Ignite Creation Date:
2025-12-25 @ 2:01 AM
Ignite Modification Date:
2026-01-02 @ 3:35 AM
Study NCT ID:
NCT03122860
Status:
COMPLETED
Last Update Posted:
2021-06-11
First Post:
2017-04-18
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study Evaluating the Safety and Efficacy of SM04690 for the Treatment of Moderately to Severely Symptomatic Knee Osteoarthritis
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2021-04-19', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D020370', 'term': 'Osteoarthritis, Knee'}, {'id': 'D010003', 'term': 'Osteoarthritis'}], 'ancestors': [{'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000627701', 'term': 'lorecivivint'}, {'id': 'C005703', 'term': 'salicylhydroxamic acid'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'chris.swearingen@biosplice.com', 'phone': '858.926.2952', 'title': 'Christopher Swearingen, PhD, VP of Biometrics', 'organization': 'Biosplice Therapeutics, Inc.'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that occur during the course of the study that are not present prior to Day 1 study medication injection, or, if present at the time of study medication injection, have worsened in severity during the course of the study. TEAEs were assessed at each study visit from the time of study medication injection on study visit Day 1 through Week 24 (End-of-Study)/Early Termination.', 'description': 'The Safety Analyses Set \\[SAS\\] includes all subjects who received a study injection, analyzed as treated. Discrepancy in subject counts between SAS and Full Analysis Set \\[FAS\\] is the result of subjects who received a treatment that is different from the planned treatment group as randomized. Subjects who received a study treatment not as prescribed in the pharmacy manual are summarized in the "Other" treatment group for safety analysis reporting.', 'eventGroups': [{'id': 'EG000', 'title': '0.03 mg SM04690', 'description': 'Single intra-articular injection of 0.03 mg SM04690 in 2 mL vehicle', 'otherNumAtRisk': 106, 'deathsNumAtRisk': 106, 'otherNumAffected': 14, 'seriousNumAtRisk': 106, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG001', 'title': '0.07 mg SM04690', 'description': 'Single intra-articular injection of 0.07 mg SM04690 in 2 mL vehicle', 'otherNumAtRisk': 104, 'deathsNumAtRisk': 104, 'otherNumAffected': 19, 'seriousNumAtRisk': 104, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': '0.15 mg SM04690', 'description': 'Single intra-articular injection of 0.15 mg SM04690 in 2 mL vehicle', 'otherNumAtRisk': 106, 'deathsNumAtRisk': 106, 'otherNumAffected': 14, 'seriousNumAtRisk': 106, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': '0.23 mg SM04690', 'description': 'Single intra-articular injection of 0.23 mg SM04690 in 2 mL vehicle', 'otherNumAtRisk': 106, 'deathsNumAtRisk': 106, 'otherNumAffected': 17, 'seriousNumAtRisk': 106, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG004', 'title': 'Placebo', 'description': 'Single intra-articular injection of 0 mg SM04690 in 2 mL vehicle', 'otherNumAtRisk': 114, 'deathsNumAtRisk': 114, 'otherNumAffected': 15, 'seriousNumAtRisk': 114, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG005', 'title': 'Sham', 'description': 'Single intra-articular injection of 0 mg SM04690 in 0 mL vehicle', 'otherNumAtRisk': 120, 'deathsNumAtRisk': 120, 'otherNumAffected': 22, 'seriousNumAtRisk': 120, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG006', 'title': 'Other', 'description': 'Single intra-articular injection of an unidentified dose of SM04690 or Placebo due to incorrectly performed dilution or documentation by a pharmacist.', 'otherNumAtRisk': 39, 'deathsNumAtRisk': 39, 'otherNumAffected': 9, 'seriousNumAtRisk': 39, 'deathsNumAffected': 0, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Abdominal tenderness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 104, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 106, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 106, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 39, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 104, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 106, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 106, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 39, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 104, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 106, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 106, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 39, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 104, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 106, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 106, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 39, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 104, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 106, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 106, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 39, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 104, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 106, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 106, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 114, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 39, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 104, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 106, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 106, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 114, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 120, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG006', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Skin infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 104, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 106, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 106, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 39, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 104, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 106, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 106, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 114, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG005', 'numAtRisk': 120, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG006', 'numAtRisk': 39, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 104, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 106, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 106, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 114, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 120, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG006', 'numAtRisk': 39, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Viral upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 104, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 106, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 106, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 114, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 120, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Blood lactate dehydrogenase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 104, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 106, 'numEvents': 3, 'numAffected': 3}, {'groupId': 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nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 104, 'numEvents': 8, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 106, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 106, 'numEvents': 12, 'numAffected': 9}, {'groupId': 'EG004', 'numAtRisk': 114, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 120, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG006', 'numAtRisk': 39, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 104, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 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'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 104, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 106, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 106, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 39, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 104, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 106, 'numEvents': 6, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 106, 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'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Skin exfoliation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 104, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 106, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 106, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 39, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Flushing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 104, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 106, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 106, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 39, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}], 'seriousEvents': [{'term': 'Coronary artery disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 104, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 106, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 106, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 114, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Supraventricular tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 104, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 106, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 106, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Appendicitis perforated', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 104, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 106, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 106, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 39, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Invasive ductal breast carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 104, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 106, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 106, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Nephrolithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 104, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 106, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 106, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}], 'frequencyThreshold': '2'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline Osteoarthritis (OA) Pain in the Target Knee as Assessed by the Weekly Average of Daily Pain Numeric Rating Scale (NRS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '98', 'groupId': 'OG000'}, {'value': '102', 'groupId': 'OG001'}, {'value': '92', 'groupId': 'OG002'}, {'value': '90', 'groupId': 'OG003'}, {'value': '95', 'groupId': 'OG004'}, {'value': '91', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': '0.03 mg SM04690', 'description': 'Single intra-articular injection of 0.03 mg SM04690 in 2 mL vehicle'}, {'id': 'OG001', 'title': '0.07 mg SM04690', 'description': 'Single intra-articular injection of 0.07 mg SM04690 in 2 mL vehicle'}, {'id': 'OG002', 'title': '0.15 mg SM04690', 'description': 'Single intra-articular injection of 0.15 mg SM04690 in 2 mL vehicle'}, {'id': 'OG003', 'title': '0.23 mg SM04690', 'description': 'Single intra-articular injection of 0.23 mg SM04690 in 2 mL vehicle'}, {'id': 'OG004', 'title': 'Placebo', 'description': 'Single intra-articular injection of 0 mg SM04690 in 2 mL vehicle'}, {'id': 'OG005', 'title': 'Sham', 'description': 'Single intra-articular injection of 0 mg SM04690 in 0 mL vehicle'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.77', 'spread': '2.44', 'groupId': 'OG000'}, {'value': '-2.93', 'spread': '2.21', 'groupId': 'OG001'}, {'value': '-2.43', 'spread': '2.18', 'groupId': 'OG002'}, {'value': '-3.03', 'spread': '2.43', 'groupId': 'OG003'}, {'value': '-2.26', 'spread': '2.44', 'groupId': 'OG004'}, {'value': '-2.21', 'spread': '2.46', 'groupId': 'OG005'}]}]}], 'analyses': [{'pValue': '0.179', 'groupIds': ['OG000', 'OG004'], 'paramType': 'Median Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.46', 'ciLowerLimit': '-1.13', 'ciUpperLimit': '0.21', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.031', 'groupIds': ['OG001', 'OG004'], 'paramType': 'Median Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.70', 'ciLowerLimit': '-1.34', 'ciUpperLimit': '-0.06', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.675', 'groupIds': ['OG002', 'OG004'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.14', 'ciLowerLimit': '-0.81', 'ciUpperLimit': '0.52', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.022', 'groupIds': ['OG003', 'OG004'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.82', 'ciLowerLimit': '-1.51', 'ciUpperLimit': '-0.12', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.780', 'groupIds': ['OG004', 'OG005'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.10', 'ciLowerLimit': '-0.79', 'ciUpperLimit': '0.59', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 24', 'description': 'Change from baseline OA pain in the target knee as assessed by the weekly average of daily pain NRS at Week 24. The pain NRS is an 11-point scale \\[0-10\\] for subject self-reporting of average knee pain in the last 24 hours; 0 indicates no pain, and 10 represents the worst possible pain (pain as bad as one can imagine).', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Data is reported as observed with no imputation. Discrepancy between the number of participants analyzed and the number of participants assigned to the arms is the result of missing data and/or subject withdrawal.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline OA Pain in the Target Knee as Assessed by Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscore (WOMAC Pain)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '94', 'groupId': 'OG000'}, {'value': '102', 'groupId': 'OG001'}, {'value': '93', 'groupId': 'OG002'}, {'value': '93', 'groupId': 'OG003'}, {'value': '93', 'groupId': 'OG004'}, {'value': '92', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': '0.03 mg SM04690', 'description': 'Single intra-articular injection of 0.03 mg SM04690 in 2 mL vehicle'}, {'id': 'OG001', 'title': '0.07 mg SM04690', 'description': 'Single intra-articular injection of 0.07 mg SM04690 in 2 mL vehicle'}, {'id': 'OG002', 'title': '0.15 mg SM04690', 'description': 'Single intra-articular injection of 0.15 mg SM04690 in 2 mL vehicle'}, {'id': 'OG003', 'title': '0.23 mg SM04690', 'description': 'Single intra-articular injection of 0.23 mg SM04690 in 2 mL vehicle'}, {'id': 'OG004', 'title': 'Placebo', 'description': 'Single intra-articular injection of 0 mg SM04690 in 2 mL vehicle'}, {'id': 'OG005', 'title': 'Sham', 'description': 'Single intra-articular injection of 0 mg SM04690 in 0 mL vehicle'}], 'classes': [{'categories': [{'measurements': [{'value': '-27.6', 'spread': '22.8', 'groupId': 'OG000'}, {'value': '-30.0', 'spread': '22.5', 'groupId': 'OG001'}, {'value': '-24.7', 'spread': '21.6', 'groupId': 'OG002'}, {'value': '-33.3', 'spread': '22.9', 'groupId': 'OG003'}, {'value': '-25.5', 'spread': '25.8', 'groupId': 'OG004'}, {'value': '-22.5', 'spread': '24.6', 'groupId': 'OG005'}]}]}], 'analyses': [{'pValue': '0.612', 'groupIds': ['OG000', 'OG004'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.70', 'ciLowerLimit': '-8.32', 'ciUpperLimit': '4.91', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.223', 'groupIds': ['OG001', 'OG004'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-4.01', 'ciLowerLimit': '-10.47', 'ciUpperLimit': '2.46', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.590', 'groupIds': ['OG002', 'OG004'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.84', 'ciLowerLimit': '-4.89', 'ciUpperLimit': '8.57', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.031', 'groupIds': ['OG003', 'OG004'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-7.36', 'ciLowerLimit': '-14.03', 'ciUpperLimit': '-0.69', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.403', 'groupIds': ['OG004', 'OG005'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.89', 'ciLowerLimit': '-9.70', 'ciUpperLimit': '3.92', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 24', 'description': 'Change from baseline OA pain in the target knee as assessed by WOMAC Numeric Rating Scale (NRS 3.1) pain subscore (WOMAC Pain) at Week 24. The WOMAC is a widely-used, proprietary outcome measurement tool used by health professionals to evaluate the condition of subjects with OA of the knee and hip, including pain (5 questions), stiffness (2 questions), and physical functioning (17 questions) of the joints. Each question is measured on a scale from 0 (lowest pain/lowest stiffness/highest function) to 10 (highest pain/highest stiffness/lowest function). The WOMAC Pain subscore is standardized and reported ranging from 0 to 100 \\[0 = no pain; 100 = pain as bad as it can be\\].', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Data is reported as observed with no imputation. Discrepancy between the number of participants analyzed and the number of participants assigned to the arms is the result of missing data and/or subject withdrawal.