Ignite Creation Date:
2025-12-25 @ 5:04 AM
Ignite Modification Date:
2025-12-26 @ 4:06 AM
Study NCT ID:
NCT03595618
Status:
COMPLETED
Last Update Posted:
2021-07-28
First Post:
2018-07-11
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
A Study to Assess Efficacy and Safety of GLPG1972/S201086 in Participants With Knee Osteoarthritis
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010003', 'term': 'Osteoarthritis'}], 'ancestors': [{'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'medicalinfo@glpg.com', 'phone': '+32 15342900', 'title': 'Galapagos Medical Information', 'organization': 'Galapagos NV'}, 'certainAgreement': {'otherDetails': 'The sponsor must review and approve any results of the study or abstracts for professional meetings prepared by the investigator(s). Published data must not compromise the objectives of the study. Data from individual study centers in multicenter studies must not be published separately.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Baseline up to 2-weeks after last dose of IMP (up to Week 54)', 'description': 'TEAEs were defined as all AEs that occurred:\n\n* between first IMP intake date (included) and last visit of participant, or\n* before first IMP intake date and that worsened (in terms of intensity) or became serious according to investigator opinion between first IMP intake date (included) and last visit of participant.\n\nAnalysis was based on the safety set. All serious AEs are reported, TEAEs are reported at a threshold of 3%.', 'eventGroups': [{'id': 'EG000', 'title': 'GLPG1972 75 mg', 'description': 'Participants received 1 film-coated tablet of GLPG1972 75 mg and 3 GLPG1972 matching placebo tablets, orally once daily for 52 weeks.', 'otherNumAtRisk': 234, 'deathsNumAtRisk': 234, 'otherNumAffected': 114, 'seriousNumAtRisk': 234, 'deathsNumAffected': 0, 'seriousNumAffected': 17}, {'id': 'EG001', 'title': 'GLPG1972 150 mg', 'description': 'Participants received 2 film-coated tablets of GLPG1972 75 mg (total dose 150 mg) and 2 GLPG1972 matching placebo tablets, orally once daily for 52 weeks.', 'otherNumAtRisk': 231, 'deathsNumAtRisk': 231, 'otherNumAffected': 124, 'seriousNumAtRisk': 231, 'deathsNumAffected': 1, 'seriousNumAffected': 17}, {'id': 'EG002', 'title': 'GLPG1972 300 mg', 'description': 'Participants received 4 film-coated tablets of GLPG1972 75 mg (total dose 300 mg), orally once daily for 52 weeks.', 'otherNumAtRisk': 232, 'deathsNumAtRisk': 232, 'otherNumAffected': 105, 'seriousNumAtRisk': 232, 'deathsNumAffected': 0, 'seriousNumAffected': 18}, {'id': 'EG003', 'title': 'Placebo', 'description': 'Participants received 4 film-coated tablets of GLPG1972 matching placebo, orally once daily for 52 weeks.', 'otherNumAtRisk': 234, 'deathsNumAtRisk': 234, 'otherNumAffected': 130, 'seriousNumAtRisk': 234, 'deathsNumAffected': 0, 'seriousNumAffected': 18}], 'otherEvents': [{'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 234, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 231, 'numAffected': 34}, {'groupId': 'EG002', 'numAtRisk': 232, 'numAffected': 26}, {'groupId': 'EG003', 'numAtRisk': 234, 'numAffected': 19}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 234, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 231, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 232, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 234, 'numAffected': 19}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 234, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 231, 'numAffected': 16}, {'groupId': 'EG002', 'numAtRisk': 232, 'numAffected': 22}, {'groupId': 'EG003', 'numAtRisk': 234, 'numAffected': 20}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 234, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 231, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 232, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 234, 'numAffected': 10}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Gamma-glutamyltransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 234, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 231, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 232, 'numAffected': 16}, {'groupId': 'EG003', 'numAtRisk': 234, 'numAffected': 4}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Blood creatine phosphokinase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 234, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 231, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 232, 'numAffected': 9}, {'groupId': 'EG003', 'numAtRisk': 234, 'numAffected': 8}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 234, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 231, 'numAffected': 20}, {'groupId': 'EG002', 'numAtRisk': 232, 'numAffected': 16}, {'groupId': 'EG003', 'numAtRisk': 234, 'numAffected': 13}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 234, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 231, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 232, 'numAffected': 11}, {'groupId': 'EG003', 'numAtRisk': 234, 'numAffected': 9}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 234, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 231, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 232, 'numAffected': 12}, {'groupId': 'EG003', 'numAtRisk': 234, 'numAffected': 16}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 234, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 231, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 232, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 234, 'numAffected': 10}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 234, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 231, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 232, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 234, 'numAffected': 4}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Musculoskeletal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 234, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 231, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 232, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 234, 'numAffected': 5}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Joint swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 234, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 231, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 232, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 234, 'numAffected': 4}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 234, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 231, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 232, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 234, 'numAffected': 6}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 234, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 231, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 232, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 234, 'numAffected': 8}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 234, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 231, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 232, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 234, 'numAffected': 7}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 234, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 231, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 232, 'numAffected': 10}, {'groupId': 'EG003', 'numAtRisk': 234, 'numAffected': 7}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 234, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 231, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 232, 'numAffected': 10}, {'groupId': 'EG003', 'numAtRisk': 234, 'numAffected': 6}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'C-reactive protein increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 234, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 231, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 232, 'numAffected': 9}, {'groupId': 'EG003', 'numAtRisk': 234, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 234, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 231, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 232, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 234, 'numAffected': 6}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 234, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 231, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 232, 'numAffected': 11}, {'groupId': 'EG003', 'numAtRisk': 234, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 234, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 231, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 232, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 234, 'numAffected': 7}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Hypercholesterolaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 234, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 231, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 232, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 234, 'numAffected': 7}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 234, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 231, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 232, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 234, 'numAffected': 8}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}], 'seriousEvents': [{'term': 'Osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 234, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 231, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 232, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 234, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 234, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 231, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 232, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 234, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 234, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 231, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 232, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 234, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Myopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 234, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 231, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 232, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 234, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Joint swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 234, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 231, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 232, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 234, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'COVID-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 234, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 231, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 232, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 234, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 234, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 231, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 232, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 234, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Pneumonia bacterial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 234, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 231, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 232, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 234, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 234, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 231, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 232, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 234, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Pyelonephritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 234, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 231, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 232, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 234, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 234, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 231, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 232, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 234, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Appendiceal abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 234, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 231, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 232, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 234, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Burn infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 234, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 231, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 232, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 234, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Face injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 234, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 231, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 232, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 234, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Procedural pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 234, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 231, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 232, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 234, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Tendon rupture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 234, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 231, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 232, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 234, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 234, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 231, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 232, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 234, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Femur fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 234, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 231, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 232, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 234, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Wrist fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 234, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 231, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 232, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 234, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Humerus fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 234, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 231, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 232, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 234, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Joint dislocation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 234, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 231, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 232, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 234, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Cervical cord compression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 234, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 231, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 232, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 234, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Sciatica', 'stats': [{'groupId': 'EG000', 'numAtRisk': 234, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 231, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 232, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 234, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Ischaemic stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 234, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 231, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 232, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 234, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Cerebrovascular accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 234, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 231, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 232, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 234, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 234, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 231, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 232, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 234, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Hypoaesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 234, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 231, 'numAffected': 0}, {'groupId': 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'numAtRisk': 232, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 234, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 234, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 231, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 232, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 234, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Acute kidney injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 234, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 231, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 232, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 234, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 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'numAtRisk': 232, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 234, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Retinal detachment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 234, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 231, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 232, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 234, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Angle closure glaucoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 234, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 231, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 232, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 234, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 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0}, {'groupId': 'EG003', 'numAtRisk': 234, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Depression suicidal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 234, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 231, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 232, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 234, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 234, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 231, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 232, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 234, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Ovarian cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 234, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 231, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 232, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 234, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Vaginal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 234, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 231, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 232, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 234, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Cholelithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 234, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 231, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 232, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 234, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Cholecystitis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 234, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 231, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 232, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 234, 'numAffected': 2}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Bile duct stone', 'stats': [{'groupId': 'EG000', 'numAtRisk': 234, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 231, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 232, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 234, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Drug-induced liver injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 234, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 231, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 232, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 234, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 234, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 231, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 232, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 234, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Chills', 'stats': [{'groupId': 'EG000', 'numAtRisk': 234, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 231, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 232, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 234, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Non-cardiac chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 234, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 231, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 232, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 234, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}], 'frequencyThreshold': '3'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline in Cartilage Thickness of the cMTFC as Assessed by qMRI on the Target Knee to Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '162', 'groupId': 'OG000'}, {'value': '158', 'groupId': 'OG001'}, {'value': '151', 'groupId': 'OG002'}, {'value': '172', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'GLPG1972 75 mg', 'description': 'Participants received 1 film-coated tablet of GLPG1972 75 mg and 3 GLPG1972 matching placebo tablets, orally once daily for 52 weeks.'}, {'id': 'OG001', 'title': 'GLPG1972 150 mg', 'description': 'Participants received 2 film-coated tablets of GLPG1972 75 mg (total dose 150 mg) and 2 GLPG1972 matching placebo tablets, orally once daily for 52 weeks.'}, {'id': 'OG002', 'title': 'GLPG1972 300 mg', 'description': 'Participants received 4 film-coated tablets of GLPG1972 75 mg (total dose 300 mg), orally once daily for 52 weeks.'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Participants received 4 film-coated tablets of GLPG1972 matching placebo, orally once daily for 52 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.06791', 'spread': '0.20169', 'groupId': 'OG000'}, {'value': '-0.09693', 'spread': '0.26839', 'groupId': 'OG001'}, {'value': '-0.08545', 'spread': '0.21697', 'groupId': 'OG002'}, {'value': '-0.11562', 'spread': '0.27275', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.165', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Adjusted mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.04514', 'ciLowerLimit': '-0.00317', 'ciUpperLimit': '0.09345', 'pValueComment': 'Two-sided adjusted p-value taking into account Dunnett adjustment (to be compared to 0.05).', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.02465', 'estimateComment': 'Two-sided 95% confidence interval of the estimate without Dunnett adjustment.', 'groupDescription': 'Estimate (Standard Error) of adjusted difference from baseline to last post baseline value between treatment groups means: GLPG1972 dose minus placebo using mixed-effects model for repeated measures (MMRM) including fixed, categorical effects of treatment, region (Asia and Rest of the World), time and treatment-by-time interaction, as well as continuous, fixed covariates of baseline and time-by-baseline interaction preceded by multiple imputation step for participants without post baseline value', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.939', 'groupIds': ['OG001', 'OG003'], 'paramType': 'Adjusted mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.01200', 'ciLowerLimit': '-0.03868', 'ciUpperLimit': '0.06267', 'pValueComment': 'Two-sided adjusted p-value taking into account Dunnett adjustment (to be compared to 0.05).', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.02585', 'estimateComment': 'Two-sided 95% confidence interval of the estimate without Dunnett adjustment.', 'groupDescription': 'Estimate (Standard Error) of adjusted difference from baseline to last post baseline value between treatment groups means: GLPG1972 dose minus placebo using MMRM including fixed, categorical effects of treatment, region (Asia and Rest of the World), time and treatment-by-time interaction, as well as continuous, fixed covariates of baseline and time-by-baseline interaction preceded by multiple imputation step for participants without post baseline value.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.682', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Adjusted mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.02329', 'ciLowerLimit': '-0.02641', 'ciUpperLimit': '0.07300', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.02536', 'estimateComment': 'Two-sided 95% confidence interval of the estimate without Dunnett adjustment.', 'groupDescription': 'Estimate (Standard Error) of adjusted difference from baseline to last post baseline value between treatment groups means: GLPG1972 dose minus placebo using MMRM including fixed, categorical effects of treatment, region (Asia and Rest of the World), time and treatment-by-time interaction, as well as continuous, fixed covariates of baseline and time-by-baseline interaction preceded by multiple imputation step for participants without post baseline value.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 52', 'description': 'Reduction in cartilage loss was assessed by cartilage thickness as measured in the medial cMTFC of the target knee using qMRI.', 'unitOfMeasure': 'mm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was based on the mRS. Overall number of participants analyzed included participants with available data of cartilage thickness in the cMTFC at baseline and Week 52.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Who Were Osteoarthritis (OA) Structural Progressors Based on Cartilage Thickness in the cMTFC Assessed by qMRI on the Target Knee', 'denoms': [{'units': 'Participants', 'counts': [{'value': '162', 'groupId': 'OG000'}, {'value': '158', 'groupId': 'OG001'}, {'value': '151', 'groupId': 'OG002'}, {'value': '172', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'GLPG1972 75 mg', 'description': 'Participants received 1 film-coated tablet of GLPG1972 75 mg and 3 GLPG1972 matching placebo tablets, orally once daily for 52 weeks.'}, {'id': 'OG001', 'title': 'GLPG1972 150 mg', 'description': 'Participants received 2 film-coated tablets of GLPG1972 75 mg (total dose 150 mg) and 2 GLPG1972 matching placebo tablets, orally once daily for 52 weeks.'}, {'id': 'OG002', 'title': 'GLPG1972 300 mg', 'description': 'Participants received 4 film-coated tablets of GLPG1972 75 mg (total dose 300 mg), orally once daily for 52 weeks.'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Participants received 4 film-coated tablets of GLPG1972 matching placebo, orally once daily for 52 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}, {'value': '35', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.396', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.47', 'ciLowerLimit': '0.84', 'ciUpperLimit': '2.58', 'pValueComment': 'Two-sided adjusted p-value taking into account Dunnett adjustment (to be compared to 0.05)', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.29', 'estimateComment': 'Two-sided 95% Confidence Interval of the estimate without Dunnett adjustment', 'groupDescription': 'Estimate (Standard Error of log \\[estimate\\]) of the adjusted odds ratio between GLPG1972 dose regimen and placebo: between the proportions of participants with response: placebo versus GLPG1972 dose regimen', 'statisticalMethod': 'Logistic Model', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.951', 'groupIds': ['OG001', 'OG003'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.89', 'ciLowerLimit': '0.53', 'ciUpperLimit': '1.50', 'pValueComment': 'Two-sided adjusted p-value taking into account Dunnett adjustment (to be compared to 0.05)', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.26', 'estimateComment': 'Two-sided 95% Confidence Interval of the estimate without Dunnett adjustment', 'groupDescription': 'Estimate (Standard Error of log \\[estimate\\]) of the adjusted odds ratio between GLPG1972 dose regimen and placebo: between the proportions of participants with response: placebo versus GLPG1972 dose regimen', 'statisticalMethod': 'Logistic Model', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.985', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.08', 'ciLowerLimit': '0.64', 'ciUpperLimit': '1.83', 'pValueComment': 'Two-sided adjusted p-value taking into account Dunnett adjustment (to be compared to 0.05)', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.27', 'estimateComment': 'Two-sided 95% Confidence Interval of the estimate without Dunnett adjustment', 'groupDescription': 'Estimate (Standard Error of log \\[estimate\\]) of the adjusted odds ratio between GLPG1972 dose regimen and placebo: between the proportions of participants with response: placebo versus GLPG1972 dose regimen', 'statisticalMethod': 'Logistic Model', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week 52', 'description': 'A "structural progressor" was defined as a participant who had an 8% cartilage loss in cMTFC. Number of participants who met the criteria of "structural progressor" at Week 52 are provided.