', 'spread': '31.2', 'groupId': 'OG003'}, {'value': '61.3', 'spread': '29.7', 'groupId': 'OG004'}]}]}, {'title': 'Week 4', 'categories': [{'measurements': [{'value': '62.9', 'spread': '26.2', 'groupId': 'OG000'}, {'value': '63.5', 'spread': '33.1', 'groupId': 'OG001'}, {'value': '64.2', 'spread': '37.2', 'groupId': 'OG002'}, {'value': '68.9', 'spread': '35.5', 'groupId': 'OG003'}, {'value': '62', 'spread': '33', 'groupId': 'OG004'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '73.3', 'spread': '29.3', 'groupId': 'OG000'}, {'value': '66.4', 'spread': '31.3', 'groupId': 'OG001'}, {'value': '72.9', 'spread': '37', 'groupId': 'OG002'}, {'value': '71.6', 'spread': '30', 'groupId': 'OG003'}, {'value': '66.9', 'spread': '31.5', 'groupId': 'OG004'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '78.9', 'spread': '29.9', 'groupId': 'OG000'}, {'value': '68.6', 'spread': '31.2', 'groupId': 'OG001'}, {'value': '81.8', 'spread': '39.7', 'groupId': 'OG002'}, {'value': '74.5', 'spread': '32.8', 'groupId': 'OG003'}, {'value': '65.1', 'spread': '30', 'groupId': 'OG004'}]}]}, {'title': 'Week 24', 'categories': [{'measurements': [{'value': '82.5', 'spread': '32.7', 'groupId': 'OG000'}, {'value': '71', 'spread': '32.5', 'groupId': 'OG001'}, {'value': '80.7', 'spread': '33.7', 'groupId': 'OG002'}, {'value': '77.8', 'spread': '27', 'groupId': 'OG003'}, {'value': '76.4', 'spread': '30.9', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 4, 8, 12, and 24 weeks', 'description': 'A higher grip strength score indicates an improvement. A positive change from baseline indicates an improvement. Grip strength testing will be performed to evaluate changes in the strength and sincerity of effort as a result of treatment for lateral epicondylitis. Testing will be performed to assess the pain-free grip strength (performing the test until discomfort is felt) and maximum grip strength (performing the test to the maximum of their ability). The test will be performed while the patient is standing with the elbow in full extension, as this position has been used to assess grip strength in patients with lateral epicondylitis. A Jamar Plus+ Digital Hand Dynamometer with the grip in the second position will be used because the second position has been assumed to be the most reliable and consistent position. Patients will be asked to perform three repetitions of each test (pain-free and maximum) at each study interval and the mean score will be calculated and used for analysis.', 'unitOfMeasure': 'lbs.', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis conducted on patients at Baseline, 4, 8, 12, and 24 weeks time points.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo Control', 'description': 'Dose A - sodium acetate buffer (0 mg rhPDGF-BB)\n\nrhPDGF-BB Injection: Comparison of placebo control (0 mg rhPDGF-BB) and different dosages (0.45, 0.75, 1.5, and 3.0 mg) of rhPDGF-BB Injection administered through a one-time injection'}, {'id': 'FG001', 'title': '0.45 mg rhPDGF-BB', 'description': 'Dose B - sodium acetate buffer + 0.45 mg rhPDGF-BB\n\nrhPDGF-BB Injection: Comparison of placebo control (0 mg rhPDGF-BB) and different dosages (0.45, 0.75, 1.5, and 3.0 mg) of rhPDGF-BB Injection administered through a one-time injection'}, {'id': 'FG002', 'title': '0.75 mg rhPDGF-BB', 'description': 'Dose C - sodium acetate buffer + 0.75 mg rhPDGF-BB\n\nrhPDGF-BB Injection: Comparison of placebo control (0 mg rhPDGF-BB) and different dosages (0.45, 0.75, 1.5, and 3.0 mg) of rhPDGF-BB Injection administered through a one-time injection'}, {'id': 'FG003', 'title': '1.5 mg rhPDGF-BB', 'description': 'Dose D - sodium acetate buffer + 1.5 mg rhPDGF-BB\n\nrhPDGF-BB Injection: Comparison of placebo control (0 mg rhPDGF-BB) and different dosages (0.45, 0.75, 1.5, and 3.0 mg) of rhPDGF-BB Injection administered through a one-time injection'}, {'id': 'FG004', 'title': '3.0 mg rhPDGF-BB', 'description': 'Dose E - sodium acetate buffer + 3.0 mg rhPDGF-BB\n\nrhPDGF-BB Injection: Comparison of placebo control (0 mg rhPDGF-BB) and different dosages (0.45, 0.75, 1.5, and 3.0 mg) of rhPDGF-BB Injection administered through a one-time injection'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '20'}, {'groupId': 'FG002', 'numSubjects': '20'}, {'groupId': 'FG003', 'numSubjects': '20'}, {'groupId': 'FG004', 'numSubjects': '20'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '17'}, {'groupId': 'FG001', 'numSubjects': '18'}, {'groupId': 'FG002', 'numSubjects': '17'}, {'groupId': 'FG003', 'numSubjects': '20'}, {'groupId': 'FG004', 'numSubjects': '20'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}, {'value': '20', 'groupId': 'BG003'}, {'value': '20', 