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline OA Function in the Target Knee as Assessed by WOMAC Physical Function Subscore (WOMAC Function)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '94', 'groupId': 'OG000'}, {'value': '102', 'groupId': 'OG001'}, {'value': '93', 'groupId': 'OG002'}, {'value': '93', 'groupId': 'OG003'}, {'value': '93', 'groupId': 'OG004'}, {'value': '92', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': '0.03 mg SM04690', 'description': 'Single intra-articular injection of 0.03 mg SM04690 in 2 mL vehicle'}, {'id': 'OG001', 'title': '0.07 mg SM04690', 'description': 'Single intra-articular injection of 0.07 mg SM04690 in 2 mL vehicle'}, {'id': 'OG002', 'title': '0.15 mg SM04690', 'description': 'Single intra-articular injection of 0.15 mg SM04690 in 2 mL vehicle'}, {'id': 'OG003', 'title': '0.23 mg SM04690', 'description': 'Single intra-articular injection of 0.23 mg SM04690 in 2 mL vehicle'}, {'id': 'OG004', 'title': 'Placebo', 'description': 'Single intra-articular injection of 0 mg SM04690 in 2 mL vehicle'}, {'id': 'OG005', 'title': 'Sham', 'description': 'Single intra-articular injection of 0 mg SM04690 in 0 mL vehicle'}], 'classes': [{'categories': [{'measurements': [{'value': '-27.7', 'spread': '21.1', 'groupId': 'OG000'}, {'value': '-29.3', 'spread': '23.0', 'groupId': 'OG001'}, {'value': '-23.6', 'spread': '21.6', 'groupId': 'OG002'}, {'value': '-32.4', 'spread': '22.1', 'groupId': 'OG003'}, {'value': '-24.9', 'spread': '23.7', 'groupId': 'OG004'}, {'value': '-23.8', 'spread': '23.7', 'groupId': 'OG005'}]}]}], 'analyses': [{'pValue': '0.432', 'groupIds': ['OG000', 'OG004'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.58', 'ciLowerLimit': '-9.04', 'ciUpperLimit': '3.88', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.180', 'groupIds': ['OG001', 'OG004'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-4.34', 'ciLowerLimit': '-10.69', 'ciUpperLimit': '2.02', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.718', 'groupIds': ['OG002', 'OG004'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.19', 'ciLowerLimit': '-5.33', 'ciUpperLimit': '7.72', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.017', 'groupIds': ['OG003', 'OG004'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-7.99', 'ciLowerLimit': '-14.54', 'ciUpperLimit': '-1.45', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.682', 'groupIds': ['OG004', 'OG005'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.39', 'ciLowerLimit': '-8.06', 'ciUpperLimit': '5.29', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 24', 'description': 'Change from baseline OA function in the target knee as assessed by WOMAC Numeric Rating Scale (NRS 3.1) physical functioning subscore (WOMAC Function) at Week 24. The WOMAC is a widely-used, proprietary outcome measurement tool used by health professionals to evaluate the condition of subjects with OA of the knee and hip, including pain (5 questions), stiffness (2 questions), and physical functioning (17 questions) of the joints. Each question is measured on a scale from 0 (lowest pain/lowest stiffness/highest function) to 10 (highest pain/highest stiffness/lowest function). The WOMAC Function subscore is standardized and reported ranging from 0 to 100 \\[0 = no functional disability, 100 = unable to function\\].', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Data is reported as observed with no imputation. Discrepancy between the number of participants analyzed and the number of participants assigned to the arms is the result of missing data and/or subject withdrawal.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in Medial Joint Space Width (mJSW) of the Target Knee', 'denoms': [{'units': 'Participants', 'counts': [{'value': '104', 'groupId': 'OG000'}, {'value': '109', 'groupId': 'OG001'}, {'value': '103', 'groupId': 'OG002'}, {'value': '101', 'groupId': 'OG003'}, {'value': '96', 'groupId': 'OG004'}, {'value': '104', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': '0.03 mg SM04690', 'description': 'Single intra-articular injection of 0.03 mg SM04690 in 2 mL vehicle'}, {'id': 'OG001', 'title': '0.07 mg SM04690', 'description': 'Single intra-articular injection of 0.07 mg SM04690 in 2 mL vehicle'}, {'id': 'OG002', 'title': '0.15 mg SM04690', 'description': 'Single intra-articular injection of 0.15 mg SM04690 in 2 mL vehicle'}, {'id': 'OG003', 'title': '0.23 mg SM04690', 'description': 'Single intra-articular injection of 0.23 mg SM04690 in 2 mL vehicle'}, {'id': 'OG004', 'title': 'Placebo', 'description': 'Single intra-articular injection of 0 mg SM04690 in 2 mL vehicle'}, {'id': 'OG005', 'title': 'Sham', 'description': 'Single intra-articular injection of 0 mg SM04690 in 0 mL vehicle'}], 'classes': [{'categories': [{'measurements': [{'value': '0.02', 'spread': '0.72', 'groupId': 'OG000'}, {'value': '-0.11', 'spread': '0.53', 'groupId': 'OG001'}, {'value': '-0.11', 'spread': '0.92', 'groupId': 'OG002'}, {'value': '-0.03', 'spread': '0.45', 'groupId': 'OG003'}, {'value': '-0.01', 'spread': '0.60', 'groupId': 'OG004'}, {'value': '-0.08', 'spread': '0.58', 'groupId': 'OG005'}]}]}], 'analyses': [{'pValue': '0.822', 'groupIds': ['OG000', 'OG004'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.02', 'ciLowerLimit': '-0.16', 'ciUpperLimit': '0.21', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.162', 'groupIds': ['OG001', 'OG004'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.11', 'ciLowerLimit': '-0.27', 'ciUpperLimit': '0.04', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.267', 'groupIds': ['OG002', 'OG004'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.12', 'ciLowerLimit': '-0.34', 'ciUpperLimit': '0.09', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.685', 'groupIds': ['OG003', 'OG004'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.03', 'ciLowerLimit': '-0.18', 'ciUpperLimit': '0.12', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.342', 'groupIds': ['OG004', 'OG005'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.08', 'ciLowerLimit': '-0.09', 'ciUpperLimit': '0.24', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 24', 'description': 'Change from baseline in mJSW as documented by radiograph of the target knee.', 'unitOfMeasure': 'mm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Data is reported as observed with no imputation. Discrepancy between the number of participants analyzed and the number of participants assigned to the arms is the result of missing data and/or subject withdrawal.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline OA Disease Activity as Assessed by Patient Global Assessment (PtGA)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '90', 'groupId': 'OG000'}, {'value': '99', 'groupId': 'OG001'}, {'value': '92', 'groupId': 'OG002'}, {'value': '92', 'groupId': 'OG003'}, {'value': '90', 'groupId': 'OG004'}, {'value': '90', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': '0.03 mg SM04690', 'description': 'Single intra-articular injection of 0.03 mg SM04690 in 2 mL vehicle'}, {'id': 'OG001', 'title': '0.07 mg SM04690', 'description': 'Single intra-articular injection of 0.07 mg SM04690 in 2 mL vehicle'}, {'id': 'OG002', 'title': '0.15 mg SM04690', 'description': 'Single intra-articular injection of 0.15 mg SM04690 in 2 mL vehicle'}, {'id': 'OG003', 'title': '0.23 mg SM04690', 'description': 'Single intra-articular injection of 0.23 mg SM04690 in 2 mL vehicle'}, {'id': 'OG004', 'title': 'Placebo', 'description': 'Single intra-articular injection of 0 mg SM04690 in 2 mL vehicle'}, {'id': 'OG005', 'title': 'Sham', 'description': 'Single intra-articular injection of 0 mg SM04690 in 0 mL vehicle'}], 'classes': [{'categories': [{'measurements': [{'value': '-16.0', 'spread': '23.5', 'groupId': 'OG000'}, {'value': '-19.8', 'spread': '27.1', 'groupId': 'OG001'}, {'value': '-11.9', 'spread': '27.5', 'groupId': 'OG002'}, {'value': '-18.3', 'spread': '24.5', 'groupId': 'OG003'}, {'value': '-13.0', 'spread': '21.6', 'groupId': 'OG004'}, {'value': '-13.8', 'spread': '24.4', 'groupId': 'OG005'}]}]}], 'analyses': [{'pValue': '0.500', 'groupIds': ['OG000', 'OG004'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.13', 'ciLowerLimit': '-8.36', 'ciUpperLimit': '4.10', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.082', 'groupIds': ['OG001', 'OG004'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-5.54', 'ciLowerLimit': '-11.80', 'ciUpperLimit': '0.72', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.552', 'groupIds': ['OG002', 'OG004'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.94', 'ciLowerLimit': '-8.36', 'ciUpperLimit': '4.48', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.033', 'groupIds': ['OG003', 'OG004'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-6.86', 'ciLowerLimit': '-13.16', 'ciUpperLimit': '-0.56', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.887', 'groupIds': ['OG004', 'OG005'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.45', 'ciLowerLimit': '-5.79', 'ciUpperLimit': '6.68', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 24', 'description': 'Change from baseline OA disease activity as assessed by PtGA at Week 24. The PtGA was completed using a 100 mm visual analog scale (VAS) adapted from the Patient Assessment Form © 1999, American College of Rheumatology. The subject rated how well he/she was doing, considering all the ways in which illness and health conditions may affected him/her. The VAS scale was anchored by "Very Well" on the left (scored as 0) and "Very Poorly" on the right (scored as 100). Higher scores indicated poorer disease assessment by the subject.', 'unitOfMeasure': 'mm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Data is reported as observed with no imputation. Discrepancy between the number of participants analyzed and the number of participants assigned to the arms is the result of missing data and/or subject withdrawal.