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was based on the mRS. Overall number of participants analyzed included participants with available data of cartilage thickness in the cMTFC at Week 52.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Total Score and Subscales Scores for Pain, Function, and Stiffness to Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '233', 'groupId': 'OG000'}, {'value': '230', 'groupId': 'OG001'}, {'value': '231', 'groupId': 'OG002'}, {'value': '234', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'GLPG1972 75 mg', 'description': 'Participants received 1 film-coated tablet of GLPG1972 75 mg and 3 GLPG1972 matching placebo tablets, orally once daily for 52 weeks.'}, {'id': 'OG001', 'title': 'GLPG1972 150 mg', 'description': 'Participants received 2 film-coated tablets of GLPG1972 75 mg (total dose 150 mg) and 2 GLPG1972 matching placebo tablets, orally once daily for 52 weeks.'}, {'id': 'OG002', 'title': 'GLPG1972 300 mg', 'description': 'Participants received 4 film-coated tablets of GLPG1972 75 mg (total dose 300 mg), orally once daily for 52 weeks.'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Participants received 4 film-coated tablets of GLPG1972 matching placebo, orally once daily for 52 weeks.'}], 'classes': [{'title': 'Total score: Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '233', 'groupId': 'OG000'}, {'value': '230', 'groupId': 'OG001'}, {'value': '231', 'groupId': 'OG002'}, {'value': '234', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '48.0', 'spread': '15.2', 'groupId': 'OG000'}, {'value': '48.7', 'spread': '15.0', 'groupId': 'OG001'}, {'value': '47.0', 'spread': '15.2', 'groupId': 'OG002'}, {'value': '48.3', 'spread': '14.5', 'groupId': 'OG003'}]}]}, {'title': 'Total score: Change from baseline to Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '189', 'groupId': 'OG000'}, {'value': '187', 'groupId': 'OG001'}, {'value': '176', 'groupId': 'OG002'}, {'value': '200', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-16.3', 'spread': '17.7', 'groupId': 'OG000'}, {'value': '-16.9', 'spread': '17.7', 'groupId': 'OG001'}, {'value': '-16.1', 'spread': '19.8', 'groupId': 'OG002'}, {'value': '-18.4', 'spread': '18.9', 'groupId': 'OG003'}]}]}, {'title': 'Pain subscore: Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '233', 'groupId': 'OG000'}, {'value': '230', 'groupId': 'OG001'}, {'value': '231', 'groupId': 'OG002'}, {'value': '234', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '10.2', 'spread': '3.2', 'groupId': 'OG000'}, {'value': '10.0', 'spread': '3.1', 'groupId': 'OG001'}, {'value': '9.8', 'spread': '3.1', 'groupId': 'OG002'}, {'value': '10.0', 'spread': '3.2', 'groupId': 'OG003'}]}]}, {'title': 'Pain subscore: Change from baseline to Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '189', 'groupId': 'OG000'}, {'value': '187', 'groupId': 'OG001'}, {'value': '176', 'groupId': 'OG002'}, {'value': '200', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-3.9', 'spread': '4.1', 'groupId': 'OG000'}, {'value': '-3.7', 'spread': '4.0', 'groupId': 'OG001'}, {'value': '-3.7', 'spread': '4.2', 'groupId': 'OG002'}, {'value': '-4.1', 'spread': '4.1', 'groupId': 'OG003'}]}]}, {'title': 'Physical function subscore: Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '233', 'groupId': 'OG000'}, {'value': '230', 'groupId': 'OG001'}, {'value': '231', 'groupId': 'OG002'}, {'value': '234', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '33.8', 'spread': '11.2', 'groupId': 'OG000'}, {'value': '34.3', 'spread': '11.2', 'groupId': 'OG001'}, {'value': '33.0', 'spread': '11.6', 'groupId': 'OG002'}, {'value': '34.1', 'spread': '10.7', 'groupId': 'OG003'}]}]}, {'title': 'Physical function subscore: Change from baseline to Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '189', 'groupId': 'OG000'}, {'value': '187', 'groupId': 'OG001'}, {'value': '176', 'groupId': 'OG002'}, {'value': '200', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-11.2', 'spread': '12.7', 'groupId': 'OG000'}, {'value': '-11.9', 'spread': '13.0', 'groupId': 'OG001'}, {'value': '-10.9', 'spread': '14.7', 'groupId': 'OG002'}, {'value': '-12.7', 'spread': '13.9', 'groupId': 'OG003'}]}]}, {'title': 'Stiffness subscore: Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '233', 'groupId': 'OG000'}, {'value': '230', 'groupId': 'OG001'}, {'value': '231', 'groupId': 'OG002'}, {'value': '234', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '4.0', 'spread': '1.7', 'groupId': 'OG000'}, {'value': '4.3', 'spread': '1.7', 'groupId': 'OG001'}, {'value': '4.2', 'spread': '1.6', 'groupId': 'OG002'}, {'value': '4.2', 'spread': '1.6', 'groupId': 'OG003'}]}]}, {'title': 'Stiffness subscore: Change from baseline to Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '189', 'groupId': 'OG000'}, {'value': '187', 'groupId': 'OG001'}, {'value': '176', 'groupId': 'OG002'}, {'value': '200', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-1.2', 'spread': '2.1', 'groupId': 'OG000'}, {'value': '-1.3', 'spread': '2.0', 'groupId': 'OG001'}, {'value': '-1.4', 'spread': '2.0', 'groupId': 'OG002'}, {'value': '-1.5', 'spread': '2.0', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.467', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Adjusted mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.1', 'ciLowerLimit': '-5.6', 'ciUpperLimit': '1.3', 'pValueComment': 'Two-sided adjusted p-value taking into account Dunnett adjustment (to be compared to 0.05).', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.7', 'estimateComment': 'Two-sided 95% Confidence Interval of the estimate without Dunnett adjustment', 'groupDescription': 'Total score: Estimate (Standard Error) of adjusted difference from baseline to last post baseline value between treatment groups means: placebo minus GLPG1972 dose using MMRM including fixed, categorical effects of treatment, region (Asia and Rest of the World), time and treatment-by-time interaction, as well as continuous, fixed covariates of baseline and time-by-baseline interaction preceded by multiple imputation step for participants without post baseline value.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.557', 'groupIds': ['OG001', 'OG003'], 'paramType': 'Adjusted mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.9', 'ciLowerLimit': '-5.4', 'ciUpperLimit': '1.5', 'pValueComment': 'Two-sided adjusted p-value taking into account Dunnett adjustment (to be compared to 0.05)', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.8', 'estimateComment': 'Two-sided 95% Confidence Interval of the estimate without Dunnett adjustment.', 'groupDescription': 'Total score: Estimate (Standard Error) of adjusted difference from baseline to last post baseline value between treatment groups means: placebo minus GLPG1972 dose using MMRM including fixed, categorical effects of treatment, region (Asia and Rest of the World), time and treatment-by-time interaction, as well as continuous, fixed covariates of baseline and time-by-baseline interaction preceded by multiple imputation step for participants without post baseline value.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.593', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Adjusted mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.9', 'ciLowerLimit': '-5.3', 'ciUpperLimit': '1.6', 'pValueComment': 'Two-sided adjusted p-value taking into account Dunnett adjustment (to be compared to 0.05).', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.8', 'estimateComment': 'Two-sided 95% Confidence Interval of the estimate without Dunnett adjustment.', 'groupDescription': 'Total score: Estimate (Standard Error) of adjusted difference from baseline to last post baseline value between treatment groups means: placebo minus GLPG1972 dose using MMRM including fixed, categorical effects of treatment, region (Asia and Rest of the World), time and treatment-by-time interaction, as well as continuous, fixed covariates of baseline and time-by-baseline interaction preceded by multiple imputation step for participants without post baseline value.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.776', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Adjusted mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.3', 'ciLowerLimit': '-1.0', 'ciUpperLimit': '0.4', 'pValueComment': 'Two-sided adjusted p-value taking into account Dunnett adjustment (to be compared to 0.05).', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.4', 'estimateComment': 'Two-sided 95% Confidence Interval of the estimate without Dunnett adjustment.', 'groupDescription': 'Pain subscore: Estimate (Standard Error) of adjusted difference from baseline to last post baseline value between treatment groups means: placebo minus GLPG1972 dose using MMRM including fixed, categorical effects of treatment, region (Asia and Rest of the World), time and treatment-by-time interaction, as well as continuous, fixed covariates of baseline and time-by-baseline interaction preceded by multiple imputation step for participants without post baseline value.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.446', 'groupIds': ['OG001', 'OG003'], 'paramType': 'Adjusted mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.5', 'ciLowerLimit': '-1.2', 'ciUpperLimit': '0.3', 'pValueComment': 'Two-sided adjusted p-value taking into account Dunnett adjustment (to be compared to 0.05).', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.4', 'estimateComment': 'Two-sided 95% Confidence Interval of the estimate without Dunnett adjustment.', 'groupDescription': 'Pain subscore: Estimate (Standard Error) of adjusted difference from baseline to last post baseline value between treatment groups means: placebo minus GLPG1972 dose using MMRM including fixed, categorical effects of treatment, region (Asia and Rest of the World), time and treatment-by-time interaction, as well as continuous, fixed covariates of baseline and time-by-baseline interaction preceded by multiple imputation step for participants without post baseline value.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.649', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Adjusted mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.4', 'ciLowerLimit': '-1.1', 'ciUpperLimit': '0.4', 'pValueComment': 'Two-sided adjusted p-value taking into account Dunnett adjustment (to be compared to 0.05).', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.4', 'estimateComment': 'Two-sided 95% Confidence Interval of the estimate without Dunnett adjustment.', 'groupDescription': 'Pain subscore: Estimate (Standard Error) of adjusted difference from baseline to last post baseline value between treatment groups means: placebo minus GLPG1972 dose using MMRM including fixed, categorical effects of treatment, region (Asia and Rest of the World), time and treatment-by-time interaction, as well as continuous, fixed covariates of baseline and time-by-baseline interaction preceded by multiple imputation step for participants without post baseline value.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.452', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Adjusted mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.6', 'ciLowerLimit': '-4.1', 'ciUpperLimit': '0.9', 'pValueComment': 'Two-sided adjusted p-value taking into account Dunnett adjustment (to be compared to 0.05).', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.3', 'estimateComment': 'Two-sided 95% Confidence Interval of the estimate without Dunnett adjustment.', 'groupDescription': 'Physical function subscore: Estimate (Standard Error) of adjusted difference from baseline to last post baseline value between treatment groups means: placebo minus GLPG1972 dose using MMRM including fixed, categorical effects of treatment, region (Asia and Rest of the World), time and treatment-by-time interaction, as well as continuous, fixed covariates of baseline and time-by-baseline interaction preceded by multiple imputation step for participants without post baseline value.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.665', 'groupIds': ['OG001', 'OG003'], 'paramType': 'Adjusted mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.2', 'ciLowerLimit': '-3.7', 'ciUpperLimit': '1.3', 'pValueComment': 'Two-sided adjusted p-value taking into account Dunnett adjustment (to be compared to 0.05).', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.3', 'estimateComment': 'Two-sided 95% Confidence Interval of the estimate without Dunnett adjustment.', 'groupDescription': 'Physical Function subscore: Estimate (Standard Error) of adjusted difference from baseline to last post baseline value between treatment groups means: placebo minus GLPG1972 dose using MMRM including fixed, categorical effects of treatment, region (Asia and Rest of the World), time and treatment-by-time interaction, as well as continuous, fixed covariates of baseline and time-by-baseline interaction preceded by multiple imputation step for participants without post baseline value.