'groupId': 'BG004'}, {'value': '100', 'groupId': 'BG005'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo Control', 'description': 'Dose A - sodium acetate buffer (0 mg rhPDGF-BB)\n\nrhPDGF-BB Injection: Comparison of placebo control (0 mg rhPDGF-BB) and different dosages (0.45, 0.75, 1.5, and 3.0 mg) of rhPDGF-BB Injection administered through a one-time injection'}, {'id': 'BG001', 'title': '0.45 mg rhPDGF-BB', 'description': 'Dose B - sodium acetate buffer + 0.45 mg rhPDGF-BB\n\nrhPDGF-BB Injection: Comparison of placebo control (0 mg rhPDGF-BB) and different dosages (0.45, 0.75, 1.5, and 3.0 mg) of rhPDGF-BB Injection administered through a one-time injection'}, {'id': 'BG002', 'title': '0.75 mg rhPDGF-BB', 'description': 'Dose C - sodium acetate buffer + 0.75 mg rhPDGF-BB\n\nrhPDGF-BB Injection: Comparison of placebo control (0 mg rhPDGF-BB) and different dosages (0.45, 0.75, 1.5, and 3.0 mg) of rhPDGF-BB Injection administered through a one-time injection'}, {'id': 'BG003', 'title': '1.5 mg rhPDGF-BB', 'description': 'Dose D - sodium acetate buffer + 1.5 mg rhPDGF-BB\n\nrhPDGF-BB Injection: Comparison of placebo control (0 mg rhPDGF-BB) and different dosages (0.45, 0.75, 1.5, and 3.0 mg) of rhPDGF-BB Injection administered through a one-time injection'}, {'id': 'BG004', 'title': '3.0 mg rhPDGF-BB', 'description': 'Dose E - sodium acetate buffer + 3.0 mg rhPDGF-BB\n\nrhPDGF-BB Injection: Comparison of placebo control (0 mg rhPDGF-BB) and different dosages (0.45, 0.75, 1.5, and 3.0 mg) of rhPDGF-BB Injection administered through a one-time injection'}, {'id': 'BG005', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': 'Age', 'categories': [{'measurements': [{'value': '44.2', 'spread': '7.1', 'groupId': 'BG000'}, {'value': '49', 'spread': '6.9', 'groupId': 'BG001'}, {'value': '46', 'spread': '7', 'groupId': 'BG002'}, {'value': '47.4', 'spread': '12.4', 'groupId': 'BG003'}, {'value': '49', 'spread': '8.3', 'groupId': 'BG004'}, {'value': '47.1', 'spread': '8.6', 'groupId': 'BG005'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}, {'value': '9', 'groupId': 'BG004'}, {'value': '51', 'groupId': 'BG005'}]}, {'title': 'Male', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}, {'value': '11', 'groupId': 'BG004'}, {'value': '49', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}]}, {'title': 'Black or African American', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '5', 'groupId': 'BG005'}]}, {'title': 'White', 'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}, {'value': '17', 'groupId': 'BG003'}, {'value': '15', 'groupId': 'BG004'}, {'value': '89', 'groupId': 'BG005'}]}, {'title': 'More than one race', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-12-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-06', 'completionDateStruct': {'date': '2014-10-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-06-12', 'studyFirstSubmitDate': '2012-12-07', 'resultsFirstSubmitDate': '2019-05-22', 'studyFirstSubmitQcDate': '2012-12-10', 'lastUpdatePostDateStruct': {'date': '2019-07-02', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-06-12', 'studyFirstPostDateStruct': {'date': '2012-12-11', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-07-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2014-10-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Elbow Pain Assessments (VAS), Treated Subjects', 'timeFrame': 'Baseline, 2, 4, 8, 12, and 24 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': 'Disabilities of the Arm, Shoulder and Hand (DASH), Treated Subjects', 'timeFrame': 'Baseline, 4, 8, 12, and 24 weeks', 'description': 'The disabilities of the arm, shoulder and hand (DASH) questionnaire is a self-administered region-specific outcome instrument developed as a measure of self-rated upper-extremity disability and symptoms. The DASH consists mainly of a 30-item disability/symptom scale, scored 0 (no disability) to 100.'}, {'measure': 'Total Score Patient Rated Tennis Elbow Evaluation (PRTEE), All Treated Subjects', 'timeFrame': 'Baseline, 4, 8, 12, and 24 weeks', 'description': 'The Pain and disability measured by the Patient Rated Tennis Elbow Evaluation (PRTEE) is a 15-item questionnaire designed to measure forearm pain and disability in patients with lateral epicondylitis (also known as "tennis elbow"). The PRTEE allows patients to rate their levels of tennis elbow pain and disability from 0 to 10, and consists of 2 subscales:\n\n1. PAIN subscale (0 = no pain, 10 = worst imaginable)\n\n -Pain - 5 items\n2. FUNCTION subscale (0 = no difficulty, 10 = unable to do)\n\n * Specific activities - 6 items\n * Usual activities - 4 items\n\nIn addition to the individual subscale