Viewing Study NCT00041756

Home Icon Home Search Icon Search Certify Doc Icon Certify Doc Certify Doc Icon Genes Certify Doc Icon Clinical Trials Certify Doc Icon CompTox Processes Icon DrugMatrix Open Targets Icon Open Targets Processes Icon Products Support Icon Support Bugs Icon Bugs
Main Search Make This Study a Gene Therapy Make This Study a Not Gene Therapy Report Bug
Ignite Creation Date: 2025-12-24 @ 11:17 PM
Ignite Modification Date: 2026-01-01 @ 7:12 AM
Study NCT ID: NCT00041756
Status: COMPLETED
Last Update Posted: 2011-11-08
First Post: 2002-07-16
Is NOT Gene Therapy: True
Has Adverse Events: True
Brief Title: Efficacy and Safety of PG-530742 in the Treatment of Mild to Moderate Knee Osteoarthritis
Sponsor:
Organization:
Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020370', 'term': 'Osteoarthritis, Knee'}], 'ancestors': [{'id': 'D010003', 'term': 'Osteoarthritis'}, {'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'thomas.pr@pg.com', 'phone': '513.622.4838', 'title': 'Peter Thomas', 'organization': 'Procter & Gamble'}, 'certainAgreement': {'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Placebo Tablet', 'description': 'Placebo tablet dosed BID', 'otherNumAtRisk': 77, 'otherNumAffected': 37, 'seriousNumAtRisk': 77, 'seriousNumAffected': 8}, {'id': 'EG001', 'title': '25 mg PG-530742', 'description': '25 mg PG-530742 dosed BID', 'otherNumAtRisk': 80, 'otherNumAffected': 41, 'seriousNumAtRisk': 80, 'seriousNumAffected': 7}, {'id': 'EG002', 'title': '50 mg PG-530742', 'description': '50 mg PG-530742 dosed BID', 'otherNumAtRisk': 79, 'otherNumAffected': 34, 'seriousNumAtRisk': 79, 'seriousNumAffected': 12}, {'id': 'EG003', 'title': '100 mg PG-530742', 'description': '100 mg PG-530742 dosed BID', 'otherNumAtRisk': 80, 'otherNumAffected': 43, 'seriousNumAtRisk': 80, 'seriousNumAffected': 10}, {'id': 'EG004', 'title': '200 mg PG-530742', 'description': '200 mg PG-530742 dosed BID', 'otherNumAtRisk': 79, 'otherNumAffected': 44, 'seriousNumAtRisk': 79, 'seriousNumAffected': 17}], 'otherEvents': [{'term': 'Blood and lymphatic system disorders (Overall)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 80, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 79, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 79, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Cardiac disorders (Overall)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 80, 'numEvents': 6, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 79, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 80, 'numEvents': 10, 'numAffected': 7}, {'groupId': 'EG004', 'numAtRisk': 79, 'numEvents': 5, 'numAffected': 4}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Ear and labyrinth disorders (Overall)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 79, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 80, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 79, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Eye disorders (Overall)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 6, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 80, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 79, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 80, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 79, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Gastrointestinal disorders (Overall)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 31, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 80, 'numEvents': 21, 'numAffected': 14}, {'groupId': 'EG002', 'numAtRisk': 79, 'numEvents': 25, 'numAffected': 15}, {'groupId': 'EG003', 'numAtRisk': 80, 'numEvents': 34, 'numAffected': 16}, {'groupId': 'EG004', 'numAtRisk': 79, 'numEvents': 37, 'numAffected': 19}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'General disorders and administration site conditions (Overall)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 7, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 80, 'numEvents': 14, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 79, 'numEvents': 13, 'numAffected': 12}, {'groupId': 'EG003', 'numAtRisk': 80, 'numEvents': 11, 'numAffected': 9}, {'groupId': 'EG004', 'numAtRisk': 79, 'numEvents': 20, 'numAffected': 19}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Infections and infestation (Overall)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 37, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 80, 'numEvents': 40, 'numAffected': 26}, {'groupId': 'EG002', 'numAtRisk': 79, 'numEvents': 18, 'numAffected': 16}, {'groupId': 'EG003', 'numAtRisk': 80, 'numEvents': 35, 'numAffected': 24}, {'groupId': 'EG004', 'numAtRisk': 79, 'numEvents': 22, 'numAffected': 16}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Injury, poisoning and procedural complications (Overall)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 9, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 80, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 79, 'numEvents': 7, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 80, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG004', 'numAtRisk': 79, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Investigations (Overall)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 14, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 80, 'numEvents': 31, 'numAffected': 16}, {'groupId': 'EG002', 'numAtRisk': 79, 'numEvents': 19, 'numAffected': 12}, {'groupId': 'EG003', 'numAtRisk': 80, 'numEvents': 16, 'numAffected': 9}, {'groupId': 'EG004', 'numAtRisk': 79, 'numEvents': 23, 'numAffected': 10}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Metabolism and nutrition disorders (Overall)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 80, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 79, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 80, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 79, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Musculoskeletal and connective tissue disorders (Overall)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 91, 'numAffected': 37}, {'groupId': 'EG001', 'numAtRisk': 80, 'numEvents': 104, 'numAffected': 41}, {'groupId': 'EG002', 'numAtRisk': 79, 'numEvents': 85, 'numAffected': 34}, {'groupId': 'EG003', 'numAtRisk': 80, 'numEvents': 135, 'numAffected': 43}, {'groupId': 'EG004', 'numAtRisk': 79, 'numEvents': 154, 'numAffected': 44}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Neoplasms benign, malignant and unspecified (Overall)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 80, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 79, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 80, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 79, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Nervous system disorders (Overall)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 8, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 80, 'numEvents': 16, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 79, 'numEvents': 15, 'numAffected': 10}, {'groupId': 'EG003', 'numAtRisk': 80, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG004', 'numAtRisk': 79, 'numEvents': 10, 'numAffected': 7}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Psychiatric disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 80, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 79, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 80, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 79, 'numEvents': 6, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Renal and urinary disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 80, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 79, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 80, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 79, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Respiratory, thoracic and mediastinal disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 80, 'numEvents': 12, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 79, 'numEvents': 8, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 80, 'numEvents': 13, 'numAffected': 7}, {'groupId': 'EG004', 'numAtRisk': 79, 'numEvents': 8, 'numAffected': 7}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Skin and subcutaneous tissue disorders (Overall)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 9, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 80, 'numEvents': 9, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 79, 'numEvents': 10, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 80, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 79, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Vascular disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 9, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 80, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 79, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 80, 'numEvents': 7, 'numAffected': 6}, {'groupId': 'EG004', 'numAtRisk': 79, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}], 'seriousEvents': [{'term': 'Athralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 80, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 79, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 80, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 79, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'COSTART'}, {'term': 'Myocardial Infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 79, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 80, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 79, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'COSTART'}, {'term': 'Pneumonia NOS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 79, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 80, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 79, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'COSTART'}, {'term': 'Cardiac failure NOS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 79, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 80, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 79, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'COSTART'}, {'term': 'Periarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 79, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 79, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'COSTART'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 79, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 79, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'COSTART'}, {'term': 'Localised Osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 79, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 79, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'COSTART'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 79, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 80, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 79, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'COSTART'}, {'term': 'Anaemia NOS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 79, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 79, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'COSTART'}, {'term': 'Eosinophilia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 79, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 79, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'COSTART'}, {'term': 'Atioventricular block NOS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 79, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 80, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 79, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'COSTART'}, {'term': 'Angina Unstable', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 79, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 79, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'COSTART'}, {'term': 'Tachycardia NOS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 79, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 80, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 79, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'COSTART'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 79, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 79, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'COSTART'}, {'term': 'Sinus tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 79, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 80, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 79, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'COSTART'}, {'term': 'Cataract', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 79, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 80, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 79, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'COSTART'}, {'term': 'Cataract unilateral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 79, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 79, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'COSTART'}, {'term': 'Diverticulitis NOS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 79, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 79, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'COSTART'}, {'term': 'Duodenal erosions', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 79, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 79, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'COSTART'}, {'term': 'Gastric erosions', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 79, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 79, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'COSTART'}, {'term': 'Gastric ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 79, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 80, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 79, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'COSTART'}, {'term': 'Appendicitis perforated', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 79, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 79, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'COSTART'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 79, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 80, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 79, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'COSTART'}, {'term': 'Reflux oesophagitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 79, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 79, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'COSTART'}, {'term': 'Fibrosis NOS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 79, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 79, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'COSTART'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 79, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 80, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 79, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'COSTART'}, {'term': 'Pharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 79, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 79, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'COSTART'}, {'term': 'Hip fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 79, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 79, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'COSTART'}, {'term': 'Tibia fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 80, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 79, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 79, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'COSTART'}, {'term': 'Tendon rupture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 79, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 79, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'COSTART'}, {'term': 'Animal bite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 79, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 79, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'COSTART'}, {'term': 'Head injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 80, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 79, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 79, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'COSTART'}, {'term': 'Humerus fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 79, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 79, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'COSTART'}, {'term': 'Biopsy lymph gland abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 79, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 79, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'COSTART'}, {'term': 'Hypoglycaemia NOS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 79, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 80, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 79, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'COSTART'}, {'term': 'Arthritis NOS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 79, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 79, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'COSTART'}, {'term': 'Periostitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 79, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 79, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'COSTART'}, {'term': 'Toe deformities NOS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 79, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 79, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'COSTART'}, {'term': 'Intervertebral