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.598', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Adjusted mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.3', 'ciLowerLimit': '-3.9', 'ciUpperLimit': '1.2', 'pValueComment': 'Two-sided adjusted p-value taking into account Dunnett adjustment (to be compared to 0.05).', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.3', 'estimateComment': 'Two-sided 95% Confidence Interval of the estimate without Dunnett adjustment.', 'groupDescription': 'Physical Function subscore: Estimate (Standard Error) of adjusted difference from baseline to last post baseline value between treatment groups means: placebo minus GLPG1972 dose using MMRM including fixed, categorical effects of treatment, region (Asia and Rest of the World), time and treatment-by-time interaction, as well as continuous, fixed covariates of baseline and time-by-baseline interaction preceded by multiple imputation step for participants without post baseline value.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.400', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Adjusted mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.2', 'ciLowerLimit': '-0.6', 'ciUpperLimit': '0.1', 'pValueComment': 'Two-sided adjusted p-value taking into account Dunnett adjustment (to be compared to 0.05)', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.2', 'estimateComment': 'Two-sided 95% Confidence Interval of the estimate without Dunnett adjustment', 'groupDescription': 'Stiffness subscore: Estimate (Standard Error) of adjusted difference from baseline to last post baseline value between treatment groups means: placebo minus GLPG1972 dose using MMRM including fixed, categorical effects of treatment, region (Asia and Rest of the World), time and treatment-by-time interaction, as well as continuous, fixed covariates of baseline and time-by-baseline interaction preceded by multiple imputation step for participants without post baseline value.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.393', 'groupIds': ['OG001', 'OG003'], 'paramType': 'Adjusted mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.2', 'ciLowerLimit': '-0.6', 'ciUpperLimit': '0.1', 'pValueComment': 'Two-sided adjusted p-value taking into account Dunnett adjustment (to be compared to 0.05)', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.2', 'estimateComment': 'Two-sided 95% Confidence Interval of the estimate without Dunnett adjustment', 'groupDescription': 'Stiffness subscore: Estimate (Standard Error) of adjusted difference from baseline to last post baseline value between treatment groups means: placebo minus GLPG1972 dose using MMRM including fixed, categorical effects of treatment, region (Asia and Rest of the World), time and treatment-by-time interaction, as well as continuous, fixed covariates of baseline and time-by-baseline interaction preceded by multiple imputation step for participants without post baseline value.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.858', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Adjusted mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.1', 'ciLowerLimit': '-0.5', 'ciUpperLimit': '0.2', 'pValueComment': 'Two-sided adjusted p-value taking into account Dunnett adjustment (to be compared to 0.05)', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.2', 'estimateComment': 'Two-sided 95% Confidence Interval of the estimate without Dunnett adjustment', 'groupDescription': 'Stiffness subscore: Estimate (Standard Error) of adjusted difference from baseline to last post baseline value between treatment groups means: placebo minus GLPG1972 dose using MMRM including fixed, categorical effects of treatment, region (Asia and Rest of the World), time and treatment-by-time interaction, as well as continuous, fixed covariates of baseline and time-by-baseline interaction preceded by multiple imputation step for participants without post baseline value.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 52', 'description': 'Western Ontario and McMaster Universities Osteoarthritis Index is a questionnaire designed to assess health status and health outcomes in participants with OA of the knee. The questionnaire contains 24 questions targeting areas of pain, stiffness, and physical function. Pain subscale includes 5 items rated on a Likert scale of 0 (none) to 4 (extreme) with a total range of 0-20 with higher scores indicating worse symptoms and function. Stiffness subscale includes 2 items rated on a Likert scale of 0 (none) to 4 (extreme) with a total range of 0-8 with higher scores indicating worse symptoms and function. Physical function subscale includes 17 items rated on a Likert scale of 0 (none) to 4 (extreme) with a total range of 0-68 with higher scores indicating worse symptoms and function. The total score is the sum of all subscales (range: 0 to 96) with higher scores indicating worse symptoms and function.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was based on mRS. Overall number of participants analyzed included participants with available data of WOMAC score at baseline. Number of participants analyzed for change from baseline to Week 52 included participants with available data of WOMAC score at baseline and Week 52.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Pain Assessment in the Target Knee as Measured by Visual Analog Scale (VAS) to Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '234', 'groupId': 'OG000'}, {'value': '231', 'groupId': 'OG001'}, {'value': '233', 'groupId': 'OG002'}, {'value': '234', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'GLPG1972 75 mg', 'description': 'Participants received 1 film-coated tablet of GLPG1972 75 mg and 3 GLPG1972 matching placebo tablets, orally once daily for 52 weeks.'}, {'id': 'OG001', 'title': 'GLPG1972 150 mg', 'description': 'Participants received 2 film-coated tablets of GLPG1972 75 mg (total dose 150 mg) and 2 GLPG1972 matching placebo tablets, orally once daily for 52 weeks.'}, {'id': 'OG002', 'title': 'GLPG1972 300 mg', 'description': 'Participants received 4 film-coated tablets of GLPG1972 75 mg (total dose 300 mg), orally once daily for 52 weeks.'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Participants received 4 film-coated tablets of GLPG1972 matching placebo, orally once daily for 52 weeks.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '234', 'groupId': 'OG000'}, {'value': '231', 'groupId': 'OG001'}, {'value': '233', 'groupId': 'OG002'}, {'value': '234', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '63.3', 'spread': '11.4', 'groupId': 'OG000'}, {'value': '63.8', 'spread': '11.5', 'groupId': 'OG001'}, {'value': '63.3', 'spread': '12.1', 'groupId': 'OG002'}, {'value': '63.5', 'spread': '11.0', 'groupId': 'OG003'}]}]}, {'title': 'Change from baseline to Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '191', 'groupId': 'OG000'}, {'value': '185', 'groupId': 'OG001'}, {'value': '178', 'groupId': 'OG002'}, {'value': '199', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-27.2', 'spread': '24.3', 'groupId': 'OG000'}, {'value': '-25.6', 'spread': '26.9', 'groupId': 'OG001'}, {'value': '-28.2', 'spread': '27.1', 'groupId': 'OG002'}, {'value': '-28.9', 'spread': '25.0', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.705', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Adjusted mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.2', 'ciLowerLimit': '-7.1', 'ciUpperLimit': '2.7', 'pValueComment': 'Two-sided adjusted p-value taking into account Dunnett adjustment (to be compared to 0.05).', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.5', 'estimateComment': 'Two-sided 95% Confidence Interval of the estimate without Dunnett adjustment.', 'groupDescription': 'Estimate (Standard Error) of the adjusted difference from baseline to last post baseline value between treatment groups means: placebo minus GLPG1972 dose regimen using a MMRM including the fixed, categorical effects of treatment, region (Asia and Rest of the World), time and treatment-by-time interaction, as well as the continuous, fixed covariates of baseline and time-by-baseline interaction preceded by a Multiple Imputation step for participants without post-baseline measurement.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.243', 'groupIds': ['OG001', 'OG003'], 'paramType': 'Adjusted mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-4.1', 'ciLowerLimit': '-9.0', 'ciUpperLimit': '0.8', 'pValueComment': 'Two-sided adjusted p-value taking into account Dunnett adjustment (to be compared to 0.05).', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.5', 'estimateComment': 'Two-sided 95% Confidence Interval of the estimate without Dunnett adjustment.', 'groupDescription': 'Estimate (Standard Error) of the adjusted difference from baseline to last post baseline value between treatment groups means: placebo minus GLPG1972 dose regimen using a MMRM including the fixed, categorical effects of treatment, region (Asia and Rest of the World), time and treatment-by-time interaction, as well as the continuous, fixed covariates of baseline and time-by-baseline interaction preceded by a Multiple Imputation step for participants without post-baseline measurement.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.949', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Adjusted mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.1', 'ciLowerLimit': '-6.1', 'ciUpperLimit': '3.9', 'pValueComment': 'Two-sided adjusted p-value taking into account Dunnett adjustment (to be compared to 0.05).', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.5', 'estimateComment': 'Two-sided 95% Confidence Interval of the estimate without Dunnett adjustment.', 'groupDescription': 'Estimate (Standard Error) of the adjusted difference from baseline to last post baseline value between treatment groups means: placebo minus GLPG1972 dose regimen using a MMRM including the fixed, categorical effects of treatment, region (Asia and Rest of the World), time and treatment-by-time interaction, as well as the continuous, fixed covariates of baseline and time-by-baseline interaction preceded by a Multiple Imputation step for participants without post-baseline measurement.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 52', 'description': 'The participant was asked "how would you rate the pain felt in the selected knee within the last 48 hours?". The participants rated the pain by marking the level of pain on a 100-mm VAS, with 0 being no pain and 100 being extreme pain. Higher score indicated higher pain intensity.', 'unitOfMeasure': 'mm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was based on mRS. Overall number of participants analyzed included participants with available data of VAS at baseline. Number of participants analyzed for change from baseline to Week 52 included participants with available data of VAS at baseline and Week 52.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Patient Global Assessment (PGA) of Disease Activity as Measured by VAS to Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '232', 'groupId': 'OG000'}, {'value': '230', 'groupId': 'OG001'}, {'value': '232', 'groupId': 'OG002'}, {'value': '233', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'GLPG1972 75 mg', 'description': 'Participants received 1 film-coated tablet of GLPG1972 75 mg and 3 GLPG1972 matching placebo tablets, orally once daily for 52 weeks.'}, {'id': 'OG001', 'title': 'GLPG1972 150 mg', 'description': 'Participants received 2 film-coated tablets of GLPG1972 75 mg (total dose 150 mg) and 2 GLPG1972 matching placebo tablets, orally once daily for 52 weeks.'}, {'id': 'OG002', 'title': 'GLPG1972 300 mg', 'description': 'Participants received 4 film-coated tablets of GLPG1972 75 mg (total dose 300 mg), orally once daily for 52 weeks.'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Participants received 4 film-coated tablets of GLPG1972 matching placebo, orally once daily for 52 weeks.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '232', 'groupId': 'OG000'}, {'value': '230', 'groupId': 'OG001'}, {'value': '232', 'groupId': 'OG002'}, {'value': '233', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '47.1', 'spread': '18.3', 'groupId': 'OG000'}, {'value': '47.9', 'spread': '19.0', 'groupId': 'OG001'}, {'value': '49.4', 'spread': '17.5', 'groupId': 'OG002'}, {'value': '50.4', 'spread': '19.2', 'groupId': 'OG003'}]}]}, {'title': 'Change from baseline to Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '191', 'groupId': 'OG000'}, {'value': '187', 'groupId': 'OG001'}, {'value': '178', 'groupId': 'OG002'}, {'value': '200', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '19.4', 'spread': '30.0', 'groupId': 'OG000'}, {'value': '14.3', 'spread': '30.7', 'groupId': 'OG001'}, {'value': '14.1', 'spread': '28.4', 'groupId': 'OG002'}, {'value': '14.0', 'spread': '31.3', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.890', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Adjusted mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.4', 'ciLowerLimit': '-3.4', 'ciUpperLimit': '6.3', 'pValueComment': 'Two-sided adjusted p-value taking into account Dunnett adjustment (to be compared to 0.05).', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.5', 'estimateComment': 'Two-sided 95% Confidence Interval of the estimate without Dunnett adjustment.', 'groupDescription': 'Estimate (Standard Error) of the adjusted difference from baseline to last post baseline value between treatment groups means: GLPG1972 dose regimen minus placebo using a MMRM including the fixed, categorical effects of treatment, region (Asia and Rest of the World), time and treatment-by-time interaction, as well as the continuous, fixed covariates of baseline and time-by-baseline interaction preceded by a Multiple Imputation step for participants without post-baseline measurement.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.682', 'groupIds': ['OG001', 'OG003'], 'paramType': 'Adjusted mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.3', 'ciLowerLimit': '-7.1', 'ciUpperLimit': '2.6', 'pValueComment': 'Two-sided adjusted p-value taking into account Dunnett adjustment (to be compared to 0.05).', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.5', 'estimateComment': 'Two-sided 95% Confidence Interval of the estimate without Dunnett adjustment.', 'groupDescription': 'Estimate (Standard Error) of the adjusted difference from baseline to last post baseline value between treatment groups means: GLPG1972 dose regimen minus placebo using a MMRM including the fixed, categorical effects of treatment, region (Asia and Rest of the World), time and treatment-by-time interaction, as well as the continuous, fixed covariates of baseline and time-by-baseline interaction preceded by a Multiple Imputation step for participants without post-baseline measurement.