scores, a total score can be computed on a scale of 100 (0 = no disability), where pain and functional problems are weighted equally'}, {'measure': 'Grip Strength Test, All Treated Subjects', 'timeFrame': 'Baseline, 4, 8, 12, and 24 weeks', 'description': 'Grip strength testing will be performed to evaluate changes in the strength and sincerity of effort as a result of treatment for lateral epicondylitis. Testing will be performed to assess the pain-free grip strength (performing the test until discomfort is felt) and maximum grip strength (performing the test to the maximum of their ability). The test will be performed while the patient is standing with the elbow in full extension, as this position has been used to assess grip strength in patients with lateral epicondylitis. A Jamar Plus+ Digital Hand Dynamometer with the grip in the second position will be used because the second position has been assumed to be the most reliable and consistent position. Patients will be asked to perform three repetitions of each test (pain-free and maximum) at each study interval and the mean score will be calculated and used for analysis.'}, {'measure': 'Maximum Grip Strength, Treated Subjects', 'timeFrame': 'Baseline, 4, 8, 12, and 24 weeks', 'description': 'A higher grip strength score indicates an improvement. A positive change from baseline indicates an improvement. Grip strength testing will be performed to evaluate changes in the strength and sincerity of effort as a result of treatment for lateral epicondylitis. Testing will be performed to assess the pain-free grip strength (performing the test until discomfort is felt) and maximum grip strength (performing the test to the maximum of their ability). The test will be performed while the patient is standing with the elbow in full extension, as this position has been used to assess grip strength in patients with lateral epicondylitis. A Jamar Plus+ Digital Hand Dynamometer with the grip in the second position will be used because the second position has been assumed to be the most reliable and consistent position. Patients will be asked to perform three repetitions of each test (pain-free and maximum) at each study interval and the mean score will be calculated and used for analysis.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['elbow'], 'conditions': ['Lateral Epicondylitis']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether recombinant human platelet-derived growth factor (rhPDGF-BB) Injection is effective in the treatment of lateral epicondylitis (tennis elbow).', 'detailedDescription': 'Methodology: Randomized, single ascending dose, double-blinded, placebo controlled, multi-center study\n\nStudy Center(s): 6\n\nNumber of Subjects: 100\n\nDiagnosis and Main Inclusion Criteria: Lateral epicondylitis; male and female subjects 21 -80 years of age\n\nStudy Drug, Dose, Regimen:\n\nDose A: sodium acetate buffer alone - placebo control Dose B: sodium acetate buffer + 0.45 mg rhPDGF-BB Dose C: sodium acetate buffer + 0.75 mg rhPDGF-BB Dose D: sodium acetate buffer + 1.5 mg rhPDGF-BB Dose E: sodium acetate buffer + 3.0 mg rhPDGF-BB\n\nDuration and Route of Administration: Single administration dose by injection into the extensor carpi radialis brevis (ECRB)\n\nDuration of Follow-up: 24 weeks (6 months) post-operative follow-up'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Subject has signed the Institutional Review Board (IRB) approved Informed Consent Form specific to this study prior to enrollment\n2. Subject has a clinical diagnosis of lateral epicondylitis\n3. Subject's symptoms can be reproduced with resisted supination or wrist dorsiflexion\n4. Subject's symptoms have persisted for at least 3 months despite conservative treatment that includes one or combinations of:\n\n 1. Physical therapy\n 2. Splinting\n 3. Nonsteroidal antiinflammatory drug (NSAID)\n 4. Corticosteroid injection\n5. Subject is independent, ambulatory, and can comply with all post-injection evaluations and visits\n6. Subject is 21-80 years of age and considered to be skeletally mature\n\nExclusion Criteria:\n\n1. Subject has undergone previous corticosteroid injection therapy to the effected elbow in less than three months prior to enrollment\n2. Subject has received previous Platelet Rich Plasma (PRP) injection to the affected elbow\n3. Subject is deemed to require a corticosteroid injection into the affected elbow during the course of the study\n4. Subject uses chronic medications known to affect the skeleton (e.g. glucocorticoid usage \\>10mg/day)\n5. Subject has undergone surgical intervention to the affected elbow for the treatment of lateral epicondylitis\n6. Subject has a