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change From Baseline OA Pain in the Target Knee as Assessed by WOMAC Pain Subscore (WOMAC Pain)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '103', 'groupId': 'OG000'}, {'value': '98', 'groupId': 'OG001'}, {'value': '100', 'groupId': 'OG002'}, {'value': '101', 'groupId': 'OG003'}, {'value': '101', 'groupId': 'OG004'}, {'value': '106', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': '0.03 mg SM04690', 'description': 'Single intra-articular injection of 0.03 mg SM04690 in 2 mL vehicle'}, {'id': 'OG001', 'title': '0.07 mg SM04690', 'description': 'Single intra-articular injection of 0.07 mg SM04690 in 2 mL vehicle'}, {'id': 'OG002', 'title': '0.15 mg SM04690', 'description': 'Single intra-articular injection of 0.15 mg SM04690 in 2 mL vehicle'}, {'id': 'OG003', 'title': '0.23 mg SM04690', 'description': 'Single intra-articular injection of 0.23 mg SM04690 in 2 mL vehicle'}, {'id': 'OG004', 'title': 'Placebo', 'description': 'Single intra-articular injection of 0 mg SM04690 in 2 mL vehicle'}, {'id': 'OG005', 'title': 'Sham', 'description': 'Single intra-articular injection of 0 mg SM04690 in 0 mL vehicle'}], 'classes': [{'categories': [{'measurements': [{'value': '-25.8', 'spread': '20.5', 'groupId': 'OG000'}, {'value': '-29.3', 'spread': '21.5', 'groupId': 'OG001'}, {'value': '-22.1', 'spread': '20.2', 'groupId': 'OG002'}, {'value': '-32.1', 'spread': '21.2', 'groupId': 'OG003'}, {'value': '-23.7', 'spread': '24.6', 'groupId': 'OG004'}, {'value': '-22.8', 'spread': '23.2', 'groupId': 'OG005'}]}]}], 'analyses': [{'pValue': '0.473', 'groupIds': ['OG000', 'OG004'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.14', 'ciLowerLimit': '-7.99', 'ciUpperLimit': '3.72', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.040', 'groupIds': ['OG001', 'OG004'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-6.31', 'ciLowerLimit': '-12.33', 'ciUpperLimit': '-0.29', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.577', 'groupIds': ['OG002', 'OG004'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.72', 'ciLowerLimit': '-4.35', 'ciUpperLimit': '7.79', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.003', 'groupIds': ['OG003', 'OG004'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-8.95', 'ciLowerLimit': '-14.90', 'ciUpperLimit': '-3.01', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.947', 'groupIds': ['OG004', 'OG005'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.21', 'ciLowerLimit': '-6.37', 'ciUpperLimit': '5.96', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 12', 'description': 'Change from baseline OA pain in the target knee as assessed by WOMAC Numeric Rating Scale (NRS 3.1) pain subscore (WOMAC Pain) at Week 12. The WOMAC is a widely-used, proprietary outcome measurement tool used by health professionals to evaluate the condition of subjects with OA of the knee and hip, including pain (5 questions), stiffness (2 questions), and physical functioning (17 questions) of the joints. Each question is measured on a scale from 0 (lowest pain/lowest stiffness/highest function) to 10 (highest pain/highest stiffness/lowest function). The WOMAC Pain subscore is standardized and reported ranging from 0 to 100 \\[0 = no pain, 100 = pain as bad as it can be\\].', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Data is reported as observed with no imputation. Discrepancy between the number of participants analyzed and the number of participants assigned to the arms is the result of missing data and/or subject withdrawal.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change From Baseline OA Function in the Target Knee as Assessed by WOMAC Physical Function Subscore (WOMAC Function)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '103', 'groupId': 'OG000'}, {'value': '98', 'groupId': 'OG001'}, {'value': '100', 'groupId': 'OG002'}, {'value': '101', 'groupId': 'OG003'}, {'value': '101', 'groupId': 'OG004'}, {'value': '106', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': '0.03 mg SM04690', 'description': 'Single intra-articular injection of 0.03 mg SM04690 in 2 mL vehicle'}, {'id': 'OG001', 'title': '0.07 mg SM04690', 'description': 'Single intra-articular injection of 0.07 mg SM04690 in 2 mL vehicle'}, {'id': 'OG002', 'title': '0.15 mg SM04690', 'description': 'Single intra-articular injection of 0.15 mg SM04690 in 2 mL vehicle'}, {'id': 'OG003', 'title': '0.23 mg SM04690', 'description': 'Single intra-articular injection of 0.23 mg SM04690 in 2 mL vehicle'}, {'id': 'OG004', 'title': 'Placebo', 'description': 'Single intra-articular injection of 0 mg SM04690 in 2 mL vehicle'}, {'id': 'OG005', 'title': 'Sham', 'description': 'Single intra-articular injection of 0 mg SM04690 in 0 mL vehicle'}], 'classes': [{'categories': [{'measurements': [{'value': '-26.0', 'spread': '19.0', 'groupId': 'OG000'}, {'value': '-29.3', 'spread': '21.8', 'groupId': 'OG001'}, {'value': '-20.9', 'spread': '20.2', 'groupId': 'OG002'}, {'value': '-30.4', 'spread': '21.3', 'groupId': 'OG003'}, {'value': '-22.7', 'spread': '23.2', 'groupId': 'OG004'}, {'value': '-22.7', 'spread': '24.2', 'groupId': 'OG005'}]}]}], 'analyses': [{'pValue': '0.299', 'groupIds': ['OG000', 'OG004'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-3.05', 'ciLowerLimit': '-8.83', 'ciUpperLimit': '2.73', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.021', 'groupIds': ['OG001', 'OG004'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-7.18', 'ciLowerLimit': '-13.24', 'ciUpperLimit': '-1.12', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.675', 'groupIds': ['OG002', 'OG004'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.29', 'ciLowerLimit': '-4.75', 'ciUpperLimit': '7.33', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.006', 'groupIds': ['OG003', 'OG004'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-8.63', 'ciLowerLimit': '-14.70', 'ciUpperLimit': '-2.55', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.925', 'groupIds': ['OG004', 'OG005'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.30', 'ciLowerLimit': '-5.99', 'ciUpperLimit': '6.59', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 12', 'description': 'Change from baseline OA function in the target knee as assessed by WOMAC Numeric Rating Scale (NRS 3.1) physical functioning subscore (WOMAC Function) at Week 12. The WOMAC is a widely-used, proprietary outcome measurement tool used by health professionals to evaluate the condition of subjects with OA of the knee and hip, including pain (5 questions), stiffness (2 questions), and physical functioning (17 questions) of the joints. Each question is measured on a scale from 0 (lowest pain/lowest stiffness/highest function) to 10 (highest pain/highest stiffness/lowest function). The WOMAC Function subscore is standardized and reported ranging from 0 to 100 \\[0 = no functional disability, 100 = unable to function\\].', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Data is reported as observed with no imputation. Discrepancy between the number of participants analyzed and the number of participants assigned to the arms is the result of missing data and/or subject withdrawal.