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '1.000', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Adjusted mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.1', 'ciLowerLimit': '-4.8', 'ciUpperLimit': '5.0', 'pValueComment': 'Two-sided adjusted p-value taking into account Dunnett adjustment (to be compared to 0.05).', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.5', 'estimateComment': 'Two-sided 95% Confidence Interval of the estimate without Dunnett adjustment.', 'groupDescription': 'Estimate (Standard Error) of the adjusted difference from baseline to last post baseline value between treatment groups means: GLPG1972 dose regimen minus placebo using a MMRM including the fixed, categorical effects of treatment, region (Asia and Rest of the World), time and treatment-by-time interaction, as well as the continuous, fixed covariates of baseline and time-by-baseline interaction preceded by a Multiple Imputation step for participants without post-baseline measurement.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 52', 'description': 'The participant was asked "Considering all the ways in which your knee osteoarthritis affects you, please rate on this 100 mm scale how well you are doing today". The participants rated the disease activity by marking on a 100-mm VAS, with 0 being no pain and 100 being extreme pain. Higher score indicated higher disease activity.', 'unitOfMeasure': 'mm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was based on mRS. Overall number of participants analyzed included participants with available data of PGA score at baseline. Number of participants analyzed for change from baseline to Week 52 included participants with available data of PGA score at baseline and Week 52.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Who Were Responders Based on the Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Criteria', 'denoms': [{'units': 'Participants', 'counts': [{'value': '189', 'groupId': 'OG000'}, {'value': '187', 'groupId': 'OG001'}, {'value': '176', 'groupId': 'OG002'}, {'value': '200', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'GLPG1972 75 mg', 'description': 'Participants received 1 film-coated tablet of GLPG1972 75 mg and 3 GLPG1972 matching placebo tablets, orally once daily for 52 weeks.'}, {'id': 'OG001', 'title': 'GLPG1972 150 mg', 'description': 'Participants received 2 film-coated tablets of GLPG1972 75 mg (total dose 150 mg) and 2 GLPG1972 matching placebo tablets, orally once daily for 52 weeks.'}, {'id': 'OG002', 'title': 'GLPG1972 300 mg', 'description': 'Participants received 4 film-coated tablets of GLPG1972 75 mg (total dose 300 mg), orally once daily for 52 weeks.'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Participants received 4 film-coated tablets of GLPG1972 matching placebo, orally once daily for 52 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '125', 'groupId': 'OG000'}, {'value': '119', 'groupId': 'OG001'}, {'value': '103', 'groupId': 'OG002'}, {'value': '127', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.991', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.05', 'ciLowerLimit': '0.70', 'ciUpperLimit': '1.58', 'pValueComment': 'Two-sided adjusted p-value taking into account Dunnett adjustment (to be compared to 0.05).', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.21', 'estimateComment': 'Two-sided 95% Confidence Interval of the estimate without Dunnett adjustment.', 'groupDescription': 'Estimate (Standard Error of log \\[estimate\\]) of the adjusted odds ratio between GLPG1972 dose regimen and placebo: between the proportions of participants with response: placebo versus GLPG1972 dose regimen.', 'statisticalMethod': 'Logistic Model', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.992', 'groupIds': ['OG001', 'OG003'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.95', 'ciLowerLimit': '0.64', 'ciUpperLimit': '1.43', 'pValueComment': 'Two-sided adjusted p-value taking into account Dunnett adjustment (to be compared to 0.05).', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.21', 'estimateComment': 'Two-sided 95% Confidence Interval of the estimate without Dunnett adjustment.', 'groupDescription': 'Estimate (Standard Error of log \\[estimate\\]) of the adjusted odds ratio between GLPG1972 dose regimen and placebo: between the proportions of participants with response: placebo versus GLPG1972 dose regimen.', 'statisticalMethod': 'Logistic Model', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.653', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.82', 'ciLowerLimit': '0.55', 'ciUpperLimit': '1.23', 'pValueComment': 'Two-sided adjusted p-value taking into account Dunnett adjustment (to be compared to 0.05).', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.21', 'estimateComment': 'Two-sided 95% Confidence Interval of the estimate without Dunnett adjustment.', 'groupDescription': 'Estimate (Standard Error of log \\[estimate\\]) of the adjusted odds ratio between GLPG1972 dose regimen and placebo: between the proportions of participants with response: placebo versus GLPG1972 dose regimen.', 'statisticalMethod': 'Logistic Model', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week 52', 'description': 'OMERACT-OARSI criteria involves improvement based on WOMAC pain and function subscales and PGA. The responders according to OMERACT-OARSI criteria were participants who had:\n\n* A high improvement in pain or in function ≥ 50% and absolute change ≥ 20, OR\n* Improvement in at least 2 of the 3 following:\n\n * Pain ≥ 20% and absolute change ≥ 10\n * Function ≥ 20% and absolute change ≥ 10\n * Patient\'s global assessment ≥ 20% and absolute change ≥ 10.\n\nWOMAC pain subscale score: range of 0 to 20, higher scores indicating more pain,\n\nWOMAC physical function subscale score: range of 0 to 68, higher scores indicating worse physical function),\n\nPGA: The participant was asked "Considering all the ways in which your knee osteoarthritis affects you, please rate on this 100 mm scale how well you are doing today". The participants rated disease activity by marking on a 100-mm VAS, with 0 being no pain and 100 being extreme pain. Higher score indicated higher disease activity.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was based on the mRS. Overall number of participants analyzed included participants with available data of WOMAC pain and function subscales and PGA at Week 52.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Cartilage Thickness of the Total Tibiofemoral Compartment (tTFC) of the Target Knee by qMRI to Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '232', 'groupId': 'OG000'}, {'value': '229', 'groupId': 'OG001'}, {'value': '231', 'groupId': 'OG002'}, {'value': '234', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'GLPG1972 75 mg', 'description': 'Participants received 1 film-coated tablet of GLPG1972 75 mg and 3 GLPG1972 matching placebo tablets, orally once daily for 52 weeks.'}, {'id': 'OG001', 'title': 'GLPG1972 150 mg', 'description': 'Participants received 2 film-coated tablets of GLPG1972 75 mg (total dose 150 mg) and 2 GLPG1972 matching placebo tablets, orally once daily for 52 weeks.'}, {'id': 'OG002', 'title': 'GLPG1972 300 mg', 'description': 'Participants received 4 film-coated tablets of GLPG1972 75 mg (total dose 300 mg), orally once daily for 52 weeks.'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Participants received 4 film-coated tablets of GLPG1972 matching placebo, orally once daily for 52 weeks.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '232', 'groupId': 'OG000'}, {'value': '229', 'groupId': 'OG001'}, {'value': '231', 'groupId': 'OG002'}, {'value': '234', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '6.49218', 'spread': '1.02749', 'groupId': 'OG000'}, {'value': '6.57424', 'spread': '1.02706', 'groupId': 'OG001'}, {'value': '6.51256', 'spread': '0.97704', 'groupId': 'OG002'}, {'value': '6.45879', 'spread': '1.01774', 'groupId': 'OG003'}]}]}, {'title': 'Change from baseline to Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '162', 'groupId': 'OG000'}, {'value': '158', 'groupId': 'OG001'}, {'value': '150', 'groupId': 'OG002'}, {'value': '172', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-0.03572', 'spread': '0.17673', 'groupId': 'OG000'}, {'value': '-0.02401', 'spread': '0.20766', 'groupId': 'OG001'}, {'value': '-0.01678', 'spread': '0.20934', 'groupId': 'OG002'}, {'value': '-0.06447', 'spread': '0.23480', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.193', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Adjusted mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.03779', 'ciLowerLimit': '-0.00448', 'ciUpperLimit': '0.08005', 'pValueComment': 'Two-sided adjusted p-value taking into account Dunnett adjustment (to be compared to 0.05).', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.02156', 'estimateComment': 'Two-sided 95% Confidence Interval of the estimate without Dunnett adjustment.', 'groupDescription': 'Estimate (Standard Error) of the adjusted difference from baseline to last post baseline value between treatment groups means: placebo minus GLPG1972 dose regimen using a MMRM including the fixed, categorical effects of treatment, region (Asia and Rest of the World), time and treatment-by-time interaction, as well as the continuous, fixed covariates of baseline and time-by-baseline interaction preceded by a Multiple Imputation step for participants without post-baseline measurement.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.256', 'groupIds': ['OG001', 'OG003'], 'paramType': 'Adjusted mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.03580', 'ciLowerLimit': '-0.00801', 'ciUpperLimit': '0.07962', 'pValueComment': 'Two-sided adjusted p-value taking into account Dunnett adjustment (to be compared to 0.05).', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.02235', 'estimateComment': 'Two-sided 95% Confidence Interval of the estimate without Dunnett adjustment.', 'groupDescription': 'Estimate (Standard Error) of the adjusted difference from baseline to last post baseline value between treatment groups means: placebo minus GLPG1972 dose regimen using a MMRM including the fixed, categorical effects of treatment, region (Asia and Rest of the World), time and treatment-by-time interaction, as well as the continuous, fixed covariates of baseline and time-by-baseline interaction preceded by a Multiple Imputation step for participants without post-baseline measurement.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.201', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Adjusted mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.03884', 'ciLowerLimit': '-0.00514', 'ciUpperLimit': '0.08281', 'pValueComment': 'Two-sided adjusted p-value taking into account Dunnett adjustment (to be compared to 0.05).', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.02243', 'estimateComment': 'Two-sided 95% Confidence Interval of the estimate without Dunnett adjustment.', 'groupDescription': 'Estimate (Standard Error) of the adjusted difference from baseline to last post baseline value between treatment groups means: placebo minus GLPG1972 dose regimen using a MMRM including the fixed, categorical effects of treatment, region (Asia and Rest of the World), time and treatment-by-time interaction, as well as the continuous, fixed covariates of baseline and time-by-baseline interaction preceded by a Multiple Imputation step for participants without post-baseline measurement.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 52', 'description': 'Reduction of cartilage loss was measured by cartilage thickness of the tTFC of the target knee using qMRI.', 'unitOfMeasure': 'mm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was based on mRS. Overall number of participants analyzed included participants with available data of cartilage thickness of the tTFC of the target knee at baseline. Number of participants analyzed for change from baseline to Week 52 included participants with available data of cartilage thickness of the tTFC of the target knee at baseline and Week 52.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Bone Area of the Medial Femoral Condyle Surface of the Target Knee by qMRI to Week 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '234', 'groupId': 'OG000'}, {'value': '229', 'groupId': 'OG001'}, {'value': '232', 'groupId': 'OG002'}, {'value': '234', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'GLPG1972 75 mg', 'description': 'Participants received 1 film-coated tablet of GLPG1972 75 mg and 3 GLPG1972 matching placebo tablets, orally once daily for 52 weeks.'}, {'id': 'OG001', 'title': 'GLPG1972 150 mg', 'description': 'Participants received 2 film-coated tablets of GLPG1972 75 mg (total dose 150 mg) and 2 GLPG1972 matching placebo tablets, orally once daily for 52 weeks.'}, {'id': 'OG002', 'title': 'GLPG1972 300 mg', 'description': 'Participants received 4 film-coated tablets of GLPG1972 75 mg (total dose 300 mg), orally once daily for 52 weeks.'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Participants received 4 film-coated tablets of GLPG1972 matching placebo, orally once daily for 52 weeks.