positive medical history of any of the following:\n\n 1. medial epicondylitis\n 2. radial tunnel syndrome\n 3. carpal tunnel syndrome\n 4. septic or gouty arthritis\n 5. cervical radiculopathy\n 6. trauma to the affected elbow within the past 6 weeks\n 7. neuromuscular or musculoskeletal deficiency, which limits the ability to perform functional measurement (e.g. grip strength test)\n7. Subject currently has an acute infection at the injection site\n8. Subject has tested positive or been treated for a malignancy in the past or is suspected of having a malignancy or are currently undergoing radio- or chemotherapy treatment for a malignancy anywhere in the body, whether adjacent to or distant from the proposed rhPDGF-BB Injection treatment site\n9. Subject is physically or mentally compromised (e.g. currently being treated 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\n10. Subject has an allergy to yeast-derived products\n11. Subject has received an investigational therapy or approved therapy for investigational use within 30 days of injection procedure or during the follow-up phase of this study\n12. Subject is a prisoner, or is known or suspected to be transient\n13. Subject's condition represents a worker's compensation case\n14. Subject is currently involved in a health-related litigation procedure\n15. Subject has documented evidence of a history (e.g. liver testing) of drug/alcohol abuse within the 12 months prior to screening for study entry\n16. Subject is pregnant, or able to become pregnant but not practicing a medically-accepted form of birth control, and/or intending to become pregnant during this study period"}, 'identificationModule': {'nctId': 'NCT01746420', 'briefTitle': 'Phase II Study of the Effects of rhPDGF-BB Injection on Lateral Epicondylitis', 'organization': {'class': 'INDUSTRY', 'fullName': 'BioMimetic Therapeutics'}, 'officialTitle': 'A Phase II Randomized, Single Ascending Dose, Double-blinded, Placebo Controlled, Multi-center Study of the Effects of rhPDGF-BB Injection on Lateral Epicondylitis', 'orgStudyIdInfo': {'id': 'BMTI-2010-02'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo Control', 'description': 'Dose A - sodium acetate buffer (0 mg rhPDGF-BB)', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': '0.45 mg rhPDGF-BB', 'description': 'Dose B - sodium acetate buffer + 0.45 mg rhPDGF-BB', 'interventionNames': ['Drug: rhPDGF-BB Injection']}, {'type': 'EXPERIMENTAL', 'label': '0.75 mg rhPDGF-BB', 'description': 'Dose C - sodium acetate buffer + 0.75 mg rhPDGF-BB', 'interventionNames': ['Drug: rhPDGF-BB Injection']}, {'type': 'EXPERIMENTAL', 'label': '1.5 mg rhPDGF-BB', 'description': 'Dose D - sodium acetate buffer + 1.5 mg rhPDGF-BB', 'interventionNames': ['Drug: rhPDGF-BB Injection']}, {'type': 'EXPERIMENTAL', 'label': '3.0 mg rhPDGF-BB', 'description': 'Dose E - sodium acetate buffer + 3.0 mg rhPDGF-BB', 'interventionNames': ['Drug: rhPDGF-BB Injection']}], 'interventions': [{'name': 'rhPDGF-BB Injection', 'type': 'DRUG', 'description': 'Comparison of placebo control (0 mg rhPDGF-BB) and different dosages (0.45, 0.75, 1.5, and 3.0 mg) of rhPDGF-BB Injection administered through a one-time injection', 'armGroupLabels': ['0.45 mg rhPDGF-BB', '0.75 mg rhPDGF-BB', '1.5 mg rhPDGF-BB', '3.0 mg rhPDGF-BB']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'sodium acetate buffer (0 mg rhPDGF-BB)', 'armGroupLabels': ['Placebo Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85023', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Arizona Research Center', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '85712', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'Tucson Orthopaedic Institute', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '72401', 'city': 'Jonesboro', 'state': 'Arkansas', 'country': 'United States', 'facility': 'NEA Baptist Clinic', 'geoPoint': {'lat': 35.8423, 'lon': -90.70428}}, {'zip': '34209', 'city': 'Bradenton', 'state': 'Florida', 'country': 'United States', 'facility': 'Coastal Orthopedics & Sports Medicine', 'geoPoint': {'lat': 27.49893, 'lon': -82.57482}}, {'zip': '33637', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'Foundation for Orthopaedic Research and Education', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '28207', 'city': 'Charlotte', 'state': 'North Carolina', 'country': 'United States', 'facility': 'OrthoCarolina', 'geoPoint': {'lat': 35.22709, 'lon': -80.84313}}], 'overallOfficials': [{'name': 'Edward Akelman, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Brown University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'BioMimetic Therapeutics', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}