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change From Baseline OA Pain in the Target Knee as Assesses by the Weekly Average of Daily Pain NRS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '103', 'groupId': 'OG000'}, {'value': '102', 'groupId': 'OG001'}, {'value': '101', 'groupId': 'OG002'}, {'value': '101', 'groupId': 'OG003'}, {'value': '105', 'groupId': 'OG004'}, {'value': '105', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': '0.03 mg SM04690', 'description': 'Single intra-articular injection of 0.03 mg SM04690 in 2 mL vehicle'}, {'id': 'OG001', 'title': '0.07 mg SM04690', 'description': 'Single intra-articular injection of 0.07 mg SM04690 in 2 mL vehicle'}, {'id': 'OG002', 'title': '0.15 mg SM04690', 'description': 'Single intra-articular injection of 0.15 mg SM04690 in 2 mL vehicle'}, {'id': 'OG003', 'title': '0.23 mg SM04690', 'description': 'Single intra-articular injection of 0.23 mg SM04690 in 2 mL vehicle'}, {'id': 'OG004', 'title': 'Placebo', 'description': 'Single intra-articular injection of 0 mg SM04690 in 2 mL vehicle'}, {'id': 'OG005', 'title': 'Sham', 'description': 'Single intra-articular injection of 0 mg SM04690 in 0 mL vehicle'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.75', 'spread': '2.22', 'groupId': 'OG000'}, {'value': '-3.02', 'spread': '2.03', 'groupId': 'OG001'}, {'value': '-2.21', 'spread': '2.23', 'groupId': 'OG002'}, {'value': '-2.87', 'spread': '2.10', 'groupId': 'OG003'}, {'value': '-2.15', 'spread': '2.39', 'groupId': 'OG004'}, {'value': '-2.27', 'spread': '2.27', 'groupId': 'OG005'}]}]}], 'analyses': [{'pValue': '0.062', 'groupIds': ['OG000', 'OG004'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.58', 'ciLowerLimit': '-1.18', 'ciUpperLimit': '0.03', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.001', 'groupIds': ['OG001', 'OG004'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.96', 'ciLowerLimit': '-1.54', 'ciUpperLimit': '-0.37', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.693', 'groupIds': ['OG002', 'OG004'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.12', 'ciLowerLimit': '-0.75', 'ciUpperLimit': '0.50', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.012', 'groupIds': ['OG003', 'OG004'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.78', 'ciLowerLimit': '-1.39', 'ciUpperLimit': '-0.17', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.697', 'groupIds': ['OG004', 'OG005'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.12', 'ciLowerLimit': '-0.49', 'ciUpperLimit': '0.74', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 12', 'description': 'Change from baseline OA pain in the target knee as assessed by the weekly average of daily pain NRS at Week 12. The pain NRS is an 11-point scale \\[0-10\\] for subject self-reporting of average knee pain in the last 24 hours; 0 indicates no pain, and 10 represents the worst possible pain (pain as bad as one can imagine).', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Data is reported as observed with no imputation. Discrepancy between the number of participants analyzed and the number of participants assigned to the arms is the result of missing data and/or subject withdrawal.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change From Baseline OA Disease Activity as Assessed by Patient Global Assessment (PtGA)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '93', 'groupId': 'OG001'}, {'value': '94', 'groupId': 'OG002'}, {'value': '101', 'groupId': 'OG003'}, {'value': '99', 'groupId': 'OG004'}, {'value': '104', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': '0.03 mg SM04690', 'description': 'Single intra-articular injection of 0.03 mg SM04690 in 2 mL vehicle'}, {'id': 'OG001', 'title': '0.07 mg SM04690', 'description': 'Single intra-articular injection of 0.07 mg SM04690 in 2 mL vehicle'}, {'id': 'OG002', 'title': '0.15 mg SM04690', 'description': 'Single intra-articular injection of 0.15 mg SM04690 in 2 mL vehicle'}, {'id': 'OG003', 'title': '0.23 mg SM04690', 'description': 'Single intra-articular injection of 0.23 mg SM04690 in 2 mL vehicle'}, {'id': 'OG004', 'title': 'Placebo', 'description': 'Single intra-articular injection of 0 mg SM04690 in 2 mL vehicle'}, {'id': 'OG005', 'title': 'Sham', 'description': 'Single intra-articular injection of 0 mg SM04690 in 0 mL vehicle'}], 'classes': [{'categories': [{'measurements': [{'value': '-16.2', 'spread': '25.0', 'groupId': 'OG000'}, {'value': '-20.0', 'spread': '28.0', 'groupId': 'OG001'}, {'value': '-10.9', 'spread': '23.4', 'groupId': 'OG002'}, {'value': '-18.4', 'spread': '24.9', 'groupId': 'OG003'}, {'value': '-12.7', 'spread': '21.9', 'groupId': 'OG004'}, {'value': '-12.7', 'spread': '22.9', 'groupId': 'OG005'}]}]}], 'analyses': [{'pValue': '0.254', 'groupIds': ['OG000', 'OG004'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-3.32', 'ciLowerLimit': '-9.04', 'ciUpperLimit': '2.40', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.031', 'groupIds': ['OG001', 'OG004'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-6.86', 'ciLowerLimit': '-13.10', 'ciUpperLimit': '-0.63', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.616', 'groupIds': ['OG002', 'OG004'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.46', 'ciLowerLimit': '-7.20', 'ciUpperLimit': '4.28', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.010', 'groupIds': ['OG003', 'OG004'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-7.62', 'ciLowerLimit': '-13.41', 'ciUpperLimit': '-1.82', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.961', 'groupIds': ['OG004', 'OG005'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.14', 'ciLowerLimit': '-5.74', 'ciUpperLimit': '5.46', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 12', 'description': 'Change from baseline OA disease activity as assessed by PtGA at Week 12. The PtGA completed using a 100 mm visual analog scale (VAS) adapted from the Patient Assessment Form © 1999, American College of Rheumatology. The subject rated how well he/she was doing, considering all the ways in which illness and health conditions may affected him/her. The VAS scale was anchored by "Very Well" on the left (scored as 0) and "Very Poorly" on the right (scored as 100). Higher scores indicated poorer disease assessment by the subject.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Data is reported as observed with no imputation. Discrepancy between the number of participants analyzed and the number of participants assigned to the arms is the result of missing data and/or subject withdrawal.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': '0.03 mg SM04690', 'description': 'Single intra-articular injection of 0.03 mg SM04690 in 2 mL vehicle'}, {'id': 'FG001', 'title': '0.07 mg SM04690', 'description': 'Single intra-articular injection of 0.07 mg SM04690 in 2 mL vehicle'}, {'id': 'FG002', 'title': '0.15 mg SM04690', 'description': 'Single intra-articular injection of 0.15 mg SM04690 in 2 mL vehicle'}, {'id': 'FG003', 'title': '0.23 mg SM04690', 'description': 'Single intra-articular injection of 0.23 mg SM04690 in 2 mL vehicle'}, {'id': 'FG004', 'title': 'Placebo', 'description': 'Single intra-articular injection of 0 mg SM04690 in 2 mL vehicle'}, {'id': 'FG005', 'title': 'Sham', 'description': 'Single intra-articular injection of 0 mg SM04690 in 0 mL vehicle'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '117'}, {'groupId': 'FG001', 'numSubjects': '116'}, {'groupId': 'FG002', 'numSubjects': '117'}, {'groupId': 'FG003', 'numSubjects': '116'}, {'groupId': 'FG004', 'numSubjects': '117'}, {'groupId': 'FG005', 'numSubjects': '117'}]}, {'type': 'Full Analysis Set', 'achievements': [{'groupId': 'FG000', 'numSubjects': '116'}, {'groupId': 'FG001', 'numSubjects': '115'}, {'groupId': 'FG002', 'numSubjects': '115'}, {'groupId': 'FG003', 'numSubjects': '116'}, {'groupId': 'FG004', 'numSubjects': '116'}, {'groupId': 'FG005', 'numSubjects': '117'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '107'}, {'groupId': 'FG001', 'numSubjects': '111'}, {'groupId': 'FG002', 'numSubjects': '105'}, {'groupId': 'FG003', 'numSubjects': '105'}, {'groupId': 'FG004', 'numSubjects': '102'}, {'groupId': 'FG005', 'numSubjects': '105'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '12'}, {'groupId': 'FG003', 'numSubjects': '11'}, {'groupId': 'FG004', 'numSubjects': '15'}, {'groupId': 'FG005', 'numSubjects': '12'}]}], 'dropWithdraws': [{'type': 'Discontinued Before Treatment', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '3'}, {'groupId': 'FG004', 'numSubjects': '5'}, {'groupId': 'FG005', 'numSubjects': '4'}]}, {'type': 'Subject Non-Compliance', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '7'}, {'groupId': 'FG004', 'numSubjects': '9'}, {'groupId': 'FG005', 'numSubjects': '8'}]}]}], 'recruitmentDetails': 'The Full Analysis Set (FAS) includes all subjects who were randomized and received a study injection, analyzed as randomized.', 'preAssignmentDetails': 'The Safety Analysis Set (SAS) \\[see \'Adverse Events\' section\\] includes all subjects who received a study injection, analyzed as treated. Discrepancy in subject counts between FAS and SAS is the result of subjects who received a treatment that is different from the planned treatment group as randomized. Subjects who received a study treatment not as prescribed in the pharmacy manual are summarized in the "Other" treatment group for safety analysis reporting.