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '234', 'groupId': 'OG000'}, {'value': '229', 'groupId': 'OG001'}, {'value': '232', 'groupId': 'OG002'}, {'value': '234', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '2343.32026', 'spread': '371.23246', 'groupId': 'OG000'}, {'value': '2346.17547', 'spread': '373.46086', 'groupId': 'OG001'}, {'value': '2354.77368', 'spread': '385.91599', 'groupId': 'OG002'}, {'value': '2333.67525', 'spread': '362.46041', 'groupId': 'OG003'}]}]}, {'title': 'Change from baseline to Week 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '202', 'groupId': 'OG000'}, {'value': '191', 'groupId': 'OG001'}, {'value': '190', 'groupId': 'OG002'}, {'value': '210', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '8.21893', 'spread': '31.81812', 'groupId': 'OG000'}, {'value': '11.11178', 'spread': '33.14557', 'groupId': 'OG001'}, {'value': '7.63991', 'spread': '33.60899', 'groupId': 'OG002'}, {'value': '11.43549', 'spread': '29.60810', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.627', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Adjusted mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.12394', 'ciLowerLimit': '-3.02464', 'ciUpperLimit': '9.27252', 'pValueComment': 'Two-sided adjusted p-value taking into account Dunnett adjustment (to be compared to 0.05).', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '3.13671', 'estimateComment': 'Two-sided 95% Confidence Interval of the estimate without Dunnett adjustment.', 'groupDescription': 'Estimate (Standard Error) of the adjusted difference from baseline to last post baseline value between treatment groups means: Placebo minus GLPG1972 dose regimen using an analysis of covariance (ANCOVA) including the factors treatment and region with baseline as covariate and no interaction, after a Multiple Imputation for missing data.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.998', 'groupIds': ['OG001', 'OG003'], 'paramType': 'Adjusted mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.46842', 'ciLowerLimit': '-5.82659', 'ciUpperLimit': '6.76343', 'pValueComment': 'Two-sided adjusted p-value taking into account Dunnett adjustment (to be compared to 0.05).', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '3.21111', 'estimateComment': 'Two-sided 95% Confidence Interval of the estimate without Dunnett adjustment.', 'groupDescription': 'Estimate (Standard Error) of the adjusted difference from baseline to last post baseline value between treatment groups means: Placebo minus GLPG1972 dose regimen using an ANCOVA including the factors treatment and region with baseline as covariate and no interaction, after a Multiple Imputation for missing data.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.449', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Adjusted mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.11756', 'ciLowerLimit': '-2.30536', 'ciUpperLimit': '10.54049', 'pValueComment': 'Two-sided adjusted p-value taking into account Dunnett adjustment (to be compared to 0.05).', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '3.27590', 'estimateComment': 'Two-sided 95% Confidence Interval of the estimate without Dunnett adjustment.', 'groupDescription': 'Estimate (Standard Error) of the adjusted difference from baseline to last post baseline value between treatment groups means: Placebo minus GLPG1972 dose regimen using an ANCOVA including the factors treatment and region with baseline as covariate and no interaction, after a Multiple Imputation for missing data.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 28', 'unitOfMeasure': 'mm^2', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was based on mRS. Overall number of participants analyzed included participants with available data of bone area of the medial femoral condyle surface of the target knee at baseline. Number of participants analyzed for change from baseline to Week 28 included participants with available data of bone area of the medial femoral condyle surface of the target knee at baseline and Week 28.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Bone Area of the Medial Femoral Condyle Surface of the Target Knee by qMRI to Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '234', 'groupId': 'OG000'}, {'value': '229', 'groupId': 'OG001'}, {'value': '232', 'groupId': 'OG002'}, {'value': '234', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'GLPG1972 75 mg', 'description': 'Participants received 1 film-coated tablet of GLPG1972 75 mg and 3 GLPG1972 matching placebo tablets, orally once daily for 52 weeks.'}, {'id': 'OG001', 'title': 'GLPG1972 150 mg', 'description': 'Participants received 2 film-coated tablets of GLPG1972 75 mg (total dose 150 mg) and 2 GLPG1972 matching placebo tablets, orally once daily for 52 weeks.'}, {'id': 'OG002', 'title': 'GLPG1972 300 mg', 'description': 'Participants received 4 film-coated tablets of GLPG1972 75 mg (total dose 300 mg), orally once daily for 52 weeks.'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Participants received 4 film-coated tablets of GLPG1972 matching placebo, orally once daily for 52 weeks.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '234', 'groupId': 'OG000'}, {'value': '229', 'groupId': 'OG001'}, {'value': '232', 'groupId': 'OG002'}, {'value': '234', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '2343.32026', 'spread': '371.23246', 'groupId': 'OG000'}, {'value': '2346.17547', 'spread': '373.46086', 'groupId': 'OG001'}, {'value': '2354.77368', 'spread': '385.91599', 'groupId': 'OG002'}, {'value': '2333.67525', 'spread': '362.46041', 'groupId': 'OG003'}]}]}, {'title': 'Change from baseline to Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '162', 'groupId': 'OG000'}, {'value': '160', 'groupId': 'OG001'}, {'value': '154', 'groupId': 'OG002'}, {'value': '172', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '15.45592', 'spread': '31.22629', 'groupId': 'OG000'}, {'value': '22.06801', 'spread': '42.85848', 'groupId': 'OG001'}, {'value': '20.78279', 'spread': '34.96462', 'groupId': 'OG002'}, {'value': '18.08990', 'spread': '35.93650', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.789', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Adjusted mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.84781', 'ciLowerLimit': '-4.51643', 'ciUpperLimit': '10.21205', 'pValueComment': 'Two-sided adjusted p-value taking into account Dunnett adjustment (to be compared to 0.05)', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '3.75674', 'estimateComment': 'Two-sided 95% Confidence Interval of the estimate without Dunnett adjustment.', 'groupDescription': 'Estimate (Standard Error) of the adjusted difference from baseline to last post baseline value between treatment groups means: placebo minus GLPG1972 dose regimen using a MMRM including the fixed, categorical effects of treatment, region (Asia and Rest of the World), time and treatment-by-time interaction, as well as the continuous, fixed covariates of baseline and time-by-baseline interaction preceded by a Multiple Imputation step for participants without post-baseline measurement.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.661', 'groupIds': ['OG001', 'OG003'], 'paramType': 'Adjusted mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-3.64759', 'ciLowerLimit': '-11.19071', 'ciUpperLimit': '3.89553', 'pValueComment': 'Two-sided adjusted p-value taking into account Dunnett adjustment (to be compared to 0.05).', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '3.84747', 'estimateComment': 'Two-sided 95% Confidence Interval of the estimate without Dunnett adjustment.', 'groupDescription': 'Estimate (Standard Error) of the adjusted difference from baseline to last post baseline value between treatment groups means: placebo minus GLPG1972 dose regimen using a MMRM including the fixed, categorical effects of treatment, region (Asia and Rest of the World), time and treatment-by-time interaction, as well as the continuous, fixed covariates of baseline and time-by-baseline interaction preceded by a Multiple Imputation step for participants without post-baseline measurement.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.843', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Adjusted mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.55176', 'ciLowerLimit': '-10.04053', 'ciUpperLimit': '4.93701', 'pValueComment': 'Two-sided adjusted p-value taking into account Dunnett adjustment (to be compared to 0.05).', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '3.81987', 'estimateComment': 'Two-sided 95% Confidence Interval of the estimate without Dunnett adjustment.', 'groupDescription': 'Estimate (Standard Error) of the adjusted difference from baseline to last post baseline value between treatment groups means: placebo minus GLPG1972 dose regimen using a MMRM including the fixed, categorical effects of treatment, region (Asia and Rest of the World), time and treatment-by-time interaction, as well as the continuous, fixed covariates of baseline and time-by-baseline interaction preceded by a Multiple Imputation step for participants without post-baseline measurement.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 52', 'unitOfMeasure': 'mm^2', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was based on mRS. Overall number of participants analyzed included participants with available data of bone area of the medial femoral condyle surface of the target knee at baseline. Number of participants analyzed for change from baseline to Week 52 included participants with available data of bone area of the medial femoral condyle surface of the target knee at baseline and Week 52.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Joint Space Width (JSW) of the Target Knee to Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '234', 'groupId': 'OG000'}, {'value': '230', 'groupId': 'OG001'}, {'value': '232', 'groupId': 'OG002'}, {'value': '233', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'GLPG1972 75 mg', 'description': 'Participants received 1 film-coated tablet of GLPG1972 75 mg and 3 GLPG1972 matching placebo tablets, orally once daily for 52 weeks.'}, {'id': 'OG001', 'title': 'GLPG1972 150 mg', 'description': 'Participants received 2 film-coated tablets of GLPG1972 75 mg (total dose 150 mg) and 2 GLPG1972 matching placebo tablets, orally once daily for 52 weeks.'}, {'id': 'OG002', 'title': 'GLPG1972 300 mg', 'description': 'Participants received 4 film-coated tablets of GLPG1972 75 mg (total dose 300 mg), orally once daily for 52 weeks.'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Participants received 4 film-coated tablets of GLPG1972 matching placebo, orally once daily for 52 weeks.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '234', 'groupId': 'OG000'}, {'value': '230', 'groupId': 'OG001'}, {'value': '232', 'groupId': 'OG002'}, {'value': '233', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '2.504', 'spread': '0.779', 'groupId': 'OG000'}, {'value': '2.500', 'spread': '0.783', 'groupId': 'OG001'}, {'value': '2.577', 'spread': '0.840', 'groupId': 'OG002'}, {'value': '2.483', 'spread': '0.859', 'groupId': 'OG003'}]}]}, {'title': 'Change from baseline to Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '169', 'groupId': 'OG000'}, {'value': '163', 'groupId': 'OG001'}, {'value': '155', 'groupId': 'OG002'}, {'value': '179', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-0.087', 'spread': '0.397', 'groupId': 'OG000'}, {'value': '-0.167', 'spread': '0.506', 'groupId': 'OG001'}, {'value': '-0.113', 'spread': '0.464', 'groupId': 'OG002'}, {'value': '-0.174', 'spread': '0.470', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.141', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Adjusted mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.0951', 'ciLowerLimit': '-0.0028', 'ciUpperLimit': '0.1929', 'pValueComment': 'Two-sided adjusted p-value taking into account Dunnett adjustment (to be compared to 0.05).', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.0499', 'estimateComment': 'Two-sided 95% Confidence Interval of the estimate without Dunnett adjustment.', 'groupDescription': 'Estimate (Standard Error) of the adjusted difference from baseline to last post baseline value between treatment groups means: GLPG1972 dose regimen minus placebo using an ANCOVA including the factors treatment and region with baseline as covariate and no interaction, after a Multiple Imputation for missing data.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.981', 'groupIds': ['OG001', 'OG003'], 'paramType': 'Adjusted mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.0158', 'ciLowerLimit': '-0.0861', 'ciUpperLimit': '0.1177', 'pValueComment': 'Two-sided adjusted p-value taking into account Dunnett adjustment (to be compared to 0.05).', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.0519', 'estimateComment': 'Two-sided 95% Confidence Interval of the estimate without Dunnett adjustment.', 'groupDescription': 'Estimate (Standard Error) of the adjusted difference from baseline to last post baseline value between treatment groups means: GLPG1972 dose regimen minus placebo using an ANCOVA including the factors treatment and region with baseline as covariate and no interaction, after a Multiple Imputation for missing data.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.349', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Adjusted mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.0753', 'ciLowerLimit': '-0.0286', 'ciUpperLimit': '0.1792', 'pValueComment': 'Two-sided adjusted p-value taking into account Dunnett adjustment (to be compared to 0.05).', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.0529', 'estimateComment': 'Two-sided 95% Confidence Interval of the estimate without Dunnett adjustment.', 'groupDescription': 'Estimate (Standard Error) of the adjusted difference from baseline to last post baseline value between treatment groups means: GLPG1972 dose regimen minus placebo using an ANCOVA including the factors treatment and region with baseline as covariate and no interaction, after a Multiple Imputation for missing data.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 52', 'description': 'The JSW is the space measured between the 2 bones in the knee joint and this is assessed by x-ray.', 'unitOfMeasure': 'mm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was based on mRS. Overall number of participants analyzed included participants with available data of JSW at baseline. Number of participants analyzed for change from baseline to Week 52 included participants with available data of JSW at baseline and Week 52.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Who Have Used at Least 1 Systemic Analgesic During the Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '234', 'groupId': 'OG000'}, {'value': '231', 'groupId': 'OG001'}, {'value': '233', 'groupId': 'OG002'}, {'value': '234', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'GLPG1972 75 mg', 'description': 'Participants received 1 film-coated tablet of GLPG1972 75 mg and 3 GLPG1972 matching placebo tablets, orally once daily for 52 weeks.'