disc herniation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 79, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 79, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'COSTART'}, {'term': "Dupuytren's contracture", 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 80, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 79, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 79, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'COSTART'}, {'term': 'Fibrositis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 79, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 79, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'COSTART'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 79, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 80, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 79, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'COSTART'}, {'term': 'Spondylosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 79, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 79, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'COSTART'}, {'term': 'Tendonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 79, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 79, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'COSTART'}, {'term': 'Breast cancer NOS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 80, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 79, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 79, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'COSTART'}, {'term': 'Hepatic cancer metastatic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 79, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 80, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 79, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'COSTART'}, {'term': 'Metastases to bone', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 79, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 80, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 79, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'COSTART'}, {'term': 'Ovarian cancer NOS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 79, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 80, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 79, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'COSTART'}, {'term': 'Basal cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 79, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 79, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'COSTART'}, {'term': 'Cerebrovascular accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 80, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 79, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 79, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'COSTART'}, {'term': 'Vertegrobasilar insufficiency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 80, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 79, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 79, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'COSTART'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 80, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 79, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 79, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'COSTART'}, {'term': 'Renal failure NOS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 79, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 79, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'COSTART'}, {'term': 'Urethral stricture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 79, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 79, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'COSTART'}, {'term': 'Haematuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 79, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 79, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'COSTART'}, {'term': 'Renal colic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 79, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 79, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'COSTART'}, {'term': 'Prostatic hypertrophy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 79, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 79, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'COSTART'}, {'term': 'Dyspnea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 79, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 79, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'COSTART'}, {'term': 'Respiratory distress', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 79, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 80, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 79, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'COSTART'}, {'term': 'Haemorrhage NOS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 79, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 79, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'COSTART'}, {'term': 'Hypertension NOS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 79, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 79, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'COSTART'}], 'frequencyThreshold': '3'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Minimum Joint Space Width in the Medial Compartment of the Tibiofemoral Joint of the Signal Knee After 1 Year of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}, {'value': '67', 'groupId': 'OG002'}, {'value': '69', 'groupId': 'OG003'}, {'value': '52', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Tablet', 'description': 'Placebo tablet dosed BID'}, {'id': 'OG001', 'title': '25 mg PG-530742', 'description': '25 mg PG-530742 dosed BID'}, {'id': 'OG002', 'title': '50 mg PG-530742', 'description': '50 mg PG-530742 dosed BID'}, {'id': 'OG003', 