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '116', 'groupId': 'BG000'}, {'value': '115', 'groupId': 'BG001'}, {'value': '115', 'groupId': 'BG002'}, {'value': '116', 'groupId': 'BG003'}, {'value': '116', 'groupId': 'BG004'}, {'value': '117', 'groupId': 'BG005'}, {'value': '695', 'groupId': 'BG006'}]}], 'groups': [{'id': 'BG000', 'title': '0.03 mg SM04690', 'description': 'Single intra-articular injection of 0.03 mg SM04690 in 2 mL vehicle'}, {'id': 'BG001', 'title': '0.07 mg SM04690', 'description': 'Single intra-articular injection of 0.07 mg SM04690 in 2 mL vehicle'}, {'id': 'BG002', 'title': '0.15 mg SM04690', 'description': 'Single intra-articular injection of 0.15 mg SM04690 in 2 mL vehicle'}, {'id': 'BG003', 'title': '0.23 mg SM04690', 'description': 'Single intra-articular injection of 0.23 mg SM04690 in 2 mL vehicle'}, {'id': 'BG004', 'title': 'Placebo', 'description': 'Single intra-articular injection of 0 mg SM04690 in 2 mL vehicle'}, {'id': 'BG005', 'title': 'Sham', 'description': 'Single intra-articular injection of 0 mg SM04690 in 0 mL vehicle'}, {'id': 'BG006', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '116', 'groupId': 'BG000'}, {'value': '115', 'groupId': 'BG001'}, {'value': '115', 'groupId': 'BG002'}, {'value': '116', 'groupId': 'BG003'}, {'value': '116', 'groupId': 'BG004'}, {'value': '117', 'groupId': 'BG005'}, {'value': '695', 'groupId': 'BG006'}]}], 'categories': [{'measurements': [{'value': '57.9', 'spread': '7.9', 'groupId': 'BG000'}, {'value': '59.9', 'spread': '8.6', 'groupId': 'BG001'}, {'value': '58.4', 'spread': '8.3', 'groupId': 'BG002'}, {'value': '58.5', 'spread': '9.0', 'groupId': 'BG003'}, {'value': '60.1', 'spread': '9.0', 'groupId': 'BG004'}, {'value': '59.0', 'spread': '8.0', 'groupId': 'BG005'}, {'value': '59.0', 'spread': '8.5', 'groupId': 'BG006'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '116', 'groupId': 'BG000'}, {'value': '115', 'groupId': 'BG001'}, {'value': '115', 'groupId': 'BG002'}, {'value': '116', 'groupId': 'BG003'}, {'value': '116', 'groupId': 'BG004'}, {'value': '117', 'groupId': 'BG005'}, {'value': '695', 'groupId': 'BG006'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '76', 'groupId': 'BG000'}, {'value': '66', 'groupId': 'BG001'}, {'value': '69', 'groupId': 'BG002'}, {'value': '61', 'groupId': 'BG003'}, {'value': '64', 'groupId': 'BG004'}, {'value': '70', 'groupId': 'BG005'}, {'value': '406', 'groupId': 'BG006'}]}, {'title': 'Male', 'measurements': [{'value': '40', 'groupId': 'BG000'}, {'value': '49', 'groupId': 'BG001'}, {'value': '46', 'groupId': 'BG002'}, {'value': '55', 'groupId': 'BG003'}, {'value': '52', 'groupId': 'BG004'}, {'value': '47', 'groupId': 'BG005'}, {'value': '289', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '116', 'groupId': 'BG000'}, {'value': '115', 'groupId': 'BG001'}, {'value': '115', 'groupId': 'BG002'}, {'value': '116', 'groupId': 'BG003'}, {'value': '116', 'groupId': 'BG004'}, {'value': '117', 'groupId': 'BG005'}, {'value': '695', 'groupId': 'BG006'}]}], 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}, {'value': '16', 'groupId': 'BG004'}, {'value': '24', 'groupId': 'BG005'}, {'value': '115', 'groupId': 'BG006'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '95', 'groupId': 'BG000'}, {'value': '93', 'groupId': 'BG001'}, {'value': '93', 'groupId': 'BG002'}, {'value': '106', 'groupId': 'BG003'}, {'value': '100', 'groupId': 'BG004'}, {'value': '93', 'groupId': 'BG005'}, {'value': '580', 'groupId': 'BG006'}]}, {'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'}, {'value': '0', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '116', 'groupId': 'BG000'}, {'value': '115', 'groupId': 'BG001'}, {'value': '115', 'groupId': 'BG002'}, {'value': '116', 'groupId': 'BG003'}, {'value': '116', 'groupId': 'BG004'}, {'value': '117', 'groupId': 'BG005'}, {'value': '695', 'groupId': 'BG006'}]}], 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}, {'value': '6', 'groupId': 'BG006'}]}, {'title': 'Asian', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '6', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}, {'value': '30', 'groupId': 'BG006'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}, {'value': '6', 'groupId': 'BG006'}]}, {'title': 'Black or African American', 'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}, {'value': '21', 'groupId': 'BG003'}, {'value': '17', 'groupId': 'BG004'}, {'value': '24', 'groupId': 'BG005'}, {'value': '133', 'groupId': 'BG006'}]}, {'title': 'White', 'measurements': [{'value': '85', 'groupId': 'BG000'}, {'value': '83', 'groupId': 'BG001'}, {'value': '84', 'groupId': 'BG002'}, {'value': '89', 'groupId': 'BG003'}, {'value': '90', 'groupId': 'BG004'}, {'value': '86', 'groupId': 'BG005'}, {'value': '517', 'groupId': 'BG006'}]}, {'title': 'More than one race', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '3', 'groupId': 'BG006'}]}, {'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'}, {'value': '0', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Body Mass Index (BMI)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '115', 'groupId': 'BG000'}, {'value': '115', 'groupId': 'BG001'}, {'value': '115', 'groupId': 'BG002'}, {'value': '116', 'groupId': 'BG003'}, {'value': '116', 'groupId': 'BG004'}, {'value': '117', 'groupId': 'BG005'}, {'value': '694', 'groupId': 'BG006'}]}], 'categories': [{'measurements': [{'value': '29.17', 'spread': '3.76', 'groupId': 'BG000'}, {'value': '29.14', 'spread': '3.64', 'groupId': 'BG001'}, {'value': '29.38', 'spread': '4.10', 'groupId': 'BG002'}, {'value': '28.53', 'spread': '4.39', 'groupId': 'BG003'}, {'value': '28.62', 'spread': '4.29', 'groupId': 'BG004'}, {'value': '28.97', 'spread': '3.84', 'groupId': 'BG005'}, {'value': '28.97', 'spread': '4.01', 'groupId': 'BG006'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m²', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'BMI was not collected for one participant in the 0.03 mg SM04690 cohort.'}, {'title': 'Kellgren-Lawrence Grade', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '116', 'groupId': 'BG000'}, {'value': '115', 'groupId': 'BG001'}, {'value': '115', 'groupId': 'BG002'}, {'value': '116', 'groupId': 'BG003'}, {'value': '116', 'groupId': 'BG004'}, {'value': '117', 'groupId': 'BG005'}, {'value': '695', 'groupId': 'BG006'}]}], 'categories': [{'title': 'Grade 1', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '1', 'groupId': 'BG006'}]}, {'title': 'Grade 2', 'measurements': [{'value': '53', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '47', 'groupId': 'BG002'}, {'value': '53', 'groupId': 'BG003'}, {'value': '43', 'groupId': 'BG004'}, {'value': '57', 'groupId': 'BG005'}, {'value': '291', 'groupId': 'BG006'}]}, {'title': 'Grade 3', 'measurements': [{'value': '63', 'groupId': 'BG000'}, {'value': '74', 'groupId': 'BG001'}, {'value': '68', 'groupId': 'BG002'}, {'value': '63', 'groupId': 'BG003'}, {'value': '72', 'groupId': 'BG004'}, {'value': '58', 'groupId': 'BG005'}, {'value': '398', 'groupId': 'BG006'}]}, {'title': 'Grade 4', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}, {'value': '5', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': "Participants' knee osteoarthritis was graded in accordance with the following definitions of Kellgren-Lawrence Grade: None (Grade 0) - Normal appearance of the knee; Doubtful (Grade 1): Doubtful narrowing of joint space and possible osteophytic lipping; Minimal (Grade 2): Definite osteophytes and possible narrowing of joint space; Moderate (Grade 3): Moderate multiple osteophytes, definite narrowing of the joint space, some sclerosis and possible deformity of bone ends; Severe (Grade 4): Large osteophytes, marked narrowing of joint space, severe sclerosis and definite deformity of bone ends.", 'unitOfMeasure': 'Participants'}, {'title': 'Osteoarthritis Laterality', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '116', 'groupId': 'BG000'}, {'value': '115', 'groupId': 'BG001'}, {'value': '115', 'groupId': 'BG002'}, {'value': '116', 'groupId': 'BG003'}, {'value': '116', 'groupId': 'BG004'}, {'value': '117', 'groupId': 'BG005'}, {'value': '695', 'groupId': 'BG006'}]}], 'categories': [{'title': 'Unilateral', 'measurements': [{'value': '59', 'groupId': 'BG000'}, {'value': '62', 'groupId': 'BG001'}, {'value': '63', 'groupId': 'BG002'}, {'value': '63', 'groupId': 'BG003'}, {'value': '61', 'groupId': 'BG004'}, {'value': '62', 'groupId': 'BG005'}, {'value': '370', 'groupId': 'BG006'}]}, {'title': 'Bilateral', 'measurements': [{'value': '57', 'groupId': 'BG000'}, {'value': '53', 'groupId': 'BG001'}, {'value': '52', 'groupId': 'BG002'}, {'value': '53', 'groupId': 