}, {'id': 'OG001', 'title': 'GLPG1972 150 mg', 'description': 'Participants received 2 film-coated tablets of GLPG1972 75 mg (total dose 150 mg) and 2 GLPG1972 matching placebo tablets, orally once daily for 52 weeks.'}, {'id': 'OG002', 'title': 'GLPG1972 300 mg', 'description': 'Participants received 4 film-coated tablets of GLPG1972 75 mg (total dose 300 mg), orally once daily for 52 weeks.'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Participants received 4 film-coated tablets of GLPG1972 matching placebo, orally once daily for 52 weeks.'}], 'classes': [{'title': 'Participants with at least one treatment', 'categories': [{'measurements': [{'value': '216', 'groupId': 'OG000'}, {'value': '213', 'groupId': 'OG001'}, {'value': '211', 'groupId': 'OG002'}, {'value': '212', 'groupId': 'OG003'}]}]}, {'title': 'Anti-inflammatory and anti-rheumatic products', 'categories': [{'measurements': [{'value': '173', 'groupId': 'OG000'}, {'value': '167', 'groupId': 'OG001'}, {'value': '180', 'groupId': 'OG002'}, {'value': '178', 'groupId': 'OG003'}]}]}, {'title': 'Analgesics', 'categories': [{'measurements': [{'value': '127', 'groupId': 'OG000'}, {'value': '135', 'groupId': 'OG001'}, {'value': '118', 'groupId': 'OG002'}, {'value': '128', 'groupId': 'OG003'}]}]}, {'title': 'Anti-diarrheals, intestinal anti-inflammatory/anti-infective agents', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'Drugs for functional gastrointestinal disorders', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline up to Week 52', 'description': 'Systemic analgesics included anti-inflammatory and anti-rheumatic products; analgesics; anti-diarrheals, intestinal, anti-inflammatory/anti-infective agents; and drugs for functional gastrointestinal disorders.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was based on mRS.'}, {'type': 'SECONDARY', 'title': 'Plasma Concentrations of GLPG1972', 'denoms': [{'units': 'Participants', 'counts': [{'value': '217', 'groupId': 'OG000'}, {'value': '210', 'groupId': 'OG001'}, {'value': '194', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'GLPG1972 75 mg', 'description': 'Participants received 1 film-coated tablet of GLPG1972 75 mg and 3 GLPG1972 matching placebo tablets, orally once daily for 52 weeks.'}, {'id': 'OG001', 'title': 'GLPG1972 150 mg', 'description': 'Participants received 2 film-coated tablets of GLPG1972 75 mg (total dose 150 mg) and 2 GLPG1972 matching placebo tablets, orally once daily for 52 weeks.'}, {'id': 'OG002', 'title': 'GLPG1972 300 mg', 'description': 'Participants received 4 film-coated tablets of GLPG1972 75 mg (total dose 300 mg), orally once daily for 52 weeks.'}], 'classes': [{'title': 'Week 4: Pre-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '217', 'groupId': 'OG000'}, {'value': '210', 'groupId': 'OG001'}, {'value': '194', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.445', 'spread': '0.319', 'groupId': 'OG000'}, {'value': '1', 'spread': '0.946', 'groupId': 'OG001'}, {'value': '2.013', 'spread': '1.468', 'groupId': 'OG002'}]}]}, {'title': 'Week 12: Pre-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '208', 'groupId': 'OG000'}, {'value': '203', 'groupId': 'OG001'}, {'value': '192', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.474', 'spread': '0.685', 'groupId': 'OG000'}, {'value': '0.952', 'spread': '0.794', 'groupId': 'OG001'}, {'value': '1.788', 'spread': '1.51', 'groupId': 'OG002'}]}]}, {'title': 'Week 28: Pre-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '197', 'groupId': 'OG000'}, {'value': '188', 'groupId': 'OG001'}, {'value': '178', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.457', 'spread': '0.409', 'groupId': 'OG000'}, {'value': '0.857', 'spread': '0.696', 'groupId': 'OG001'}, {'value': '1.714', 'spread': '1.206', 'groupId': 'OG002'}]}]}, {'title': 'Week 28: 2-4 hours post-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '199', 'groupId': 'OG000'}, {'value': '188', 'groupId': 'OG001'}, {'value': '182', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.399', 'spread': '0.668', 'groupId': 'OG000'}, {'value': '2.609', 'spread': '1.022', 'groupId': 'OG001'}, {'value': '4.764', 'spread': '1.912', 'groupId': 'OG002'}]}]}, {'title': 'Week 40: 4-8 hours post-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '187', 'groupId': 'OG000'}, {'value': '184', 'groupId': 'OG001'}, {'value': '176', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.54', 'spread': '0.678', 'groupId': 'OG000'}, {'value': '3.13', 'spread': '1.2', 'groupId': 'OG001'}, {'value': '5.664', 'spread': '2.425', 'groupId': 'OG002'}]}]}, {'title': 'Week 52: Pre-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '159', 'groupId': 'OG000'}, {'value': '151', 'groupId': 'OG001'}, {'value': '147', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.603', 'spread': '0.6', 'groupId': 'OG000'}, {'value': '1.12', 'spread': '1.048', 'groupId': 'OG001'}, {'value': '2.132', 'spread': '1.597', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-dose at Weeks 4, 12, and 52; Pre-dose and one post-dose sample (2-4 hours interval) at Week 28; one post dose sample (interval 4-8 hours) at Week 40', 'unitOfMeasure': 'μg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Overall number of participants included participants with available data for plasma concentrations of GLPG1972. Number of participants analyzed included participants with available data for plasma concentrations of GLPG1972 at individual timepoints. As participants in the placebo arm did not receive GLPG1972, measurement of plasma concentrations of GLPG1972 for placebo arm is not applicable.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Treatment-emergent Adverse Event (TEAE)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '234', 'groupId': 'OG000'}, {'value': '231', 'groupId': 'OG001'}, {'value': '232', 'groupId': 'OG002'}, {'value': '234', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'GLPG1972 75 mg', 'description': 'Participants received 1 film-coated tablet of GLPG1972 75 mg and 3 GLPG1972 matching placebo tablets, orally once daily for 52 weeks.'}, {'id': 'OG001', 'title': 'GLPG1972 150 mg', 'description': 'Participants received 2 film-coated tablets of GLPG1972 75 mg (total dose 150 mg) and 2 GLPG1972 matching placebo tablets, orally once daily for 52 weeks.'}, {'id': 'OG002', 'title': 'GLPG1972 300 mg', 'description': 'Participants received 4 film-coated tablets of GLPG1972 75 mg (total dose 300 mg), orally once daily for 52 weeks.'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Participants received 4 film-coated tablets of GLPG1972 matching placebo, orally once daily for 52 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '174', 'groupId': 'OG000'}, {'value': '177', 'groupId': 'OG001'}, {'value': '174', 'groupId': 'OG002'}, {'value': '174', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline up to 2-weeks after last dose of IMP (up to Week 54)', 'description': 'TEAEs were defined as all adverse events (AEs) that occurred:\n\n* between first IMP intake date (included) and last visit of participant, or\n* before first IMP intake date and that worsened (in terms of intensity) or became serious according to investigator opinion between first IMP intake date (included) and last visit of participant.\n\nNumber of participants with at least 1 TEAE (serious or non-serious) are reported.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Set: All participants having taken at least one dose of IMP.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'GLPG1972 75 mg', 'description': 'Participants received 1 film-coated tablet of GLPG1972 75 mg and 3 GLPG1972 matching placebo tablets, orally once daily for 52 weeks.'}, {'id': 'FG001', 'title': 'GLPG1972 150 mg', 'description': 'Participants received 2 film-coated tablets of GLPG1972 75 mg (total dose 150 mg) and 2 GLPG1972 matching placebo tablets, orally once daily for 52 weeks.'}, {'id': 'FG002', 'title': 'GLPG1972 300 mg', 'description': 'Participants received 4 film-coated tablets of GLPG1972 75 mg (total dose 300 mg), orally once daily for 52 weeks.'}, {'id': 'FG003', 'title': 'Placebo', 'description': 'Participants received 4 film-coated tablets of GLPG1972 matching placebo, orally once daily for 52 weeks.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '234'}, {'groupId': 'FG001', 'numSubjects': '231'}, {'groupId': 'FG002', 'numSubjects': '233'}, {'groupId': 'FG003', 'numSubjects': '234'}]}, {'type': 'Treated', 'comment': 'All participants having taken at least one dose of investigational medicinal product (IMP)', 'achievements': [{'groupId': 'FG000', 'numSubjects': '234'}, {'groupId': 'FG001', 'numSubjects': '231'}, {'groupId': 'FG002', 'numSubjects': '232'}, {'groupId': 'FG003', 'numSubjects': '234'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '191'}, {'groupId': 'FG001', 'numSubjects': '191'}, {'groupId': 'FG002', 'numSubjects': '177'}, {'groupId': 'FG003', 'numSubjects': '200'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '43'}, {'groupId': 'FG001', 'numSubjects': '40'}, {'groupId': 'FG002', 'numSubjects': '56'}, {'groupId': 'FG003', 'numSubjects': '34'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '17'}, {'groupId': 'FG002', 'numSubjects': '20'}, {'groupId': 'FG003', 'numSubjects': '8'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '14'}, {'groupId': 'FG002', 'numSubjects': '14'}, {'groupId': 'FG003', 'numSubjects': '10'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '6'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '6'}, {'groupId': 'FG003', 'numSubjects': '2'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '2'}]}, {'type': 'Miscellaneous', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '10'}, {'groupId': 'FG003', 'numSubjects': '6'}]}]}], 'recruitmentDetails': "The first participant was screened on 14 August 2018. The last study visit occurred on 14 July 2020. Due to the exceptional circumstances in relation to the COVID-19 pandemic, the Sponsor decided in accordance with competent regulatory authorities' guidelines to implement some precautionary measures in order to mitigate the risk of infection.", 'preAssignmentDetails': 'A total of 3319 participants were screened and 932 participants were randomized and 931 participants were treated.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '234', 'groupId': 'BG000'}, {'value': '231', 'groupId': 'BG001'}, {'value': '233', 'groupId': 'BG002'}, {'value': '234', 'groupId': 'BG003'}, {'value': '932', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'GLPG1972 75 mg', 'description': 'Participants received 1 film-coated tablet of GLPG1972 75 mg and 3 GLPG1972 matching placebo tablets, orally once daily for 52 weeks.'}, {'id': 'BG001', 'title': 'GLPG1972 150 mg', 'description': 'Participants received 2 film-coated tablets of GLPG1972 75 mg (total dose 150 mg) and 2 GLPG1972 matching placebo tablets, orally once daily for 52 weeks.'}, {'id': 'BG002', 'title': 'GLPG1972 300 mg', 'description': 'Participants received 4 film-coated tablets of GLPG1972 75 mg (total dose 300 mg), orally once daily for 52 weeks.'}, {'id': 'BG003', 'title': 'Placebo', 'description': 'Participants received 4 film-coated tablets of GLPG1972 matching placebo, orally once daily for 52 weeks.'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '234', 'groupId': 'BG000'}, {'value': '231', 'groupId': 'BG001'}, {'value': '233', 'groupId': 'BG002'}, {'value': '234', 'groupId': 'BG003'}, {'value': '932', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '62.9', 'spread': '7.5', 'groupId': 'BG000'}, {'value': '63.2', 'spread': '7.2', 'groupId': 'BG001'}, {'value': '62.1', 'spread': '7.4', 'groupId': 'BG002'}, {'value': '63.3', 'spread': '7.1', 'groupId': 'BG003'}, {'value': '62.9', 'spread': '7.3', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '234', 'groupId': 'BG000'}, {'value': '231', 'groupId': 'BG001'}, {'value': '233', 'groupId': 'BG002'}, {'value': '234', 'groupId': 'BG003'}, {'value': '932', 'groupId': 'BG004'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '164', 'groupId': 'BG000'}, {'value': '165', 'groupId': 'BG001'}, {'value': '154', 'groupId': 'BG002'}, {'value': '163', 'groupId': 'BG003'}, {'value': '646', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '70', 'groupId': 'BG000'}, {'value': '66', 'groupId': 'BG001'}, {'value': '79', 'groupId': 'BG002'}, {'value': '71', 'groupId': 'BG003'}, {'value': '286', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '234', 'groupId': 'BG000'}, {'value': '231', 'groupId': 'BG001'}, {'value': '233', 'groupId': 'BG002'}, {'value': '234', 'groupId': 'BG003'}, {'value': '932', 'groupId': 'BG004'}]}], 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '52', 'groupId': 'BG000'}, {'value': '52', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}, {'value': '53', 'groupId': 'BG003'}, {'value': '193', 'groupId': 'BG004'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '182', 'groupId': 'BG000'}, {'value': '179', 'groupId': 'BG001'}, {'value': '197', 'groupId': 'BG002'}, {'value': '181', 'groupId': 'BG003'}, {'value': '739', 'groupId': 'BG004'}]}, {'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'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '234', 'groupId': 'BG000'}, {'value': '231', 'groupId': 'BG001'}, {'value': '233', 'groupId': 'BG002'}, {'value': '234', 'groupId': 'BG003'}, {'value': '932', 'groupId': 'BG004'}]}], 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}]}, {'title': 'Asian', 'measurements': [{'value': '31', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}, {'value': '32', 'groupId': 'BG003'}, {'value': '121', 'groupId': 'BG004'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}]}, {'title': 'Black or African American', 'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}, {'value': '25', 'groupId': 'BG003'}, {'value': '96', 'groupId': 'BG004'}]}, {'title': 'White', 'measurements': [{'value': '167', 'groupId': 'BG000'}, {'value': '177', 'groupId': 'BG001'}, {'value': '168', 'groupId': 'BG002'}, {'value': '171', 'groupId': 'BG003'}, {'value': '683', 'groupId': 'BG004'}]}, {'title': 'More than one race', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '28', 'groupId': 'BG004'}]}, {'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'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Cartilage Thickness of the Central Medial Tibiofemoral Compartment (cMTFC) of the Target Knee', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '233', 'groupId': 'BG000'}, {'value': '229', 'groupId': 'BG001'}, {'value': '231', 'groupId': 'BG002'}, {'value': '234', 'groupId': 'BG003'}, {'value': '927', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '3.25316', 'spread': '0.75857', 'groupId': 'BG000'}, {'value': '3.23101', 'spread': '0.75531', 'groupId': 'BG001'}, {'value': '3.33075', 'spread': '0.79839', 'groupId': 'BG002'}, {'value': '3.18554', 'spread': '0.81513', 'groupId': 'BG003'}, {'value': '3.24996', 'spread': '0.78289', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'description': 'Cartilage thickness of the cMTFC of the target knee was measured by quantitative magnetic resonance imaging (qMRI)', 'unitOfMeasure': 'mm', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Number of participants analyzed included participants with available data of cartilage thickness in the cMTFC at baseline.'