'title': '100 mg PG-530742', 'description': '100 mg PG-530742 dosed BID'}, {'id': 'OG004', 'title': '200 mg PG-530742', 'description': '200 mg PG-530742 dosed BID'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.1361', 'spread': '0.0627', 'groupId': 'OG000'}, {'value': '-0.0442', 'spread': '0.0624', 'groupId': 'OG001'}, {'value': '-0.2261', 'spread': '0.0650', 'groupId': 'OG002'}, {'value': '-0.2000', 'spread': '0.0650', 'groupId': 'OG003'}, {'value': '-0.1916', 'spread': '0.0723', 'groupId': 'OG004'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'baseline and 12 months', 'description': 'The structural primary efficacy endpoint is the 1-year change from baseline in minimum joint space width (JSW) in the medial compartment of the tibiofemoral joint of the signal knee, as measured by microfocal knee radiographs obtained in the semi-flexed position.', 'unitOfMeasure': 'mm', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'An intent-to-treat (ITT) analysis was conducted on all patients who were randomized and took at least one dose of study drug. Any missing data for these patients was not imputed in the primary analysis.\n\nanalysis.'}, {'type': 'PRIMARY', 'title': 'Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Total Score at 1 Year', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}, {'value': '62', 'groupId': 'OG002'}, {'value': '62', 'groupId': 'OG003'}, {'value': '30', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Tablet', 'description': 'Placebo tablet dosed BID'}, {'id': 'OG001', 'title': '25 mg PG-530742', 'description': '25 mg PG-530742 dosed BID'}, {'id': 'OG002', 'title': '50 mg PG-530742', 'description': '50 mg PG-530742 dosed BID'}, {'id': 'OG003', 'title': '100 mg PG-530742', 'description': '100 mg PG-530742 dosed BID'}, {'id': 'OG004', 'title': '200 mg PG-530742', 'description': '200 mg PG-530742 dosed BID'}], 'classes': [{'categories': [{'measurements': [{'value': '-9.1', 'spread': '2.81', 'groupId': 'OG000'}, {'value': '-6.7', 'spread': '2.78', 'groupId': 'OG001'}, {'value': '-10.0', 'spread': '2.88', 'groupId': 'OG002'}, {'value': '-5.8', 'spread': '2.92', 'groupId': 'OG003'}, {'value': '-9.3', 'spread': '3.96', 'groupId': 'OG004'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'baseline and 12 months', 'description': 'The symptomatic primary efficacy endpoint is the change in total WOMAC scores after 1 year of treatment. The WOMAC consists of 24 items divided into 3 subscales: Pain (5 items), Stiffness (2 items), Physical Function (17 items). The WOMAC uses descriptors for all items: none, mild moderate, severe, and extreme (corresponding to an ordinal scale of 0-4.) Scores are summed for items in each subscale, with possible ranges as follows: pain=0-20, stiffness=0-8, physical function=0-68. The total WOMAC score is created by summing the items for all three subscales (min=0, max=96)', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'An intent-to-treat (ITT) analysis was conducted on all patients who were randomized and took at least one dose of study drug. Any missing data for these patients was not imputed in the primary analysis.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo Tablet', 'description': 'Placebo tablet dosed BID'}, {'id': 'FG001', 'title': '25 mg PG-530742', 'description': '25 mg PG-530742 dosed BID'}, {'id': 'FG002', 'title': '50 mg PG-530742', 'description': '50 mg PG-530742 dosed BID'}, {'id': 'FG003', 'title': '100 mg PG-530742', 'description': '100 mg PG-530742 dosed BID'}, {'id': 'FG004', 'title': '200 mg PG-530742', 'description': '200 mg PG-530742 dosed BID'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '77'}, {'groupId': 'FG001', 'numSubjects': '80'}, {'groupId': 'FG002', 'numSubjects': '79'}, {'groupId': 'FG003', 'numSubjects': '80'}, {'groupId': 'FG004', 'numSubjects': '79'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '69'}, {'groupId': 'FG001', 'numSubjects': '65'}, {'groupId': 'FG002', 'numSubjects': '66'}, {'groupId': 'FG003', 'numSubjects': '64'}, {'groupId': 'FG004', 'numSubjects': '19'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '15'}, {'groupId': 'FG002', 'numSubjects': '13'}, {'groupId': 'FG003', 'numSubjects': '16'}, {'groupId': 'FG004', 'numSubjects': '60'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '10'}, {'groupId': 'FG002', 'numSubjects': '6'}, {'groupId': 'FG003', 'numSubjects': '11'}, {'groupId': 'FG004', 'numSubjects': '34'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '3'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Unable to meet protocol criteria', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}]}, {'type': 'Data Monitoring Committee Recommendation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '21'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '77', 'groupId': 'BG000'}, {'value': '80', 'groupId': 'BG001'}, {'value': '79', 'groupId': 'BG002'}, {'value': '80', 'groupId': 'BG003'}, {'value': '79', 'groupId': 'BG004'}, {'value': '395', 'groupId': 'BG005'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo Tablet', 'description': 'Placebo tablet dosed BID'}, {'id': 'BG001', 'title': '25 mg PG-530742', 'description': '25 mg PG-530742 dosed BID'}, {'id': 'BG002', 'title': '50 mg PG-530742', 'description': '50 mg PG-530742 dosed BID'}, {'id': 'BG003', 'title': '100 mg PG-530742', 'description': '100 mg PG-530742 dosed BID'}, {'id': 'BG004', 'title': '200 mg PG-530742', 'description': '200 mg PG-530742 dosed BID'}, {'id': 'BG005', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '62.0', 'spread': '0.92', 'groupId': 'BG000'}, {'value': '62.4', 'spread': '0.86', 'groupId': 'BG001'}, {'value': '62.6', 'spread': '0.92', 'groupId': 'BG002'}, {'value': '62.9', 'spread': '0.95', 'groupId': 'BG003'}, {'value': '63.1', 'spread': '0.80', 'groupId': 'BG004'}, {'value': '62.6', 'spread': '0.40', 