'BG003'}, {'value': '55', 'groupId': 'BG004'}, {'value': '55', 'groupId': 'BG005'}, {'value': '325', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Widespread Pain (WP)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '116', 'groupId': 'BG000'}, {'value': '115', 'groupId': 'BG001'}, {'value': '115', 'groupId': 'BG002'}, {'value': '116', 'groupId': 'BG003'}, {'value': '116', 'groupId': 'BG004'}, {'value': '117', 'groupId': 'BG005'}, {'value': '695', 'groupId': 'BG006'}]}], 'categories': [{'title': 'WP-', 'measurements': [{'value': '92', 'groupId': 'BG000'}, {'value': '93', 'groupId': 'BG001'}, {'value': '90', 'groupId': 'BG002'}, {'value': '93', 'groupId': 'BG003'}, {'value': '93', 'groupId': 'BG004'}, {'value': '94', 'groupId': 'BG005'}, {'value': '555', 'groupId': 'BG006'}]}, {'title': 'WP+', 'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}, {'value': '23', 'groupId': 'BG003'}, {'value': '23', 'groupId': 'BG004'}, {'value': '23', 'groupId': 'BG005'}, {'value': '140', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Subjects were required to complete the Widespread Pain Index \\& Symptom Severity questionnaire. The Widespread Pain Index (WPI) is a body map consisting of 19 prespecified areas where subjects can indicate the presence of pain during the past seven days with a possible score 0-19. Question 2 of the Symptom Severity section of the questionnaire (SSQ2) focuses on the presence and severity of three prespecified symptoms (fatigue, trouble thinking or remembering, and waking up tired) during the past seven days with a possible score of 0-9. WP+: WPI \\> 4 and/or SSQ2 \\> 2, WP-: WPI \\<= 4 and SSQ2 \\<= 2', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'All subjects who were randomized and received a study injection, analyzed as randomized (Full Analysis Set \\[FAS\\]). FAS is used to describe the analysis set which is as complete as possible and as close as possible to the intent-to-treat ideal of including all randomized subjects.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-04-23', 'size': 5499398, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2021-03-19T03:05', 'hasProtocol': True}, {'date': '2018-09-13', 'size': 1583677, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2021-03-19T02:29', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 700}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-04-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-05', 'dispFirstSubmitDate': '2019-05-10', 'completionDateStruct': {'date': '2018-04-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-05-20', 'studyFirstSubmitDate': '2017-04-18', 'dispFirstSubmitQcDate': '2021-04-26', 'resultsFirstSubmitDate': '2021-03-19', 'studyFirstSubmitQcDate': '2017-04-20', 'dispFirstPostDateStruct': {'date': '2021-05-18', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2021-06-11', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-04-26', 'studyFirstPostDateStruct': {'date': '2017-04-21', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2021-05-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-04-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Change From Baseline OA Pain in the Target Knee as Assessed by WOMAC Pain Subscore (WOMAC Pain)', 'timeFrame': 'Baseline and Week 12', 'description': 'Change from baseline OA pain in the target knee as assessed by WOMAC Numeric Rating Scale (NRS 3.1) pain subscore (WOMAC Pain) at Week 12. The WOMAC is a widely-used, proprietary outcome measurement tool used by health professionals to evaluate the condition of subjects with OA of the knee and hip, including pain (5 questions), stiffness (2 questions), and physical functioning (17 questions) of the joints. Each question is measured on a scale from 0 (lowest pain/lowest stiffness/highest function) to 10 (highest pain/highest stiffness/lowest function). The WOMAC Pain subscore is standardized and reported ranging from 0 to 100 \\[0 = no pain, 100 = pain as bad as it can be\\].'}, {'measure': 'Change From Baseline OA Function in the Target Knee as Assessed by WOMAC Physical Function Subscore (WOMAC Function)', 'timeFrame': 'Baseline and Week 12', 'description': 'Change from baseline OA function in the target knee as assessed by WOMAC Numeric Rating Scale (NRS 3.1) physical functioning subscore (WOMAC Function) at Week 12. The WOMAC is a widely-used, proprietary outcome measurement tool used by health professionals to evaluate the condition of subjects with OA of the knee and hip, including pain (5 questions), stiffness (2 questions), and physical functioning (17 questions) of the joints. Each question is measured on a scale from 0 (lowest pain/lowest stiffness/highest function) to 10 (highest pain/highest stiffness/lowest function). The WOMAC Function subscore is standardized and reported ranging from 0 to 100 \\[0 = no functional disability, 100 = unable to function\\].'}, {'measure': 'Change From Baseline OA Pain in the Target Knee as Assesses by the Weekly Average of Daily Pain NRS', 'timeFrame': 'Baseline and Week 12', 'description': 'Change from baseline OA pain in the target knee as assessed by the weekly average of daily pain NRS at Week 12. The pain NRS is an 11-point scale \\[0-10\\] for subject self-reporting of average knee pain in the last 24 hours; 0 indicates no pain, and 10 represents the worst possible pain (pain as bad as one can imagine).'}, {'measure': 'Change From Baseline OA Disease Activity as Assessed by Patient Global Assessment (PtGA)', 'timeFrame': 'Baseline and Week 12', 'description': 'Change from baseline OA disease activity as assessed by PtGA at Week 12. The PtGA completed using a 100 mm visual analog scale (VAS) adapted from the Patient Assessment Form © 1999, American College of Rheumatology. The subject rated how well he/she was doing, considering all the ways in which illness and health conditions may affected him/her. The VAS scale was anchored by "Very Well" on the left (scored as 0) and "Very Poorly" on the right (scored as 100). Higher scores indicated poorer disease assessment by the subject.'}], 'primaryOutcomes': [{'measure': 'Change From Baseline Osteoarthritis (OA) Pain in the Target Knee as Assessed by the Weekly Average of Daily Pain Numeric Rating Scale (NRS)', 'timeFrame': 'Baseline and Week 24', 'description': 'Change from baseline OA pain in the target knee as assessed by the weekly average of daily pain NRS at Week 24. The pain NRS is an 11-point scale \\[0-10\\] for subject self-reporting of average knee pain in the last 24 hours; 0 indicates no pain, and 10 represents the worst possible pain (pain as bad as one can imagine).'}, {'measure': 'Change From Baseline OA Pain in the Target Knee as Assessed by Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscore (WOMAC Pain)', 'timeFrame': 'Baseline and Week 24', 'description': 'Change from baseline OA pain in the target knee as assessed by WOMAC Numeric Rating Scale (NRS 3.1) pain subscore (WOMAC Pain) at Week 24. The WOMAC is a widely-used, proprietary outcome measurement tool used by health professionals to evaluate the condition of subjects with OA of the knee and hip, including pain (5 questions), stiffness (2 questions), and physical functioning (17 questions) of the joints. Each question is measured on a scale from 0 (lowest pain/lowest stiffness/highest function) to 10 (highest pain/highest stiffness/lowest function). The WOMAC Pain subscore is standardized and reported ranging from 0 to 100 \\[0 = no pain; 100 = pain as bad as it can be\\].'}, {'measure': 'Change From Baseline OA Function in the Target Knee as Assessed by WOMAC Physical Function Subscore (WOMAC Function)', 'timeFrame': 'Baseline and Week 24', 'description': 'Change from baseline OA function in the target knee as assessed by WOMAC Numeric Rating Scale (NRS 3.1) physical functioning subscore (WOMAC Function) at Week 24. The WOMAC is a widely-used, proprietary outcome measurement tool used by health professionals to evaluate the condition of subjects with OA of the knee and hip, including pain (5 questions), stiffness (2 questions), and physical functioning (17 questions) of the joints. Each question is measured on a scale from 0 (lowest pain/lowest stiffness/highest function) to 10 (highest pain/highest stiffness/lowest function). The WOMAC Function subscore is standardized and reported ranging from 0 to 100 \\[0 = no functional disability, 100 = unable to function\\].'}, {'measure': 'Change From Baseline in Medial Joint Space Width (mJSW) of the Target Knee', 'timeFrame': 'Baseline and Week 24', 'description': 'Change from baseline in mJSW as documented by radiograph of the target knee.'