}], 'populationDescription': 'Modified Randomised Set (mRS): All included participants to whom a therapeutic unit was randomly assigned using the interactive web response system.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-12-09', 'size': 15126707, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2021-04-13T07:57', 'hasProtocol': True}, {'date': '2020-09-29', 'size': 2415263, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2021-04-13T07:57', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 932}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-08-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-07', 'completionDateStruct': {'date': '2020-07-14', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-07-27', 'studyFirstSubmitDate': '2018-07-11', 'resultsFirstSubmitDate': '2021-04-20', 'studyFirstSubmitQcDate': '2018-07-20', 'lastUpdatePostDateStruct': {'date': '2021-07-28', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-04-20', 'studyFirstPostDateStruct': {'date': '2018-07-23', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2021-05-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-07-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline in Cartilage Thickness of the cMTFC as Assessed by qMRI on the Target Knee to Week 52', 'timeFrame': 'Baseline, Week 52', 'description': 'Reduction in cartilage loss was assessed by cartilage thickness as measured in the medial cMTFC of the target knee using qMRI.'}], 'secondaryOutcomes': [{'measure': 'Number of Participants Who Were Osteoarthritis (OA) Structural Progressors Based on Cartilage Thickness in the cMTFC Assessed by qMRI on the Target Knee', 'timeFrame': 'Week 52', 'description': 'A "structural progressor" was defined as a participant who had an 8% cartilage loss in cMTFC. Number of participants who met the criteria of "structural progressor" at Week 52 are provided.'}, {'measure': 'Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Total Score and Subscales Scores for Pain, Function, and Stiffness to Week 52', 'timeFrame': 'Baseline, Week 52', 'description': 'Western Ontario and McMaster Universities Osteoarthritis Index is a questionnaire designed to assess health status and health outcomes in participants with OA of the knee. The questionnaire contains 24 questions targeting areas of pain, stiffness, and physical function. Pain subscale includes 5 items rated on a Likert scale of 0 (none) to 4 (extreme) with a total range of 0-20 with higher scores indicating worse symptoms and function. Stiffness subscale includes 2 items rated on a Likert scale of 0 (none) to 4 (extreme) with a total range of 0-8 with higher scores indicating worse symptoms and function. Physical function subscale includes 17 items rated on a Likert scale of 0 (none) to 4 (extreme) with a total range of 0-68 with higher scores indicating worse symptoms and function. The total score is the sum of all subscales (range: 0 to 96) with higher scores indicating worse symptoms and function.'}, {'measure': 'Change From Baseline in Pain Assessment in the Target Knee as Measured by Visual Analog Scale (VAS) to Week 52', 'timeFrame': 'Baseline, Week 52', 'description': 'The participant was asked "how would you rate the pain felt in the selected knee within the last 48 hours?". The participants rated the pain by marking the level of pain on a 100-mm VAS, with 0 being no pain and 100 being extreme pain. Higher score indicated higher pain intensity.'}, {'measure': 'Change From Baseline in Patient Global Assessment (PGA) of Disease Activity as Measured by VAS to Week 52', 'timeFrame': 'Baseline, Week 52', 'description': 'The participant was asked "Considering all the ways in which your knee osteoarthritis affects you, please rate on this 100 mm scale how well you are doing today". The participants rated the disease activity by marking on a 100-mm VAS, with 0 being no pain and 100 being extreme pain. Higher score indicated higher disease activity.'}, {'measure': 'Number of Participants Who Were Responders Based on the Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Criteria', 'timeFrame': 'Week 52', 'description': 'OMERACT-OARSI criteria involves improvement based on WOMAC pain and function subscales and PGA. The responders according to OMERACT-OARSI criteria were participants who had:\n\n* A high improvement in pain or in function ≥ 50% and absolute change ≥ 20, OR\n* Improvement in at least 2 of the 3 following:\n\n * Pain ≥ 20% and absolute change ≥ 10\n * Function ≥ 20% and absolute change ≥ 10\n * Patient\'s global assessment ≥ 20% and absolute change ≥ 10.\n\nWOMAC pain subscale score: range of 0 to 20, higher scores indicating more pain,\n\nWOMAC physical function subscale score: range of 0 to 68, higher scores indicating worse physical function),\n\nPGA: The participant was asked "Considering all the ways in which your knee osteoarthritis affects you, please rate on this 100 mm scale how well you are doing today". The participants rated disease activity by marking on a 100-mm VAS, with 0 being no pain and 100 being extreme pain. Higher score indicated higher disease activity.'}, {'measure': 'Change From Baseline in Cartilage Thickness of the Total Tibiofemoral Compartment (tTFC) of the Target Knee by qMRI to Week 52', 'timeFrame': 'Baseline, Week 52', 'description': 'Reduction of cartilage loss was measured by cartilage thickness of the tTFC of the target knee using qMRI.'}, {'measure': 'Change From Baseline in Bone Area of the Medial Femoral Condyle Surface of the Target Knee by qMRI to Week 28', 'timeFrame': 'Baseline, Week 28'}, {'measure': 'Change From Baseline in Bone Area of the Medial Femoral Condyle Surface of the Target Knee by qMRI to Week 52', 'timeFrame': 'Baseline, Week 52'}, {'measure': 'Change From Baseline in Joint Space Width (JSW) of the Target Knee to Week 52', 'timeFrame': 'Baseline, Week 52', 'description': 'The JSW is the space measured between the 2 bones in the knee joint and this is assessed by x-ray.'}, {'measure': 'Number of Participants Who Have Used at Least 1 Systemic Analgesic During the Study', 'timeFrame': 'Baseline up to Week 52', 'description': 'Systemic analgesics included anti-inflammatory and anti-rheumatic products; analgesics; anti-diarrheals, intestinal, anti-inflammatory/anti-infective agents; and drugs for functional gastrointestinal disorders.'}, {'measure': 'Plasma Concentrations of GLPG1972', 'timeFrame': 'Pre-dose at Weeks 4, 12, and 52; Pre-dose and one post-dose sample (2-4 hours interval) at Week 28; one post dose sample (interval 4-8 hours) at Week 40'}, {'measure': 'Number of Participants With Treatment-emergent Adverse Event (TEAE)', 'timeFrame': 'Baseline up to 2-weeks after last dose of IMP (up to Week 54)', 'description': 'TEAEs were defined as all adverse events (AEs) that occurred:\n\n* between first IMP intake date (included) and last visit of participant, or\n* before first IMP intake date and that worsened (in terms of intensity) or became serious according to investigator opinion between first IMP intake date (included) and last visit of participant.\n\nNumber of participants with at least 1 TEAE (serious or non-serious) are reported.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Osteoarthritis']}, 'referencesModule': {'references': [{'pmid': '40826764', 'type': 'DERIVED', 'citation': 'Chen L, Huang FL, Tang Q, Zhao ZK, Ye ZY, Liang JH. Targeted therapy for knee osteoarthritis: From basic to clinics. Medicine (Baltimore). 2025 Aug 15;104(33):e43686. doi: 10.1097/MD.0000000000043686.'}, {'pmid': '37059327', 'type': 'DERIVED', 'citation': 'Schnitzer T, Pueyo M, Deckx H, van der Aar E, Bernard K, Hatch S, van der Stoep M, Grankov S, Phung D, Imbert O, Chimits D, Muller K, Hochberg MC, Bliddal H, Wirth W, Eckstein F, Conaghan PG. Evaluation of S201086/GLPG1972, an ADAMTS-5 inhibitor, for the treatment of knee osteoarthritis in ROCCELLA: a phase 2 randomized clinical trial. Osteoarthritis Cartilage. 2023 Jul;31(7):985-994. doi: 10.1016/j.joca.2023.04.001. Epub 2023 Apr 13.'}, {'pmid': '33719441', 'type': 'DERIVED', 'citation': 'Brebion F, Gosmini R, Deprez P, Varin M, Peixoto C, Alvey L, Jary H, Bienvenu N, Triballeau N, Blanque R, Cottereaux C, Christophe T, Vandervoort N, Mollat P, Touitou R, Leonard P, De Ceuninck F, Botez I, Monjardet A, van der Aar E, Amantini D. Discovery of GLPG1972/S201086, a Potent, Selective, and Orally Bioavailable ADAMTS-5 Inhibitor for the Treatment of Osteoarthritis. J Med Chem. 2021 Mar 25;64(6):2937-2952. doi: 10.1021/acs.jmedchem.0c02008. Epub 2021 Mar 15.'}]}, 'descriptionModule': {'briefSummary': 'This study is a phase 2, 52-week international, multi-regional, multi-center, randomized, double-blind, placebo-controlled dose-ranging study for the treatment of osteoarthritis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male participants or female participants of non-childbearing potential and not breastfeeding.\n* Body weight \\> 40 kg, body mass index (BMI) \\< 40 kg/m\\^2.\n* Diagnosed for knee osteoarthritis based on clinical and radiological criteria of the American College of Rheumatology.\n* History of knee pain for at least 6 months and on the majority of days (\\> 50%) during the preceding month.\n* Symptom severity defined by a pain ≥ 40 mm and ≤ 90 mm on visual analogue scale (VAS, 100 mm) at screening and inclusion visits.\n* Documented need for symptomatic as needed-treatment for osteoarthritis (OA) in the target knee with systemic non-steroidal anti-inflammatory drugs (NSAIDs) and/or other analgesics\n\nExclusion Criteria:\n\n* Severe clinical knee malalignment according to the investigator.\n* Knee prosthesis already implanted (\\< 1 year) or not well-tolerated (contralateral side).\n* Knee prosthesis already foreseen within the study period (whichever side).\n* Hip prosthesis recently implanted (\\< 1 year) or foreseen within the study period (whichever side).\n* Previous osteotomy on the inferior limbs (whichever side).\n* Surgical operation on the target knee within the 12 months prior to the screening visit or planned during the study.\n* Diagnostic arthroscopy of the target knee within the 6 months prior to the screening visit or planned during the study.\n* Other pathologies affecting the target knee.\n* Any contraindication to magnetic resonance imaging (MRI) including the inability to undergo a knee MRI exam because of inability to fit in the scanner or knee coil.'}, 'identificationModule': {'nctId': 'NCT03595618', 'acronym': 'Roccella', 'briefTitle': 'A Study to Assess Efficacy and Safety of GLPG1972/S201086 in Participants With Knee Osteoarthritis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Galapagos NV'}, 'officialTitle': 'Efficacy and Safety of 3 Doses of S201086/GLPG1972 Administered Orally Once Daily in Patients With Knee Osteoarthritis. A 52-week International, Multi-regional, Multi-center, Randomized, Double-blind, Placebo-controlled, Dose-ranging Study', 'orgStudyIdInfo': {'id': 'GLPG1972-CL-201'}, 'secondaryIdInfos': [{'id': '2017-004581-10', 'type': 'EUDRACT_NUMBER'}, {'id': 'U1111-1205-0321', 'type': 'OTHER', 'domain': 'Universal Trial Number'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'GLPG1972 75 mg', 'description': 'Participants received 1 film-coated tablet of GLPG1972 75 mg and 3 GLPG1972 matching placebo tablets, orally once daily for 52 weeks.', 'interventionNames': ['Drug: GLPG1972', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'GLPG1972 150 mg', 'description': 'Participants received 2 film-coated tablets of GLPG1972 75 mg (total dose 150 mg) and 2 GLPG1972 matching placebo tablets, orally once daily for 52 weeks.', 'interventionNames': ['Drug: GLPG1972', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'GLPG1972 300 mg', 'description': 'Participants received 4 film-coated tablets of GLPG1972 75 mg (total dose 300 mg), orally once daily for 52 weeks.', 'interventionNames': ['Drug: GLPG1972']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Participants received 4 film-coated tablets of GLPG1972 matching placebo, orally once daily for 52 weeks.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'GLPG1972', 'type': 'DRUG', 'description': 'Film-coated tablets of GLPG1972 for oral use.', 'armGroupLabels': ['GLPG1972 150 mg', 'GLPG1972 300 mg', 'GLPG1972 75 mg']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Film-coated tablets of matching placebo for oral use.', 'armGroupLabels': ['GLPG1972 150 mg', 'GLPG1972 75 mg', 'Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35205', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Central Research Associates, Inc.', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '35216', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Achieve Clinical Research, LLC', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '85018', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Elite Clinical Studies', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '85018', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Hope Research Institute, LLC - 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