'groupId': 'BG005'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '54', 'groupId': 'BG000'}, {'value': '60', 'groupId': 'BG001'}, {'value': '61', 'groupId': 'BG002'}, {'value': '57', 'groupId': 'BG003'}, {'value': '49', 'groupId': 'BG004'}, {'value': '281', 'groupId': 'BG005'}]}, {'title': 'Male', 'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}, {'value': '23', 'groupId': 'BG003'}, {'value': '30', 'groupId': 'BG004'}, {'value': '114', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'American Indian', 'categories': [{'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': 'Asian Oriental', 'categories': [{'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', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}]}]}, {'title': 'Caucasian', 'categories': [{'measurements': [{'value': '77', 'groupId': 'BG000'}, {'value': '79', 'groupId': 'BG001'}, {'value': '77', 'groupId': 'BG002'}, {'value': '75', 'groupId': 'BG003'}, {'value': '76', 'groupId': 'BG004'}, {'value': '384', 'groupId': 'BG005'}]}]}, {'title': 'Hispanic', 'categories': [{'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': 'Asian Indian', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '8', 'groupId': 'BG005'}]}]}, {'title': 'Multi-Racial', 'categories': [{'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': 'NUMBER', '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': 395}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2002-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-11', 'completionDateStruct': {'date': '2004-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-11-07', 'studyFirstSubmitDate': '2002-07-16', 'resultsFirstSubmitDate': '2011-08-03', 'studyFirstSubmitQcDate': '2002-07-16', 'lastUpdatePostDateStruct': {'date': '2011-11-08', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2011-11-07', 'studyFirstPostDateStruct': {'date': '2002-07-17', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2011-11-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2004-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Minimum Joint Space Width in the Medial Compartment of the Tibiofemoral Joint of the Signal Knee After 1 Year of Treatment', 'timeFrame': 'baseline and 12 months', 'description': 'The structural primary efficacy endpoint is the 1-year change from baseline in minimum joint space width (JSW) in the medial compartment of the tibiofemoral joint of the signal knee, as measured by microfocal knee radiographs obtained in the semi-flexed position.'}, {'measure': 'Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Total Score at 1 Year', 'timeFrame': 'baseline and 12 months', 'description': 'The symptomatic primary efficacy endpoint is the change in total WOMAC scores after 1 year of treatment. The WOMAC consists of 24 items divided into 3 subscales: Pain (5 items), Stiffness (2 items), Physical Function (17 items). The WOMAC uses descriptors for all items: none, mild moderate, severe, and extreme (corresponding to an ordinal scale of 0-4.) Scores are summed for items in each subscale, with possible ranges as follows: pain=0-20, stiffness=0-8, physical function=0-68. The total WOMAC score is created by summing the items for all three subscales (min=0, max=96)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Primary Disease: Knee Primary Osteoarthritis'], 'conditions': ['Osteoarthritis, Knee']}, 'referencesModule': {'references': [{'pmid': '17958901', 'type': 'DERIVED', 'citation': 'Krzeski P, Buckland-Wright C, Balint G, Cline GA, Stoner K, Lyon R, Beary J, Aronstein WS, Spector TD. Development of musculoskeletal toxicity without clear benefit after administration of PG-116800, a matrix metalloproteinase inhibitor, to patients with knee osteoarthritis: a randomized, 12-month, double-blind, placebo-controlled study. Arthritis Res Ther. 2007;9(5):R109. doi: 10.1186/ar2315.'}]}, 'descriptionModule': {'briefSummary': 'Matrix metalloproteinases (MMPs) have been implicated in the cartilage degradation. PG-530742 inhibits some MMPs, potentially limiting cartilage degradation and disease progression. This study will test the efficacy and safety of PG-530742 in the treatment of mild to moderate knee osteoarthritis.', 'detailedDescription': 'Matrix metalloproteinases have been implicated in the cartilage degradation that occurs in osteoarthritis. PG-530742 inhibits some of these matrix metalloproteinases, thus potentially limiting cartilage degradation and disease progression. This study will test the efficacy and safety of PG-530742 in the treatment of mild to moderate knee osteoarthritis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* mild to moderate knee osteoarthritis confirmed by a radiographic technique.\n\nExclusion Criteria:\n\n* secondary knee osteoarthritis;\n* diseases other than osteoarthritis that could cause knee pain;\n* any disease or intervention (surgery, intra-articular injection) that would have an impact on knee pain or mobility;\n* drugs that act potentially on the bone or cartilage component of the knee joint.'