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline OA Disease Activity as Assessed by Patient Global Assessment (PtGA)', 'timeFrame': 'Baseline and Week 24', 'description': 'Change from baseline OA disease activity as assessed by PtGA at Week 24. The PtGA was completed using a 100 mm visual analog scale (VAS) adapted from the Patient Assessment Form © 1999, American College of Rheumatology. The subject rated how well he/she was doing, considering all the ways in which illness and health conditions may affected him/her. The VAS scale was anchored by "Very Well" on the left (scored as 0) and "Very Poorly" on the right (scored as 100). Higher scores indicated poorer disease assessment by the subject.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['SM04690', 'Wnt pathway inhibitor', 'osteoarthritis', 'Samumed'], 'conditions': ['Knee Osteoarthritis']}, 'referencesModule': {'references': [{'pmid': '33588087', 'type': 'RESULT', 'citation': 'Yazici Y, McAlindon TE, Gibofsky A, Lane NE, Lattermann C, Skrepnik N, Swearingen CJ, Simsek I, Ghandehari H, DiFrancesco A, Gibbs J, Tambiah JRS, Hochberg MC. A Phase 2b randomized trial of lorecivivint, a novel intra-articular CLK2/DYRK1A inhibitor and Wnt pathway modulator for knee osteoarthritis. Osteoarthritis Cartilage. 2021 May;29(5):654-666. doi: 10.1016/j.joca.2021.02.004. Epub 2021 Feb 12.'}, {'pmid': '39495154', 'type': 'DERIVED', 'citation': 'Tambiah J, Kennedy S, Swearingen C, McAlindon T, Yazici Y. Impact of structural severity on outcomes in knee osteoarthritis: an analysis of data from phase 2 and phase 3 lorecivivint clinical trials. Rheumatology (Oxford). 2025 May 1;64(5):2583-2590. doi: 10.1093/rheumatology/keae610.'}, {'pmid': '35005990', 'type': 'DERIVED', 'citation': 'Tambiah JRS, Simsek I, Swearingen CJ, Kennedy S, Cole BJ, McAlindon TE, Yazici Y. Comparing Patient-Reported Outcomes From Sham and Saline-Based Placebo Injections for Knee Osteoarthritis: Data From a Randomized Clinical Trial of Lorecivivint. Am J Sports Med. 2022 Mar;50(3):630-636. doi: 10.1177/03635465211067201. Epub 2022 Jan 10.'}, {'pmid': '34101138', 'type': 'DERIVED', 'citation': 'Tambiah JRS, Kennedy S, Swearingen CJ, Simsek I, Yazici Y, Farr J, Conaghan PG. Individual Participant Symptom Responses to Intra-Articular Lorecivivint in Knee Osteoarthritis: Post Hoc Analysis of a Phase 2B Trial. Rheumatol Ther. 2021 Jun;8(2):973-985. doi: 10.1007/s40744-021-00316-w. Epub 2021 Jun 8.'}]}, 'descriptionModule': {'briefSummary': 'This phase 2 study is a placebo-controlled, double-blind, parallel group study of four concentrations of SM04690 (0.03, 0.07, 0.15, and 0.23 mg per 2 mL injection) injected intraarticularly (IA) into the target knee joint of subjects with moderately to severely symptomatic osteoarthritis (OA). Based on previous studies of SM04690, key phenotypes of laterality (unilateral vs bilateral) as well as chronic pain (as measured by the Widespread Pain Index) were identified as confounding variables impacting the overall assessment of both radiologic and clinical efficacy outcomes. The design of SM04690-OA-04 is based upon previous study designs while assessing strategies to combat the confounding impact of laterality and chronic pain. To evaluate the effect of IA vehicle injection on patient-reported outcomes (PRO) such as pain, stiffness, and function in OA, this study also includes one cohort that receives a 2 mL IA injection of vehicle (placebo), and one cohort that receives a sham injection (i.e., a needle stick with 0 mL vehicle injected).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Ambulatory\n* Diagnosis of femorotibial OA in the target knee by standard American College of Rheumatology (ACR) criteria at screening (clinical AND radiographic criteria); OA of the knee is not to be secondary to any rheumatologic conditions (e.g., rheumatoid arthritis)\n* Pain compatible with OA of the knee(s) for at least 26 weeks prior to screening\n* Primary source of pain throughout the body is due to OA in the target knee\n* Willingness to use an electronic diary on a daily basis in the evening for the screening period and 24-week study duration\n* Negative drug test for opioids and drugs of abuse, except alcohol and marijuana, at screening\n* Subjects with depression or anxiety must be clinically stable for 12 weeks prior to screening, and, if on treatment for depression or anxiety, be on 12 weeks of stable therapy\n* Full understanding of the requirements of the study and willingness to comply with all study visits and assessments\n* Subjects must have read and understood the informed consent form, and must have signed it prior to any study-related procedure being performed\n\nExclusion Criteria:\n\n* Women who are pregnant, lactating, or have a positive pregnancy result at screening\n* Women of child bearing potential who are sexually active and are not willing to use a highly effective method of birth control during the study period\n* Males who are sexually active and have a partner who is capable of becoming pregnant, neither of whom have had surgery to become sterilized or whom are not using a highly effective method of birth control\n* Body mass index (BMI) \\> 35\n* Partial or complete joint replacement in either knee\n* Currently requires regular use of ambulatory assistive devices (e.g., wheelchair, parallel bars, walker, canes, or crutches) or use of a lower extremity prosthesis, and/or a structural knee brace\n* Previous participation in a Samumed clinical trial investigating SM04690\n* Any surgery (e.g., arthroscopy) in either knee within 26 weeks prior to screening\n* Any planned surgery during the study period\n* History of malignancy within the last 5 years; however, subjects with prior history of in situ cancer or basal or squamous cell skin cancer are eligible if completely excised. Subjects with other malignancies are eligible if they have been continuously disease free for at least 5 years prior to any study injection\n* Comorbid conditions that could affect study endpoint assessments of the target knee, including, but not limited to, rheumatoid arthritis, psoriatic arthritis, systemic lupus erythematosus, gout or pseudogout, and fibromyalgia\n* Any diagnosed psychiatric condition that includes, but is not limited to, a history of mania, bipolar disorder, psychotic disorder, schizophrenia, schizoaffective disorder, major depressive disorder, or generalized anxiety disorder\n* Participation in a clinical research trial that included the receipt of an investigational product or any experimental therapeutic procedure, or an observational research trial related to osteoarthritis within 8 weeks prior to any study injection, or planned participation in any such trial\n* Treatment of the target knee with intra-articular glucocorticoids (e.g., methylprednisolone) within 12 weeks prior to screening\n* Any intra-articular injection into the target knee with a therapeutic aim including, but not limited to, viscosupplementation (e.g., hyaluronic acid), platelet-rich plasma (PRP), and stem cell therapies within 24 weeks prior to screening; treatment of the target knee with intra-articular glucocorticoids greater than 12 weeks prior to screening is allowed\n* Treatment with systemic glucocorticoids greater than 10 mg prednisone or the equivalent per day within 4 weeks prior to screening\n* Effusion of the target knee clinically requiring aspiration within 12 weeks prior to screening\n* Use of electrotherapy, acupuncture, and/or chiropractic treatments for knee OA within 4 weeks prior to screening\n* Any known active infections, including urinary tract infection, upper respiratory tract infection, sinusitis, suspicion of intra-articular infection, hepatitis B or hepatitis C infection, and/or infections that may compromise the immune system such as human immunodeficiency virus (HIV) at study start\n* Use of centrally acting analgesics (e.g., duloxetine) within 12 weeks prior to screening\n* Use of anticonvulsants within 12 weeks prior to screening, unless used for seizure or migraine prophylaxis\n* Subjects requiring the usage of opioids \\>1x per week within 12 weeks prior to screening\n* Use of topical local anesthetic agents (gels, creams, or patches such as the Lidoderm patch) for the treatment of knee OA within 7 days of screening'}, 'identificationModule': {'nctId': 'NCT03122860', 'briefTitle': 'A Study Evaluating the Safety and Efficacy of SM04690 for the Treatment of Moderately to Severely Symptomatic Knee Osteoarthritis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Biosplice Therapeutics, Inc.'}, 'officialTitle': 'A Phase 2, 24-Week, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of SM04690 for the Treatment of Moderately to Severely Symptomatic Knee Osteoarthritis', 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