}, 'identificationModule': {'nctId': 'NCT00041756', 'briefTitle': 'Efficacy and Safety of PG-530742 in the Treatment of Mild to Moderate Knee Osteoarthritis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Procter and Gamble'}, 'officialTitle': 'Efficacy and Safety of PG-530742 in the Treatment of Mild to Moderate Knee Osteoarthritis', 'orgStudyIdInfo': {'id': '2001065'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo tablet', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': '25 mg PG-530742', 'description': '25 mg PG-530742', 'interventionNames': ['Drug: PG-530742']}, {'type': 'EXPERIMENTAL', 'label': '50 mg PG-530742', 'description': '50 mg PG-530742', 'interventionNames': ['Drug: 50 mg PG-530742']}, {'type': 'EXPERIMENTAL', 'label': '100 mg PG-530742', 'description': '100 mg PG-530742', 'interventionNames': ['Drug: 100 mg PG-530742']}, {'type': 'EXPERIMENTAL', 'label': '200 mg PG-530742', 'description': '200 mg PG-530742', 'interventionNames': ['Drug: 200 mg PG-530742']}], 'interventions': [{'name': 'PG-530742', 'type': 'DRUG', 'description': 'One 25 mg PG-530742 tablet, twice daily for for one year', 'armGroupLabels': ['25 mg PG-530742']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'One placebo tablet, twice daily for for one year', 'armGroupLabels': ['Placebo']}, {'name': '50 mg PG-530742', 'type': 'DRUG', 'description': 'One 50 mg PG-530742 tablet, twice daily for for one year', 'armGroupLabels': ['50 mg PG-530742']}, {'name': '100 mg PG-530742', 'type': 'DRUG', 'description': '100 mg PG-530742 tablet, twice a day for one year', 'armGroupLabels': ['100 mg PG-530742']}, {'name': '200 mg PG-530742', 'type': 'DRUG', 'description': '200 mg PG-530742 tablet, twice a day for one year', 'armGroupLabels': ['200 mg PG-530742']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2026', 'city': 'Visegrád', 'state': 'Gizella Telep', 'country': 'Hungary', 'facility': 'Rehabilitation Hospital, Gizella telep', 'geoPoint': {'lat': 47.78526, 'lon': 18.9709}}, {'zip': '9025', 'city': 'Győr', 'state': 'Hid Utica 2', 'country': 'Hungary', 'facility': 'Petz A. Country Hospital, Department of Rheumatology, Hid utca 2.', 'geoPoint': {'lat': 47.68333, 'lon': 17.63512}}, {'zip': '1027', 'city': 'Budapest', 'country': 'Hungary', 'facility': 'National Institute of Rheumatology and Physiotherapy, Dept. of Rheumatology and Immunology, Frankel Leo u. 38-40', 'geoPoint': {'lat': 47.49835, 'lon': 19.04045}}, {'zip': '1027', 'city': 'Budapest', 'country': 'Hungary', 'facility': 'National Institute of Rheumatology and Physiotherapy, Dept. of Rheumatology I and Metabolic Osteology, Frankel Leo u. 38-40', 'geoPoint': {'lat': 47.49835, 'lon': 19.04045}}, {'zip': '1027', 'city': 'Budapest', 'country': 'Hungary', 'facility': 'National Institute of Rheumatology and Physiotherapy, Dept. of Rheumatology IV., Frankel Leo u. 38-40', 'geoPoint': {'lat': 47.49835, 'lon': 19.04045}}, {'zip': '1113', 'city': 'Budapest', 'country': 'Hungary', 'facility': 'Orthopedic Clinic, Karolina ut 17', 'geoPoint': {'lat': 47.49835, 'lon': 19.04045}}, {'zip': '3529', 'city': 'Miskolc', 'country': 'Hungary', 'facility': 'Szent Ferenc Hospital, Department of Rheumatology, Csabai Kapu 42.', 'geoPoint': {'lat': 48.10327, 'lon': 20.77806}}, {'zip': 'TW15 3EA', 'city': 'Ashford', 'state': 'Middlesex', 'country': 'United Kingdom', 'facility': '95 Stanwell Road', 'geoPoint': {'lat': 51.14648, 'lon': 0.87376}}, {'zip': 'HA 7 4LP', 'city': 'Stanmore', 'state': 'Middlesex', 'country': 'United Kingdom', 'facility': 'Royal National Orthapaedic Hsopital, Brackley Hill', 'geoPoint': {'lat': 51.61667, 'lon': -0.31667}}, {'city': 'London', 'state': 'Se17eh', 'country': 'United Kingdom', 'facility': 'St Thomas Hospital, Lambeth Place Road', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'KT15 2BH', 'city': 'Addlestone', 'state': 'Surrey', 'country': 'United Kingdom', 'facility': 'The Crouch Oak Practice, 45 Station Road, Addlestone', 'geoPoint': {'lat': 51.37135, 'lon': -0.49353}}, {'zip': 'KT24 6QT', 'city': 'East Horsley', 'state': 'Surrey', 'country': 'United Kingdom', 'facility': 'The Medical Centre, Kingston Avenue', 'geoPoint': {'lat': 51.27358, 'lon': -0.43207}}, {'zip': 'CV37 6HE', 'city': 'Stratford-upon-Avon', 'state': 'Warwickshire', 'country': 'United Kingdom', 'facility': 'Bridge House Medical Centre, Scholars Lane', 'geoPoint': {'lat': 52.19166, 'lon': -1.70734}}, {'zip': 'RH10 7DX', 'city': 'Crawley', 'state': 'West Sussex', 'country': 'United Kingdom', 'facility': 'Pound Hill Surgery, 1 Crawley Lane, Pound Hill', 'geoPoint': {'lat': 51.11303, 'lon': -0.18312}}, {'zip': 'B29 6JD', 'city': 'Birmingham', 'country': 'United Kingdom', 'facility': 'Dept of Rheumatology Selly Oak Hospital, Raddleburn Road, Selly Oak', 'geoPoint': {'lat': 52.48142, 'lon': -1.89983}}, {'zip': 'B15 2SQ', 'city': 'Edgbaston', 'country': 'United Kingdom', 'facility': 'Synexus Birmingham Clinical Research Centre, Birmingham Research Park', 'geoPoint': {'lat': 52.4623, 'lon': -1.92115}}, {'zip': 'TN 1 2DX', 'city': 'Kent', 'country': 'United Kingdom', 'facility': 'Grosvenor Medical Centre Clinical Trials Unit, 18 upper Grosvenor Road, Tunbridge Wells', 'geoPoint': {'lat': 51.27893, 'lon': 0.52021}}, {'zip': 'E11 1NR', 'city': 'London', 'country': 'United Kingdom', 'facility': 'Dept of Rheumatology Whipps Cross University Hospital, Whipps Cross Road', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'SE22 8PT', 'city': 'London', 'country': 'United Kingdom', 'facility': 'Dept of Rheumatology Dulwich Hospital, East Dulwich', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'SE1 9RT', 'city': 'London Bridge', 'country': 'United Kingdom', 'facility': "Rheumatology Department, Fourth Floor, Thomas Guy House, St Guy's House"}, {'zip': 'RG2 7AG', 'city': 'Reading', 'country': 'United Kingdom', 'facility': 'Synexus Reading Clinical Research Centre, Whiteley Glebe, 11 Glebe Road, off Christchurch Gardens', 'geoPoint': {'lat': 51.45625, 'lon': -0.97113}}, {'zip': 'TN10 3ET', 'city': 'Tonbridge', 'country': 'United Kingdom', 'facility': 'Hildenborough Medical Group, Trenchwood Surgery, 264 Shipbourne Road', 'geoPoint': {'lat': 51.19532, 'lon': 0.27363}}, {'zip': 'WN6 9EW', 'city': 'Wigan', 'country': 'United Kingdom', 'facility': 'Synexus Wrightington, Wrightington Hospital, Hall Lane, Awpley Bridge', 'geoPoint': {'lat': 53.54296, 'lon': -2.63706}}], 'overallOfficials': [{'name': 'John Beary, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Procter and Gamble'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Procter and Gamble', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}